CA2223102A1 - Therapeutic system for dietary health management - Google Patents

Abstract

A dietary health management system for administration to a patient having at least one diet-responsive condition such as hypertension, hyperlipidemia, cancer, diabetes, and combinations thereof. In particular, the system comprises a plurality of prepackaged meals which may provide dietary fiber in the range of about 20 to 30 grams; vitamins and minerals at about 100 % USRDA; less than about 2400 mg of sodium; at least about 3500 mg of potassium; less than about 96 grams of simple sugars; protein, such about 20 to 30 % of caloric intake is derived from protein; and fat, such that about 15 to 20 % of caloric intake is derived from fat. Consumption of a daily diet comprising a plurality of the individual meals supplies the patient with the desired total daily calorie intake, improved quality of life, and sufficient nutritional enhancement to facilitate the management of the diet-responsive condition.

Description

:; ~

W O 96~9050 PCTrUS96/10188 THERAPEUTIC SYSTEM FOR DIETARY
HEALTH MANAGEMENT
BACKGROUND OF THE INVENTION
l . Field of the Invention This invention relates generally to lh~ tic systems and methodc for dietary health mq-nagem~nt i.e.~ the p, ~e.,lion, ~ .l or reduction of risk factors accociqted with diet-responsi~re conditions, or a co",l)inalion thereof. In particular, it relates to systems providing a choice of prepc~l~qge(l7 easy to prepare, and good tasting, ~ ,.~eulic meals which are intçnded to improve the health and l0 quality of life of patients utili7i~ the system. Further, it relates to the fortification of meals and food products for use with such a system. As col~i,.l.ed by clinical trials, the systems and methods disclosed herein achieve improvements in qn~ hleil~iC~QI~ of diet-re~or~;~e conditions, improved quality of life, and a high degree of co...~ nce 15 2. Description of the Related Art People have bcco.lle hl~,reas.ngly aware of the .~ o.lance of a proper diet for health mqintenqnce and disease prevention and ll-.dl---k--l Unfortunately, because n.~ ,.olls d;rr~re..l and often conflicting dietary ~idçlin~s are pres~ ed in such COlll~ A ,..anne,~, it is often very difficult for a person20 atte",pling to follow a diet for health and disease mqnqg~m~nt (he,~ aller a "patient") to understand and fully and effectively ;",~le...~ a healthy diet. For eYqmrle, a diet which ",a~,.,..~es health and disease mqn~g~rn~nt conce",s mightcontrol the intake of simple sugars, cholesterol, and .li~renl qllqntitieC and types of fat, as well as calories, while also atte~"~ g to o,~)li-...2e levels of macro- and 25 micronutrients, eg., protein, carbohyd-~les, and fat, and vitamins and m-inerals~ and to provide a~eq~q-te dietary fiber. As s~l~gested above, however, the problem ofpl~ ~";~g and ...~ p a h~lthfill diet goes beyond the usual health concellls andexists with respect to special diet Citu~qtio~c incl~lrling those associated with diet-I e~l,onsi~e conditions, such as cardiovascular disease (hypertension and 30 hyperlipidemia), dia~Les and cancer.

W O 96/39050 PCT~US96/10188 Diet planning ~ccist~nce available to pa~ienls has been of limited value and o~en fails to satisfy long term ~...~ ce Much additional planning has been left in the hands of patients who usually lack s~fficient knowledge in the field of nutrition to fully and propc.ly i,.")'~m~nt an ~deqll~te diet plan as part of a 5 system or method for health m~n~e~m~nt More specific-~lly, prior approaches tothe pl~ p and mqintçnqnce of a patient's diet have supplied the patient with general food and beverage categories to be consumed or avoided: for example, meat, eggs, and fish; fruits and vegetables; breads and cereals; and dairy products.
Such approaches generally fail to achieve their desired goal, however, because 10 patients do not consume general food and beverage calegolies; instead, they con.~me complex meals co",posed of specific foods and beverages. Even within these broad categories, specific foods and beverages are so diverse that it is often difficult for patients to convert the broad categories into meals, i.e., to plan actual diets, while still .~ ;~ adequate consumption of protein, carbohydrates, fat, 15 sugars, cholesterol, fiber and other macro- and micro~ icnls ...e~ the dietary lineS
Previous appr~a-hçs to health ...~ e~ ., have incl~lded various physical devices to assist the patient in counting macro- or ",.cronul~ients or otherwise plal~lfing and ...~ in;.~e his or her diet. These have inclllded 20 m~nirll~t~hle devices, as shown, for ç~ .le, in U.S. Patent Nos. 4,606,555 and 4,625,675; various coupon and label systems, as shown, for example, in U.S. Patent Nos. 4,310,316, 4,652,241, and 4,689,019; and card menus identifying meal eXc~ e~c as shown, for c,.~,lple, in U.S. Patent No. 4,950,164. Nevertheless, these devices, coupons, labels, and the like do not solve the problems addressed25 above of aCcictin~ p~ti~ntc by providing a simple, daily plan for Conc ~ming convenient meals composed of approp~iale foods and beverages which satisfy the complex goals of a healthy diet over a period of time.
One procedure for providing a diet which is highly specific as to r ~c,.. ~, .ded foods and beverages is simply to provide a single fixed list of meals for a given day, week or other time period or to provide the actual meals described on such a list. However, a fixed list or daily menu has the disadvantage of being too rigid and monotonous and, therefore, generaliy unappealing to patients after a relatively short period of time. Moreover, even a single fKed list of meals for a 5 given day requires that patients purchase the components of the listed meals and assemble or prepare those meals. Both of these steps are time consuming and depending on the meals listed may require some degree of skill in the assembly or preparation. If it is more inconvenient, i.e., costly, difficult, or time concuming, to comply with the dietary recommendations, the satisfaction and compliance with the 10 diet will be low. Moreover, if these nutritional goals are not met, malnutrition may result.
French Patent No. 2,176,569 to M. Perrin describes ration packs of complete meals for all illness regimens. The ration packs provide a predetermined calorie content and include a soup, an appetizer, meats and vegetables, and a 15 dessert Food included in these meals may be raw, cooked, frozen or freeze-dried.
Further, the ration packs may be provided in a carton or other suitable packaging, which may CoMain a single meal; a daily supply of meals, i.e., two meals; or a meal supply for a selected period.
German Patent No. 24 47 266 to B. Winicki describes dietetic 20 rations and ready-made dishes which represent a means for treating a variety of complaints, including diabetes, associated with being overweight. The dietetic rations allow the patient or a person seeking to lose weight to avoid the constant assessment and calculation of calories and to achieve a specific calorie consumption with greater certainty. These rations include a combination of a foodstuff '~ composition or a dish having a predetermined and standardized calorie content, which remains the same irrespective of the ingredients used with a nutritional supplement, e.~J., side dishes, which is calculated exactly on the basis of the composition. These combinations of foodstuffs may have a standardized calorie content that is low in lipids and carbohydrates and the ready-made dishes may DC01 1~,0971 1 ~h~ENoED SHEET

include vitamins that are required for balanced nutrition; in particular, the vitamins ofthe B group. Further, the sodium chloride composition may be less than 0.12%.
Nutrient imbalance may lead to physiological effects in humans, such as compromising cellular functions, e.g, imrnunoresponse, and, therefore, may 5 negatively impact a patient' s quality of life. Researchers have shown that, in many cases, these problems may be treated by orthomolecular therapy, such as that discussed in U.S. Patent No. 4,973,467. Orthomolecular therapy is the treatment of a condition in a patient by varying the concentration of nutrients normally present in humans. These nutrients may include micronutrients, such as vitarnins, minerals, 10 trace elements, horrnones, amino acids, and enzymes. If the concentration of any of these substances in a patient's system is low, it may disturb biochemical homeostasis, which may result in increased patient anxiety and/or stress. Thus, such imbalances may adversely impact quality of life. Regulating the concentration ofthese substances in the body helps to attain and m~int~in improved quality of life 15 and health.
Another condition often associated with improper diet and health management is excess weight. Excess wei~ht is associated with an increased risk of several chronic disorders, including non-insulin dependent (or Type II) diabetes, hypertension and cardiovascular disease, such as coronary heart disease (CHD) and ~0 atherosclerotic disease. These risks, however, appear to decline following a DC01:140971.1 ~E~DEo Sf~EET

s~lstsinecl reduction in weight. Nevertheless, neither large fl-~ct ~stions in body weight nor extreme restrictions in food intake are desirable.
In the North American population and other we~le~l~ed societies, body weight and body mass index are h~c,~,as;ng in spite of a reduction in overall 5 caloric intake in some populations. Additionally, physical activity is decreasing.
These trends as well as the association of moderate, regular physical activity with reduced risks of heart disease have led to the ~eco~ n~n~ ;on that the U.S.
population increase its physical activity level and that all healthy people ...~physical activity at a moderately active level, and moderate their dietary intake to 10 ,,.z;.,l~;n appro~,iale caloric intake and body weight.
Diet may also have an effect on hypertension. It is probable that hy~ ion susceptibility to salt (salt sensitivity) is genetically detel"l.ned, but a reliable genetic marker for salt sensitivity has not yet been id~1;r.ed. Thus, individuals with h~ ;on, who are salt sensitive, are most likely to benefit from15 salt re l--~tion The American Heart .Associstion (AHA) reCo~ n~c consumption of no more than about 3000 mg of sodium per day. However, even in salt-sensitivepatients, a sodium intake of less than about 3000 mg is unlikely to conl~ ule toblood pressure elevation and may even lead to blood pressure l~;du~il;ol- There is some evidence to suggest that frequent conc..~nption of salt-preserved or salt-20 pickled foods incl ~,ases the risk of stom~ cancer.
A large and convincing body of evidence from studies in humans andlaboratory animals shows that diets low in saturated fatty acids (SFAs) and ~llcle,st~rol are associated with lower risks and rates of cardiovascular ~iice~ces than diets that are high in fat and cholesterol. High-fat diets are also linked to a high 25 incidence of some types of cancer (e.~., colon and breast cancer) and obesity.
Thus, reducing total fat and SFA intake seems likely to lower the rates and variety ofthese diet-related chronic ~ice~ces Different types of fatty acids have di~ren~ effects on health. SFAs and dietary ~holect~rol tend to increase serum, low density (LDL) and very low W O 96~9050 PCT~US96/10188 density (VLDL) lipoproteins, and cholesterol and, con.cequPntly, the risk of cardiovascular disease. The evidence linking high-fat diets, e.~., diets which provide greater than 40% calories from fat, to increased cancer risk may be lessfim~ly e~ bliihed than that ~Csori~ting SFAs and dietary cholesterol to CHD. TheS weight of evidence in-lir~tes that high-fat diets, which are also high in saturated fats, are ~csori~ted with a higher risk of some cancers, especi~lly of the colon, prostate, and breast. Most studies with humans suggest that diets with high total fat or SFA content adversely affect cancer risk. Few studies in humans have yet eY~minPd the benefits of Gl~ 8Jn~ to low-fat diets; however, such evidence exists 10 from eApe~in~enls in animal trials. The co,-.bined evidence from human epidellLn~c and labo.alo.y animal studies s~gests that reduction oftotal dietaryfat is likely to reduce the risk of these cancers. Concern that an inc,~ase in polyunsaturated fatty acids (PUFAs) intake may i".ilease risk of certain cancersderives primarily from studies of animals on very-high-PlJFA diets. Given the 15 absence of human diets naturally very high in total PUFAs and the lack of i.~",~tio" about the long-term conceqll~ncpc of high PI~FA intake, PUFA intake has not been ;"c, ~ased above about 10%.
Another diet-respons;ve condition which may be helped by improved health m~n~ment is non-insulin dependPnt di~betes Generally, the 20 bodies of patients suffering from non-insulin depPndent diabtLes produces insulin, but the insulin produced does not function p.opc,ly. Insulin depPnd~nt di~beticsdo not produce any insulin and must receive injections of insulin to avoid keto~ci~osic i.e., the build-up of ketones in the blood stream. Some non-insulindependent diabetics may control their diabetes simply by limiting the amount and25 types of foods and beverages that they consume and increasing their physical activity levels or losing weight. However, many must also take oral hypoglycemicagents or insulin in order to metabolize their glucose.
The Arnerica Diabetes Association (ADA) states that non-insulin dependent diabetics may use a co"lbi"a~ion of diet, exercise, and medication to W O 96~9050 PCTAUS96/10188 lower plasma glucose and plasma lipid levels. Diet is important not only to control plasma glucose and lipid levels, but to .nA;..I~in control over body weight. As noted above, obesity may be linked to the onset or p-oglc~sion of non-insulin dependent diabetes. Moreover, insulin functions better in pe~ons near their 5 approp,iale body weight. Weight inclcases also may cause r~i~hetes-related problems, such as hypertension or CHD. Thelero,e, an applo~";ale diet for etics gencl~lly is cAlculAted to include mAnAg~m~nt of caloric intake and body weight.
In addition, the ADA reco.~....- nds a diet low in fat and sugars, 10 especially simple sugars. This is important in order to keep plasma glucose and plasma lipid levels under control. A low-fat diet, which is also low in sodium, further may reduce the likelihood of related pl~bl~"s such as hypertension and CHD. Moreover, a diet which is low in fat, simple sugars, and sodium is also generally high in fiber and complex carbohydrates. Dietary fiber has been shown 15 to reduce plasma glucose and plasma lipid levels. In addition, foods high in complex carbohydrates, e.g., grains, le~-mes, vegetables, and fruits, are also excellent sources of vitamins, minerals, and calories.
Observational epidemi~l~cA~ studies and clinical e,.~,~,.i",c.,ls also have generated a number of hypotheses about the role of dietary factors in the 20 etiology of various types of cancer. As rlicc~cced in U.S. Patent No. 4,777,045, epidemiologic studies have idçntified low intake of dietary fiber as one of the factors associated with an increased rate of cancer of the colon and rectum. Thepresence of fiber in the ~ e~ AI tract may decrease food transit time, which reduces contact time between potential carcinogens and the ml-cosA and dilute the 25 intestinal contents. Thus, the presence of fiber may reduce the interaction of procaranoe~n.c with bacteria. ~Ithnu~h there currently appears to be no definitive d~finition of the material which is generally I ere~ red to as "fiber," the term "dietary fiber" has been applied to the plant cell wall conctihlentc that are not digested by the secretions of the human digestive tract. The National Cancer Tnctihlte (NCI) W O 96~9050 PCTAJS96/10188 currently leco.. ~ c that patients consume about 20 to 30 grams of dietary fiber daily. Excessive consumption of fiber, e.~., greater than about 35 grams daily, however, may cause adverse health m~nagrmçnt effects.
The NCI also su~gestc that diets rich in foods co..l~ g Vitamin 5 C and Vitamin A from fruits and veget~ble,c may also reduce the risk of cancer.
Epidemiologic studies have shown that diets high in Vitamin A and Vitamin C are associated with lower risks of some kinds of cancers. Thele~le, the NCI
n~l~ conq~mrtion of a variety of fruits and vegetables, inclu(li~ fruit and vegetable juices that are high in Vitamin A and Vitamin C. Fcperi~lly ben~fi~ l are 10 cruciferous vegetables which are good sources of fiber, as well as vitamins and mmerals.
It also is increasingly apprtciated that hypertension, non-insulin dependent diabetes, and various dy li~:dA-ni~c frequently coexist. Further, these conditions may share cG"I~"on pathophysiological features inA-ln-li~ insulin 5 1~ Ce7 hn~ iCAI~mj~ and ~n~ sodium or calcium metabolism, or both.
The association of each ofthese cQ.I l;~;OI.c with accelerated athelosclerolic disease has been termed Generalized Cardiovascular and Metabolic Disease (GCMD).
In an attempt to fiAArilit~te m~n~rmçnt of GCMD, complex therapeutic strategies for each of these conditions emphasize nutritional 20 interventions as one of the primary strategies for tl eA~ Diet alone may be afirst choice of llçfll~ l for a large number of patients with one or more of these conditions, and diet, alone or in co",binalion with other lifestyle rhAAngec, e.g, increased physical activity and cessation of smoking, or with pha",.acological agents. Tnrlnded in the nutritional interventions generally are a dietary sodium25 restriction; calcium supple~ l;on; reduced intake of simple sugars; and cG.I~olled intake of saturated fat and cholesterol coupled with increased intake of dietary fiber and PUFAs.
In practice, choosing the proper co",binations of therapeutic meals that implement a health mAAn~m~nt system approp,;ale for GCMD is difficult.

W O 96/39050 PCT~US96/10188 For many pqfi~ntc this complexity in choosing meals is so difficult that cGr.,pliance will be inqde~u~te to achieve desired health improvement. Concequently, a simpleto follow, con.prehe,ls.~e health mqnq.~om~nt system de-cigned specificqlly for individuals diagnosed with one or more cardiovascular or metabolic conditions, or S both, is needed. Simplicity and co..,i)rehe~ eness are both ess~ ;Al if adequate co...pliance is to be achieved.
Various health o~g~alions have developed individual dietary elines aimed at interventions for specific conditions. While such interventions have the potenlial to greatly reduce health risks, unfortunately, they often are10 performed in isolation from each other. Thus, a nutritional health m~qn~g~m~nt system targeted at ,cimllhqneously achieving a desirable therapeutic balance of vitamin, mineral, fiber, carbohydrate, protein, and fat content has been lacking.
A s~cceccfi~l health mqn~g~ment system CGIlll~lising healthy meals composed of specific foods and beverages inrludes a l~ecllqnicm for providing 15 ~lffi~entvarietyand~il;;yto...~;nl~ theinterestofpal; .~sforane-l~n-~e~, or even an inl1~.finit~, period of time. If a diet is tasty, simple to understand, and easy to follow and the meals are simply and quickly obl~i,.ed and prepa.~d, compliance with the diet also will be high. Taste and appea-~lce also may be critical factors in all~in;~p adequate cG...p!i~nce. If the patient does not enjoy 20 concnming the meals inrluded in the diet, he or she is less likely to remain on the diet.
Thus, a need exists for a system and method which provides to the patient highly specific~ yet flexible, meal, i.e., food and beverage, il~,.nalion that will satisfy the majority of the complex health ~lid~lines applicable to the patient.
These ~lid~lines include meeting reco.. ~ ed dietary levels for calories, fat, proteins, simple sugars, sodium, cholesterol, or macro- and micronutrients.
Further, such systems and mPtho~s should be sufficiently flexible to permit day-to-day variation oftheir selected variety offoods and beverages within the system and W 0 96~9050 PCT~US96/10188 should involve an exchange r..ecl-al-;cm which may be easily and conveniently utilized by patif~ntc SUMMARY OF THE INVENTION
In light ofthe above descl;bed need, it is an object ofthe present S invention to provide a dietary health IIIAI~a~ nl s~vstem which adeql~atçly supplies desired levels of macro- and IlliClOnu~ 'nlS. It is also an object of this invention that such a system provide specific directions which may readily be followed by pati~ntc to achieve s~lccec~fi-l i",pl~ .lal;on while providing sufficient variety, taste, and versatility to achieve ~dequ-te compliance. Further, it is an object of this 10 invention that the system provide prep~cL ~ged therapeutic meals which are readily obtainable and easily pl~cd by patients and which may be stored, e.~., frozen orsheLf-stable, without loss of nul~ilion~ benefits. An advantage of such meals is that their p,ep~lion is simple and convenient to the patient. Thus, pAtiçntc are morelikely to achieve higher dietary sAticf~Gtir n and co...~ nr,e. It is a feature of this 15 invention that s~ffisiçnt levels of macro- and micronutrients are added, such that meals may be initially ploce~A pa~ L;~g~l, stored, either frozen or non-frozen, for extended periods, and preparcd, e.g., heated, rehydrated, or cooked, for consumption within a reA~ol-~ble period from pacL A~ eg., within a range of about three (3) to twelve (12) months and plcîclably~ at least about nine (9) 20 months, and still provide the desired level of macro- and micronutrients when con~umed In addition, it is an object of the present invention to provide a method for dietary health mAn~gom~nt i.e., preventing or treating and reducin~ risk factors A~or:a~ed with diet-l~*,ons;~e conrl:~iQns such as: obesity; hyperlipidemia;
25 non-insulin depçnd~ d;~betes; hypertension; and cancer, for example, colo-rectal cancer; by supplying a diet providing leco.. rnrled dietary levels of macro- and micronutrients. In addition to treating such conditions, this method may assist in the reduction of the dosages and quAntities of pharmAceuticAlc ~minictPred to patients suffering from these c~ntlitionc This method is convenient to enable ready compliAnce, while ensuring that nutritional needs are met.
With regard to the system and method described above, it is another object ofthe present invention to provide a prepacl~ged Lllel~eutic meal which s..ppli~s a predet~.lllil.ed pe-ct-l~age of a Dietary Food FnhAncç...r..l Agent (DFEA) col-lAin;~g the desired micronutrients to meet a patient's daily needs. Aplurality of such meals may be used as part of the system or method described 10 above. Because it is p~e~ ''e to fortify di~ food products to di~r~--l levels, it is desirable that the fortified meal be packaged, such that the various cGIllporl~.lls remain separate during storage.
In another object, the present invention is to provide a DFEA
cG.ItA;";ng desired amounts of micronutrients, such as vitamins and minerals, for 15 use in fortifying lhc;la~c~ltic meals and particular meal cG...~)oncnts. Various CO~ ;onc of macro- and micronul.ients are de~ 'le to address specific needs in treating and prev~.lti lg diet--t~ ol~;-/e CQI-~ n~, as well as ",~ I;1;n;nP general good health. The t ldition ofthe DFEA may be used in cl nnç~ ;on with controlling levels of sodium, simple sugars, çnl lçct~rol, fat, carbohydrates, proteins and fatty 20 acids.
In one embodim~ont the invention provides a dietary health management system for ~ l;cl~alion to a patient having at least one diet-responsive condition. Such diet-responsive condition may include obesity, hypertension, hyperlipidemia, cancer, ~i~hetes and combil-alions thereof. The 25 system may comprise a meal program CQn~ ;ng a plurality of prepaç~ged individual meals. Each ofthese individual meals may contain a predetermined level of nutritional çnh~ncernent whereby consumption of a diet collll~lising a plurality of the individual meals supplies the patient with the desired total daily calorie content, improved quality of life, and 5~lffi~Pnt nutritional çnh~nc~ l to f~ it~te W O 96/39050 PCTrUS96/10188 management of the diet-responsive condition. Such a diet may be decigned to provide a core calorie content, e.~., about 1200 to 1500 calories per day, and individual meals may be fortified, such that the total daily diet provides up to 100%
of a DFEA daily portion. The èl~l e, the DFEA may be designed to meet 100% of S the USRDA or NAS/NRC RDA.
The dietary health management system of the present invention plerel~ly is ;,~ df d to be supplemented with foods and beverages s~lected from the group co~ ;..g of dairy products, fruits, and vegetables. These su~pl~
foods and beverages add to the variety and versatility of the diet; and because they 10 are selected by the patient, they are more likely to be s~ti~f~ctory to a particular patient's taste. Further, diet adjustors, e.~., snack meals, may be used to increase the level of micronutrients consumed by the patient and/or to increase the diet's calorie content dep~ g on the patient's daily needs.
In another embo-iimpntJ the invention provides a dietary health 15 m~n~gf~ment p!~nnil-g and control system for providing nutritionally f nhAnced dietary m~nag,om~nt to a patient having at least one diet-responsive condition, as désclibed above. The system may co..-~ e a plurality of prepa ~ged individual meals. Each ofthese meals is in~luded within a group and has a group identifyingcode cG~Iespondi~lg to the type of meal. For c~.alllplc, the type ofthe meals may 20 comprise breakfast, lunch, and diMer, and the group identifying code may be selected from the group consisting of alphabe~ic indicia, numeric indicia, colorindicia, graphic indicia, and cGI~.binalions thereof. Moreover, each of the meals also may include at least one category identifying code cGl.esponding to a particular diet-responsive condition. This category identifying code also may be25 selected from the group consisting of alphabetic indicia, numeric indicia, color indicia, graphic indicia, and combinations thereof. Each of the individual mealscc,.,l;.;n~ a predetermined level of nutritional enh~nc~ ..f nl, wl.ereby consumption of a daily diet comprising a plurality of the individual meals supplies the patient W O 96139050 PCT~US96/10188 with a desired total daily calorie content, improved quality of life, and sufficient nut:ritional 1 .h~ to facilitate management of the diet-responsi~e condition.
In still another embodiment, the invention provides a method for treating patients having a diet-~ Jons;~e condition. The method may comprise theS steps of identifying at least one quA~ able inr~icator of the condition and arlminist~ring to the patient a daily diet. The diet may comprise a plurality ofprepackaged individual meals. Each of the individual meals conlail~s a pledè~el llli,led levêl of nutritional enh~ncprn~nt whereby consumption of the diet com~ , a plurality of the individual meals supplies the patient ~,vith the desired 10 total daily calorie content, improved quality of life, and sufficient nutritional enhanc~ nl to facilit~te m~n~gem~nt of the diet-responsive condition. The method further may comprise the step of monitoring the previously identified at least one inrlicator of the diet-re;.~onsi~e condition.
In yet another embo-liment~ the invention provides a prepacl~ged 15 thelapeulic meal, such as a frozen or shelf-stable meal, for ~tlmini~ alion to a patient having at least one diet-l~ ,onsi-~e condi~ion. The meal may collllJIi;~e a plurality of separate meal cG"")onenls. At least one of the meal cGlllpone.lts corlt~in.C a predelelll~ined level of nutritional f..~h~nce.~ l, wL~,,eby consullll)tion of a diet comprising a plurality of the meals supplies the patient with the desired 20 total daily calorie content, improved quality of life, and s~ffi~ient nutritional enhA~ 1 to f~rilit~te management of the diet-responsive condition. Although the n~ltrition~l ~nh~ncçm~nt may be conc~ led in a single meal component, it is preferable to nutritionally enh~nce a plurality of meal components. Further, because patients may consume meal cG"")onenls selectively, by ~nh~ncing a 25 plurality of meal c(~ )ntllls~ the likelihood that the patient will consume some, if not all, of the DFEA additions is increased.
In an adtlition~l embodiment, the invention provides a food product for adminictration to a patient having at least one diet-re~,onsi~e condition. The product comprises a nutritionally ~nh~nced meal col"pone.ll s~lected from the group col~ illg of meats, baked goods, e. ., rolls, muffins and breads; sauces, e. ., vegetable, pasta, and meat sauces; starch sources, e.g., whipped potatoes and rice;
soups; cereals; desserts; and fruit or vegetable juice beverages. The meal component supplies dietary fiber in a range of up to about 10 grams (0.35 ounces);
vitamins and minerals in a range of about 5 to 3 5% the U. S . Recommended Dietary Allowance (USRDA); protein, such that caloric intake of up to about 20% is derived from protein; and fat, such that caloric intake of up to about 3 0% is derived from fat.
In a further embodiment, the invention is a DFEA, for fortifying food products comprising predetermined amounts of vitamins and rninerals. In particular, the DFEA may include combinations of essential vitamins and mineralsselected from the group consisting of vitamins and minerals for which a recommended dietary allowance as determined by governmental or national health organizations, such as the National Academy of Sciences (NAS) or by the U.S.
Food and Drug Administration (FDA) for USRDA, has been established. Such a DFEA may comprise varying amounts of the following vitamins and minerals Vitamins A, B1, B,, B3, B6, Bl~, C, D, E, and K, and Biotin, Calcium, Copper, Folic Acid, Iodine, Iron, Magnesium, i~[anganese, Pantothenic Acid, Phosphorus, and Zinc.
In still another embodiment of the invention is a compliance support package for improving the compliance of a patient with a dietary health management system, which provides a predetermined daily calorie content and level of nutritional enhancement. The compliance support package includes portion identification aids, in which portion sizes of meal components are identified. Such portion identifications aids may include measuring devices, e.~., measuring cups, bowls, or spoons, for determining portion sizes, drawings and diagrams depictingthe size of portions of various food products, and templates for identifying portion sizes on serving plates. Further, it includes food exchange lists, in which the meal components are identified by the calorie content and level of nutritional DCOl-141~'53.1 AMENDE~ Sh'-'~T

CA 02223l02 l997-l2-02 WO 96~9050 PCTAUS96/10188 ~hAI~C~ 1 per portion size. Food record sheets are also included for ~ecoldh~g daily consumption of meal components and the calorie content and nutritional enhancçmPnt col~ onding to the portion sizes con.~umed. I~ addition, the p~r~e contains a "survival kit" which inr.ludes il~-...aliol- and food products that S enable the patient to stay within the gl~idPlines of the dietary health m~n~gPmPnt system when traveling or when meal components of the system are otherwise unavailable.
In another embodiment, the invention is a method for improving the compliance of a patient with a dietary health m~n~gPmPnt system which provides 10 a predetermined daily calorie content and level of nutritional Çnh~nr~ I Thismethod in~.ludes the steps of providing the patient with portion idPntifi~tion aids for identifying portion sizes of meal co.-.ponel-ls con~--me-l, providing the patient with food record sheets for recording daily consumption of the meal COnli)Oll~,-lLS
and the calorie content and nutritional P.nhance.~c.l~l cGIle~onding to the portion 15 siZêS, and providing the patient with food P.l~l~AI~ge lists delellllinlng the calorie content and nutritional enh~ncçmPnt per portion sizes conel~med The method further co---,~-ises the step of COI~ellillg with the patient on a regular basis to revie~,vthe food record sheets and provide co-~l.cP~ legdlding food consumption pattems. Moreover, the method in~ des the step of providing the patient with the20 survival kit described above.
Yet a further embodiment of the invention is a method for determining the effectiveness of a diet program for ~...;..;c~.~lion to a patient having at least one diet-respol-si~e condition. This method includçs the steps of selectin~ a plurality of patients, each having at least one qu~ Ahle indicator of 25 each ofthe conditions. The at least one q~l~ntifi~hle indicator of each ofthe diet-responsive con~iti~n~ may then be identified and measured for each of the patients during a baseline period. Further, each of the patients may be monitored during the baseline period, e.g., about four weeks, to determine a ba~line quality of life. The pluralit,v of patients then may be randomly divided between a first group and a W O 96/39050 PCTrUS96/10188 second group, and the diet program may be ~dminictçred to each of the patients in the first group during an intervention period, eg., about 10 weeks. During that same period, however, each ofthe patients in the second group is ~a;~ ned on a control diet, e.g., the AHA diet, with known b~n~fiçiql effects on the at least one S ;..-l ~10r. The at least one indicator of each ofthe conditions is .,lon.lo.~d for each ofthe p~ lc after the intervention period.
The diet program may indude the dietary health mana~m~nt system described above incl~l-ling a plurality of the individual meals, which supply the patient with a desired total daily calorie content, improved quality of life, and 10 snffiri~-nt nutritional enhanc~ to f~çilit~te m~n~Pm~nt ofthe diet-responsivecondition. Moreover, each of the patients may also be tested to determine his orher quality of life before (e.g., during the baceline period) and after the intervention period. In n~dition~ initial serum vitamin, iron, and trace mineral levels may be dete...l.l.ed for each patient at a be~..n;~g and an end ofthe bac~linç period and 15 after the intervention period. By ~Cse~ s in serum vitarnin, iron, andtrace mineral levels at a bee,...-il~g and an end of the bAcçl;~c period and after the intervention period, dietary adeq~l~cy and adverse effects may be ~csçcced It is a teçhn:~ql advantage ofthis invention, cG..LI.,ed by clinical trials, that the system and method claimed herein achieve weight loss, improved 20 quality of life, improve...e..ls in ~v~l;r~kle inrliç~tors of diet-l~ ons;~e conditions, and a high degree of ccj~..p~ r,e.
Other objects, features, and advalllages will be apparenl to those of ordinary skill in the art when the following detailed des_-;plion ofthe invention and the d-dwillgs are considered.
25 BRIEF DESCRIPTION OF T~ DRAWINGS
Fig. 1 depicts a sçh~ ;c replesenlalion ofthe relationship between the categories, meal groups, and meals in a diet pl~nning and control system.
Fig. 2 shows a chart for delellllllfing specific dietary allol-..enls at differing caloric levels.

W O 96~9050 PCTAJS96tlO188 Figs. 3a-c show charts depicting the reductions in systolic and diastolic blood pressure measu~f;~ s and chclestP.rol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels for a patient with hypertension over a ten (10) week clinical trial period.
5Figs. 4a-c show charts ~epicting the reductions in systolic and diastolic blood pres~ule measuremtl,ls and cholesterol, triglyceride, HDL, and LDL levels for a patient with hyperlipidemia over a ten ( 10) week clinical trial period.
DETAILED DESCRIPTION OF THE INVENTION
Dietary Health M~nA~Pment System 10In one embodiment, the present invention provides a therapeutic dietary system for a patient having at least one diet-responsive condition. Suchdiet-responsive conditions may include obesity, hypertension, hy~,.;lliF-dfmia, cancer"1iAbetes, and cull~ tions thereof. The system colllplises a meal program co.n; ~ g a plurality of p~ArL ,er~ individual meals. Each ofthe individual meals 15 contains a pred~elll~ined level of nutritional en11~nc~ e .l Consulll~Jtion of a plurality of the individual meals, optionally with the addition of supplemPntAI foods, supplies the patient with the desired total daily calorie content and sLIfrl~;e~lL
nutritional f nh~ -llfr-11 to f~.ilit~te m~n~gemf~nt of the diet-re~pons;~e condition.
Generally, m~ ional PnhAncP.mPnt involves fortification of meal 20 corllponc.lt~ ofthe preparL-AePA meals ~,vith macro- or micronutrients, or both, and controlling of the levels of other clc",~nls within those co"~pone-lts. Thus, nutritional ~.~hAI~c~ e~l may include fortifying one or more components of a meal with vitamins, minerals, or a c4. ..b~ ;c n of these rle ~ 1 '., In addition, nutritional enh~ncement may involve adding or controlling dietary fiber; controlling of the 25 amounts of simple sugars through the use of fructose or sugar substitutes, or both, and controlling of levels and types of fat and protein and the levels of cholesterol and sodium in the meal. Preferably, after nutritional enh~ncçment, a daily diet of preparL ~ged meals provides: (I) dietary fiber in the range of about 20 to 30 grams (0.71 to 1.06 ounces); (2) vitamins and minerals at about 100% of levels recornmended by authoritative governmental (e.~., National Academy of Sciences, National Research Council, Food and Nutrition Board Subcommittee on the Recommended Dietary Allowances) and scientific/professional organization (e.P., National Cancer Institute, American Diabetes Association, American Heart Association, and American Dietetic Association); (3) sodium in an amount less than about 3000 mg; (4) protein, such that about 15 to 20% of caloric intake is derived from protein; and (5) fat, such that about 20 to 30% of caloric intake is derived from fat.
The degree of fortification is determined by a variety of factors, includin~ the methods of processing, packaging, storing, and preparing the meals;
the duration of storage; and the amounts of these elements desired for effectivemanagement of the diet-responsive condition. The meal components may include a meat component, e.g., beef, pork, fish, or poultry, and under the present therapeutic system, nutritional enhancement may be applied to either the meat ornon-meat components or both. Because fortification of some meal components may require approval by a governmental regulatory authority, such as the U. S .
Department of Agriculture (USDA), the meals may employ compartmentalized containers to segregate the fortified meal components from those which are not fortified.
The micronutrients are added to the meals with overages that are designed to deliver levels of these nutrients when the meals are consumed by thepatient. Thus, the micronutrient overages must be sufficiently high to provide the desired levels after proces~.inP;, e.g., the mixing, precooking and cooking; freezing, dehydrating, or freeze-drying; storing, e.g., m~int~ining the meal in a frozen or dry condition for an extended period; and plepa~ g, e g., the reheating or final cooking, of the meal. Preferably, such meals may be reheated or cooked by placing the meal on a stove top, in a conventional, or microwave oven or by submerging a sealed cooking bag in boiling water. Because the system is designed to be used over extended periods of time, the individual meals preferably have a sufficiently DCo1:141262.1 Ab~ENDED S~EET

W O 96/39050 PCT~US96/10188 long storage or shelf-life that they may be pu~ ~Lased and stored well in advance of consumption.
A storage or shelf-life under retail conditions in a range of about nine to twelve months is desirable, but p~t rt;,~ly the storage or shelf-life is not less 5 than about nine months. Under retail conditions, frozen meals are ...A;..~ ed at a telll;)e,a~-lre of about -18~C (0~F) and may have a shelf-life of about twelve months. Because storage telllpelal~lres of resid~Pnti~l frozen storage equipmentvary greatly, shelf-life of meals stored in re~id~nces is less predictable.
Supplemental foods may include at least one food selected from one 10 or more ofthe following categories offruits, vegetables, and dairy products. The sPIection of supplemental foods involves the active participation of the patient, and the suppl~m~nt~l foods may be consumed with or between consul"~llion of the prepack~ged individual meals. For e~ ,lç, a selection from the dairy product group may include a se~ving, e.~., about 237 mL (8 ounces), of skim milk; light,15 non-fat, or plain yogurt; or the like. For c,.~"ple, a sclec~ion from the fruit group may include an apple, banana, orange, pear, plum, or the like, or a predetelll"llcd serving size of a~lled types of berries (e.g., about 1 1/4 cup), ~ap~Luil (e.g., 1/2 grapefruit), melon (e.~., 1/3 melon), or cherries or grapes (~, about one cup -about 12 cherries or 15 grapes). Alternatively, the fruit selection may colll~"ise 20 about 1/2 cup of chopped, cooked, or canned unsweetened fruit, or fruit juice. For example, a s~ ;OI~ from the vegetable group may include a serving of asparagus, beets, tomatoes, mushrooms, carrots, 7ucçhini green beans, broccoli, or the like.
These vegetables may be consumed raw (~, 1 cup) or cooked (e.g., 1/2 cup).
Further, the vegetable selection may consist of a bowl of tossed salad inrl~lrling 25 controlled amo~nts of low-calorie and low-sodium salad dressing. For example,a dairy product such as skim milk, may be consumed with the breakfast meals including a fortified cereal; a fruit, such as an apple may be com--med with thelunch meals; and a vegetable such as a tossed salad, may be con.~-lmed with the dinner meals. Thus, a wide variety offruits, vegetables, and dairy products may be chosen to comply with the health mqnq.~m~nt system. The fo-egoing eY-qmplec ~mphqci7e this ~ersa~ y.
The dietary health ...~ systems and methods ofthe present invention are dç~igned to provide a controlled and consistent daily caloric level.
5 For example, the systems and ~ hod5 may provide a core caloric level of between about 1200 and IS00 calories per day. This core level is provided by the con.~-mrtion of a diet comprising a breakfast meal, a lunch meal, a dinner meal, a snack meal, and supplement~ql foods selected from the group cor,~;~ling of dairyproducts, fruits, and vegeta~'os I0 No single caloric level or range is approp,iale for all patients. A
caloric level, however, may be cq-lcuhqted for patients based on their sex, present body weight, height, and level of activity. Such c-q~ qtions may be made using the Harris-Benedict equations desc.il,ed herein in Example 14, infra. Rectqlllce dietary health .. ~l-~.. ~1 most often will include some degree of weight loss, the systems I5 and ~hods ofthe present invention are dç~igned to provide a daily caloric intake for achi_~hl,cnl of weight loss while conc-.mi~ a h~qhhier diet.
In addition, using known rel~lionsllil.s between cqlc~lqted caloric intake needs (e.~., from Harris-13enedi.il equations) and actual caloric intake, it is po~iblE to e~ 1e the amount of weekly weight loss. Similarly, for pqti~nts who 20 have caloric levels above the core caloric level of the systems and methor~ of the present invention it is pos~;ble to accurately qnticip"te llnintended or unwanted weight loss. For c~"yle, a patient with a caloric level of about I 600 calories per day, who con~u",es a core diet providing about I~00 calories per day, will lose about 0.91 kg (2 Ibs.) each week during which the patient consumes that diet. Such 25 weight loss can be avoided by the consumption of adjustors, e.~., snack meals, which increase the daily caloric intake by incl ~ ql qmounts Snack meals may inrl~d~, for exarnple, frozen low-fat yogurt, pretzels, bagels, pOpCOlll, and low-fat corn or potato chips. By con~ming an appropliale number of such snacks meals, the patient may i~ ,ase his or her daily caloric intake to a desired range. For ~,,.a~ le, if desired daily caloric intake is in a range of about 1600 to 1700 calories, a patient may consume one snack meal.
If, however, he or she desires to increase daily caloric intake to b~Lween about1800 and 1900 calories, the patient may consume two snack meals. Prerelably~
5 each of the adjustors has the same content of calories and macro- and micronutrients, so that a patient may choose to consume the appJol,liate number of a variety of adjustors or of the same adjustor, depending upon individual tastes or ch~ ..P. desires.
Vitamins and Minerals The vitamins and minerals that form a part of the nutritional enh~nc~ nt of the present invention are generally provided in the form of a DFEA. The composition of the DFEA may vary, but typically incllldes the following: Vitamins A, Bl, B2, B3, B6, Bl2, C, D, E, and K, and Biotin, C~lr.il.m, Copper, Folic Acid, Iodine, Iron, Ma{~rs;~lm, ~ng~nesç, Pantothenic Acid, 15 Pllos~,holus, and Zinc. For c~lllple, as noted above, the plurality of meal groups may cG...~,r;se a breakfast meal group, a lunch meal group, and a dinner meal group. I~ meals and the dinner meals each may be fortified with the DFEA
to provide about 35% of the desired daily level of the vitamins and minerals, and lunch meals may be fortified to provide about 30% of the desired daily level of the 20 vitamins and minerals. ~Q Table I, infra. Adjustors may be fortified to provide about 5% of the desired daily level of the vitamins and minerals. Thus, adjustors may be used to add vitamins and minerals to a patient's diet, as well as to increase caloric intake.
By complying with the steps in the health m~n~g~rnPnt system 25 inr~ i~ consuming supplemental foods in addition to a plurality of fortified meals each day, the patient receives a predetermined amount of the daily desired level(~, USRDA, where applicable) of vitamins and minerals. In general, total daily for~ifir~tion provided by the health m~n~g~mrnt system may be at least about 50%and preferably at least about 75% and more preferably at least about 90% of the W O 96~79050 PCTAUS96/10188 USRDA. In the most p-efcl.cd embodiment, the fortification is at least about 100% of the USRDA.
Simple Su~ars The ADA has ~eco........ --nde(i for ~ hetics that the intake of simple 5 sugars be restricted and that complex carbohydrates be increased. Typical 1500calorie menus for the ADA show simple sugars to be within a range of about 96 to107 grams of sugar from fruits and vegetables from the ADA eAchange lists. In order to reduce the amount of simple sugars in each meal (such as sucrose, tablesugar, and glucose), fructose or sugar subsfitutes, such as aspa- I~--e and the like, 10 may be added to meal col--?ont--ls in place ofthe simple sugars. The diet ofthe present invention is inten~ed to supply less than about 96 grarns of sirnple sugars per day mainly in the form offructose. Plefclably, however, the lllc.~c~tic meals provide no more than about 65 grams of simple sugar per day. This amount is signifir~ntly lower than the amount c~lr~ ted for 1500 ADA caloric menus. As 15 noted above, good or pl--Qing taste is i",?o,l~u.l to high co.n~ -ee with a health n~,~ system. However, it acluEv~i. this result in part beca..se fructose and sugar sl~bstitut~s are generally sweeter than simple sugars, and, thelcfore, less sugar may be re~uired to obtain the desired flavor.
Fiber As d~ cecl above, the levels of dietary fiber, as well as the levels of sodium in a diet may effect blood ples~ure. The addition of fiber to meal co~ onenLs brings the daily fiber supply to within the r~co"....cnded range of about 20 to 30 grams per day in accoldance with the reco.n...en~tions of the NCI.
Dietary fiber added to the meal colll~,one~ or adjustors may be selected from any 25 of the known co.l,l,.ercially available fiber-providing sources such as pectin;
maltodextrin products; gum arabic, and hydrolyzed guar gum, x~ ... gum, and the like. Other sources of fiber, such as apple, wheat, citrus pulp, citrus, cellulose, corn, cotton~ oat, pea, rice, soy, sugarbeet fiber, and the like, may also be used.
However, due to the i,..~,o. ~ce of good taste and appea. ~ce to diet compliance, the addition of fiber is controlled, so that the appea~nce, con.cistency, taste, and aroma of the meal co",pone"ls remain substantially unaffected. Further, because excessive amo!.ntc of dietary fiber may result in adverse effects, in the present invention, daily dietary fiber intake does not exceed about 35 grams per day.
Sodium Sodium content of meals is controlled, such that total daily sodium intake is less than about 3000 mg. Preferably, total daily sodium intake is less than about 2400 mg, e.g., in a range of about 2000 to 2400 mg. Sodium, especially that derived from the use of salt (NaCl) to flavor meals, may be replaced with other 10 elements or "non-salt" compositions to reduce overall sodium content. The primary"non-salt" co"",o~i~ions for sodium repl~-çm~nt are potassium salts, suchas potassium chloride (~CCl) or potassium lactate.
Potassium In the present invention, daily potas ,;ll", intake under the diet may 15 be at least about 3000 mg, preferably in a range of about 3150 to 3850 mg andmore pl~lably, about 3~00 mg. Meal co"".onenls may be modified with "non-salt" flavor çnh~ncers such as those co~ n;..g pot~csil~m to preserve flavor in view of the ~lrlitil)n of macro- and micronutrients during the fortification process.
In addition to its beneficial use as a "salt" substitute, the addition of potassium to a patient's diet has positive health effects. In ep demiologic and animal studies, the risk of stroke-related deaths has been shown to be inversely related to potassium intake. These results have been observed over a range of blood p~ess.l~es.
However, the relationship appears to be dependent upon daily intake. In additionto the potassium chloride or lactate sources, nutritional enh~nc~.. nl by increasing potassium content may be achieved through the addition of food grade potassium salts such as potassium citrate.
The cG",bh-ation of a low sodium diet with a high potassium diet may result in lower blood pressure levels. Moreover, such a diet may result in reduced frequency of stroke.

~ .

Protein In accordance with reco.. lçl-dations by the National Academy of Science, National Research Council and Food and Nutrition Board Subco.. ;l~eeon the Reco.. ~l-ded Dietary Allowances, diets preferably provide about 20 to 5 30% of calories from fat, about 15 to 20% from protein, and about 55 to 60% from carboh~dl~es. These ~lidçlin~Ps are met by the system and method of the present invention. Further, mixed protein from plant and animal sources are used ~he~ crpossible. Moreover, when animal proteins are utilized lean and medi~lm-fat meats, poultry, and fish are the p.er~"~d source. The precise amount of protein consumed~0 by a patient daily is dependent on the total calories to be conc-.mPd Fats Under the present invention, calories from fat are pl~;relably limited about 20 to 30% of the daily total calories. In particular, under the ~y~lt~lls and metho-ls dec~-~ ibed herein, SFA intake is reduced, such that less than about 10% of 15 calories each day is derived from SFA, and pr~felably, calories derived from SFAs are in a range of about 7 to 10%. Such further reductions may be best achievcd by substit~lting ~d~litiQn~l complex carbohydrates and ",onounsalL~rated fatty acids (MUFAs) for SFAs in the diet. Similarly, intake of PUFAs are also strictly controlled. Currently, North Americans derive about 7% of daily calorie needs 20 (caloric intake) from PUFAs. ~lthough studies have shown an increase in colonand breast cancer at very high PUFA intake levels, where PUFAs are partially substitllte~ for SFAs, PUFA intake accounting for up to about 10% of daily caloric intake does not appear to significantly h~cl ease the risk of cancer. In the systems and m~thorl.c ofthe present invention, about 10% of daily calories are derived from 25 PUFAs. Finally, the rem~indçr of the decrease is SFA intake is met by a relative i"."~ase in MUFA intake. Studies have in~lic~ted that the substitution of MUFAs for SFAs may reduce cancer risks, especially with respect to colo-rectal cancer.Under the systems and methods of the present invention, more than about 10% of W O 96~9050 PCTAJS96/10188 daily caloric intake is derived from MUFAs and preferably, daily calories derived from MUFAs are in a range of about 10 to 13%.
Plcrcl~ly, fat intake may be reduced by curtailing the major sources of dietary fat rather than by ~ ,g whole categories of foods. For eA~,.lple,S by substit~lting fish, poultry without skin, lean meats and low- or non-fat dairy products for high-fat foods, a patient may lower total fat and SFA intake while ensuring an ~dequ~te intake of iron and calcium -- two nutrients of special ""po, L~ce to female p~tientc Dietary fat may also be reduced by limiting intakeof baked goods co..l~;..;..g high levels offat and spreads and dlcssil gs col-l;.;l-i.~g 10 fat and oils.
In addition to SFA intake, cholesterol intake is a major dietary dcLc~ t of serum total and LDL cholesterol levels. Thus, the reduction of SFA
intake is preferably coupled with a reduction in cholesterol intake. In particular, it is de~ ~le to maintain c~-lo~rol intake at less than about 300 mg per day. The 15 systems and metho~ls desc~ ed herein p,ere~bly supply cholesterol in a range of about 200 to 300 mg per day. This is accG...plicl-ed in part by the reduction or;on of fatty meats and whole-milk dairy products from the prcpl alion of Ihcl~pelltic meals. Further, as noted above, the use of oils and fat in meal co",~one.,l plep6lalion is strictly controlled.
20Diet-Re;",onsi~e Conditions Obesity For adult patients of normal weight, the systems and methods of the present invention permit the ingestion of adequate calories to meet most çssçntiAl nutrient needs. Physicians may prescribe caloric reduction, e.~., less than 25 ~A;nlc ~nce caloric level, for overweight patients. The systems and methods take into account the caloric requiren~e"Ls of the patient based on height, weight, sex, age, and activity level. Although the health m~nA~m~nt system is designed to provide a core of between about 1200 and 1500 calories daily, this amount may beincreased through the addition of adjustors, i.e., snacks, to increase caloric levels to desired targets. However, if weight loss is desired, it is strictly controlled, such that after the first two weeks employing the system or utili7i~ the method, weight loss does not exceed about 0.91 kg (2 lbs.) per week. Weight loss may continue until a weight loss goal or endpoint, individually dete", i"ed for a patient by a S nutritionist, is reached.
Hypertension The systems and ...~I.o~c ofthe present invention provide low daily sodium intake levels. Therapeutic meals are decign~d to provide less than about 2400 mg of sodium per day, and preferably, a daily sodium intake in a range of 10 about 2000 to 2400 mg.
Benefits from the lowering of sodium may accrue to any patient.
However, the systems and metho~s desclil)ed herein are not intP.ntled to replaceantih~,c, ~ e medication where such merli~qtion is approp, ;ale. In some cases, however, proper utili7-q-tion of the systems and methotic of this invention limiting 15 sodium intake may reduce or el;n.;.l~e the need for such me-lic~q,tion. The monitorable ;.~ or for the use of the systems and methods to control diet-r~is~,ons;~e hypertension is blood pres~ule. Palienls most likely to achieve a re~lction are patients who are without antih~"w l~ e me-licq,-ion that have blood pressure (sitting) with a systolic pressure in a range of about 140 to 180 mmHg or 20 a ~liqct~lic pressure in a range of about 90 to 105 mmHg, or with antihypertensive ",P~ ;O,~ that have a blood ple~ure (sitting) with a systolic ples~ul~ in a range of about 135 to 180 mmHg or a ~iqcto!ic pressure in a range of about 85 to 100 mmHg.
~diti~nq~lly~ the systems and m~thodc ofthe present invention, may 25 achieve a reduction of systolic and diastolic blood pressure measurements in a range of at least about 1 to 10 mmHg. However, in a p, ere" ed embodiment the reduction in blood pressure is greater than about 5 mmHg.

CA 02223l02 l997-l2-02 W O 96/39050 PCT~US96/10188 Hyperlipidemia The systems and methods of the present invention provide that the PUFA intake of patients not signifi~ntly exceed about 10% oftotal calories. The applu~liate health m~n~mPnt end~oillls, i e., monitorable in~lic~tors, are totalS serum cholesterol, LDL, and triglycerides. Further the systems and methods desclibed herein are not intçntled to replace any lipid lowering medication where such ...eA;c~t;ol- is app~ ;,;ate. In some cases, however, through proper utilization ûf the systems and the methûds of this invention lowering cholesterol levels mayreduce or e~ e the need for such medi~tion. Patients most likely to achieve 10 reductions in cholesterol and triglyceride levels are pa~ lls who are without lipid lowering me~lic~tion that have cholestçrol levels in a range of about 220 to 300mg/dl or triglyceride levels in a range of about 200 to 1000 mg/dl, or both, or with lipid lowering me~ tion that have cholesterol levels in a range of about 200 to 260 mg/dl or ~liglycelides in a range of about 200 to 1000 mg/dl.
The systems and methods of the present invention may achieve -;fi~ l re~ ctiorlc in serum cho!esterol levels. Cholesterol may be reduced by an amount in a range of about 10 to 20 mg/dl, and more pleÇ~;,ably, by at least about 15 mg/dl. Tli~lycelides may be reduced by an amount in a range of about 10 to 25 mg/dL and more pl c;r~ ly, by an at least about 20 mg/dl. LDL may also 20 be reduced by an amount in a range of about 5 to 20 mg/dl, and more plc;rt;lably, by at least 15 mg/dl. In addition to reductions in serum cholesterol, this invention may result in redu~tion~ in systolic and diastolic blood pressure in a range of about 1 to 10 mmHg for a patient ~u~, ing from hyperlipidemia. More preferably, the patient's systolic blood pressure may be reduced by an amount in a range of less25 than about 5 mmHg, and the patient's diastolic blood pressure may be reduced by about 1 mmHg.
Diabetes The indicators associated with diet-responsive diabetes are dete,lllined for the individual patient. The diet is designed to control plasma glucose and plasma lipid levels and ...~ n body weight at a level applop~;àle for the particular patient. As noted above, the systems and methods described hereinformulate ~pr~pl;dte caloric diets tailored to the patient's height, weight, age, sex and activity level and which provide about 15 to 20% of calories from protein, 5 about 20 to 30% of calories from fat, and about 55 to 60% of calories from carbohydrates. The diet provides between about 20 and 30 grams of dietary fiber each day. Finally, by using fructose and sugar subsfit~tes~ such as as~,&l l~lle, less than about 96 grams of simple sugars are consumed daily by the patient, and pref~l ably, about 65 grams of simple sugars are co~.~. ..ned daily.
Patients most likely to benefit from the systems and methods of the present invention are non-insulin deprn~rnt diabetics who take no hypoglycemic agents and have fasting plasma glucose levels of greater than about 140 mg/dl and HbA,c levels of not greater than about 200% of median for assay, i.e., less thanabout 15.4, or who take oral hypoglycemic agents and have HbA,c levels of 15 between about 100 and 175% of median for assay, i.e., between about 7.7 and 13.48 mg/dl.
The systems and methods of the present invention may achieve stabilization or signifir~rlt reduction~ in HbAIC. For ~ ~h...ple, both medically ~Ihh li~ed and non-...~ y stabilized diabetics may obtain reductions in HbA,C of20 at least about 1%, and in a pre~lled e.llbodi.l.ent, the reduction in HbAIc may be up to about 2% when c~ &,ing ba~ ne period to the end of the intervention period. Further, non-metlic~lly stabilized diabetics may tA~,e,ience reductions in plasma glucose levels whi1e employing the systems and methods described herein.
MedicaUy ~ h~ tir,c may experience increased ease in Ill~ h;ni~g plasma 25 glucose level stability or redur.ing plasma glucose levels while employing these - systems and methods.

- -Cancer The systems and methods of the present invention are d~sign~d to provide dietary fiber in the ranges .ccon.."ended by the NCI and to limit fat consumption to no more than about 30% of daily caloric intake. Moreover, the 5 ~l-lition ofthe DFEA to therapeutic meals for inclusion in the health m~nagem~nt systems and methods is intçn-ied to ensure that the patient receives the daily ~eco~ n n-led allowances of numerous vitamins and minerals, in~lu-ling VitarninsA and C. Funher, as noted above, the systems and methods disclosed herein provide for S~ ;ol~ of suppl~m~nt~l foods by the patient from among the groups 10 co~ ;..g offruits, vegetables, and low-fat dairy products. All of these approaches reduce the risk factors associated with various types of cancers, as diccusse~l above.
Co~ ce and Quality of Life Compliance is perhaps the single most illlpol~ elC.lle~lL in a SllCCÇccfill dietary health m~n~onnPnt system or method. The level of co~ iAnce 15 depends in part on the motivation and drive of the patient. Nevel Iheless~ it may also be inflllenced by ide..l;~hle and controllable factors, such as the ease with which the system may be utilized or the method may be followed; the taste, appearance, and in general, the de~i-abilily of concuming the p. ~sc-ibed meals; the flexibility of the system or method; and the degree of s~ticf~ction~ e.~., the 20 improvement in quality of life experienced by the patient.
In support of the systems and methods of the present invention, patients are supplied with a Compliance Support Package (CSP). This CSP
includes (1) food record sheets, (2) dietary i,~l,na~ion, inclll-li~ exchange lists and portion size control i.~.l.~lion, and (3) a survival kit. The food record sheets 25 allow patients to record daily food consumption and are useful during councelinp sessions to confirm th~t the diet is being followed. The exchange lists allow a patient to select meals suitable to a variety of diet-responsive conditions (meal categories) from a variety of meal groups. Further, the exchange lists identify various supplemental foods which may be s~lected by the patients to fulfill the W O 96~9050 PCTAUS96/10188 requ"~;",e,lt~ ofthe dietary health ...~ system or method The portion size control il~fo~ ;01- allows the patient to ul,del~d and better control portion sizes con~m~ Other dietary i,~",~lion instructs the patient as to how the system or method opc ales and why the patient should or should not cons--",e various foodsS or foods ~ p.ued in a particular manner. Also inclllded is i,~""aLion on exercise behavior modification and proper nutrition.
The CSP inr.l~ldec a survival kit which allows a patient to consume foods when p~esc,;bed meals or food eYçh~nge items are not available without forcing the patient to abandon the system or method. In this manner, the patient10 may avoid "~he~ti~" on his or her diet even in an e",el~ ncy. Survival kits may be e~ ly al,p,~ iale to pe,~ons who travel frequently for business or pleasure or who, for other reasons, are denied the f~cilities to prepare a meal rtco....~.en-~ed by the system or method Not only may the survival kit identify pos~il,'c substih-tçs but such kits may contain c."~ n.;y snacks to satisfy an ;~ e~ e 15 need while preselving the progless achieved by the system or meth~
As clinical results have shown, this CSP aclfie.~cs l~ Jlo-ed cc....~ , and, ll,..~rur~, improves the effectiveness of the sy~le"~s and methods of the present invention. In addition, use of the CSP of this invention has beenshown to improve co..~ ce ,eg~-dless ofthe diet used. Thus the CSP ofthis 20 invention can be used with other diets.
In ,~ ion to the health benefits of a succec.cfill health m~n~ .mçnt system, the patient's ~ttihldçc, mental health and outlook and overall sense of well-being i.e., the patient s quality of l~fe may also be positively imp~cte~ This impact may be l"e~ur~d by relatively objective criteria such as improved compliance with 25 the health m~n~m~nt system s dietary requi,e"le"~s, and improved function in daily activities. It may also be reflected in more subjective, but equally measurable criteria, such as stress levels, perception of mental health7 s~ticf~ction with the dietary health management system, acsec~ " of personal appea,~-lce, and self-esteem.

W O 96~9050 PCTAUS96/10188 Quality of life may be measured by various empirical tests. These may consist of established quality of life ~Cses~ f ~ts along with three new scales that were dec;~.ed to assess the impact of nutritional interventions on quality of life. Thus, these tests provide a broad profile on quality of life that is sensitive to S dietary m~nipl.lqtionc The primary indices of quality of life are the Mental Health Index and the General Health Perceptions scale. The instruments were developed by the Rand Corporation for the Health Insurance Study and are considered among the best available instruments for measuring quality of life. Additional tests may be a~lminictP-red which measure nutritional affect, work pe.rollllance, daily activity, 10 sexual function, nutritional health pe.~e,c ~ions, nutritional hassles, and the impact of nutrition on social function. When the dietary health m~n~gP.mPnt system of the present invention is employed by p~tif ntc7 they cc ~ ly df~llon~ le st~ticticqlly significant, e.g., p ~ 0.05 level, higher scores on these quality of life ~csF,~ n~s as colllpaled to when these same patients are not employing the systems or 15 methods ofthe present invention, eg., intervention vs. ~c~linç ~cseCc.
Dietary Health M~nagem~nt Pl~l,lil.g and Control System A health m~nqgemPnt r'~ .g and control system, accol.lil~g to this invention, may provide nutl;l;onally cnh~-ce~ dietary m~n~g~.m~nt to a patient having at least one ofthe diet-lejponsi.~e conditions rlisc~csed above. This system 20 coll,plises a plurality of prepaçl~ged individual meals wL~,re;n each of the meals is associated with a particular group. Each meal has a group idellliryillg code corresponding to the type of meal, e.g, meal occasion, such as breakfast.
Moreover, each ofthe meals further in~ des at least one categorv identifying code collespol1ding to a particular diet-responsive condition. Each of the individual25 meals contains a predetermined level of nutritional enh~ncPm~nt By con.c--min~
a plurality of the individual meals having the appropl ;ate category identifying code, the patient is supplied with a desired total daily calorie content and s~ffi~ient nutritional enh~n~ to f~çilit~te m~nagement ofthe diet responsive condition.
A typical desired total daily caloric intake may be belwetn about 1200 and 1500 W O 96~9050 PCTrUS96/10188 calories per day. If necess-,y, this daily caloric intake may be adjusted by thecon~.mptinn of adjustors, such as frozen low-fat yogurt; health food bars, such as granola bars; popcorn; low-fat potato or corn chips; bagels, pret~els, fruit and vegelable juice beverages, and the like.
S Rert.ling to Fig. 1, a sch~ ;c rep.~,se .l;ll;on of a prer~,.. edembodiment a health m~n~gfm~nt plal~nil~g and control system accoldi..g to the present invention is depicted. Twelve meals are dep cte~i~ which have been divided into four groups: breakfast meals (B), lunch meals (L), dinner meals (D), and snack meals (S). Each group has a group idc;~liryillg code, i.e., B, L, D, and S.
10 Nevertheless, the group identifying codes may be selected from the group con~isfi~ of a plurality of letters, numbers, colors, shapes, textures, or co...binalions thereof.
These group identifying codes are used to ~ -el-~e or s~bsl;lule items of a meal group within a category or to select meals suitable to more than one 15 category. These calego.ies may include groups of meals that address conditions such as (1) I.~ ;on, e.g., meals with low sodium COnl~.lt, (2) I.~,.,,Lpidemia, e.g., meals low in çholesterol and SFAs; (3) non-insulin depf ndc-.l ~' ~bçtes, e.g., low in simple sugars and high in fiber; (4) cancer prevention, e g., high in fiber low in chc'e~t~ol and SFAs. In Fig. 1, for e Aa...~:le, meals in a meal group associated 20 with a first dietary category, h~"~. Iel~s;on, may be identified with a th~t~.hed box, while a second dietary category, hyperlipidemia, may be id~nfified with a dottedbox. As shown in the figure, individual meals may be ~soci~ted with more than one category. In Fig.l, the categories are identified by graphically unique boxes, but in accG-Jance with the role~olng desc-i~lion, a variety of colors, shapes, or the 25 like may be used.
In another example, meals in a meal group associated with a first dietary category may be idf~nfified with a blue circle. Similarly, meals in a meal group ~c~oci~ted with a second dietary category may be identified with a red star.
Meals in a meal group, which are suitable for inclusion in the first and second dietary categories, may be identified with a blue circle and a red star, or somecoml)illalion of the features of the two identifying codes, e.~., a blue star. Thus, meals are not limited to inclusion in a single dietary category.
Dietary Health Management Method In accoldance with this invention, a method for dietary health m~n~gP~mPnt col~lplises treating a diet-resyon~i~re condition by adherence to particular leco.~....ç~-ded dietary levels. Such methods include the step of idcnlirying qn~ntifi~ble l~ ..l in~ic~tors ofthe diet-les~,onsi~e condition. Forexample, when disease state is obesity, the q~ hlc llr~ l indicator usually 10 will be body weight and Body Mass Index (BMI). Similarly, when the condition is non-insulin dep~n~ 1 diabetes me~ l.c the qll~ntifi~hle l~ nl intlir~tors maybe fasting plasma glucose level and HbAIc. When the condition is hyperlipidemia,the qu~ntifi~ble 11~ l in~iic~tors may be total serum cholesterol, LDL, and triglycerides; and when the condition is hypertension, the qu~nt~-ble 11~
15 in-licators may be average sitting diastolic blood pressure and average sitting systolic blood pressure. Thus, unique qu~ hle tle~ nl indicators are identifi~ble for the majority of diet-responsi.~e conditions.
The method further inrludes the step of î dminicte~ing a complete daily diet co..~ g a plurality of pl~p~ ~e individual meals to the patient. Each20 ofthe individual meals collldins a predetellllllled level of nutritional P.nh~l~cP .1l~
Consumption of a diet comprising a plurality of the individual meals supplies the patient with the desired total daily sl~cten~nce and suffici~nt nutritional ~..h~nrf .~ to fi~eilit~te m~nagP~mP~nt ofthe diet-res~orlsi~e condition. As noted above, this diet ple~l~ly is supplemrnted by the patient's selection of foods from 25 each of three groups consisting of fruits, vegetables, and dairy products. Further, the method may include the step of monitoring the condition ll e~ 1 indicators.
Prepackaged Therapeutic Meals Accordhlg to an embodiment of the invention, a prepar~gP,d therapeutic meal may be used by a patient having at least one diet-les~,orlsi~re condition. Such meals co,.".,ije a plurality of separate meal components. At least one of these meal components may include a predetermined level of nutritional enh~ncement By con~.lmi~ a plurality of these meals along with applop.iate adjustors and supplemental foods chosen by the patient, the patient receives the5 desired total daily calories and sufficient nutritional f.-h~l-CP...~ to f~ilit~te m~n~ment ofthe diet-re~,or~s;~e condition.
The meal col,.~,ont"l~ may include a meat co.,.pone.~l, e.~., beef or pork, fish, or poultry. The health m~n~g~m~nt system may apply the nutritional enhAnc~.. l to either the meat or non-meat COmpOl~e.~S or both. Because 10 fortification of some meal components, may require approval by a gove~
agency, such as the USDA with respect to meats, the meals are parl~ged in co."~,a,l~ li7ed COlll~;llGl~ to seg~ ale the meal COIllpOAen~S. As ~ c~ssed above, the degree offo,l;r.~ ;ol- is determined by a variety offactors, inr.llldi~ the methods of procçssing p~r~ging storage, and p~ alion of the meals; the I5 duration of storage; the ~mount~ ofthese el~ ..ls desired for effective ~ ",P -l of the diet-re~ ol~si~re condition, and meal ap~:ea~ance. The prep~cl~ged, individual meals may be frozen for storage or in some cases parL aged for room telllpela~lre storage, e.g., retorted soups, stews, and pastas .
In a p~ ~ rt "ed embodiment, as shown in Table I, the breakfast and 20 dinner meals may contain about 35% ofthe DF~A and the lunch meal may contain about 30% ofthe DFEA. The prepa.~lion of DFEA in the various meals may of course be varied to suit particular patients needs. Because patients may not desire to cor~.mP all ofthe cG.~ r,.,.lts of a particular meal on any given day or because additional calories or micronutrient levels are desired, the breakfast, lunch, and 25 dinner meals may be supplPmented with an adjustor, each co..l ~ g about 5% ofthe DFEA As noted above, such adjustors may also be used to il~clease the caloric content of a diet. Suitable adjustors may include low-fat frozen yogurt, granolabars, bagels, popcorn, low-fat potato or corn chips, and pretzels.

TABLE I

Daily Desired Level of Fortificati~ln Nutrient Breakfast MealLunch MealDinner Meal (35%) (30%) (35%) VITAMIN A, (IU) 1750 1500 1750 VITAMIN D, (IU) 140 120 140 S VITAMINE,(~lJ) 10.5 9 10.5 VITAMrN C, (mg) 35 30 35 VITAMINBI, (mg) 0.53 0.45 0.53 VITAMINB2, (mg) 0.6 0.51 0.6 VITAMINB3, (mg) 7 6 7 VITAMINB6, (mg) 0.7 0.6 0.7 VITA~NB", (mcg) 2.1 1.8 2.1 BIOTIN, (mcg) 105 90 105 FOLIC ACID, (mg) 0.14 0.12 0.14 PANTOTHENIC ACID, (mg) 3.5 3 3.5 VITA~N K, (mcg) 28 24 28 CALCIUM, (mg) 420 360 420 COPPER, (mg) 1 05 0.9 1.05 IRON, (mg) 6.3 5.4 6.3 MAGNESIUM, (mg) 105 90 105 MANGANESE, (mg) 1.75 1.5 1.75 PHOSPHORUS, (mg) 262 5 225 262.5 ZINC, (mg) 5.25 4.5 5.25 IODINE, (mcg) 52.5 45 52.5 As seen in the embo~imçrlts of Table II, it is pler~l,ed to distribute the DFEA among at least two food cGl~ponents. This distribution helps to avoid CA 02223l02 l997-l2-02 W O 96~9050 PCTAUS96/10188 problems with taste and insure at least partial benefits of the fortification when the patient does not consume any one fortified component.
TABLE n A. BREAKFASTS
S Tvpe Meal Corl,pori~,.lL - % DFEA (Approx.) Panc~ke~ p~nr~kes - 15% (2 P~nr~kes) Orange Juice Beverage - 20%
French Toast French Toast - 15% (2 Slices) Orange Juice Beverage - 20%
Scrarnbled Eggs Apple Oatmeal Muffins - 15% (2 Muffins) Orange Juice Beverage - 20%
Breakfast Sandwich English Muffin - 15%
Orange Juice Beverage - 20%

B. LUNCHES
Type Meal Colllpollen~ - % DFEA (Approx.) Beef Soup Roll - 20%
Apple Cinnarnon Sauce - 10%
Chicken Noodle Soup Roll - 20%
Apple Crisp - 10%
Split Pea Soup Corn Bread - 20%
Cherry Crisp - 10%
Pasta Dinner Garlic Roll - 25%
Fruit Compote - 5%
Turkey Sandwich Apple Crisp - 18%
Whipped Potatoes - 12%

W O 96~9050 PCTrUS96/10188 C. DINNERS
Tvpe Meal Co,.. por,e.~ - % DFEA (Approx.) Pot Roast Roll - 20%
Sauce for Corn - S%
Peach Crisp - 10%
Traditional Turkey Roll - 20%
Sauce for Vegetabl~s - 5%
Cheesec~ke- 10%
Sirloin Tips Roll - 20%
Sauce for Vegetables - 5%
Chçeseç~ke- 10%
Glazed Turkey Sauce for Vegetables - 10% Total (5% for each vegetable) Pasta Sauce - 15%
Apple Crisp - 10%
Barbecue Chicken Garlic Roll - 25%
Rice Mixture - 5%
Sauce for Vegetables - 5% Total (2.5% for each vegetable) Grilled Mustard Chicken Roll - 25%
Rice Mixture - 5%
Sauce for Vegetables - 5% Total (2.5% for each vegetable) Meatloaf Sauce for Veg~tablcs - 5%
Mushroom Sauce - 5%
Cheese Sauce - 15%
Cheesec~ke- 10%
Salisbury Steak. Sour Cream Sauce - 15%
Sauce for Vegetables - 5%
Mushroom Sauce- 5%
Apple Crisp - 10%
Herb Roasted Chicken Roll - 20%
Sauce for Vegetables - 5%
Cherry Crumb - 10%
Beef Stew Corn Bread - 20%
Sauce for Vegetables - 5%
Apple Cilll,~"on Sauce - 10%

Food Products An embodiment of the invention also includes a food product for administration to a patient having at least one diet-responsive condition. The S product comprises a nutritionally enhanced meal component selected from the group consisting of meats, baked goods, sauces, starch sources, soups, cereals, desserts, and fruit and vegetable juice beverages. The component supplies dietary fiber in an amount of up to about 30 grams; vitamins and minerals at a range of about 5 to 35% ofthe USRDA, see Table III, infra, cont~ining recently determined10 USRDA values; sodium in an amount less than about 2400 mg; protein, such thatup to about 20% of daily caloric intake is derived from protein; and fat, such that up to about 30% of daily caloric intake is derived from fat. Although the meal components may include a meat component, preferably, the nutritionally enhanced meal components are non-meat components. As noted above, the nutritionally 15 enhanced meal component may include baked goods, e.(7., rolls, muffins, and breads; sauces, e.~J., vegetable sauces, pasta sauce, and meat sauces; starch sources, e.~., whipped potatoes and rice; cereals; soups; desserts; and fruit and vegetable juice beverages.
Examples of meal components of which may be fortified by adding 20 the DFEA at a specified level, include meats, such as poultry, fish or beef, i e., Salisbury Steak and Meatloaf; baked goods, such as rolls, i.e., garlic rolls, muffins and breads; cereals; soups; desserts, i e., apple crisp; starch sources, i e., whipped potatoes; fruit or vegetable juice beverages, i e. orange juice drink; and fruitcompotes; and sauces for vegetables and meats, i e., sour cream sauce. See Tables ~5 X[-XVIII, infra, which details the fortification of particular food components.
Dietarv Food Enhancement A~ent A DFEA for fortifying food products may comprise predetermined amounts of vitamins and minerals. As discussed above, various vitamins and minerals included in the DFEA may include a combination of essential vitamins and DCo1:14128~.1 A~NDEQ S~ET

WO 96~9050 PCTrUS96/10188 minerals for which a lecoll""ended dietary allowance, such as the USRDA, has been t;~ icl,e~ In a p,efe"t d embodiment, the combilla~ion of esc~nti~l vitamins and minerals comprises A, B, C, D, and E Vitamins and Calcium, Pl,osphorus, Magnesium, and Iron. In a more prere,led embodiment, the co.l,binalion of S esse~ vitamins and minerals may coll,y~ise Vitamins A, B" B2, B3, B6, Bl2, C, D, E, and K, and Biotin, Calcium, Copper, Folic Acid, Iodine, Iron, ~Cium~
M~e~e~, P'alltolll~llic Acid, Phosphorus, and Zinc. Preferably, the vitamins andIllin~ ls are prt"~ed with an excipient to provide a powdered, free-flowing, stable DFEA useful for fortification of various food coll,ponel-ls.
The vitamins and minerals in~ ded in the DFEA may be present in amounts equivalent to those present in a lcco~ enrled dietary allowance as detelnlined by go~ l or national health ole~ ;ons, e.g., USRDA.
Vitamins and minerals, for which a USRDA amount has been established, are idPntified in Table m.

W O 96~9050 PCT~US96/10188 TABLE m U.S. Recommended Dietary Allowance (USRDA) NUTRIENT USRDA

S VITA~NBl 1.5 mg VITAMINB2 1.7mg VITAMIN B3 20 mg NE' VITAM[N B6 2 mg VITAMIN B,? 6 mcg VITAM~ C 60 mg VITAMIN K 80 mcg BIOTIN 300 mcg CALCIUM 1000 mg COPPER 2 mg FOLIC ACID 400 mcg IODINE 150 mcg IRON 18 mg MAGNESIUM 400 mg MANGANESE 2 mg PANTOTHENIC ACID 10 mg PHOSPHORUS 1000 mg ZINC 15 mg Niacin Equivalent.

WO 96~9050 PCTAJS96/10188 The DFEA may also include various vitamins and minerals in the ranges depicted on Table IV. The precise composition of vitamins and minerals selected from about the ranges disclosed on Table IV, depend on the type of mealcomponent to which the DFEA is to be added and the method of plepalalion of 5 that meal co",i)one"l and its method of storage. The DFEA also optionally contains an e,.c;~ "l. For cA~yle~ the DFEA for frozen and retorted food products may include eYçiriPnt in an amount up to about 20% by weight of the mixture. Known food grade excipients such as those based on maltodextrins may be used. The form. (both chemical and physical) of the food grade vitamins and 10 minerals employed to make the DFEA should be sPlected to r.~ ;.- good taste and attractive appe~ ance of food products an meals co..~ the DFEA. The vitamin and mineral forms also should have s ~ffir~Pnt ~l~bilily to remain active after the procç~cine and storage conditions rli~cll~sed above. Any ofthe conventional forms of vitamins having the desired characteristics set out above can be used to 15 formulate the DFEA. Mineral fortification to the extent cont~..pl~led by thisinvention, however, may require selection of noncon.lentional forms to avoid problems with taste and appea. ~nce. In one pl e~, I ed embodiment this objective is achieved by employing calcium citrate and ~liç~lci~.m phosphate as a mixed source of calcium; employing ~ lci.-m phosphate additionally as a source of 20 phosphorus; and employing m~en~Pcillm phosphate as an additional source of pl-Gspho,.ls and a source of m~nP~i~lm In another embodiment, this objective is achieved by employing calcium carbonate, or the like, as a source of calcium;
employing m~g-.P-: .... phosphate as a source of phosphorous; and employing m~gnPsillm oxide in addition to the m~gn~PSillm phosphate as a source of 25 m~enpsi~lm PCTtUS96tlO188 W 0 96t39050 TABLE IV
DFEA Compositions NUTRIENT CONCENTRATION
RANGE

S VITAMlN Bl 0.41 - 2.07 mg VITAMIN B2 0.23 - 2.24 mg VITAMIN B3 6.3 - 25.3 mg NE
VITAMIN B6 0.54 - 2.75 mg VITAMIN B12 1.08 - 8.58 mcg VITA~ C 31.5 - 330 mg VITAMlN E 9.45 - 49.5 IU
VITAMIN K 0 - 110 mcg BIOTlN 94.5 - 412.5 mcg CALCIUM 108 - 1333.2 mg COPPER 0 95 - 3.63 mg FOLIC ACID 126 - 660 mcg IODlNE 47.25 - 189.75 mcg IRON 5.67 - 20.79 mg MAGNESIUM 72 - 339.9 mg MANGANESE 1.58 - 6.05 mg PANTOTHENIC ACID 2.7 - 13.75 mg PHOSPHORUS 33.75 - 841.65 mg ZINC 4.05 - 17.66 mg Fnc~rs~ tion technology may be employed during the processing ofthe various meal c~...pone.l~s to ensure that vitamins and minerals are delivered in sufflcient quantity and remain stable during meal procç~cin~, storage, and p.epa.~lion Any method of encarsl~l~tion capable of achieving these results may 5 be used In the vitamin and mineral mixture described above, for PY~mrle, the vitamins and minerals may be ~ osed within edible microc~psules One pler~lled form of microencaps.llation technology is described in U S Patent Application Serial No 08/076,709 filed June 15, 1993, entitled "Fn~rs~ ted Additives,"
which is h~col~,olated herein by refelence The microc~ps ~IP~S may have cores 10 co~ ;n ~p the vitamins and minerals, which is insoluble in water, but which melts and releases the vitamins and minerals at water t~llp~alures above about 35~C
(95~F) Each core may be completely surrounded by an outer shell This shell may co--.~,-ise a shell forming material that has a thermal gelation ttlllpelalllre within a range of about 35 to 77~C (95 to 171~F) In particular, the outer shell may 15 comprise methylcçll~-lose Clinical Testing Method Accurate clinical testing is h..po.lanl to the development and impl~...r ~ ;on of a dietary health management system Clinical testing, however,does not cease when such a system enters use Continued clinical testing is used 20 to ensure the continued efficacy of therapeutic meals and therapeutic products, to introduce additional varieties of therapeutic meals and therapeutic products, and to identify areas for improvement in the m~nllf:~ ,tllre and ;...pl~ ;on of the system A clinical testing method for d~le~lll~ing the effectiveness of a diet 25 program, such as a dietary health m~n~g~rnçnt system, for ,~mini~tration to apatient having at least one diet-re~luonsi~e condition in~ des the steps of sPlecting a plurality of p~tiPnt~ each having at least one ql ~ nl; r.~ble in~ir~tor of at least one ofthe co~ ;l;ol~ Patients continue their usual diet during a b~çline period The baseline period serves several functions in the clinical testing method First, it - - -W O 96/39050 PCTrUS96/10188 allows test supervisors to identify l)nel~it~ e patientc and remove them from the patient pop~llatiQn before the dietary health management system is a 1~ ed to a group ofthe patient population. Further, each ofthe pa~ienLi may be monitored during the baseline period to del~ll,llne a b~PIine quality of life. Moreover, the at 5 least one in~ tor for the at least one diet-leil,orl ,;~e condition, as well as other health criteria, may be measured for each patient during the b~celinp~ period. Thus, all of the p~ may be placed on a more equal footing by gathering data and elimin~ti~ l~n~cceplable lll~,.llbe.~ of the patient population before the testing a dietary health management system, and the patients may be edllç~ted on how to use lO a dietary health m~n~gP.mP.nt system. In addition, during the b~cçline period, the test supervisors may educate the pa~;P~ s on the purpose of the dietary health m~n~emPInt system and benefits of a nllt-~ti~nally P..~h~nt~.ed diet in add,ess;llg diet-res~,ori~ive conditions.
At least one q!l~ntifi~ble in~icatQr of each of the diet-rej~onsi~e 15 conditions is identified and measured for each of the pati~pntc during a b~ ine period. Each of the patiPnte is monitored during the baseline period to determine a baseline quality of life. The plurality of patients then is randomly divided between a first group and a second group. The system then is a~lmini~tered to each ofthepatients in the first group during an intervention period. Each of the patients in the 20 second group, however, is ...~ A on a control diet, e.g., a diet that follows the AHA ~idPl;nps7 with known benPfi~i~l effects on the at least in~ atQr of each ofthe conditions. These in~icators are monitored for each of the p~ti~nt~ after the intervention period. As described above, the system in~ des a plurality of prepacl~ged individual meals, such as the therapeutic meals, which supply the 25 patients with a desired total daily calorie content, improved quality of life, and ~lffiri~Pnt m~ ional çnhAnce...e~l to fiqcilitate m~n~gPnnent ofthe diet-le~,~,onsi~/e.
Because the control diet is has known benefits, this method allows the test supervisors to colnpare active diets.

Referring to Tables V-V~, the activities involved in a clinical testing method are described in greater detail. The clinical test described in these tables is essçnti~lly the same test descl~ed herein at Example 14. The test incl~ldes afour week ba~line period followed by a ten week intervention period. Table V
5 describes the clinical events sclled~lled for each period. These events include the physical testing of the patients during each period, the ~l...;. ,;~l alion of quality of life questio~ es, and the like. In Table VI, the clinical sc.hed~-le for laboratory testing is set forth. These tests include some initial scr~ c~ lg tests for identifying unacceptable members of the patient population and initial and final tests for the 10 intervention period. Table VII describes the nutrition related activities during the baseline and intervention periods. Each of the activities, events, and tests is descl;bed in more detail with respect to Fy~nnrle 14, infra.

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~ " X X X X X X

cn ~ X X x X

u r' u S

u . ~ ~3 . ~ . 3 ~ .
fi ~ 3 ~ ~ o :
: ~ . ~ ~ Z o ~ ~~ r :: ~ c ~ a ~ 8 ~' ~ L ~ ~ i ; C- ~

E~a~ ,lts The invention may be further understood by a consideration of the following e,.~,.p!cs, which are int~n~led to be purely eYe...l,la.y ofthe use ofthe invention.
5 Example 1 This e,.~llplc demonstrates the plep~alion of DFEAs suitable for use ac~,L,g to the present invention. The composition of a vitamin and mineral mixture comprising one pr~;ftlled DFEA for use in follirying meals and meal cu"~,one,-l~ ofthis invention, which are to be frozen before con~u."~lion, is shown 10 in Table VIII.

TABLE VIII
Vitamin and Mineral Mixture (Frozen Foods) NUIRI~ CONCENTRATION FORM
VITAMIN A 9000 IU Vitamin A Palmitate S VITAMIN B~ 1.88 mg Thiamine I~
VITAMIN B2 2.04 mg Ribofla~in VITAMIN B3 23 mg NE ~; ' VITA~NB6 2.5mg E~.iduAi--eHvd,- " ' VITAMIN Bl2 7.8 mcg Vitamin B"
VITA~N C 300 mg Ascorbic Acid VITAMIN D 620 IU Vitamin D3 VITAMIN E 45 IU Vitamin E Acetate VITAMINK 100mcg Vitan~inK, BIOTIN 375 mcg Biotin CALCIUM 1212 mg C;lcium Citrate/Dicalcium COPPER 3.3 mg Copper t"--FOLIC AC~) 600 mcg Folic Acid IOD~E 172.5 mcg PUL;~ Iodine IRON 16 mg Ferric Or~h~h~h~t~
MAGNESIUM 309 mg M1~ Pl.u;,lAla~
MANGANESE 5.5 mg M , Sulfate PANTOTHENIC ACID 12.5 mg Calcium P
PHOSPHORUS 765.14mg ~" PLv~ /Dicalcium ZINC 16.05 mg Zinc Oxide The vitamin and mineral concentrations given in Table VIII include sufficient overage percentages to insure that the desired concentrations are available for con~llmption a~er proce~ g storing, eg., about a nine month frozen retail storage period, and ,ol epa~ g of the therapeutic meals.
The DFEA of Table VIII was p.e~,ared as follows: first, the following vitamin components (available from Roche Vitamins and Fine Chemicals) WO 96~9050 PCT~US96/10188 were combined in a Day mixer at room te~l,pG~ re and under controlled humidity, eg. in a range of about 35 to 75% RH, to produce a homogP.nolus vitamin mix: 36 mg of Vitamin A Palmitate (250 micron spray dried); 300 mg of Ascorbic Acid; 6.2mg of Vitarnin D3 -100 S.D.; 90 mg of Vitamin E acetate 50% (CWS/F); 10 mg of S Vitamin Kl, 1% (spray dried); 1.88 mg of ThiAmine Mononitrate; 2.04 mg of Riboflavin; 23 mg of ~i_in,Am;de; 3.03 mg of Pyridoxine IIyd~ocllloride; 0.6 mg of Folic Acid; 7.8 mg of Vitamin Bl2, 0.1% (spray dried); 0.375 mg of Biotin; and 13.63 mgofC-Alri~lmP,..l1u~ e Second, amineralmixwas sepal~ely prepared in a Day mixer under similar conditions to those r~ ed above by U~ illillg 1.65 10 grams of DiçA~ m Phosphate; 3.45 grams of CAAl~A,illm Citrate; 2.2 grams of ~l~gnecillm Phosphate; 57.1 mg of Ferric O,ll,ophosphate; 20.06 mg of Zinc Oxide; 0.25 mg of Potassium Iodide; 23.57 mg of Copper ~'lucon~te; and 15.85 mg of ~,Ang, i~ese Sulfate. The vitamin and mineral mixes were then co",bined in a Day mixer along with less than about 20% by weight of mAltodPYtrin (as an 15 excipient) and mixed under the above desc,ibed controlled atmospheric conditions until the product was free flowing and homogenous, and would not separate. The DFEA, dcsc~ibed above, has a DFEA daily portion in a range of about 7.9 to 10 grams.
Similarly, Table IX sets forth another embodiment of a DFEA for 20 use in cereals accor~ g to this invention. The cereals are inten~le~ to be consumed with about 237 mL (8 ounces) of skim milk, i.e., a dairy product ~elected as a supplAmPnt,Al food by the patient. The skim milk supplies some of the vitarnins and minerals, e.g, calciurn, ~upplied in larger quantities in the DFEA described in Table VIII.

wo 96/39050 PCT/USg6/10188 TABLE IX
Vitamin a 1d Mineral Mixture (C~reals) NUI~IENT CONCENTRATION FORM
VITA~N A 2500 IU Vitamin A P~lmit~te S VITA~N Bl 0.59 mg Thi~lnin~
Mono~ ale VITAMIN B2 0.32 mg Riboflavin VITAMlN B3 7.7 mg NE ~i~in~mi~e VITAMINB6 0.84mg Pyridoxine Hydrochloride VITAMIN Bl, 2.4 mcg Vitamin B,~
VITA~N C 140 mg Ascorbic Acid/Sodium Ascorbate VITA~N D 80 IU Vitamin D3 VITAMIN E 15.75 IU Vitamin E Acetate VITAMIN K 35 mcg Vitamin K
BIOTIN 141.75 mcg Biotin CALCrUM 123.6 mg Calcium Carbonate COPPER 1.16 mg Copper Gluconate FOLIC ACID 210 mcg Folic Acid IOD~E 60.38 mcg Potassium Iodide IRON 5.6 mg Ferric Orthophosphate MAGNESrUM 82.4 mg M~ecillm Phosphate/~gneciu m Oxide MANGANESE 1.93 mg M~ng~nese Sulfate PANTOTHENIC ACID 4.5 mg Calcium Pantothenate PHOSPHORUS 38.63 mg ~gne~ m Phosphate ZINC 4.73 mg ZincOxide .

r~col Ic3sls.l CA 02223l02 l997-l2-02 W O 96~9050 PCTAUS96/10188 The DFEA of Table IX was plepared as follows: first, the following vitamin components (available from Roche Vitamins and Fine Chernicals) were co-..l,;.-~ in a Day mixer at room telllpelalllre and under controlled humidity, eg.
in a range of about 35 to 75% RH, to produce a homog~nous vitamin mix: 10 mg S of Vitamin APalrnitate (250 micron spray dried); 140 mg of Ascorbic Acid; 0.8 mg of Vitamin D3 - 100 S.D.; 31.5 mg of Vitamin E acetate 50% (CWSrF); 3.5 mg of Vitamin Kl, 1% (spray dried); 0.59 mg of Thi~mine Monolllllale; 0.32 mg of Riboflavin; 7.7 mg of ~i~r.in~mil1e; 1.018 mg of Pyridoxine Hydrochloride; 0.21 mg of Folic Acid; 2.4 mg of Vitamin B,2, 0.1% (spray dried); 0.14175 mg of Biotin;
10 and 4.9068 mg of Calcium Pantothenate. Second, a mineral mix was separately prepared in a Day mixer under similar conditions to those ~iccnssed above by combining 307.98 mg of Calcium Call,ondte; 86.37 mg of ~gn.o~illm Oxide;
217.36 of ~gnPcil~m Phosphate; 20 mg of Ferric Orthophosphate; 5.9117 mg of Zinc Oxide; 0.0875 mg of Potassium Iodide; 8.285 mg of Copper Gluconate; and 15 5.5619 mg of I~ gi.nese Sulfate. The vitamin and mineral mixes were then colllbined in a Day mixer along with less than about 86% by weight of maltodextrin (as an excipient) and mixed under the above des.,l;bed controlled atmospheric conditions until the product was free flowing and homogenous, and would not separate. The DFEA, described above, has a DFEA daily portion in a range of 20 about 0.86 to 1.6 grams.
Table X sets forth yet another embodiment of a DFEA for use in fortifying soups, stews, pastas, and other retorted, shelf-stable meals and mealcomponents of this invention.

W 0 96~9050 PCTrUS96/10188 TABLE X
Vitamin and Mineral Mixture (Soups and Oth~r Retorted Meals) NUI~IENT CONCENTRATION FORM
VITAMlN A 9000 IU Vitamin A p~lmit~te VITAMlN B, 2.63 mg Thi~minç Mononitrate VITAMlN B2 2.04 mg Riboflavin VITAMINB3 23 mgNE ~i~in~mitle VITAMlN B6 2.5 mg Pyridoxine Hydrochloride VITAMIN Bl? 7.8 mcg Vitamin B"
VITAMlN C 300 mg Ascorbic Acid VITAMlN D 620 IU Vitamin D3 VITAMlN E 45 IU Vitamin E Acetate VITAMIN K 100 mcg Vitamin K, BIOTIN 375 mcg Biotin CALCIUM 1212 mg C~killm Citrate/Dicalcium Phosphate COPPER 3.3 mg Copper Gluconate FOLIC ACID 600 mcg Folic Acid IODrNE 172.5 mcg Potassium Iodide IRON 16 mg Ferric Orthophosphate MAGNESIUM 309 mg ~n.ocil~m Phosphate MANGANESE 5.5 mg Manganese Sulfate PANTOTHENIC 12.5 mg Calcium Pantothenate ACID
PHOSPHORUS 765.14 mg l~gn~ci~lm Phosphate/Dicalcium Phosphate ZINC 16.05 mg Zinc Oxide W O 96/39050 PCTrUS96/10188 Example 2: Bread Products A nutritionally ~l~h~l~ced garlic roll col.,?on~ according to the present invention was formnlAted as follows:
Ingredient P~,~e(bywei~ht) Water 35.6916 Flour, std patent 29.78 Butter 2.98 Salt (NaCI) 0.67 Wheat Gluten 7.45 Yeast Co"~plessed 1.2384 Fructose (Crystalline) 1.49 S-500 Blue Dough Conditioner2 0.6 Traviata Flavoring3 0.6 Solka Floc Fiber4 8.94 Lac Prodan P~oleins 2.98 DFEA 6.33 OnionPowder 1.19 Garlic Powder 0.06 100%
20 To prepare the garlic roll, the water, flour, wheat gluten7 and yeast slurry were u...~ ~lly scaled to a Stefan Mixer for mixing. The re..IA;.~ . ingredients werehand scaled to the mixer. The dough was mixed at a tell~pe~alllre of about 28~C
0.55~ (83~F I 1~). The dough was then divided, relaxed, and shaped into uncooked rolls with a length in a range of about 5.08 to 5.72 cm (2 to 2.25 in.).
25 The uncooked rolls were then proofed for about 55 minllt~s at a telllpeldlure in a range of about 27 to 32~C (80 to 90~F). The proofed rolls were then baked for about 17 minlltes at a tell"~e~ re in a range of about 188 to 221~C (370 to 2 Available from Puratos Col~Jolalion of Cherry Hill, New Jersey.
3 Available from Puratos Co~ lioll of Cherry Hill, New Jersey.

4 Available from Fiber Sales & Development Col~ulalion of Urbana, Ohio.

5 Available from Royal ~l~,s Col~ldtion of R~semont~ Illinois.

W O 96~9050 PCTrUS96/10188 430~F). A~er baking, the rolls were spiral cooled for about 55 minlltes to a tenlpe~a~re of about 13~C (55~F) After cooling the rolls were blast frozen.
Table X~ depicts the vitamin and mineral content of the res~ltinp: fortified garlic roll, which COnlalllS about 25% of the daily DFEA portion in about a 29 gram S serving.
TABLE XI
Garlic Roll Nutrient FulliL~i~
Level VITAMIN A, (~U) 2250 VITAMIND, (IU) 155 VlTAMlN E, (IU) 11.25 VlTAMlN C, (mg) 75 VlTAMlN B" (mg) 0 47 VlTAMlNB2,(mg) 0.51 VITAMIN B3, (mg NE) 5.75 VlTAMlN B6, (mg) 0.63 VITAMIN B,2, (mcg) I .95 BIOTIN, (mcg) 93.75 FOLIC ACID, (mcg) 150 PANTOTHENIC ACID, (mg) 3.13 VITAMIN K, (mcg) 25 CALCIUM, (mg) 303 COPPER, (mg) 0.83 IRON, (mg) 4 MAGNES~UM, (mg) 77.25 MANGANESE, (mg) 1.38 PHOSPHORUS, (mg) 191.29 ZINC, (mg) 4.01 IODINE, (mcg) 43.13 PCT~US96/10188 Example 3: Cereal Products A cereal product, e.g., a raisin bran cereal co~ )oncnl, obtained from Gilster-Mary Lee Col~,olalion of Chester, Illinois, may be nutritionally çnh~nced accordillg to the present invention by adding DFEA thereto and 5 suppk.~ ~ with about 237 mL (8 ounces) of skim milk to form a breakfast meal.
Table XII depicts the vitamin and mineral content of the fortified raisin bran cereal, which when cQ.~ .~ with about 237 rnL (8 ounces) of skim milk, contains about 35% ofthe daily DFEA por~ion in about a 56 gram serving of the raisin bran cereal.

TABLE XII
Raisin Bran Cereal Nutrient Fu~
Level VlTAMlN A, aU) 2500 VlTAMlN D, (IU) 80 VlTAMlN E, (IU) VlTAMlN C, (mg) 140 VlTA~N B" (mg) 0.59 VlTA~ B2, (mg) 0.32 ~lTAMlN B7, (mg NE) 7.7 VlTAMIN B6, (mg) 0.84 VlTAMlNB,7, (mcg) 2.4 VITAMIN K, (mcg) 12.25 BIOllN, (mcg) 141.75 FOLIC ACID, (mcg) 210 PANTOTE~IC ACID, (mg) 4.5 CALCIUM, (mg) 123.6 COPPER,(mg) 1.16 lRON, (mg) 5.6 MAGNESIUM, (mg) 82.4 MANGANESE, (mg) 1.93 PHOSPHORUS, (mg) 38.63 ZINC, (mg) 4.73 IOD~E, (mcg) 60.38 Example 4: Dessert Products A nutritionally enh~nced glaze for dessert product, i e., an apple crisp component, accord"~g to the present invention was form~ ted as follows:
Ingredient Weight (Ibs) Apple Concentrate 147 Natural Apple Flavoring 2.5 FT33 (Flavor F.nh~nc~r) 0.42 Ground Cim1~"on 3.36 Fine Gr~mll~ted Salt (NaCI) 0.32 DFEA 37.6 A~"~ L~,.e 0.84 Starch Slurry 141.75 to 156.75 To prepare the apple crisp glaze, about 57 liters (15 gallons) of water were placed in a kettle, and the apple concentrate was added to the water.The water and apple conce.~ e were ~t~ted in the kettle, and during agitation, the ~ !-, salt, a~al~,le, flavor ~l~h~ncçr, DFEA, and natural apple flavoring were added. The mixture was then gauged to about 265 liters (70 gallons) and heated to a te"-pe,~ure of about 88~C (190~F). As agitation contim~e~l, the starch slurry was added to the kettle mixture and the te~pe~a~ule was simlllt~neously il~ ased to about 91 ~C (195~F). Hot water, eg., water at a te~ )el~ re of about91 ~C (195~F), was added to the kettle mixture to adjust the volume to about 379liters (100 gallons). Agitation of the adjusted kettle mixture was continued until a s~ti~ctory color and viscosity of the mixture was obtained. The kettle mixturewas then ll~lsrtlled for g~lllisl~ing of the apple crisp component.
Table ~II depicts the vitamin and mineral content of the resulting fortified apple crisp, which CQn~ about 18% of the daily DFEA portion in about a 70 gram serving.

PCT~US96/10188 TABLE XIII
Apple Crisp Nutrient Fortification Level VITAMIN A, (IU) 1620 VITA~N D, (IU) 111.6 VITA~N E, (IU) 8.1 VITAMIN C, (mg) 54 VITAMIN B" (mg) 0.34 VITAMINB2, (mg) 0.37 VITAMINB3, (mgNE) 4.14 VITAMIN B6, (mg) 0.45 VITAMIN Bl?, (mcg) 1.4 BIOTIN, (mcg) 67.5 FOLIC ACID, (mcg) 108 PANTOTHENIC ACID, (mg) 2.25 VITAMINK, (mcg) 18 CALCIUM, (mg) 218.16 COPPER, (mg) 0.59 IRON, (mg) 2 88 MAGNESIUM, (mg) 55.62 MANGANESE, (mg) 0.99 PHOSPHORUS, (mg) 137.72 ZINC, (mg) 2.89 IODINE, (mcg) 31.05 Example 5: Starch Products A nutritionally ~h~nced ~l,ip~,ed potatoes component according to the present invention was form~ ted as follows:
Ingredients Weight (lbs) Unsalted Butter 19.4 Non-fat Milk (Spray-dried) 7.14 White Brazilian Pepper (Pulverized)0.21 FineGr~n~ ted Salt (NaCl) 1.26 Water 161.55 Granular Potassium Chloride (KCI) 0.85 DFEA 5.5 Soy Fiber (Fibrim 1200~)6 8 Spice Mix Dehydrated Potato Flakes 54.6 Water (for rehydration) 161.55 To prepare the whipped potatoes col,.ponenls, the spray-dried non-fat milk and sufficient water to rehydlale the milk are added to a Norman mixer. Salt, potassium chloride, white pepper, soy fiber, DFEA, a fluid premix, and melted butter also are added to the mixer, and the co",binalion is mixed until it forms a 20 homogenous solution. The solution then is L~nsr~.led via a C-Bucket or an equivalent to an AMF mixer equipped with a double-wing spade. The potato flakes and rehydrating water are added to the AMF mixer, and the AMF mixer is run at slow speed, e.g, about 40 rpms, until uniform, e.g., for about one minute. The mixer speed then is increased to a medillm speed, e.g, about 100 rpms, until the25 solution is smooth, e.g., in a range of about 3 to 4 minllte~. The whipped potatoes are packaged within about 30 minutes of the completion of mixing or may be covered and refrigerated for no more than about two hours prior to p~Cl~gin~

6 Available from Protein Technology Co~ ion of St. Louis, IUie.eomi.

Table XIV depicts the vitamin and mineral content of the resulting for~fied ~I..pped potato co..lpo~ which contains about 12% of the daily DFEA
portion in about an 80 gram serving.
TABLE XIV
Whipped Potatoes Nutnent F<"l,r.~t,o,.
Level VITAMIN A, (rU) 1080 VITAMIN D, (IU) 74 4 VlTAMlN E, (IU) 5.4 VITA~N C, (mg) 36 VlTAMIN B" (mg) 0.23 VITAMIN B2, (mg) 0.25 VITAMIN B3, (mg NE) 2.76 VlTAM~B6,(mg) 0.3 VITAMIN B~, (mcg) 0.94 BIOTIN, (mcg) 45 FOLIC ACID, (mcg) 72 PANTOTH~IC ACID, (mg) 1.5 VITAMIN K, (mcg) I ~
CALCIUM, (mg) 145.44 COPPER, (mg) 0.4 IRON, (mg) 1.92 MAGNESIUM, (mg) 37.08 MANGANESE, (mg) 0.66 PHOSPHORUS. (mg) 91.82 ZINC, (mg) 1.93 IODINE, (mcg) 20 7 F.lr~mrle 6: Fruit or Vegetable Juice Products A nutritionally enh~need orange juice drink cG-..ponc"l according to the present invention was form~ ted as follows:
Ingl edienl ~e.~e(byweight) Citric Acid 1.2 Potassium Citrate 0.93 Keltrol~) TF Xanthan Gum' 0.20 A~ ,e 0.11 Water 50 Fibersol~P 12.83 DFEA 2.9 Orange Juice Conce,ll,ale 25 Glycerin 3 Beta Carotene 1% CWS 0.06 Orange Booster 0.07 Orange Flavor 0.4 Orange Pulp 3.3 100%
To prepare the orange juice drink, one half of the batch weight of water and 20 Fibersol~) a Maltodextrin fiber source was blended in a Norman mixer for about one minute. A dry blend of citric acid, potassium citrate, Keltrol~ nth~m gum, as},~ ~"e, DFEA, and beta carotene was added to the ingredients in the Norman mixer. The co~,bil-ed mixture was then blended for about another two mimltçs.
Finally, the orange flavors and glycerine were added to the co",bined mixture, and 25 the contents of the Norman mixer are blended for about three more min~1tçs~
A~er the initial blending was complete, the contents of the Norman mixer were l~n~rc~cd to a holding tank. The orange juice concentrate, orange pulp, and remaining water were added to the holding tank, and the contents of the holding tank were thoroughly mixed. A~er final mixing, the contents of the holding Available from Kelco, a unit of Monsanto, of Okmulege, Oklahoma.
8 Available from ~ ...i Co. of Itami City, Hyogo, Japan.

PCTrUS96/10188 tank was ~ red to about 60 grarn ~ 1 gram pouches. The pouches are enclosed in cartons and frozen with dly ice.
Table XV depicts the vitamin and mineral content ofthe r~c~.lting fortified orange juice drink, which co.llaills about 20% of the daily D~EA portion S in about a 60 gram serving.
TABLE XV
Orange Juice Drink Nutrient F~ ~Lcvel VlTAMIN A, (IU) 1800 VITAMIND, (IU) 124 VITAMIN E, (rlJ) 9 VITAMIN C, (mg) 60 VITAMIN B" (mg) 0.38 VITAMlN B2, (m~) 0.41 VITAMIN B~, (mg NE) 4.6 VITAMIN B6, (mg) 0 5 VITAMIN B,2, (mcg) 1.56 BIOTIN, (mc~) 75 FOLIC ACID, (mcg) 120 PANTOTH~IC ACID, (mg) 2.5 VITAMIN K, (mcg~ - 20 CALCIUM, (mg) 242.4 COPPER, (mg) 0.66 IRON, (mg) 3.2 MAGNESIUM, (mg) 61.8 MANGANESE, (mg) 0.66 PHOSPHORUS, (mg) 153.03 Z~C, (mg) 3.21 IOD~E, (mcg) 34.5 Example 7: Soup Products A nutritionally çnhanred vegetable soup component according to the present invention was form~ ted as follows:
Ingredient Weight (Ibs) Dry Beef Stock 6.81 Deh~dlaled Granular Garlic 0.81 Granular KCI 1.62 Gum Arabic 4.32 Maltodextlin 72.43 Salted, Conce.lLraled BeefBone Stock 10.81 BeefFlavor 1.08 Tomato paste 7.57 Liquid, burnt sugar (50% conc~,lL-aLion - 0.049 Gallon) 0.5 Fine Gr~nnl~ted Salt (NaCI) 1.2 Brine (26.4% Salt (NaCI) 4.92 Textured Vegetable Protein Strips (70% Protein) 68.11 Carrots(Freshweight)* 108.11 Celery Stalks (Fresh) 59.46 Potatoes (Fresh weight)* 75.68 Potatoes (cubed-dehydl orl ozel-) 37.84 Beans (1 " cut-bl~nrhe~/frozen) 34 Corn (Yellow-Frozen) 33 Peas (Alaska) 33 Peas (Sweet - Std Grade) 33 Peas (Sweet - Grade B) 33 Tomatoes 200 Oil (Corn) 10.81 Oil (Cottonseed) 10.81 Oil (Cottonseed - Non hydrogen~ted) 10.81 Oil (Soybean - lightly hydrogenated) 10.81 Oil (Soybean) 10.81 DFEA 8.32 Potato Starch 30 W O 96t39050 PCTrUS96/10188 Yellow Dye 9.73 Flavor Fnh~ .ç~ ~ 2.62 $ Bl~nr.hed weight equals about 94.7% offresh weight.

To prepare the vegetable soup, the potatoes and carrots were b!~nch~d for about 5 one minute. The tomato paste, beef bone stock beef flavor, burnt sugar, flavorçnh~nc~rs, yellow dye, maltodextrin, garlic, KCl, salt, and gum arabic were combined with water at a te,l,pelal~lre less than about 82~C (180~F) in a kettle.
The kettle mixture was heated to a tenlpel~ re of about 82~C (180~F), and the t.,ALwed ~ b!e protein and DFEA were added to the kettle. The heating ofthe 10 kettle was stopped, and the potato starch was mixed into the kettle mixture for about one minute. A~er the addition of the potato starch was colllplele, the green beans, peas, corn, potatoes, carrots, celery, tomato pieces, and oils were added to the kettle mixture, and the kettle weight was ~clju~ted Table XVI depicts the vitamin and mineral content of the resl.lting 15 fortified vegetable soup, which cGIlL~ills about 30% of the daily DFEA portion in about a 340 gram serving.

PCT~US96/10188 WO 96~9050 TABLE XVI
Vegetable Soup Nutrient Fortification Level VITAMIN A, (rU) 2700 S VITAMIN D, (~U) 186 VITAMIN E, (IU) 13.5 VITAMIN C, (mg) 90 VITAMIN Bl, (mg) 0.79 VITAMINB2, (mg) 0.61 VITAMIN B3, (mg NE) 6.9 VITAMIN B6, (mg) 0.75 VITAMIN B,7, (mcg) 2.34 BIOTIN, (mcg) 112.1 FOLIC ACID, (mcg) 180 PANTOTHENIC ACID, (mg) 3.75 VITAMIN K, (mcg) 30 CALCIUM, (mg) 363 6 COPPER, (mg) o 9g IRON, (mg) 4 8 MAGNESrUM, (mg) 92.7 MANGANESE, (mg) 1.65 PHOSPHORUS, (mg) 229.54 ZINC, (mg) 4.82 IODINE, (mcg) 51.75 WO 96~9050 PCTrUS96/10188 Example 8: Sauce Products A nutritionally enh~nced fruit sauce component accoldhlg to the present invention was forrn.-l~ted as follows:
In~lc;d;~,.ll Weight (Ibs) Apple Concellllale 55.25 Natural Apple Flavor 2.15 Beet Juice 3.1 Crystalline Fructose 69.85 Citric Acid 1.64 FineGr~n.. l~ted Salt(NaCI) 1.77 Potassium Citrate 1.77 DFEA 8.12 Maize Starch 151.05 to 166.95 Water (for Starch Slurry) 110 15 To prepare the fruit sauce, 57 liters (15 gallons) of water was placed in a kettle, and the apple con~ ale~ apple ~avor, beet juice, fructose, salt, citric acid, DFEA, and potAC' ~11 citrate were added to the water. The beet juice was diluted in a ratio of about 1:1 with water at a tenlpel~Lure less than about 88~C (190~F) before itwas added to the kettle. The contents of the kettle were gauged to a volume of 20 about 284 liters (75 gallons) and then stirred and heated to about 88~C (190~F).
A starch slurry was formed by mixing the starch and water in a Norman mixer.
A~er the initial heating, the starch slurry was screened and added to the kettle, and the kettle contents were reheated to about 91~C (195~F) to fully expand the thickener. The contents of the kettle were then gauged to a volume of about 379 25 liters (100 gallons).
Table XVII depicts the vitamin and mineral content of the res~-lting fruit sauce colll~,onel.l, which contains about 5% of the daily DFEA portion in about a 90 gram serving.

TABLE XVII
Fruit Sauce Nutrient Fortification Level VITAMlN A, (IU) 450 S VITAMIND, (IU) 31 VITAMIN E, (IU) 2.25 VITAMIN C, (mg) 15 VITAMIN B1, (mg) 0.09 VITAMIN B2, (mg) 0 1 VITAMINB3, (mgNE) 1.15 VITAMINB6, (mg) 0.13 VITAMIN B,?, (mcg) 0.39 BIOTIN, (mcg) 18.75 FOLIC ACID, (mcg) 30 PANTOTHENIC ACID, (mg) 0 63 VITAMIN K, (mcg) 5 CALCIUM, (mg) 60.6 COPPER, (mg) 0.17 IRON, (mg) 0.8 MAGNESrUM, (mg) 15 45 MANGANESE, (mg) 0.28 PHOSPHORUS, (mg) 38.26 ZINC, (mg) 0.8 IODINE, (mcg) 8.63 W O 96~9050 PCTrUS96/10188 Example 9: Bagel A bagel, ob~ed from Brooklyn Bagel Boys, Inc. of Franklin Park, Illinois, may be nutritionally enh~n~e~ acco~ g to the present invention by adding DFEA thereto. Table XVIII depicts the vitamin and mineral content of the fortified S bagel, which contains about 5% of the daily DFEA portion in about an 82 gram serving.

TABLE XVIII
Bagel Nutrient Fortification Level VITAMIN A, (IU) 450 VITAMIND, (IU) 31 VITAMIN E, (IU) 2.25 VITAMIN C, (mg) 15 VITAMrNB" (mg) 0.09 VITAMIN B2, (mg) 0.1 VITAMINB3, (mgNE) 1.15 VITAMrN B6, (mg) 0.13 VITAMINBI,, (mcg) 0.39 BIOTIN, (mcg) . 18.75 FOLIC ACID, (mcg) 30 PANTOTHENIC ACID, (mg) 0.63 CALCrUM, (mg) 60.6 COPPER, (mg) 0.17 IRON, (mg) 0.8 MAGNESIUM, (mg) 15.45 MANGANESE, (mg) 0.28 PHOSPHORUS, (mg) 38.26 ZrNC, (mg) 0.8 IODINE, (mcg) 8.63 W O 96~9050 PCT~US96/10188 Example 10: Meats A m~ ionally çnh~nced Salisbury Steak col,.pone." according to the present invention is form~ ted as follows:
IngredientPe.~,~,e(byweight) BeefBoneless 95% 65.2500 Soy Protein Isolate5.3500 Salt 0.2402 Water 16.3793 Potassium Chloride 0.2402 Onions 1/4 IQF 2.4000 Garlic (Ground) 0.2500 Mixed Spices 0.0451 Blk Pepper Gr. 0.0378 Onion Flavor 0.0976 Breading 1.8000 Mixed Spices (fluid)0.0671 BeefFlavor 2.0000 Flavor Additive 0.0732 Sodium Phosphate 0.3305 Potassium Lactate 1.6695 DFEA 3.7195 Flavor F.nh~n~çr 0 0500 100%
To prepare the Salisbury Steak, boneless beef is s~lected which has been 25 sl~ughtered within about 75 days, and ple~,ably, within about 30 days, of thep~ ion date. The beef is tempered to a te",~,t~a~llre in a range of about -4 to -2~C (25 to 28 ~F) within about 36 hours of use. Further, the beef at about -2 ~C
(28~F) is refrigerated and used within 12 hours of reaching -2~C (28~F).
The beef is then ground through a 1.6 cm (5/8 inch) die and is 30 placed in a mixer, such as a Mepaco or Ribbon mixer. Water (eg., 147.3 kgs (324 Ibs)), soy proteirL and DFEA are added to the mixer, and these ingredients are mixed at about 45 RPMs for about 30 seconds or until the in~edients are uniformly - rnixed.

The beef flavor, potassium lactate, flavor .onh~nr~r, mixed spices (fluid), flavor additive, and IQF Onions are then added to the ingredients in the mixer. The beef and fried onion flavors are diluted with water (eg., 17 kgs (37.5 Ibs) water) before they are added to the mixer. In addition, a dry preblend 5 inr~ salt, potassium chloride, sodium phosphate, garlic powder, mixed spices, black pepper, and breading is added to the ingredients in the mixer. These ingredients may be added to the mixer in various orders. The diluted onion flavor, however, is preferably added last. After all ingredients have been added to the mixer, the ingredients are mixed at about 45 RPMs until uniformly mixed, e.g., for 10 about one to three min~ltçs Up to 5% of the total mix weight may be added in the form of previously cooked Salisbury Steak patties. Such patties are reground through a 1.6 cm (5/8 inch) die before addition to the mixer. If the storage te""~e~ ~LIlre of such previous cooked patties is in a range of about 0 to 4.4~C (32 to 40~F), they may15 be l~loul1d and added to the mixer within not more than 14 hours. However, previously cooked patties stored at about -18~C (0~F) in sealed plastic bags maybe used within about 30 days of storage.
The co",l,il1dLion of ingredients from the mixture is then reground through a 0.32 cm (1/8 inch) die. Moreover, the die plate in this grinding is 20 prer~l ~bly equipped with a bone collection device.
The reground mix is then formed into patties with a length of about 13.7 cm (5.4 inches), a thickness of about 1.2 cm (0.47 inches), and a width of about 7.9 cm (3.1 inches). Each of such raw patties weighs about 85 grams (3.1 ounces). The patties are cooked to a minimllm internal th"pe,~ re of about 25 69.4~C (157~F) and until a uniform browned surfiace color is achieved. Each cooked patty weighs about 82 grams (3 ounces).
Table XIX depicts the vitamin and mineral content of the resulting fortified Salisbury Steak patty, which contains about 30% of daily DFEA portion in about a 82 gram (3 ounces) ser~ing.

PCTrUS96/10188 TABLE XIX
Salisbuty Steak Nutrient Fortification Level VITAMIN A, (IU) 2700 S VITA~ND, (IU) 186 VITAMIN E, (IU) 13.5 VITA~N C, (mg) go VITA~N Bl, (mg) 0.54 VITAMINB2, (mg) 0.61 VITAMINB3, (mgNE) 6.9 VITAMlN B6, (mg) 0.75 VITAMIN B,?, (mcg) 2.34 BIOTIN, (mcg) 112.1 FOLIC ACID, (mcg) 180 PANTOTHENIC ACID, (mg) 3.75 VITAMIN K, (mcg) 30 CALCIUM, (mg) 363.6 COPPER, (mg) 0.99 IRON, (mg) 4.8 MAGNESIUM, (mg) 92.7 MANGANESE, (mg) 1.65 PHOSPHORUS, (mg) 229.54 ZINC, (mg) 4.82 IODINE, (mcg) 51.75 Example I 1: Meat Sauces A nutritionally enh~nced Salisbury Steak Gravy co"ll)onent according to the present invention is form..l~ted as follows:
Ingredient Pel ce,l~age (by weight) Burnt Sugar 0.1709 Yeast Extract 0.5100 Beef Base 0.2900 Salt 0.0200 Potassium Chloride 0.0200 BeefFlavor 5.9001 Wheat Flour 2.2100 Mixed Spices (fiuid) 0.0900 Tomato Paste 1.1200 Potassium Lactate 1.5600 Garlic (Granular) 0.1400 Onion Pd. 1.2300 Flavor Fnh~ncer 0 0500 DFEA 0.7857 Modified Food Starch 1.9700 Water Suspension 15.1801 Water Batch 56.9387 SUBTOTAL 88.1999 Sauce From Above 88.2008 Onions IQF 1/4 1.9700 Mushrooms 9.8201 100.0000 To prepare the Salisbury Steak Gravy, the tomato paste is diluted with water andadded to a steamjacketed kettle. The diluted tomato paste is then mixed until 30 homogenous. The beef base, beef flavor, and water C~L about 38 liters (10 gallons)) is then added to the kettle and heated to a boil to dissolve the powdered i l~c:d;~ s. Additional hot water is added to the kettle to increase the volume of the collll,i,ld~ion in the kettle to about 152 liters (40 gallons). Moreover, salt, yeast extract, burnt sugar, potassium chloride, garlic granules, mixed spices (fluid), potassium lactate, and the flavor Pnh~ncçr are added to the col~lbinaLion in thekettle and stirred thoroughly until dissolved. The volume of the kettle contents is then readjl-cted with hot water to about 303 liters (80 gallons), and the kettlecontents are steam heated to at least about 88~C (190~F).
S A thickener slurry is plep~cd by col,lb;llil1g the modified food starch, wheat flour, onion powder, and DFEA with water in a Norman Mixer and mixing the colr~ alion thoroughly. The mixer col,lbinalion is then passed through a 20# mesh screen. Within about 30 minutes ofthe prep&~Lion ofthe slurr,v, the scl ccned slurry is mixed into the kettle contents, and the kettle contents are further heated to about 91 ~C (195~F). A final adjustm~nt is made to the kettle contentsto raise their volume to about 379 liters (100 gallons). The kettle contents are then le~ to stand for about five min..tPc a~er which the volume is re~dj~lcted to about 379 liters (100 gallons) and the mixture is stirred until uniform.
The kettle mixture is then cooled to at least about 21.1 ~C (70~F).
15 The kettle contents are l,~,src,led to a crazy kettle or soup cart, and the mu~hloo"ls and IQF Onions are added to the co",bil,aLion of ingredients. Before adding the mushrooms, however, they must be cleaned and collected in a cooling insert and hllll~c~ed in boiling water. Although the mushrooms are boiled for about five minlltec~ they are rinsed with cold water before addition to the ingredient 20 co~ I;on Thus, the final gravy tclllpclalLlFe is about 18.3~C _ 2.7~C (65~F +
5~F). Preferably, the gravy is applied to the Salisbury Steak patty within aboutthree hours of prepalalion.
Table XX depicts the vitamin and mineral content ofthe rçsl.lting fortified Salisbury Steak Gravy, which contains about 5% of daily DFEA portion 25 in about a 55 gram (2 ounces) serving.

CA 02223l02 l997-l2-02 TABLE XX
Salisbury Steak Gravy Nutrient Fortification Level VITAMlN A, (IU) 450 S VITAMIND, (IU) 31 VITAMIN E, (IU) 2.25 VITAMIN C, (mg) 15 VITAMlN Bl, (mg) 0.09 VITAMIN B2, (mg) 0.1 VITAMINB3, (mgNE) 1.15 VITA~NB6, (mg) 0.13 VITAMINBI7, (mcg) 0.39 BIOTIN, (mcg) . 18 75 FOLIC ACID, (mcg) 30 PANTOTHENIC ACID, (mg) 0.63 VITAMIN K, (mcg) 5 CALCIUM, (mg) 60.6 COPPER, (mg) 0.17 IRON, (mg) 0.8 MAGNESIUM, (mg) 15.45 MANGANESE, (mg) 0.28 PHOSPHORUS, (mg) 38.26 ZINC, (mg) 0.8 IODrNE, (mcg) 8.63 25 Example 12: Meals This example demonstrates the prepalalion of prep~cl~ged meals according to the present invention. Soup meals were prepaled by retorting as described above and other meals were frozen. The nutritional characteristics of certain breakfast meals are shown in Table X~, lunch meals are shown in Table X~I, dinner meals are shown in Table ~II, and snack meals are shown in Table X~V.
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m z ~ E Ee - E' W O 96~9050 PCTAJS96/10188 Example 13: Organoleptic Storage Program This example dçmonctrates the results of organoleptic testing of a nutritionally enh~nced frozen meal according to the present invention. The meal comprises a pasta co~.ponenl, a garlic roll component and a fruit compote S co...pone~L. The test is d~cignçd to evaluate the ability ofthe therapeutic meals and Lh~euLic meal products to ""~ avor, aroma, appe&~lce, and the like, when stored for periods up to nine months under retail storage conditions, i.e., at about -18~C (0~F). Results are set out on Tables XXV, ~VI, and XXVII below. In ~rlitiQn, a terminology key co~ in;ng dçfinition~ and reference points is inr.luded 10 for each theldp~ulic meal co...ponel.l described in the tables.
Intensity Scale 0.0 = none 1.0 = threshold 2.5 = very slight 5.0 = slight 7.5 = moderate 10.0 = moderate 12.5 = moderate to extreme 15.0 = extreme NR = not rated V = variable Tnt~n.~itiçs TABLE XXV
Garlic Roll StorageTime rNITIAL 1 3 6 9 (-18~C(0~F)) (s 2 MONTH MONTHS MONTHS MONlHS
Weeks) APPEARANCE
Yellow (inside) 3 4 3.5 4 3.5 Brown (outside) 6 7 7 7 7 AROMA
Stale Freezer 5 3 4 5.5 V 5 V
Yeasty/Wheaty 4 4.5 4 4.5 4 Sour 3 3 2.5 3 3 Vegetable 2.5 3 3 4 3 Sweet Aromatics 3 1.5 2 2 3 GarlicAroma NR NR 2 0 0 FLAVOR
Stale Freezer 5 5 4 5 5.5 V
Yeasty/Wheaty 4 5 4 4.5 4 Sour 3 3 2.5 2.5 2.5 Vegetable 3 2.5 3 4 3 5 Sweet 2 2 2.5 2 2 Astringent 3 3 2 3 2 Garlic Flavor NR NR 2.5 0 0 Bitter Aftertaste 2 2.5 2 2 2.5 (30 sec.) Chalky Aftertaste 3 3.5 4 V 4.5 3.5 V
TEXTUR~
Chewiness 5 6 5 5.5 V 5.5 V
Dryness 13 11 12 12 10.5 wo 96/39050 PCT/US96/10188 TABLE XXVI
Pasta With Meat Sauce Storage Time (-18~C(0~F)) INITIAL I 3 6 9 (s 2 Weeh~ MONTHMONTHS MONTHS MONTHS
APPEARANCE
~u~u~iul~ofVegetableMeat 11 11 IOV 9V 9 Sauce to Pasta Orange/Red(Orange - Red) 6 7 7 7 7 Amount of HerbParticles 5 4 4.5 5.5 4 5 AROMA
Green Bell Pepper 6 5 7 V 6.5 V 7.5 V
BlackPepper 3 3 5 V 5 5 V
Italian Herbs 6 5 7 8 7.5 V
Cooked Tomato 2 5 3.5 4 5 FLAVOR
Green Bell Pepper 6 6 4.5 5.5 6 Black Pepper 4 4.5 5 6 6 V
Italian Herbs 5.5 6.5 7 7 6 V
Chemical Heat 7 6 6.5 6.5 6.5 V
CookedTomato 3 6 4 5 6 V
Sweet 2.5 2 3 2.5 2.5 Sour 3 2 3 3 2 Salt 3 3 3 3 5 3 Chemical Heat Aftertaste (30 NR 7 5.5 8.5 6.5 sec.) Chemical Heat Aftertaste (I 10 8 7 7.5 5.5 min.) 1 ~;~'1 U~E
First Bite:
Firmness (Pasta) - First Bite 5 4 4 4 4 Chew Down:
Chewiness (Whole Product) 4 4 4.5 V 4.5 3.5 TABLE XXVII
Fruit Compote Storage Time INITIAL 1 3 6 9 (-18~C(0~F))(s 2 Weeks) MONTH MONlHS MONTHS MON~HS
APPEARANCE : :
Pink/Purple 7 8 7.5 7.5 7.5 Color SaucefFruit 10 9 9 8 8 Ratio Red Specks 7.5 8 6 7 7 RedResidue 11 10 7.5 8.5 10 on Spoon/Bowl AROMA
Fermented 5 5 6 6.5 6 V
Sweet 4 5 4 5 5 Aromatics Fruity 7 7 6 5.5 5 FLAVOR
Cooked Apple 5 4 4 4 4 Stale Freezer 3.5 2.5 2 3 2.5 Cooked Pear 2.5 2.5 V (0- 3 V 3.5 4.5 5) Sour 6 5 4.5 4.5V 4V
Sweet 5 4 4 V 4.5 V 4.5 Bitter NR NR 2.5 2 2 F;,l,lness 7 6.5 7 6 6 (Molars) Viscosity of 3.5 4 4.5 V 4.5 4 Sauce Chew"~ess 6.5 5 6 5 5 PASTA Wl~ MEAT SAUCE
GARLIC ROLL DEFINmONS OF TERMS
APPEARANCE
Yellow Color Inle.~sily of yellow color going from light to dark (3.0 = Ivory Chalk). Rate inside of roll.
5 Brown Color Intensity of brown color going from light to dark (7.5= Raw Sienna Crayola~) Crayon, 15.0 = Sepia Cl~ola~ Crayon). Rate outside of roll.
AROMA/FLAVOR
Stale Freezer Characteristic aroma/flavor of an undefrosted freezer.
Yeasty/Wheaty Bakery-like aromatics Ik~ ce~,l of yeast leavened wheat bread.
Sour Aroma Aroma colll"lon to products that taste sour.
10 Vege~able Aroma/flavor remini~cent of vegetables in general.
Sweet Aromatics Aromatics common to products that taste sweet such as caramel, honey, brown sugar, maple syrup, and butterscotch.
Sour Flavor One of the four basic tastes, perceived primarily on the sides of the tongue; collllllon to acids such as citric acid and acetic acid (vinegar).
Sweet One of the four basic tastes, perceived primarily on the tip of the tongue; common to sucrose and other sugars.
A~llingenl Puckering or mollthtlrying s~n~ti~n felt in the oral cavity caused by ~ubsl~lces such as tannins (in tea) and alum (in pickles).
15 Bitter A~ertaste One ofthe four basic tastes, perceivt;d primarily at the back of the tongue; common to c~ in~ and quinine.
Bitter aftertaste rated about 30 seconds after ~,A~e~l a~ g.
Chalky A~ertaste The lingering sensalion of fine particulate matter similar to chalk powder.

l~;Xl U~E
Chewiness Degree to which sample takes a large number of chews until ready for swallowing (not chewy to e~.L~ ely chewy).
Dryness Lack of moisture in product when chewed and manipulated.

PASTA WlIH MEAT SAUCE
PASTA COMPARTMENT DE~lNmONS OF TERMS
APPEARANCE
Orange/Red Color Amount of color (hue) present in the sample.
Rated orange to red. (7.5 = Burnt Orange Crayola~}) Crayon).
Amount of Herb Particles Amount of herb-like particles perceived in products.
AROMA/FLAVOR
Green Bell Pepper Aroma/flavor associated with green bell p~pe~
Black Pepper Characteristic aroma/fiavor of ground black pepper. Rated none to extreme.
Italian Herbs Aromatics rçmini~cçnt of Italian herbs such as basil, oregano, rosemary, tarragon, and thyme.
Cooked Tomato Aromatics r~miniscçnt of cooked tomato as del.,ollsl,~ted by canned tomato paste.
Chemical Heat Burning sensation in the mouth caused by spicy foods such as capsaicin (red pepper) and piperine (black pepper). Not related to the telllpe~ re of the food. Rated none to extreme. Chemical heat aftertaste is rated one minute after expectorating.
Sweet One ofthe four basic tastes, perceived primarily on the tip of the tongue; common to sucrose and other sugars. Rated none to extreme.
Sour One of the four basic tastes, perceived primarily on the sides of the tongue; common to acids such as citric acid and acetic acid (vinegar).

W O 96~9050 PCT~US96/10188 Salty One of the four basic tastes; perceived primarily on the side of the tongue; colnl~on to sodium chloride (table salt). Rated none to extreme.
PIOPGI lion of Vegelable Pl OpGI Lion of sauce to pasta. A sample with an Meat Sauce to Pasta equal amount would be rated a 7.5 [rated from 100% sauce (~, 0) to 100% pasta (i.e., 15)].

I ~;X l UKE
Firmness of Pasta The force to attain a given de~ollllalion; force to bite through with molars (incisors) or COlllp-cSS
against palate (tongue). Rated soft to fi~n.
Chewiness of Whole Degree to which sarnple takes a large number of Product chews until ready for swallowing. Rated not chewy to extremely chewy.

PASTA WITH MEAT SAUCE
FRUIT COMPOTE DE~lNmONS OF TERMS

Pink/Purple Color Amount of color (hue) present in the sample.
Rated pink to purple. (7.0 = Salmon Crayola~
Crayon).
Sauce/Fruit Ratio Pl opol lion of sauce to fruit. A sample with an equal amount of both shall be rated in the middle.
(100% sauce to 100% fruit).
Red Specks Amount of red specks appealing in sauce. Rated none to extreme.
Red Residue on Amount of red streaking and bleeding of color Spoon/Bowl left on spoon and bowl after tasting.
AROMA/~AVOR
Fermented Aromatic associated with products that have been fermented (e.g., wine, beer, bread) perceived at high levels in bread when the yeast has been ferrnented almost completely. Also, a characteristic flavor of fruit that has undergone fcllllcll~alion during storage.

-Sweet Aromatics Aromatics co~ on to products that taste sweet such as caramel, honey, brown sugar, maple syrup, and bul~ co~ch.
Fruity Aromatics CO~ llOn to fruits in general.
Cooked Apple Characteristic aroma/flavor of cooked or baked apples.
Stale Freezer Characteristic aroma/flavor of an undefrosted freezer.
Cooked Pear Characteristic aroma/flavor of cooked pear.
Sour One of the four basic tastes, perceived primarily on the sides of the tongue; co----l.on to acids such as citric acid and acetic acid (vinegar).
Sweet One of the four basic tastes, perceived primarily on the tip of the tongue; common to sucrose and other sugars. Rated none to extreme.
l ~;X I IJ~E
Firmness The force to attain a given d~fc,-l.. alion; force to bite through with molars.
Viscosity of Sauce Force required to manipulate sample with tongue.
Rated thin to thick or none to ~,~lle..,e.
Chewiness Degree to which sample takes a large number of chews until ready for swallowing. Rated not chewy to extremely chewy).
REFERENCES FOR PASTA WITH MEAT SAUCE
ROLL COMPARTMENT

APPEARANCE SCALE
VALUE
Yellow 3.0 Alpha Ivory Chalk Brown Color 7.S Raw Sienna Crayola~) Crayon 10.0 Sepia Crayola~ Crayon W O 96/39050 PCTrUS96/10188 AROMAI~LAVOR AROMA FLAVOR
SCALE SCALE
VALUE VALUE
Yeasty/Wheaty 6.0 4.0 Bridg~rulJ~) bread dough, thawed Sour 2.0 about 0.025% citric acid in purified water Sweet 2.0 about 2% sucrose in purified water S Astringent 3.5 about 0.04% alum Chalky a~le,l~le 4.0 Raw potato l~;Xl UKE
Chewiness 4.0 Hebrew National~) Frankfurter Dryness 15.0 Nabisco~ Unsalted Tops Premium Crackers REFERENCES FOR PASTA Wl~ MEAT SAUCE
PASTA COMPARTMENT
APPEARANCE SCALE
VALUE
Vegetable Meat 0.0 about 100% Sauce Sauce/Pasta Ratio 7.5 about 50% Sauce, about 50% Pasta 15.0 about 100% Pasta Orange/Red Color 7.5 Burnt Orange Crayola~) Crayon Arnount of Herb 4.0 about 0.05% CVC parsley granules in Particles 6.0 water 9.0 about 0.10% CVC parsley granules in 1 1.0 water about 0.15% CVC parsley granules in water about 0.20% CVC parsley granules in water W O 96~9050 PCTAUSg6/10188 AROMA/FLAVOR AROMA FLAVOR
SCALE SCALE
VALUE VALUE
Green Bell Pepper 9.0 6.0 Green bell pepper, 1" pieces cooked in boiling water for about 5 mimltes Black Pepper 6.0 8.0 about 0.2%
S~hilling~) black pepper in purified water Italian Herbs 10.0 8.0 about 0.2%
Scllilling~) basil in purified water Chemical Heat --- 15.0 Ortega~ jalapeno peppers Cooked tomato 10.0 10.0 Contadina~) tomato paste Sweet --- 2.0 about 2% sucrose in purified water Sour ~ 2.0 about 0.025% citric acid in purified water Salt --- 2.0 about 0.2% sodium chloride in purified water l~;Xl UKE
Firmness 4.5 Kra~) Deluxe American Cheese Chewiness 4.0 Hebrew National~
Frankfurter wo 96/39050 PCT/US96/10188 REFERENCES FOR PASTA Wll~ MEAT SAUCE
FRUIT COMPOTE COMPARTMENT

APPEARANCE SCALE
VALUE
Pink/Purple Color 7.0 Salrnon Crayola~ Crayon S Sauce/FruitRatio 0.0 about 100% Sauce 7.5 about 50% Sauce, about 50%
15.0 Fruit about 100% Fruit AROMA/FLAVOR AROMA FLAVOR
SCALE SCALE
VALUE VALUE
Fermented 7.5 --- Budwc;isel~) Beer Sweet Aromatics 8.0 8.0 Brown Sugar Fruity 7.0 7.0 Del Monte~ fruit cocktail Cooked Apple 4.0 4.0 RedDelicious, 1" pieces cooked about 5 minutes in boiling water Cooked Pear 6.0 6.0 Del Monte~ canned pear Sour 5.0 about 0.04% citric acid in purified water Sweet 5.0 about 5% sucrose in purified water I~;Xl UKE
Firmness 7.0 Starr Queeng) Size Spanish Olives, pimento removed Viscosity 4.0 Carnation~ evaporated milk 5.0 Heavy cream Chewiness 6.0 Brach's~) Perky's Fruit Bunch CA 02223l02 l997-l2-02 W O 96/39050 PCTrUS96/10188 Example 14: Clinical Trials A clinical trial was ~n~ln~.ted of a diet system which provided daily recor............. ~ ed dietary levels for vi~ ns and minerals as spe~ified by the NAS/NRC Reco.. ~.~ded Daily Allowances and followed the dietary gl~idelines 5 of the AHA for total fat, saturated fat, cholesterol, and sodium and the American Diabetes Association recG.. - n~tionC for redu~ing simple sugar intake.
The objectives of this clinical trial were to investigate the acceptability of following a diet prtpal~d accordil~g to the invention (hereinafter "Prepared Diet") in adults with suboptimally controlled GCMD, to d~L~ e the 10 di~ ,lce b~lweel~ the control and eA,uelilllel~Lal groups on the outcome variables:
body weight, blood plc~ure, fru~ilos~ ; .e, plasma glucose and plasma lipid levels, insulin, hemoglobin (Hb) A~c~ acceplability and s~tisf~ction with diet, compliance with pl~ililed diet, and quality of life. The trial was also to ,llonilor the safety of the P~epal ed Diet by monitoring nutritional intake in plasma vitamins (Vitamin A
15 and Vitamin D) and mineral (iron), and trace minerals levels.
The trial was de~ d to be a multi-center r~n~omi7~, prospective study co~ l;..g of two periods: Period 1: a four week baseline of usual diet andPeriod 2: a ten week intervention period of an individually plt:sclibed diet using a Prepared Diet (~, the expe,i"lell~al group) vs. self-selected foods (~, the 20 control group). During the b~c~line period, patients followed their usual diets.
During the intervention period, the e ~c-im~ al group co.. ~ ced the Prepared Diet. The patient population consisted of about 560 male and female patients (about 80 to 160 per category), who have been advised by a physician to modify their dietary lifestyle as the first approach or in conjunction with other medical 25 therapy in order to manage any one of the following four diagnostic categories:
Category Cl: mild to l"odt;~Le ess~nti~l h~"~e, l~,ns;on, Category C2: hyperlipidemia;
Category C3: non-insulin treated diabetes mellitllc; and Category C i two or allthree of the above Categories C,-C3 All subjects were required to meet the following criteria:

1. Age bcLween about 25 to 70 years of age;
2. Females subjects of child bearing potential must use an accepted method of birth control;
3. Body Mass Index ~ about 42 kg/m2;
4. Able to comply with following the Plepared Diet for all meals during the intervention period; and 5. Able to sign illÇul~led consent and comply with all study procedures.
Additionally, the .li~ostic category specific criteria were:
CATEGORY Cl - Mild to Moderate Essential II~,e. l~nsion. Either:
1. a. On no antihypertensive me~lic~tion and b. Average sitting r~ olic blood pressures of about 90 to 105~ mmHg and/or sitting systolic blood ples~lles about 140 to 180~ mmHg;
or 2. a. S~bil;~d on antihy~ e ~ ;on for at least one month prior to study entry and b. Suboptimally Controlled with diastolic about 85 to 100 mmHg or systolic about 135 to 180 m~nHg esse~ti~l hypertension.
CATEGORY C2 - Ely,~ idemia. Either:
1. a. On no lipid lowering agent and b. Total rholestProl of about 220 to 300 mg/dL, and/or triglycerides about 200 to 1000 mg/dL;
or Any patient who exce~As any upper limits in any categ~l ~ was not enrolled into the study in that ûr any other ~tego- ~.

W O 96~9050 PCT~US96/10188 2. a. Stabilized on lipid lUWC~ lg agents for at least one month prior to study entry and b. S~o~;,..ally controlled with cholesterol about 200 to 260 mg/dL and/or triglycerides about 200 to 1000 mg/dL.
CATEGORY C3- Non-insulin Dependent Diabetes. Either:
1. a. On no hypoglycemic agent and b. Fasting plasma glucose level 2 about 140 mg/dL
and HbAIc s about 200% of median for assay (<
about 15.4);
or 2. a. Stabilized on oral hypoglycemic agents for at least one month prior to entry and b. Suboptimally controlled with HbAIC, about 100 to 17~% of median for assay (about 7.7 to 13.48).
CATEGORY C4: Meet the criteria for two or all three of the above diagnostic ca~ego~ies.
Other exclusion criteria included:
1. Serious abnorrnality on physical scleel ing blood work or ECG;
2. Renal disease with serum c-eali~line greater than about 1.8 mg/dL;
3. Myocardial infarction within about 6 months, angina pectoris congestive heart failure insulin ~ ..e~.l for diabetes or secondary forms of hypertension;

~Any patient who eYeee~s any upper limits in any calegol ~ was not enrolled into the study in that or any other ca~ego, ~.

4. Any chronic life-thre~t~ning disease insl~ltling active m~lign~nr.y, active infl~mm~tory bowel disease, active immllnological disorders;
5. Any patient who eYcee~s any upper limits in any category was enrolled into the study in that or any other category.
6. Any gastrointestin~l disease that would interfere with the absorption and/or excretion of dietary products;
7. Any woman who is l:~ctslti~, plC~;llall~ or ;~ n~ g to become prcgnalll during the course of study;

8. History of ~ ce abuse within about the past 12 months;

9. Current alcohol abuse as defined by more than two "yes"
answers to the CAGE questions;

10. Unwilling or unable to discG"Li"-le any vitamin or mineral supple~"~"l or both;

11. Il"pai""enl of intellectual or psychological functioning which would prevent undt,~l~nriing the consent form or having normal psycho-social function; and 12. Currently partin;p~;ng in another study.
All patients are encouraged to drink at least about six to eight 20 glasses, i.e., about 1421 to 1894 mL (48 to 64 ounces), of water per day. In addition, patients were allowed to consume non-caloric beverages at their own discretion inr~ i~ black coffee, tea, club soda, diet soda, unflavored seltzer water, or mineral water. Cong~mnrtion of alcohol was discouraged. However, a maximum of two alcoholic beverages (e.g., about 355 mL (12 ounces) of beer, 148 mL (5 25 ounces) of wine, or 30 mL (I ounce) of distilled spirits) per day was allowed for patients whose dietary intervention innl~lded greater than about 1500 calories and who wished to con.~me alcohol. Any alcohol con.C ~mrtion, however, was factored into the pres~ilibed caloric levels for both the prepared and control diets.

W O 96~9050 PCTAUS96/10188 If all initial sclee~ g criteria were met, p~tientc entered the four week baseline period. Patients were instructed to follow their usual diet and tokeep three day food records during the b~celine period. All p~tiPntc had biweekly evaluation visits, and patients whose ...~ ;on for ll e~ of one of the disease 5 categories c~ Ped or who failed to keep the required food records or failed tocooperate with all col~.pol enls of study, were eYcl~lded prior to randomization. If all study criteria were met at Week -2, patients were randomized to receive either the Prepared Diet or to self select foods for their presc,il,ed diet. Patients were unaware to which group they had been ~ssi_ned until Week 0.
After the b~celine period, all patients were given an individually prescribed diet and then were randomized equally into the c~lJ~;lilll~;lllal group which received the P~L~d Diet and the control group which self-selected foods.
Randomization was done centrally with str~tifi~tion for each of the diagnostic categories and clinical centers. All individually prescl;lJed dietary intervention was 15 de,si~ed for either moderate weight loss or weight m~int~n~nce depell~1;..g on the patient's needs.
The appro~,lia~e caloric level for each patient was c~lc~ ted using age, body weight, height, gender, and level of physical activity. Normal weight patients were prescribed a diet having an app,~,p,iate caloric level. If weight loss 20 was needed or desired, the patient and a nutritionist together determined an applo~Jl;aLe weight loss goal to achieve over the 10-week intervention period. This level did not exceed about 0.91 kg. (2 Ibs.) per week after the first two weeks for a total not to exceed 10.91 kgs. (24 Ibs.) total over the intervention period. The prescribed caloric intake was not lower than about 1200 calories per day for any25 patient. Using the caloric level determined by the nutritionist according to known equations, and the agreed upon weight loss goal, the applu~liale caloric level for weight loss may be determined.
The caloric level is c~lc~ ted by entering patient specific data into the gender specific Harris-Benedict equation. First, the patient's sex, weight (W) W O 96/39050 PCT~US96/10188 (in ~lograms), height (H) (in c~ ), and Age (A) (in years) are determined.
The patient's activity level then is dete.l..ined from the following scale.

Very light 1.3 (about 10 hours rest, about 14 hours of very light activity) Light 1.5 (sed~-nt~ry job, minim~l leisure time activity) Light-moderate 1.625 (sedçnt~ry job, about 2-3 hours regular leisure-time) activily/~,e~) Moderate 1.75 (sedçnt~ry job, > about 3 hours regular leisure-time acti~ y/~eel~) Strenuous 2 (light-moderatemanual labor) Very Strenuous 2.3 (heavy labor) The weight, age, height, and activity values are then entered into the following10 gender-correct equation:
Males:
[66.5 + (13.8 x W) + (5.0 x H) - (6.8 x A)] x activity allowance Females:
[6S5 . I + (9.6 x W) + ( 1. 8 x H~ - (4.7 x A)] x activity allowance Patients randomized to the expe,i.. enlal group received the P~t;p~ed Diet. Foods provided in the P~ t;d Diet were form~ ted in accordance with dietary recon--"endations specified by the NASINRC Reco.. -~led Daily Allowances for vitamins and minerals and for protein, carbohydrates, and fiber.
These reco.. el-d~tions incl~lded a dietary profile that provides less than about 20 30% of calories from fat, about 15 to 20% of calories from protein, and about 55 to 60% of calories from carbohydrate as well as control of simple sugars. In addition, the Prepared Diet satisfied the reccs,.. en-led dietary levels, inf.~ ing those for macro- and micronutrients specified above, in q~l~ntities that were shown to be h"pol~anl for disease management. These recomm~.n~ed dietary levels 25 include low levels of sodium and refined sugart and adequate-to-high levels of W O 96/39050 PCT~US96/10188 Plep~d Diet had fat (about 20 to 30% of calories), saturated fat (about 7 to 10%of calories), cholesterol (less than about 300 mg), sodium (less than about 3000mg), and simple sugars are controlled such that the diet in~hldes less than about 96 grams.
S Food intakes for no~mal weight patients on the Prepared Diet were based on about a 1500 calorie diet in which caloric intake may be increased through the ~rlition of provided adjustors. For all subjects in the Pl~?ared Diet group who consume up to about 2600 calories/day, the number of entree items rPm~inP,d constant, but the number of adjustors, e.g., bagels, pretzels, and low-fat yogurt, 10 was varied accoldi-~g to caloric pres,,,i~ on. These adjustors consisted of about 170 to 200 calories per serving and were low-fat, i.e., less than about 3 grams of fat per serving. Patients with high daily caloric needs were permitted to consume additional meals, as shown in Fig. 2.
Food intakes for patients on the Pl~ared Diet, who were also on 15 a weight loss program, were based on a about 1200 calorie diet. Consumption of the daily entrees yielded an average daily intake of about 1135 calories. The addition of either about 100 calories of supplemental foods selected from the groups consisting of fruits, vegetables, or low or nonfat dairy products provided a total of about 1235 calories.
Patients li.,--lo~ A to the Pl~aled Diet group were provided with their breakfast, lunch, and dinner entrees and needed adjustors. Patients selected food varieties by specifying a menu selection before hand. These foods provided subjects with nearly all foods that they required to complete the intervention s lcc~c.cfillly. Supplc .~ foods were not provided, but included one serving of a low-fat dairy product, a one cup serving of fruit, and a one cup serving of vegetables to be concllrned daily.
Patients r~n-lomi7ed to the control intervention group followed the AHA and ADA leco.~.l..e~ tions. These lecor,,,,,~n-l~tions incl~lded a diet consisting of about 20 to 30% of calories from fat, about 15 to 20% of calories from protein, and about 55 to 60% of calories from c~bohydl~Le, as well as control of simple sugars. While p~tientS on the control diet were instructed how to make~p.u~,-;ale food selections to achieve m~imllm co...~ nce unlike the patients inthe P~ c~al ed Diet group, these control group patients were not provided the actual 5 foods to comply. The control group did not have the benefit of D~EA fortified foods.
Week 0 begins the ten week intervention period. At this time, all patients met with the nutritionist to receive instructions for an individuâlly prescribed thc;l~eulic diet. During their next study visit, patients met with the 10 nutritionist for follow up and review of diet instructions. No cou.~çl;..p, session occurred after Week 2. However, all palicnls were monitored every two weeks.
At each visit, three day food records were collected and reviewed with the nutritionist, and the eA~e~ul.e.ltal group ordered their ~l~ared Diet items from the menu sPlectiQn for the next two weeks. The ~ epared Diet was provided by home 15 delivery or picked-up by the patient at a predete..lul.ed site.
The st~ticti~ analyses con.iJa.~d the ~;I.anges from bac~line to the end of the Ll eàLIll~ periods between the prepared diet and control diet for each of the primary, secon~,y, safety, and c~...pli~-çe endpoints using a repeated measure ANOVA model. Objectives ofthe st~ti.ctic~l analysis were to determine (1) the 20 effects ofthe Plcpaled Diet on selected medical e.-dpoi--ls and (2) the acceptability offollowing the Ple~ d Diet in patients with the medical disorders studied herein.
The primary endpoints for the effect of this diet inçlllded change in blood pressure, plasma glucose levels, plasma lipid levels, and quality of life. In addition, an analysis was done to determine the safety (e.g., to identify adverse effects) of 25 this diet by ~Cce~ ~p change in select vitamin levels, serum iron, and trace minerals.
Compliance was assecsed by ev~lu~tin_ food records, body weight, and urinary electrolyte excretion. To this end, the plOpOI Lion of prescribed foods consumedco..e~i~ly and dietary non-co~..pliAIlce (eating foods outside the presc.ibed diet) was measured. This rate was ~ccessed weekly for trends, with non-co...~ l.çe of greater than about 80% deçmed lln~cceptable. Study dlo~,oul rates were also co..,pdled beLween the groups.
The equality of randomization was tested t~,lween the ~l e~
groups and among the centers; adjl.~ ............ le were made as approp.iale. An S intention to treat analysis was p~,.r~... ed, inc~ ing all individuals randomized regardless of compliance or withdrawal. Major sources of variation that may contribute to di~rences in response inrl~lded: error in recalling diet, cultural, geographic and climatologic variation among the centers, activity level, seasonal effect, cigarette smoking, alcohol consumption, and plesc.il,ed merlic~tion.
Blood pressure were measured using a standard mercury sphygmomanometer according to the American Heart Association ~lid~linec.
After resting five minlltçs~ two supine followed by two sitting blood pressure measu~t;...en~ were recolded.
Dietary records were collected throughout the study in order to 15 accomplish distinct goals. The first goal was to characterize the usual diet of all subjects during the baseline phase. The second goal was to monitor food intake in order to assess the con.cllmed diet against the prescribed diet. Three-day food records were recorded by patients and collected by the nutritionist beginnin~
baseline Week -2. This resulted in two sets of three day food records recorded 20 during the baseline period and five sets of three day food records during theintervention period. Patients recorded their intake on three non-consecutive days specified by the nutritionist, and were given appl op.iaLe forms at each clinical visit.
During the study visit, patients were interviewed by the nutritionist for co.,.l-'et~ -e~ ofthe food records. Any additions or deletions to the prescribed diet 25 were doc~lm~nted in these records.
Food records then were analyzed using the NCC nutrient data base.
Compliance was monitored primarily by subjective measures. These inr.l~lded completion of food records by the patient, nutritionist interviews for food intake, monilo,ing of menu selections by the intervention group, and ~ nd~nce at regularly sçhedl~led clinic visits. Objective measures of dietary compliance also were monitored by colllt,a,ing actual and projected weight m~int~n~nce or loss, urinary electrolytes excretion, and analysis of food records.
S Acceptability of P~ ~aled Diets was measured, inter alia, by two questior~ailes directed to the quality of the diet and s~ticf~tion with the diet1r~ed throughout the study. The questions ~sessed the quality of life and s~ti~f~ction with diet. In addition, the completed scores from the two questionn~iles were co,l",aled between the control and tr~tm.ont groups by two 10 sample non-p~al"el,ic or pala~ llic methods as approplia~e. Saficf~ction withdiet also was a~sessed by a Diet S~ti~f~ction Scale that was developed to assessglobal and specific aspects of dietary s~fi~f~ctiQn. Additionally, quality of life measurtl~,enl~ were effected by a battery of tests. At present, there are no scales specifically designed to measure the impact of nutrition on quality of life.
15 Therefore, a battery of tests consisting of eslablislled quality of life instruments along with three new scales that were specific~lly designed to assess the impact of nutritional interventions on quality of life were s~lected. This battery provides a broad profile of quality of life that is sensitive to dietary manipulations. Theprimary indices of quality of life are the Mental Health Index and the General 20 Health Perceptions scale. These instruments were developed by the Rand Co",ol~lion for the Health Insurance Study and generally are considered among the best available instruments for measuring quality of life. Additional tests were ~rlTnini~tered which measure the effects of diet on daily activities, work activities, nutrition hassles, nutrition and social function, nutritional health, and nutrition and 25 affect on diet-le~l,o~ e conditions. Thus, at least eight qu~ e quality of life measu, ~"~e"l~ were obtained for each patient during the baseline and intervention penods.
The clinical trials demonstrated that the system of the invention s lcceeded in reducing blood pressure for hypertension, reducing serum cholesterol W O 96/39050 PCT~US96/10188 and other lipid levels for hyperlipidemics; rec~lcing or ~-.A;.-~ ;ng plasma glucose levels for diabetics; providing positive nutritional b~l~nce, as measured by blood and urine analysis; and irnproving the p~fi~nt.c' quality of life, as measured through the qu~ctiG~ es described above. Results of the clinical trials revealed that over 5 a ten week intervention period, the systems and methods described herein may achieve a red~lction in systolic blood pressure of as much as about 7 mmHg and of .cto!iG blood pressure of as much as about 4 mmHg. Further, in hy~e~ idemics, total serum cholesterol may be reduced by as much as about 15 mg/dL, and in particular, triglycerides may be reduced by as much as about 13 mg/dL and LDL
10 may be reduced by as much as about 10 mg/dL. In addition, HbAlC in diabetics may be reduced by as much as about 2%.
Thus, at the conc~ on of the clinical trials, it was dete"",ned that the therapeutic meals and individual therapeutic food products were well tolerated by the patients. No cignific~nt adverse reactions were observed in either the 15 control or ~lè~aled Diet group. In addition to the specific improvements in the qll~ntifi~ble indicators of diet-responsive conditions ~iiccllcsed above, the clinical trials revealed improvements in the quality of life of patients' con.cllming therapeutic meals and therapeutic food products according to the dietary health management system of the present invention. Further, these improvements were 20 significant even in co",?a,ison to the control diet.
Referring to Figs. 3a-c, the charts depict the results of the clinical trials with regard to the reduction of blood pressure and cholesterol levels forhypertensives. The charts compare the reduction in systolic and diastolic blood pressure (Fig. 3a), total serum cholesterol and triglycerides (Fig. 3b), and HDL25 and LDL (Fig. 3c) over a ten week intervention period for the systems and methods of the invention and the control diet. As these charts indicate, the system of the present invention (e.g., the P~epared Diet) achieved significantly greater W O 96~9050 PCTrUS96/10188 red~lction~ in the systolic and rli~tolic blood pressures of hy~ lel,~ e patients than the control diet. However, the dietary health management system of the inventionalso reduced total serum cholesterol and LDL in the L~ .ls;on patients, eg., Category Cl or C4, or both.

TABLE xxvm DIET-RESPONSIVE CONDITION: HYPERTENSION
TREATMENT REDUCTION (mlTIHg) SYSTOLIC DIASTOLIC
PREPAREDDIET 7.0 4.1 CONIROL DIET 3.7 3.2 BLOCKERS

ADVERERGIC AGENT

In Table XXVIII, the reductions in systolic and diastolic blood pressure obtained with the systems and methods of the invention and those of thecontrol diet over a ten week intervention period are co~ Jal èd to the reductions in systolic and diastolic blood pressure achieved through the use of antihypertensive S agents over a twelve month ll é~ nl period. As may be seen from this table, the reductions oblained through the use of the dietary health management system are COIllp~able to those achieved with several of the hyl~el len~ e agents.
Nevertheless, the reductions were more rapidly achieved with the systems and methods of the present invention than with any of the identified anti-hypertensive 10 agents.
Referring to Figs. 4a-c, the charts depict the results of the clinical trials with regard to the reduction of blood pres~ule and cholesterol levels forhyperlipidemics. The charts co",pa, è the reduction in systolic and diastolic blood pressure (Fig. 4a), total serum cholesterol and triglycerides (Fig. 4b), and HDL15 and LDL (Fig. 4c) over a ten week intervention period for the systems and methods of the invention and the control diet. As the charts of Figs. 4b and 4c indicate, the dietary health management system of the invention achieved ~jgnifir.~ntly greater reductions in total serum cholesterol, triglycerides, and LDL.
When considered in con,binalion with the reductions in the other lipid levels, the 20 results achieved by the dietary health management system are clearly superior to those ob~,ed with the control diet. Moreover, the system of the present invention also reduced systolic and diastolic blood pressure in the hyperlipidernia patients, eg., Category C2 or C4, or both.

W O 96/39050 PCTrUS96/10188 TABLE XX~
DET-RESPONSIVE CONDITION: HYPERLIPIDEMIA

TREATMENT REDUCTION (mg/dl) TRG HDL LDL
PREPARED DIET 22 0.2 12 CONTROL DIET 14 0.9 11 BILE ACID 15-30 (+) 3-5 SEQUESTRANTS
NICOTINIC ACID 10-25 (+) 15-35 20-50 STATINS 20~0 (+) 5-15 10-20 FIBRIC ACID 10-15 (+) 10-15 20-50 DERIVATIVES

W O 96/39050 PCT~US96/10188 In Table X~X the re~ tion~ in serum cholesterol levels obtained with the systems and methods of the invention and those of the control diet overa ten week intervention period are co".l)al ed to the reductions achieved through the use of anti-hyperlipidemic agents.
5As tiiccll~ced above, the systems and methods of the present invention may achieve reductions in HbAIC levels, as well as stabilization of orreduction in plasma glucose levels. During the clinical trials, HbA~C levels arereduced by ~IllOlllll!; in a range of about 1 to 2%. Plasma glucose levels of diabetic patients using stabilizing medication experience stabilization or a trend toward10reduction. Patients who control their diabetes without me~ tion generally experience a trend toward the reduction of plasma glucose levels.
As ~iccll~sed above, quality of life may be measured by various e"".i.ical tests. In the clinical trials, these measures inrl~lde~, but were not limited to, the Mental Health Index and the General Health Pe~c~y~ion Scale. The Mental 15Health Index is measured by ~ .g re~onses to questions dçs;g.,ed to quantify the patient's anxiety, depression, loss behavior and positive affect of ch~nged circ.. ~ .ec, and emotional ties. Similarly, General Health Pelcep~ions Scale is measured by ~ responses to questions dçsigned to quantify the patients general health, vitality, and sleep disturbance. Additional tests were ~-lministered 20 which measure the effects of diet on daily activities, work activities, nutrition hassles, nutrition and social function, nutritional health, and nutrition and affect on diet-responsive conditions. Thus, at least eight quantitative quality of life during the baseline and intervention periods. This enabled co,..pa,ison of the results of the health management system and method to a patient's the baseline ~sçssmPnt and 25 co",pa-ison of the results of the health management system and method to those of the AHA control diet during the intervention period.
The quality of life questio~aires revealed that a statistically significant change, i.e., p ~ 0.05 level, was observed for each of the eight factors identified above. This statistically significant improvement in quality of life was observed between the group of p~tientS ~lrninictered a diet in accordance with the systems and methods of the invention and the control die, as well as between thegroup of patients ~ eleled a diet in accoldance with the systems and methods and those patients' b~cPIine ~cce,cc..,...l S Other embo~imPnts of the invention will be apparenl to the skilledin the art from a consideration of the speçific~tion or practice of the invention disclosed herein. It is intPndPd that the spe~ifiç~tion and examples be considered as e"e~,.yl~y only with the true scope and spirit of the invention being indicated by the following claims.

Claims (97)

116 We claim:

1. A dietary health management system for administration to a patient having at least one diet-responsive condition comprising a meal program containing a plurality of prepackaged individual meals for each day, each of said individual meals including a plurality of meal components and containing a predetermined level ofnutritional enhancement, whereby consumption of a daily diet comprising a plurality of said individual meals supplies said patient with a desired total daily calorie content, improved quality of life, and sufficient nutritional enhancement to improve the management of said diet-responsive condition by adding a source of dietary fiber and a source of potassium and controlling at least one of a level of protien and a level of fat and wherein consumption of said daily diet provides vitamins and minerals of at least 50% USRDA.

2. The dietary health management system of claim 1, wherein said diet-responsive condition is selected from the group consisting of obesity, hypertension, hyperlipidemia, cancer, diabetes, cardiovascular disease, and combinations thereof.

3. The dietary health management system of claim 2, wherein said cancer is selected from the group consisting of colo-rectal, breast, stomach, and prostatecancer.

4. The dietary health management system of claim 1, wherein said desired total daily calorie content is in a range of 1200 to 1500 calories.

5. The dietary health management system of claim 1, wherein said patient has a plurality of said diet-responsive conditions.

6. The dietary health management system of claim 1, wherein said patient has coronary heart disease.

7. The dietary health management system of claim 1, wherein at least one of said prepackaged, individual meals are frozen.

8. The dietary health management system of claim 1, wherein at least one of said prepackaged, individual meals are retorted or shelf-stable.

9. The dietary health management system of claim 1, wherein said nutritional enhancement includes fortification of at least one meal component with a material selected from the group consisting of vitamins, minerals, and mixtures thereof, such that consumption of said daily diet provides vitamins and minerals in a range of 75%
to 100% USRDA.

10. The dietary health management system of claim 1, wherein said nutritional enhancement includes addition of dietary fiber to at least one component of saidmeal, such that consumption of said daily diet provides dietary fiber in a range of 20 to 30 grams.

11. The dietary health management system of claim 1, wherein said nutritional enhancement includes control of the level of protein in said meal, such that consumption of said daily diet provides in a range of 15% to 20% of caloric intake from protein.

12. The dietary health management system of claim 11, wherein said controlled level of protein in said meal comprises an adjusted a ratio between animal protein and vegetable protein.

13. The dietary health management system of claim 1, said nutritional enhancement includes control of the level of simple sugars in said meal, such that consumption of said daily diet provides simple sugars in a range of 96 to 107 grams.

14. The dietary health management system of claim 1, wherein said nutritional enhancement includes control of the level of saturated fat in said meal, such that consumption of said daily diet provides less than 10% of caloric intake from saturated fat.

15. The dietary health management system of claim 1, wherein said nutritional enhancement includes control of the level of cholesterol in said meal, such thatconsumption of said daily diet provides less than 300 mg of cholesterol.

16. The dietary health management system of claim 1, wherein said nutritional enhancement includes control of the level of sodium in said meal, such that consumption of said daily diet provides less than 2400 mg.

17. The dietary health management system of claim 1, wherein said nutritional enhancement includes control of the level of potassium in said meal, such that consumption of said daily diet provides 3500 mg.

18. The dietary health management system of claim 1, wherein each of said meals comprises a plurality of segregated meal components.

19. The dietary health management system of claim 18, wherein said meal components include at least one meat component.

20. The dietary health management system of claim 19, wherein said nutritional enhancement includes fortification of at least one meat component.

21. The dietary health management system of claim 19, wherein said nutritional enhancement includes fortification of at least one non-meat component.

22. The dietary health management system of claim 1, wherein said daily diet includes at least one of three supplemental foods selected from the group consisting of dairy products, fruits, and vegetables.

23. The dietary health management system of claim 1, wherein consumption of said daily diet of said meals provides dietary fiber in the range of 20 to 30 grams;
vitamins and minerals at at least 100% USRDA; sodium in an amount less than 2400 mg, potassium in an amount of at least 3000 mg; protein, such that 15 to 20%
of caloric intake is derived from protein; and fat, such that 20 to 30% of caloric intake is derived from fat.

24. The dietary health management system of claim 1, wherein said diet-responsive condition is obesity and said desired total daily calorie content is less than said patient's maintenance caloric level.

25. The dietary health management system of claim 1, wherein said daily diet includes potassium in a range of 3150 to 3850 mg.

26. The dietary health management system of claim 25, wherein said daily diet includes 3500 mg of potassium.

27. The dietary health management system of claim 1, wherein said diet-responsive condition is hypertension and said daily diet includes sodium in a range of 2000 to 2400 mg.

28. The dietary health management system of claim 1, wherein said diet-responsive condition is hyperlipidemia and said daily diet includes cholesterol in a range of 200 to 300 mg and wherein less than 30% of daily calories are derived from fat.

29. The dietary health management system of claim 28, wherein said fat comprises SFA in a range of 7 to 10%, MUFA in a range of 10 to 13%, and PUFA
of less than 10%.

30. The dietary health management system of claim 1, wherein said diet-responsive condition is colo-rectal cancer and said daily diet includes dietary fiber in a range of 20 to 30 grams and wherein less than 30% of daily calories are derived from fat.

31. The dietary health management system of claim 30, wherein said fat comprises SFA in a range of 7 to 10%, MUFA in a range of 10 to 13%, and PUFA
of less than 10%.

32. The dietary health management system of claim 1, wherein said diet-responsive condition is diabetes and said daily diet includes less than 96 grams of simple sugars and daily diet includes dietary fiber in a range of 20 to 30 grams and wherein less than 30% of daily calories are derived from fat.

33. The dietary health management system of claim 32, wherein said fat comprises SFA in a range of 7 to 10%, MUFA in a range of 10 to 13%, and PUFA
of less than 10%.

34. A dietary health management planning and control system for providing nutritionally enhanced dietary management to a patient having at least one diet-responsive condition comprising:
a plurality of prepackaged individual meals for each day wherein each of said meals is included within a group and has a group identifying code corresponding to the type of meal and wherein each of said meals further includes at least one category identifying code corresponding to a particular diet-responsive condition;
each of said individual meals includes a plurality of meal components and contains a predetermined level of nutritional enhancement, whereby consumption of a daily diet comprising a plurality of said individual meals supplies said patient with a desired total daily calorie content, improved quality of life, and sufficient nutritional enhancement to improve management of said diet-responsive condition by adding a source of dietary fiber and a source of potassium and controlling at least one of a level of protien and a level of fat and wherein consumption of said daily diet provides vitamins and minerals of at least 50% USRDA.

35. The planning and control system of claim 34, wherein said type of meal comprises breakfast, lunch, dinner, and snack.

36. The planning and control system of claim 34, wherein said group identifying code is selected from the group consisting of alphabetic indicia, numeric indicia, color indicia, graphic indicia, and combinations thereof

37. The planning and control system of claim 34, wherein said category identifying code is selected from the group consisting of alphabetic indicia, numeric indicia, color indicia, graphic indicia, and combinations thereof.

38. The planning and control system of claim 34, wherein said diet-responsive condition is selected from the group consisting of obesity, hypertension, hyperlipidemia, cancer, diabetes, cardiovascular disease, and combinations thereof.

39. The planning and control system of claim 34, wherein said cancer is selectedfrom the group consisting of colo-rectal, breast, stomach, and prostate cancer.

40. The planning and control system of claim 34, wherein said desired total daily calorie content is in a range of 1200 to 1500 calories.

41. The planning and control system of claim 34, wherein said patient has a plurality of said diet-responsive conditions.

42. The planning and control system of claim 34, wherein at least one of saidprepackaged, individual meals are frozen.

43. The planning and control system of claim 34, wherein at least one of saidprepackaged, individual meals are retorted or shelf-stable.

44. The planning and control system of claim 34, wherein said daily diet includes three supplemental foods selected from the group consisting of dairy products, fruits, and vegetables.

45. The planning and control system of claim 34, wherein said nutritional enhancement includes fortification of at least one meal component with a material selected from the group consisting of vitamins, minerals, and mixtures thereof, such that consumption of said daily diet provides vitamins and minerals in a range of 75%
to 100% USRDA.

46. The planning and control system of claim 34, wherein said nutritional enhancement includes fortification of at least one meal component with dietary fiber, such that consumption of said daily diet provides dietary fiber in a range of 20 to 30 grams.

47. The planning and control system of claim 34, wherein said nutritional enhancement includes controlling the level of protein in said meal, such that consumption of said daily diet provides in a range of 15% to 20% of caloric intake from protein.

48. The planning and control system of claim 47, wherein control of level of protein in said meal comprises adjusting a ratio between animal protein and vegetable protein.

49. The planning and control system of claim 34, wherein said nutritional enhancement includes control of the level of simple sugars, such that consumption of said daily diet provides simple sugars in a range of 96 to 107 grams.

50. The planning and control system of claim 34, wherein said nutritional enhancement includes control of the level of saturated fat in said meal, such that consumption of said daily diet provides less than 10% of caloric intake from saturated fat.

51. The planning and control system of claim 34, wherein said nutritional enhancement includes control of a level of cholesterol in said meal, such that consumption of said daily diet provides less than 300 mg of cholesterol.

52. The planning and control system of claim 34, wherein said nutritional enhancement includes control of a level of sodium in said meal, such that consumption of said daily diet provides less than 2400 mg.

53. The planning and control system of claim 34, wherein said nutritional enhancement includes control of the level of potassium in the meal, such that consumption of said daily diet provides 3500 mg.

54. The planning and control system of claim 34, wherein each of said meals comprises a plurality of segregated meal components.

55. The planning and control system of claim 34, wherein said meal components include at least one meat component.

56. The planning and control system of claim 34, wherein said nutritional enhancement includes fortification of at least one non-meat components.

57. The planning and control system of claim 34, wherein said nutritional enhancement includes fortification of at least one meat component.

58. The planning and control system of claim 34, wherein a full day of meals provide dietary fiber in the range of 20 to 30 grams; vitamins and minerals at 100%
USRDA; sodium in an amount less than 2400 mg; potassium in an amount of at least 3000 mg, protein, such that 15 to 20% of caloric intake is derived from protein; and fat, such that 20 to 30% of caloric intake is derived from fat.

59. The planning and control system of claim 34, wherein said diet-responsive condition is obesity and said desired total daily calorie content is less than said patient's maintenance caloric level.

60. The planning and control system of claim 34, wherein said diet-responsive condition is hypertension and said daily diet includes sodium in a range of 2000 to 2400 mg.

61. The planning and control system of claim 34, wherein said diet-responsive condition is hyperlipidemia and said daily diet includes cholesterol in a range of 200 to 300 mg and wherein less than 30% of daily calories are derived from fat.

62. The planning and control system of claim 61, wherein said fat comprises SFA in a range of 7 to 10%, MUFA in a range of 10 to 13%, and PUFA of less than 10%.

63. The planning and control system of claim 34, wherein said diet-responsive condition is colo-rectal cancer and said daily diet includes dietary fiber in a range of 20 to 30 grams and wherein less than 30% of daily calories are derived from fat.

64. The planning and control system of claim 63, wherein said fat comprises SFA in a range of 7 to 10%, MUFA in a range of 10 to 13%, and PUFA of less than 10%

65. The planning and control system of claim 34, wherein said diet-responsive condition is diabetes and said daily diet includes less than 96 grams of simple sugars and wherein less than 30% of daily calories are derived from fat.

66. The planning and control system of claim 65, wherein said fat comprises SFA in a range of 7 to 10%, MUFA is a range of 10 to 13%, and PUFA of less than 10%.

67. A method for treating a patient having a diet-responsive condition comprising the steps of:
identifying at least one quantifiable indicator of said condition;
administering to said patient a daily diet comprising a plurality of prepackaged individual meals, each of said individual meals containing a predetermined level of nutritional enhancement, whereby consumption of a daily diet comprising a plurality of said individual meals supplies said patientwith a desired total daily calorie content, improved quality of life, and sufficient nutritional enhancement to facilitate management of said diet-responsive condition; and monitoring said at least one indicator of said condition.

68. The method of claim 67, wherein said diet-responsive condition is selected from the group consisting of obesity, hypertension, hyperlipidemia, cancer, diabetes, cardiovascular disease, and combinations thereof.

69. The method of claim 67, wherein said cancer is selected from the group consisting of colo-rectal, breast, stomach, and prostate cancer.

70. The method of claim 67, wherein said desired total daily calorie content is in a range of 1200 to 1500 calories.

71. The method of claim 67, wherein said patient has a plurality of said diet-responsive conditions.

72. The method of claim 67, wherein said at least one of said prepackaged, individual meals are frozen.

73. The method of claim 67, wherein at least one of said prepackaged, individual meals are retorted or shelf-stable.

74. The method of claim 67, wherein said daily diet includes at least one supplemental food selected from the group consisting of dairy products, fruits, and vegetables.

75. The method of claim 67, wherein said meal comprises at least one meal component and said nutritional enhancement includes fortifying said at least onecomponent a material selected from the group consisting of vitamins, minerals, and mixtures thereof

76. The method of claim 67, wherein said meal comprises at least one meal component and said nutritional enhancement includes fortifying said at least onecomponent with minerals.

77. The method of claim 67, wherein said meal comprises at least one meal component and said nutritional enhancement includes fortifying said at least onecomponent with dietary fiber.

78. The method of claim 67, wherein said meal comprises at least one meal component and said nutritional enhancement includes controlling the level of protein in said meal.

79. The method of claim 78, wherein controlling the level of protein in said meal comprises adjusting a ratio between animal protein and vegetable protein.

80. The method of claim 67, wherein said meal comprises at least one meal component and said nutritional enhancement includes controlling the level of simple sugars.

81. The method of claim 67, wherein said nutritional enhancement includes controlling the level of fat in said meal.

82. The method of claim 67, wherein said nutritional enhancement includes controlling the level of cholesterol in said meal.

83. The method of claim 67, wherein said nutritional enhancement includes controlling the level of sodium in said meal.

84. The method of claim 67, wherein said nutritional enhancement includes controlling the level of potassium in said meal.

85. The method of claim 67, wherein each of said meals comprises a plurality of segregated meal components.

86. The method of claim 85, wherein said meal components include at least one meat component.

87. The method of claim 86, wherein said nutritional enhancement includes fortifying a non-meat component.

88. The method of claim 85, wherein said nutritional enhancement includes fortifying at least one meat component.

89. The method of claim 67, wherein a full day of meals provide dietary fiber inthe range of 20 to 30 grams; vitamins and minerals at 100% USRDA, sodium in an amount less than 2400 mg; potassium in an amount of at least 3000 mg; protein, such that 15 to 20% of caloric intake is derived from protein; and fat, such that 20 to 30% of caloric intake derived from fat.

90. The method of claim 67, wherein said diet-responsive condition is obesity and said desired total daily calorie content is less than said patient's maintenance caloric level.

91. The method of claim 67, wherein said diet-responsive condition is hypertension and said daily diet includes sodium in a range of 2000 to 2400 mg.

92. The method of claim 67, wherein said diet-responsive condition is hyperlipidemia and said daily diet includes cholesterol in a range of 200 to 300 mg and wherein less than 30% of daily calories are derived from fat.

93. The method of claim 92, wherein said fat comprises SFA in a range of 7 to 10%, MUFA in a range of 10 to 13%, and PUFA of less than 10%.

94. The method of claim 67, wherein said diet-responsive condition is colo-rectal cancer and said daily diet includes dietary fiber in a range of 20 to 30 grams and wherein less than 30% of daily calories are derived from fat.

95. The method of claim 94, wherein said fat comprises SFA in a range of 7 to 10%, MUFA in a range of 10 to 13%, and PUFA of less than 10%

96. The method of claim 67, wherein said diet-responsive condition is diabetes and said daily diet includes less than 96 grams of simple sugars and wherein less than 30% of daily calories are derived from fat.

97. The method of claim 96, wherein said fat comprises SFA in a range of 7 to 10%, MUFA in a range of 10 to 13%, and PUFA of less than 10%.