WO2001032034A1 - A palatable composition comprising an oil phase containing an unpalatable edible marine oil, a hydrocolloid base, a sweetening agent and an aqueous phase - Google Patents

A palatable composition comprising an oil phase containing an unpalatable edible marine oil, a hydrocolloid base, a sweetening agent and an aqueous phase Download PDF

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Publication number
WO2001032034A1
WO2001032034A1 PCT/EP2000/010650 EP0010650W WO0132034A1 WO 2001032034 A1 WO2001032034 A1 WO 2001032034A1 EP 0010650 W EP0010650 W EP 0010650W WO 0132034 A1 WO0132034 A1 WO 0132034A1
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WO
WIPO (PCT)
Prior art keywords
composition according
oil
composition
palatable
unpalatable
Prior art date
Application number
PCT/EP2000/010650
Other languages
French (fr)
Inventor
Sarah Britton
Sarah Marshall
Original Assignee
Smithkline Beecham P.L.C.
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Publication date
Application filed by Smithkline Beecham P.L.C. filed Critical Smithkline Beecham P.L.C.
Priority to AU12769/01A priority Critical patent/AU1276901A/en
Publication of WO2001032034A1 publication Critical patent/WO2001032034A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115Fatty acids or derivatives thereof; Fats or oils
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/20Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
    • A23L29/206Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
    • A23L29/212Starch; Modified starch; Starch derivatives, e.g. esters or ethers
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/20Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
    • A23L29/206Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
    • A23L29/256Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin from seaweeds, e.g. alginates, agar or carrageenan
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/20Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
    • A23L29/206Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
    • A23L29/262Cellulose; Derivatives thereof, e.g. ethers
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/20Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
    • A23L29/269Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of microbial origin, e.g. xanthan or dextran
    • A23L29/27Xanthan not combined with other microbial gums
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23VINDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention relates to compositions comprising unsavoury edible oils having improved sensory characteristics such as improved mouthfeel, taste and odour.
  • Edible oils are also known for their use in the field of drug delivery.
  • soybean oil has been used in pharmaceutical preparations as a vehicle for drugs administered orally.
  • EP296116 (Warner-Lambert) discloses that it is desirable to deliver large doses of unpleasant edible oils without the unpleasant odour and taste problems associated with these oils.
  • This prior art aims to address this problem and discloses a palatable suspension of an unpleasant edible oil containing up to 80% of the oil, an inorganic complexing agent, a sweetening agent and a taste and/or odour masking agent.
  • the inorganic complexing agent is disclosed as being selected from a list of compounds including magnesium trisilicate, calcium carbonate ground oyster shells and mixtures thereof.
  • Taste masking agents disclosed include anethole, eugenol and vanillin whilst the odour masking agent includes lime, orange, cinnamon and wintergreen.
  • EP567433 (Sandoz) identifies a number of factors that contribute to the unpleasant flavours of nutrition support compositions namely (1) bitter-tasting amino acids such as arginine; (2) fish oils; (3) thermoprocessing of the compositions and (4) the protein source such as casein.
  • orally-ingestible nutrition compositions having improved taste comprise a low pH ( ⁇ 7) form of an amino acid selected from arginine, valine and other compounds associated with the synthesis of polyamines .
  • compositions comprising an edible oil having improved sensory characteristics.
  • This object is achieved according to the present invention which is based on the unexpected finding that a hydrocoUoid base incorporating for example starch and a thickening agent provides improved sensory characteristics, such as improved organoleptic properties such as mouthfeel and a reduction in the mouthcoating cloying sensation experienced with conventional oil-containing compositions.
  • the unpleasant lingering flavours found in conventional oil-containing products, are reduced in compositions of the invention.
  • the hydrocoUoid base has been found to contain flavour masking properties so that the characteristic "oily" taste of the compositions is reduced.
  • a palatable composition comprising an oil phase containing an unpalatable edible oil, a hydrocoUoid base, a sweetening agent and an aqueous phase characterized in that the hydrocoUoid base either consists of starch and at least one thickening agent eg starch and one thickening agent or starch and two thickening agents, or alternatively two or more different thickening agents, absent any starch.
  • compositions of the invention are in the form of a liquid and suitably are emulsions i.e. colloidal solutions comprising a continuous phase that is water-based and a disperse phase that is oil-based.
  • emulsions in which the continuous phase comprises an oil and the disperse phase comprises water are also within the scope of the present invention.
  • the former type of emulsion i.e. oil-in- water emulsions are preferred.
  • the oil phase comprises an unpalatable edible oil that is suitably of animal, vegetable or mineral origin.
  • the unpalatable edible oil contains at least one omega-3 fatty acid such as docosahexaenoic acid (DHA) and eicoosapentaenoic acid (EHA).
  • DHA docosahexaenoic acid
  • EHA eicoosapentaenoic acid
  • the ratio of DHA: EPA is 1 : 1, and even more preferably there is more DHA than EPA.
  • Animal oils are generally derived from the organs and tissues of animals and may be isolated via extraction processes or the like. Vegetable oils are commonly derived from plant seeds and are generally obtained also by extraction processes. Methods of producing oils are known.
  • oils include animal oils such as marine oils such as capelin oil, seal oil, whale oil , fish oils such as fish liver oil e.g. cod liver oil, and fish oils produced from additional body parts (also referred to as fish oils); vegetable oils such as castor oil, soybean oil, corn oil, linseed oil.
  • Compositions of the invention may contain a mixture of oils for example a mixture containing a marine oil such as cod liver oil with a vegetable oil such as soybean oil.
  • Marine oils are preferred, in particular fish oils, and a combination of cod liver oil and oils produced from additional fish body parts are especially preferred.
  • compositions comprise an oil phase containing an amount of an unpalatable edible oil ranging from about 0.1 % to about 99% w/w, preferably from about 0.1 % to about 30% w/w and more preferably from about 1 to 20% w/w, such as from about 5 % to about 25 % w/w, even more preferably from about 1 % to about 15% w/w .
  • compositions of the invention comprise an aqueous phase containing water in an amount ranging from about 0.1 % to about 99% w/w, preferably from about 70% to about 99% w/w, even more preferably from about 75% to about 95 % w/w.
  • water serves as a solvent for any water-soluble additives of the compositions.
  • hydrocoUoid base is meant a combination of starch and at least one thickening agent or alternatively a combination of two or more different thickening agents. It is to be understood that by “combination” is meant “at least two components" of the hydrocoUoid base. Each component may be added separately or in a mixture to the oil phase or to the aqueous phase.
  • Starch obtainable from a variety of sources may be used e.g. corn/maize, high amylose maize, waxy maize, potato, rice and wheat and the starch may be in a pregelatinized or non-pregelatinized form.
  • Starch available form corn/maize is preferred.
  • Particularly preferred is pregelatinized starch such as that obtained from waxy maize.
  • starch Various types are available commercially from National Starch & Chemical Ltd, Prestbury Court, Greencourts Business Park, 333 Styal Road, Manchester M22 5LW. When present starch will suitably be included in the compositions of the invention in an amount ranging from about 0.1 to about 10% w/w, for example from about 0.5 to about 5% w/w of the composition, even more preferably from about 0.3 % to about 3 % w/w of the composition.
  • Suitable thickening agents for use in the invention include gums such as xanthan gum, corn sugar gum, guar gum, gum acasia, gum tracananth, locust bean gum, gellan gum and carageenan; cellulose derivatives such as carboxymethylcelluloses, hydroxypropylcelluloses, ethylcelluloses e.g. hydroxyethylcelluloses; alginic acid and salts thereof such as sodium alginate, and mixtures thereof.
  • Carboxymethylcelluloses and in particular carboxymethylcellulose sodium, is a preferred cellulose derivative.
  • a hydrocoUoid base consisting of starch and xanthan gum is preferred.
  • Xanthan gum is a polymer with five sugar residues, two glucose units, two mannose units and one glucuronic acid and is available in a variety of particle sizes, including 80- mesh and 200-mesh. It is available from many commercial sources including Kelco, a division of the Merck Company (California). A preferred commercial product is Keltrol F from Kelco.
  • the hydrocoUoid base may consist of starch and two or more thickening agents such as combinations of the agents referred to above.
  • compositions comprising a hydrocoUoid base consisting of starch and xanthan gum, as a first thickening agent, and a second agent selected from guar gum, carragenan, cellulose derivatives such as carboxymethylcelluloses, hydroxypropylcelluloses, ethylcelluloses eg. hydroxyethylcelluloses; alginic acid and salts thereof such as sodium alginate, and mixtures thereof, are preferred.
  • Carboxymethylcelluloses, and in particular carboxymethylcellulose sodium is a preferred cellulose derivative.
  • compositions comprising a hydrocoUoid base consisting of two or more different thickening agents, absent any starch, have also shown surprisingly good organoleptic properties. Accordingly in one aspect of the invention there is provided a palatable composition in which the inclusion of starch is entirely optional.
  • a hydrocoUoid base consisting of at least two thickening agents that are different i.e. chemically different and not merely different grades of the same material such as different grades of hydroxyethyl cellulose e.g. Cellosize QP 300 and 4400.
  • compositions comprise xanthan gum as a first thickening agent and a second thickening agent selected from guar gum, carragenan, cellulose derivatives such as carboxymethylcelluloses, hydroxypropylcellulose and ethylcelluloses e.g. hydroxyethylcelluloses; alginic acid and salts thereof such as sodium alginate, and mixtures thereof.
  • Carboxymethylcelluloses and in particular carboxymethylcellulose sodium is a preferred cellulose derivative.
  • compositions comprising a hydrocoUoid base consisting only of xanthan and alginates are known and are not encompassed within the scope of the present invention. Moreover such compositions do not give rise to improved sensory properties, characteristic of compositions if the present invention. However it is to be understood that compositions that comprise xanthan and an alginate(s) and at least one additional thickening agent are contemplated within the scope of the invention.
  • Thickening agents will suitably be present in compositions of the invention in an amount sufficient to impart the desired thickness to the compositions; thus the amount of a particular thickening agent required will be determined by the thickening agent to be used.
  • each thickening agent or the total amount of thickening agents present will be in the range from about 0.1 to about 5% w/w, preferably from about 0.1 % to about 3 % w/w of the composition.
  • compositions of the inventions will comprise a total amount of thickening agent in the range from about 0.7% to about 3% w/w, with each individual thickening agent being present in an amount from about 0.1 %w/w.
  • compositions of the invention obviates the need for a separate texturizing or stabilizing system.
  • amount of hydrocoUoid base present in the composition By varying the amount of hydrocoUoid base present in the composition, a desired thickness or viscosity may be obtained.
  • the addition of any further viscosity modifying agents is entirely optional.
  • the viscosity of the compositions will generally be in the range 5000 to 15000 cps, preferably 6000 to lOOOOcps, as determined at room temperature and at a shear rate of lOrpm using a Brookfield Viscometer with a disc spindle, spindle 5.
  • compositions are robust and show good physical stability, with minimal separation of the oil and aqueous phases and good pourability i.e. compositions in the form of emulsions, stored in bottles have been shown to pour readily from the bottles, even after storage for a period of months. In addition, minimal changes to colour and odour are also observed.
  • a sweetening agent is present in compositions of the invention in order to impart a sweet taste to the compositions and may be selected from solid natural and synthetic sweeteners.
  • Non-limiting examples include nutritive sugars such carbohydrates e.g. sucrose (cane sugar), glucose and fructose, maltodextrins and mixtures thereof.
  • Non-nutritive sugars include aspartame and saccharin.
  • the sweeteners may be used in amounts necessary to impart sweetness. Suitably such amounts include from about 0.01 to about 10% w/w, preferably from about 0.5 to about 6% w/w of the composition.
  • compositions of the present invention may comprise an agent that further modifies the taste and/or odour of the compositions, above that already achieved with the hydrocoUoid base.
  • agents include alkali earth metal salts or amino acids.
  • Illustrative non-limiting examples of such salts include sodium salts for example selected from the group consisting of sodium citrate, sodium carbonate and sodium tripolyphosphate.
  • the salts may comprise about 0.005 to about 1 %, preferably from about 0.05 to about 0.2% w/w of the composition.
  • amino acids include amino acids selected from the group consisting of leucine, lysine and aspartic acid.
  • L-lysine a preferred amino acid
  • the amino acids are present in an amount ranging from about 0.01 to about 1 % w/w, preferably from about 0.1 to about 0.5 % w/w of the composition.
  • the water component or aqueous phase of the compositions of the invention has a low pH, i.e. ⁇ 7, preferably from about 3 to about 7, more preferably from about 3 to about 5.
  • a low pH is essential when the compositions comprise a further taste or odour modifier which is in the form of an amino acid as described herein.
  • a low pH may be achieved by the use of a pH modifying agent such as an acid or a suitable buffer such as a salt of an acid that is physiologically acceptable and that does not have an objectionable taste.
  • a pH modifying agent such as an acid or a suitable buffer such as a salt of an acid that is physiologically acceptable and that does not have an objectionable taste.
  • Suitable pH modifying agents include acids such as citric, malic, phosporic, fumaric, lactic, tartaric, glycolic, mandelic, or acetic and salts thereof.
  • compositions of the invention may further comprise accessory food factors such as minerals, trace elements and vitamins.
  • accessory food factors such as minerals, trace elements and vitamins.
  • the compositions comprise a nutritionally supplemental amount, i.e. a nourishing amount, of the food factors.
  • RDA Recommended Dietary Allowance
  • Non-limiting examples of mineral elements and trace elements suitable for use in the invention include sodium, potassium, calcium, phosphorous, magnesium, manganese, copper, zinc, iron, selenium, chromium, and molybdenum in pharmaceutically acceptable form.
  • suitable sources of calcium include calcium phosphate such as tricalcium phosphate and monocalcium phosphate, calcium carbonate and mixtures thereof. Mixtures of tricalcium phosphate and monocalciumphosphate are preferred.
  • the trace elements and minerals are present in an amount ranging from about 0.5% to about 5% w/w, preferably from about 0.8% to about 2.5 % w/w of the composition.
  • Non-limiting examples of vitamins suitable for incorporation in the composition include vitamin A and provitamins thereof, vitamin D, vitamin K, vitamin C, folic acid, thiamine, riboflavin, vitamin Bl , vitamin B6, vitamin B12, niacin, biotin, and panthotenic acid in pharmaceutically suitable form.
  • Vitamins will be included in the compositions so as to give the desired amount, in line with the RDA; for example vitamin A palmitate, at a concentration of 1.7MIU/g may typically be present in an amount not greater than 0.01 %w/w of the composition, whilst Vitamin D3 at a concentration of l.OMIU/g will be present in an amount not exceeding 0.001 %w/w of the composition.
  • a problem associated with edible oil-containing compositions is that they are susceptible to fungal contamination, e.g. contamination with yeasts and/or moulds.
  • compositions of the invention aim to overcome this problem and may comprise a preservative or preservative mixture.
  • Preservatives suitable for use in the invention include sorbic acid or a salt thereof, a paraben and benzoic acid or a salt thereof.
  • the sorbic acid component is in the form of an alkali metal salt such as potassium sorbate and the paraben is an alkyl paraben, such as methylparaben e.g. sodium methyl hydroxybenzoate or propyl paraben e.g. sodium propyl hydroxybenzoate or an ionic paraben preferably sodium paraben.
  • the preservative content of the compositions may range from about 0.001 to about 5 % w/w of the composition.
  • compositions of the present invention will contain additives or excipients conventional in the field of nutrition and pharmaceutical compositions, including for example opacifiers, colorants and flavourings.
  • the additives or excipients used in any given composition will be compatible both with each other and with the essential ingredients of the composition such that there is no interaction that would impair the performance of the compositions. All additives or excipients must of course be non-toxic and of sufficient purity to render them suitable for human use.
  • Suitable opacifiers include alginates e.g. propylene glycol alginate and sodium alginate.
  • An opacifier may be used in an amount ranging from 0.005 % to around 0.5% w/w of the composition.
  • sodium alginate or propylene glycol alginate will suitably be present in an amount ranging from about 0.005 % to about 0.20% w/w.
  • flavourings for the compositions are the natural and artificial flavourings such as lemon, lime, orange, peach pineapple, raspberry and the like.
  • Suitably flavourings may be used in an amount ranging from about 0.005 % to about 2.00% w/w of the composition, preferably in an amount less than 1 %w/w.
  • a palatable composition as hereinbefore described for use in therapy.
  • the present invention extends to a process for preparing a composition as hereinbefore defined.
  • the hydrocoUoid base and the sweetening agent, together with any water-soluble additives are dissolved in water to form an aqueous phase and the pH is checked and adjusted if required.
  • An oil phase is prepared containing oil-soluble or oil-miscible additives, if any, and the unpalatable edible oil, which is then admixed with the aqueous phase. If required, the mixture is heated in order to obtain a homogenous mix of the two phases.
  • the hydrocoUoid base may be added directly to the oil phase, which is then combined with the aqueous phase as described above. The final mix may then be mixed at high shear in order to ensure adequate dispersion of the oily and aqueous phases.
  • An aqueous phase and an oil phase is prepared.
  • the water-soluble ingredients of the composition are dissolved in the aqueous phase, whilst the oil-soluble ingredients are dissolved in the oil phase.
  • a premix of ingredients may be prepared and added to the oil or aqueous phases prior to forming the final mix.
  • the final mix consisting of all the components of the composition, is mixed at room temperature, at high shear rates sufficient to form the emulsion product.
  • a reference emulsion was prepared and tested against formulations containing varying combinations of thickeners and starch/thickener(s) combinations. The results are detailed below.

Abstract

The invention relates to palatable compositions, comprising an oil phase containing an unpalatable edible oil, a hydrocolloid base, a sweetening agent and an aqueous phase characterized in that the hydrocolloid base either consists of starch and at least one thickening agent or alternatively, comprises two or more thickening agents, optionally with starch.

Description

A PALATABLE COMPOSITION COMPRISING AN OIL PHASE CONTAINING AN UNPALATABLE EDIBLE MARINE OIL, A HYDROCOLLOID BASE, A SWEETENING AGENT AND AN AQUEOUS PHASE
The present invention relates to compositions comprising unsavoury edible oils having improved sensory characteristics such as improved mouthfeel, taste and odour.
The use of edible oils in nutritional and pharmaceutical compositions is well known. For example marine oils and marine oil concentrates containing omega-3 fatty acids have been recommended for use in the prevention of coronary heart disease, migraine headaches, arthritis and some allergies. Cod liver oil has been recommended for use as a 'cure-all remedy' since the nineteenth century, and current marketing claims include its application in the therapeutic areas of immunity, brain development and eye/vision development, in addition to its use in promoting the formation of strong, healthy bones and teeth in children.
Edible oils are also known for their use in the field of drug delivery. For example soybean oil has been used in pharmaceutical preparations as a vehicle for drugs administered orally.
Such oils are equally well known for their objectionable taste and organoleptic properties.
EP296116 (Warner-Lambert) discloses that it is desirable to deliver large doses of unpleasant edible oils without the unpleasant odour and taste problems associated with these oils. This prior art aims to address this problem and discloses a palatable suspension of an unpleasant edible oil containing up to 80% of the oil, an inorganic complexing agent, a sweetening agent and a taste and/or odour masking agent. The inorganic complexing agent is disclosed as being selected from a list of compounds including magnesium trisilicate, calcium carbonate ground oyster shells and mixtures thereof. Taste masking agents disclosed include anethole, eugenol and vanillin whilst the odour masking agent includes lime, orange, cinnamon and wintergreen. EP567433 (Sandoz) identifies a number of factors that contribute to the unpleasant flavours of nutrition support compositions namely (1) bitter-tasting amino acids such as arginine; (2) fish oils; (3) thermoprocessing of the compositions and (4) the protein source such as casein. This art discloses that orally-ingestible nutrition compositions having improved taste comprise a low pH ( < 7) form of an amino acid selected from arginine, valine and other compounds associated with the synthesis of polyamines .
It is an object of the present invention to provide compositions comprising an edible oil having improved sensory characteristics. This object is achieved according to the present invention which is based on the unexpected finding that a hydrocoUoid base incorporating for example starch and a thickening agent provides improved sensory characteristics, such as improved organoleptic properties such as mouthfeel and a reduction in the mouthcoating cloying sensation experienced with conventional oil-containing compositions. In addition the unpleasant lingering flavours, found in conventional oil-containing products, are reduced in compositions of the invention. Surprisingly the hydrocoUoid base has been found to contain flavour masking properties so that the characteristic "oily" taste of the compositions is reduced.
According to the present invention there is provided a palatable composition, comprising an oil phase containing an unpalatable edible oil, a hydrocoUoid base, a sweetening agent and an aqueous phase characterized in that the hydrocoUoid base either consists of starch and at least one thickening agent eg starch and one thickening agent or starch and two thickening agents, or alternatively two or more different thickening agents, absent any starch.
Compositions of the invention are in the form of a liquid and suitably are emulsions i.e. colloidal solutions comprising a continuous phase that is water-based and a disperse phase that is oil-based. Alternatively emulsions in which the continuous phase comprises an oil and the disperse phase comprises water are also within the scope of the present invention. The former type of emulsion i.e. oil-in- water emulsions are preferred.
The oil phase comprises an unpalatable edible oil that is suitably of animal, vegetable or mineral origin. Suitably the unpalatable edible oil contains at least one omega-3 fatty acid such as docosahexaenoic acid (DHA) and eicoosapentaenoic acid (EHA). Preferably the ratio of DHA: EPA is 1 : 1, and even more preferably there is more DHA than EPA. Animal oils are generally derived from the organs and tissues of animals and may be isolated via extraction processes or the like. Vegetable oils are commonly derived from plant seeds and are generally obtained also by extraction processes. Methods of producing oils are known.
Illustrative non-limiting examples of oils include animal oils such as marine oils such as capelin oil, seal oil, whale oil , fish oils such as fish liver oil e.g. cod liver oil, and fish oils produced from additional body parts (also referred to as fish oils); vegetable oils such as castor oil, soybean oil, corn oil, linseed oil. Compositions of the invention may contain a mixture of oils for example a mixture containing a marine oil such as cod liver oil with a vegetable oil such as soybean oil. Marine oils are preferred, in particular fish oils, and a combination of cod liver oil and oils produced from additional fish body parts are especially preferred.
The compositions comprise an oil phase containing an amount of an unpalatable edible oil ranging from about 0.1 % to about 99% w/w, preferably from about 0.1 % to about 30% w/w and more preferably from about 1 to 20% w/w, such as from about 5 % to about 25 % w/w, even more preferably from about 1 % to about 15% w/w .
Compositions of the invention comprise an aqueous phase containing water in an amount ranging from about 0.1 % to about 99% w/w, preferably from about 70% to about 99% w/w, even more preferably from about 75% to about 95 % w/w. In addition to forming an essential component of the emulsion, the water serves as a solvent for any water-soluble additives of the compositions. By "hydrocoUoid base" is meant a combination of starch and at least one thickening agent or alternatively a combination of two or more different thickening agents. It is to be understood that by "combination" is meant "at least two components" of the hydrocoUoid base. Each component may be added separately or in a mixture to the oil phase or to the aqueous phase.
Starch obtainable from a variety of sources may be used e.g. corn/maize, high amylose maize, waxy maize, potato, rice and wheat and the starch may be in a pregelatinized or non-pregelatinized form. Starch available form corn/maize is preferred. Particularly preferred is pregelatinized starch such as that obtained from waxy maize.
Various types of starch are available commercially from National Starch & Chemical Ltd, Prestbury Court, Greencourts Business Park, 333 Styal Road, Manchester M22 5LW. When present starch will suitably be included in the compositions of the invention in an amount ranging from about 0.1 to about 10% w/w, for example from about 0.5 to about 5% w/w of the composition, even more preferably from about 0.3 % to about 3 % w/w of the composition.
Suitable thickening agents for use in the invention include gums such as xanthan gum, corn sugar gum, guar gum, gum acasia, gum tracananth, locust bean gum, gellan gum and carageenan; cellulose derivatives such as carboxymethylcelluloses, hydroxypropylcelluloses, ethylcelluloses e.g. hydroxyethylcelluloses; alginic acid and salts thereof such as sodium alginate, and mixtures thereof.
Carboxymethylcelluloses, and in particular carboxymethylcellulose sodium, is a preferred cellulose derivative.
A hydrocoUoid base consisting of starch and xanthan gum is preferred. Xanthan gum is a polymer with five sugar residues, two glucose units, two mannose units and one glucuronic acid and is available in a variety of particle sizes, including 80- mesh and 200-mesh. It is available from many commercial sources including Kelco, a division of the Merck Company (California). A preferred commercial product is Keltrol F from Kelco.
Advantageously the hydrocoUoid base may consist of starch and two or more thickening agents such as combinations of the agents referred to above. In particular compositions comprising a hydrocoUoid base consisting of starch and xanthan gum, as a first thickening agent, and a second agent selected from guar gum, carragenan, cellulose derivatives such as carboxymethylcelluloses, hydroxypropylcelluloses, ethylcelluloses eg. hydroxyethylcelluloses; alginic acid and salts thereof such as sodium alginate, and mixtures thereof, are preferred. Carboxymethylcelluloses, and in particular carboxymethylcellulose sodium, is a preferred cellulose derivative.
Alternatively compositions comprising a hydrocoUoid base consisting of two or more different thickening agents, absent any starch, have also shown surprisingly good organoleptic properties. Accordingly in one aspect of the invention there is provided a palatable composition in which the inclusion of starch is entirely optional. In this aspect there is provided a hydrocoUoid base consisting of at least two thickening agents that are different i.e. chemically different and not merely different grades of the same material such as different grades of hydroxyethyl cellulose e.g. Cellosize QP 300 and 4400. Preferred compositions comprise xanthan gum as a first thickening agent and a second thickening agent selected from guar gum, carragenan, cellulose derivatives such as carboxymethylcelluloses, hydroxypropylcellulose and ethylcelluloses e.g. hydroxyethylcelluloses; alginic acid and salts thereof such as sodium alginate, and mixtures thereof.
Carboxymethylcelluloses and in particular carboxymethylcellulose sodium is a preferred cellulose derivative.
Compositions comprising a hydrocoUoid base consisting only of xanthan and alginates are known and are not encompassed within the scope of the present invention. Moreover such compositions do not give rise to improved sensory properties, characteristic of compositions if the present invention. However it is to be understood that compositions that comprise xanthan and an alginate(s) and at least one additional thickening agent are contemplated within the scope of the invention.
Thickening agents will suitably be present in compositions of the invention in an amount sufficient to impart the desired thickness to the compositions; thus the amount of a particular thickening agent required will be determined by the thickening agent to be used. Suitably each thickening agent or the total amount of thickening agents present will be in the range from about 0.1 to about 5% w/w, preferably from about 0.1 % to about 3 % w/w of the composition. Preferably compositions of the inventions will comprise a total amount of thickening agent in the range from about 0.7% to about 3% w/w, with each individual thickening agent being present in an amount from about 0.1 %w/w.
Advantageously inclusion of the hydrocoUoid base in compositions of the invention obviates the need for a separate texturizing or stabilizing system. By varying the amount of hydrocoUoid base present in the composition, a desired thickness or viscosity may be obtained. The addition of any further viscosity modifying agents is entirely optional. The viscosity of the compositions will generally be in the range 5000 to 15000 cps, preferably 6000 to lOOOOcps, as determined at room temperature and at a shear rate of lOrpm using a Brookfield Viscometer with a disc spindle, spindle 5. Advantageously such compositions are robust and show good physical stability, with minimal separation of the oil and aqueous phases and good pourability i.e. compositions in the form of emulsions, stored in bottles have been shown to pour readily from the bottles, even after storage for a period of months. In addition, minimal changes to colour and odour are also observed.
A sweetening agent is present in compositions of the invention in order to impart a sweet taste to the compositions and may be selected from solid natural and synthetic sweeteners. Non-limiting examples include nutritive sugars such carbohydrates e.g. sucrose (cane sugar), glucose and fructose, maltodextrins and mixtures thereof.
Non-nutritive sugars include aspartame and saccharin. The sweeteners may be used in amounts necessary to impart sweetness. Suitably such amounts include from about 0.01 to about 10% w/w, preferably from about 0.5 to about 6% w/w of the composition.
Compositions of the present invention may comprise an agent that further modifies the taste and/or odour of the compositions, above that already achieved with the hydrocoUoid base. Such agents include alkali earth metal salts or amino acids. Illustrative non-limiting examples of such salts include sodium salts for example selected from the group consisting of sodium citrate, sodium carbonate and sodium tripolyphosphate. Suitably the salts may comprise about 0.005 to about 1 %, preferably from about 0.05 to about 0.2% w/w of the composition. Illustrative non- limiting examples of amino acids include amino acids selected from the group consisting of leucine, lysine and aspartic acid. L-lysine, a preferred amino acid, has been shown surprisingly to improve to palatability and to reduce the degree of "fishiness" of fish oil-containing compositions. Suitably the amino acids are present in an amount ranging from about 0.01 to about 1 % w/w, preferably from about 0.1 to about 0.5 % w/w of the composition.
Suitably the water component or aqueous phase of the compositions of the invention has a low pH, i.e. <7, preferably from about 3 to about 7, more preferably from about 3 to about 5. A low pH is essential when the compositions comprise a further taste or odour modifier which is in the form of an amino acid as described herein.
A low pH may be achieved by the use of a pH modifying agent such as an acid or a suitable buffer such as a salt of an acid that is physiologically acceptable and that does not have an objectionable taste. Suitable pH modifying agents include acids such as citric, malic, phosporic, fumaric, lactic, tartaric, glycolic, mandelic, or acetic and salts thereof.
Compositions of the invention may further comprise accessory food factors such as minerals, trace elements and vitamins. Suitably the compositions comprise a nutritionally supplemental amount, i.e. a nourishing amount, of the food factors.
This is supplemental or in addition to the amount found in the average diet and will provide from about 10% to about 200% of the Recommended Dietary Allowance (RDA).
Non-limiting examples of mineral elements and trace elements suitable for use in the invention include sodium, potassium, calcium, phosphorous, magnesium, manganese, copper, zinc, iron, selenium, chromium, and molybdenum in pharmaceutically acceptable form. Suitably salt forms of the above may be used. Advantageously the food factors falling within the scope of the invention do not adversely affect the palatability and organoleptic properties of the compositions. For example suitable sources of calcium include calcium phosphate such as tricalcium phosphate and monocalcium phosphate, calcium carbonate and mixtures thereof. Mixtures of tricalcium phosphate and monocalciumphosphate are preferred. Suitably the trace elements and minerals are present in an amount ranging from about 0.5% to about 5% w/w, preferably from about 0.8% to about 2.5 % w/w of the composition.
Non-limiting examples of vitamins suitable for incorporation in the composition include vitamin A and provitamins thereof, vitamin D, vitamin K, vitamin C, folic acid, thiamine, riboflavin, vitamin Bl , vitamin B6, vitamin B12, niacin, biotin, and panthotenic acid in pharmaceutically suitable form. Vitamins will be included in the compositions so as to give the desired amount, in line with the RDA; for example vitamin A palmitate, at a concentration of 1.7MIU/g may typically be present in an amount not greater than 0.01 %w/w of the composition, whilst Vitamin D3 at a concentration of l.OMIU/g will be present in an amount not exceeding 0.001 %w/w of the composition.
A problem associated with edible oil-containing compositions is that they are susceptible to fungal contamination, e.g. contamination with yeasts and/or moulds.
Accordingly compositions of the invention aim to overcome this problem and may comprise a preservative or preservative mixture. Preservatives suitable for use in the invention include sorbic acid or a salt thereof, a paraben and benzoic acid or a salt thereof. Suitably the sorbic acid component is in the form of an alkali metal salt such as potassium sorbate and the paraben is an alkyl paraben, such as methylparaben e.g. sodium methyl hydroxybenzoate or propyl paraben e.g. sodium propyl hydroxybenzoate or an ionic paraben preferably sodium paraben. Suitably the preservative content of the compositions may range from about 0.001 to about 5 % w/w of the composition.
Additionally compositions of the present invention will contain additives or excipients conventional in the field of nutrition and pharmaceutical compositions, including for example opacifiers, colorants and flavourings. The additives or excipients used in any given composition will be compatible both with each other and with the essential ingredients of the composition such that there is no interaction that would impair the performance of the compositions. All additives or excipients must of course be non-toxic and of sufficient purity to render them suitable for human use.
Suitable opacifiers include alginates e.g. propylene glycol alginate and sodium alginate. An opacifier may be used in an amount ranging from 0.005 % to around 0.5% w/w of the composition. When used as an opacifier, sodium alginate or propylene glycol alginate will suitably be present in an amount ranging from about 0.005 % to about 0.20% w/w.
Preferred flavourings for the compositions are the natural and artificial flavourings such as lemon, lime, orange, peach pineapple, raspberry and the like. Suitably flavourings may be used in an amount ranging from about 0.005 % to about 2.00% w/w of the composition, preferably in an amount less than 1 %w/w.
In a further aspect of the invention there is provided a palatable composition as hereinbefore described for use in therapy.
The present invention extends to a process for preparing a composition as hereinbefore defined. Generally the hydrocoUoid base and the sweetening agent, together with any water-soluble additives, are dissolved in water to form an aqueous phase and the pH is checked and adjusted if required. An oil phase is prepared containing oil-soluble or oil-miscible additives, if any, and the unpalatable edible oil, which is then admixed with the aqueous phase. If required, the mixture is heated in order to obtain a homogenous mix of the two phases. Alternatively the hydrocoUoid base may be added directly to the oil phase, which is then combined with the aqueous phase as described above. The final mix may then be mixed at high shear in order to ensure adequate dispersion of the oily and aqueous phases. The invention will now be described with reference to the following non-limiting Examples.
Example 1 - Fish Oil Composition
Figure imgf000012_0001
Example 2 - Fish Oil Composition
Figure imgf000012_0002
Example 3 - Fish Oil Composition
Figure imgf000013_0001
Example 4 - Fish Oil Composition
Figure imgf000013_0002
Example 5 - Preparation of Fish Oil Compositions of Examples 1 to 4
An aqueous phase and an oil phase is prepared. The water-soluble ingredients of the composition are dissolved in the aqueous phase, whilst the oil-soluble ingredients are dissolved in the oil phase. If desired, a premix of ingredients may be prepared and added to the oil or aqueous phases prior to forming the final mix. The final mix, consisting of all the components of the composition, is mixed at room temperature, at high shear rates sufficient to form the emulsion product.
Example 6 - Sensory Evaluation of Fish Oil Compositions
A reference emulsion was prepared and tested against formulations containing varying combinations of thickeners and starch/thickener(s) combinations. The results are detailed below.
Reference Emulsion
Aqueous Phase
Figure imgf000014_0001
Preparation of Emulsion
10% cod liver oil was added to 90% of the above aqueous phase to formulate the required emulsion. Test Emulsions
Figure imgf000015_0001
Results
The following aspects were evaluated in the above test: stability, texture/viscosity, mouthfeel, flavour (fishy or not), "cloyingness" and aftertaste. The formulas (1-17) were awarded a ' + ', when a positive result was observed for each of these criteria. The only positive result obtained for the reference formula was in respect of its stability. In comparison to other formulas, the reference emulsion was watery with a cold, thin mouthfeel, it also gave a mouthcoating sensation, a fishy taste and an unpleasant fatty aftertaste. Other formulas showed varying degrees of enhanced sensory characteristics, with Formulas 2 and 15 performing extremely well in the test.

Claims

Claims
1. A palatable composition, comprising an oil phase containing an unpalatable edible marine oil, a hydrocoUoid base, a sweetening agent and an aqueous phase characterized in that the hydrocoUoid base consists of a starch and at least one thickening agent.
2. A palatable composition according to claim 1 wherein the total amount of thickening agent is present in an amount ranging from 0.7% to 3% w/w of the composition.
3. A palatable composition according to claim 1 or claim 2 wherein at least one thickening agent is selected from the group consisting of xanthan gum, guar gum, carageenan, cellulose derivatives, alginic acid and salts thereof.
4. A palatable composition according to claim 3 wherein at least one of the thickening agents is xanthan gum.
5. A palatable composition according to any one of claims 1 to 4 comprising a hydrocoUoid base consisting of two thickening agents.
6. A palatable composition according to claim 5 wherein a first thickening agent is xanthan gum and a second thickening agent is selected from the group consisting of guar gum, carageenan, cellulose derivatives and alginic acid and salts thereof.
7. A palatable composition according to claim 6 wherein the thickening agents are present in an amount ranging from 0.7% to 3. % w/w of the composition.
. A palatable composition, comprising an oil phase containing an unpalatable edible marine oil, a hydrocoUoid base, a sweetening agent and an aqueous phase characterized in that the hydrocoUoid base consists of two or more thickening agents, and wherein one of the thickening agents is selected from the group consisting of xanthan gum, guar gum, carageenan, cellulose derivatives, alginic acid and salts thereof, and excluding compositions comprising a hydrocoUoid base consisting only of xanthan gum and alginic acid or salts thereof.
9. A palatable composition according to claim 8 comprising xanthan gum.
10. A palatable composition according to any one of claims 1 to 9 is in the form of an oil-in-water emulsion.
11. A composition according to any one of claims 1 to 10 wherein the amount of unpalatable edible marine oil is in the range 1 % to 20% w/w of the composition.
12. A composition according to any one of claims 1 to 11 wherein the amount of water is in the range 75% to 95 % w/w of the composition.
13. A composition according to any one of claims 1 to 12 wherein the unpalatable edible marine oil contains at least one omega-3 fatty acid.
14. A composition according to any one of claims 1 to 13 wherein the unpalatable edible marine oil is a fish oil.
15. A composition according to claim 14 wherein the fish oil is selected from the group consisting of cod liver oil and oil produced from additional fish body parts and mixtures thereof.
16. A composition according to any one of claims 1 to 15 having a viscosity of 6000 to lOOOOcps.
17. A composition according to any one of claims 1 to 16 wherein the sweetening agent is a carbohydrate selected from the group consisting of sucrose (cane sugar), glucose, fructose, a maltodextrin and mixtures thereof, and is present in an amount ranging from 0.5 % to 6% w/w of the composition.
18. A composition according to any of claims 1 to 17 comprising trace elements, minerals and/or vitamins.
19. A composition according to any of claims 1 to 18 comprising a preservative.
20. A composition according to any one of claims 1 to 19 comprising a taste modifier that is an alkali earth metal salt.
21. A composition according to any one of claims 1 to 20 wherein the pH of the aqueous phase is <7.
22. A composition according to claim 21 wherein the pH is 3 to 5.
23. A composition according to any one of claims 21 or 22 comprising a taste modifier that is an amino acid.
24. A composition according to claim 23 wherein the amino acid is selected from the group consisting of leucine, lysine and aspartic acid.
25. A method of preparing a palatable composition comprising the steps of: A. dissolving a sweetening agent and any other water soluble- ingredients) in water forming an aqueous phase;
B. adjusting the pH if required; C. dissolving a hydrocoUoid base in an unpalatable edible oil forming an oil phase;
D. admixing the aqueous phase with the oil phase.
PCT/EP2000/010650 1999-10-30 2000-10-25 A palatable composition comprising an oil phase containing an unpalatable edible marine oil, a hydrocolloid base, a sweetening agent and an aqueous phase WO2001032034A1 (en)

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