WO2014027022A1 - Compositions diététiques pour le traitement de malnutrition, de maladies neurologiques et de maladies métaboliques - Google Patents

Compositions diététiques pour le traitement de malnutrition, de maladies neurologiques et de maladies métaboliques Download PDF

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Publication number
WO2014027022A1
WO2014027022A1 PCT/EP2013/066988 EP2013066988W WO2014027022A1 WO 2014027022 A1 WO2014027022 A1 WO 2014027022A1 EP 2013066988 W EP2013066988 W EP 2013066988W WO 2014027022 A1 WO2014027022 A1 WO 2014027022A1
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composition
weight
protein
present
composition according
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PCT/EP2013/066988
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English (en)
Inventor
Maura O'donnell
Patricia WALLIS
Patricia RUTHERFORD
Cassie MCMULLEN
Catherine Patterson
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Nestec S.A.
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Publication of WO2014027022A1 publication Critical patent/WO2014027022A1/fr

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, 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
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
    • A23L33/22—Comminuted fibrous parts of plants, e.g. bagasse or pulp
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, 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
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, 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
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12—Fatty acids or derivatives thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, 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
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/19—Dairy proteins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, 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
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention is directed to compositions, preferably dietetic compositions suitable for the treatment of malnutrition, malabsorption states and other condi- tions requiring fortification with energy, protein and micronutrients for nutritional support. Further compositions as described herein are also suitable for use in for instance the treatment of neurological diseases, and in the treatment of metabolic diseases or other diseases.
  • inventive compositions as detailed herein specifically provide novel diets and compositions suitable therefore. Further inventive compositions as detailed herein are also suitable for use in dietary modification or manipulation involving the intake of fat, protein and carbohydrate, in isolation or combination, for therapeutic effect and benefit.
  • the present invention also describes a method for preparing such compositions and the use of such compositions.
  • Dietetic compositions usually aim to provide an adequate delivery of nutrients, e.g. of a specific distribution of fat, carbohydrates and lipids, and thereby try to reduce negative effects of e.g. malnutrition and or specific diseases.
  • Malnutrition is both a cause and consequence of ill health. A poor food intake, especially if for a prolonged period, makes us more prone to illness and injury. Furthermore, illness and injury can lead to a reduced appetite through a wide va- riety of mechanisms. Furthermore, factors such as the presence of fever, diarrhoea or vomiting often makes matters worse. Malnutrition often leads to weight loss and muscle wasting. Furthermore, once in a weakened state we are more likely to fall or injure our. In addition, malnutrition also weakens our immune systems and hence one is more likely to pick up infections.
  • Food Fortification wherein calories and protein are added to the food and drink the individual is already consuming.
  • Food fortification can be achieved for instance with the addition of commonly-used household ingredients such as butter, cream, milk powder, cheese, sugar, oil, etc.
  • food fortification can also be achieved with prescribed supplements to add to food which are used to boost the energy (calories) and/or protein, hopefully resulting in a minimal effect on bulk/texture and/or the organoleptic properties of the food.
  • Compact Nutrition This requires the use of high energy, high protein supplements in low volumes (even as low as 30ml_ to 60ml_) at set doses and times throughout the day.
  • compositions are only suita- ble for a small group of patients, such as infants (see e.g. EP 2 219 476) or have only shown to provide an effect for treatment of an extremely limited number of diseases. Accordingly, it is an object of the present invention to further improve dietetic compositions for use in the dietary management of malnutrition, malabsorption states and other conditions requiring fortification with energy, protein and micronu- trients, which may be cured or at least ameliorated by supplemental or full nutritional feeding.
  • the object underlying the present invention is preferably to be accomplished by means of the independent claims as attached.
  • the dependent claims advantageously illustrate further preferred aspects of the inventive embodiments.
  • the object underlying the present invention is preferably solved by a composition, which typically comprises about 4 to about 12% by weight protein, about 5 to about 15% by weight carbohydrate and about 20 to about 38% by weight fat, preferably about 25 to about 38% by weight fat.
  • the inventive composition may be used for treatment of diseases and disorders as defined herein.
  • the inventive composition may be a ketogenic composition.
  • the composition of the present invention is a nutritional composition, preferably a pasteurized composition, more preferably a pasteurized nutritional composition.
  • the composition of the present in- vention may be for use as a supplement or may be used as a sole source of nutrition, e.g. as a full meal.
  • the inventive composition may be furthermore suitable for use in the treatment of a disease as defined herein.
  • the term "supplement” as used herein refers to a nutrient that may be added to the diet or a meal thereof.
  • the inventive composition typically comprises about 4 to about 12% by weight protein, about 5 to about 15% by weight carbohydrate and about 20 to about 38% by weight fat.
  • the protein, the fat and/or the carbohydrate, particularly of the inventive composition is/are preferably derived from at least two different sources, namely animal and vegetal.
  • the proteins are derived at least partly from animal, such as whey protein, but optionally also partly from plant source, the fat at least partly from vegetal or plant source, and the carbohydrates at least partly from vegetal source, or from a combination of animal and vegetal.
  • such proteins, fats and/or carbohydrates of the inventive composition may be derived from at least two different sources, namely animal and vegetal.
  • a fat derived from a vegetal source may be a high oleic sunflower oil; furthermore, a vegetal carbohydrate employed may be sucrose, preferably castor sugar, etc.
  • the carbohydrate source as used herein also functions as a sweetener. Nevertheless, a sweetener as defined herein may be likewise added as an additional ingredient.
  • the protein as contained in the inventive composition typically may be selected from any suitable protein selected from the group comprising or consisting of e.g. whey protein, whey protein isolate, preferably acidified whey protein isolate, whey protein concentrate, whey powder, egg protein, pea protein, potato protein, soy protein, soy protein isolate, and combinations thereof and the like either alone or in combination.
  • the protein may be hy- drolysed or intact protein.
  • the composition does not contain whole milk protein in a ratio of 80:20 casein protein to whey protein.
  • the composition as defined herein preferably comprises about 4 to about 12% by weight protein, preferably about 4 to about 1 1 % by weight protein, likewise preferably about 4 to about 10%, or about 5 to about 10%, or about 5 to about 7%, or about 6 to about 8%, or about 7.5 to about 9%, or about 8.5 to about 10%.
  • the present invention most preferably has a protein content of about 6.7 % by weight, which is particularly preferably acidified whey protein isolate.
  • the fat as contained in the inventive composition typically may be selected from any suitable fat source, selected from the group comprising or consisting of coconut oil, preferably fractionated coconut oil (MCT), lemon oil, dietary fats, vegetable oil, such as sunflower oil, preferably high oleic sunflower oil, canola oil, corn oil, soybean oil, sesame seed oil, safflower oil, walnut oil, evening primrose oil, peanut oil, cottonseed oil, rapeseed oil, olive oil, fish oil (e.g., menhaden oil, sardine oil) macadamia oil, palm oil, palm kernel oil, or mixtures thereof, etc., either alone or in combination.
  • coconut oil preferably fractionated coconut oil (MCT)
  • MCT fractionated coconut oil
  • lemon oil preferably olive oil
  • dietary fats such as sunflower oil, preferably high oleic sunflower oil, canola oil, corn oil, soybean oil, sesame seed oil, safflower oil, walnut oil, evening primrose oil, peanut oil, cottonseed oil
  • dietary fats are preferably selected from (fat) molecules composed of individual carbon atoms linked into chains ranging from 2 to 24 carbon atoms in length.
  • the inventive composition does not comprise soy protein and/or olive oil and/or canula oil.
  • the fat source used in the inventive composition can be a 100% LCT or 100% MCT fat source, which can be employed either alone or in combination.
  • the inventive compositions may comprise a mixture of MCT and LCT as defined herein.
  • MCT 100% MCT
  • LCT low-to-to-to-to-hexide
  • the composition as defined herein pref- erably comprises about 20 to about 38% by weight fat, preferably about 25 to about 38% by weight fat, or preferably about 25 to about 35% by weight fat, more preferably about 26 to about 28%, or about 22 to about 38% by weight fat, or about 23 to about 35% by weight, or about 24 to about 30%, or about 27 to about 28.5%, or about 27.5 to about 30%, or about 29 to about 31 %, or about 30.5 to about 32 %, or about 31 .5 to about 33.5 %, or about 33 to about 34.5%, or about 34 to about 36%, or about 35 to about 37% by weight fat.
  • the present invention most preferably has a fat content of about 28.2 % by weight.
  • the present invention preferably has a fat content of about 23.9 % by weight.
  • the inventive composition may also comprise or contain fat comprising saturates, mono-unsaturates, and/or polyunsaturates.
  • the inventive composition preferably comprises in a range of about 2 to about 30% by weight saturates, about 1 to about 25% by weight mono-unsaturates and about 0.1 to about 5% by weight poly-unsaturates.
  • the saturated fat is present in the inventive composition in a range of about 2 to about 30% by weight, preferably about preferably about 3 to about 4 %, or about 3.5 to about 4.5 %, or about 4.1 to about 6 %, or about 5 to about 10 %, or about 8 to about 15 %, or about 13 to about 18 % by weight.
  • the present invention has saturated fat present at about 4.08% by weight.
  • the composition has saturated fat present at about 3.65 % by weight.
  • the term "%" is preferably defined as "% by weight” and in this context reflects the total amount of the saturated fat component in the inventive composition.
  • the mono-unsaturated fat is present in the inventive composition in a range of about 1 to about 25% by weight, preferably about 9 to about 15 %, or about 14 to about 18 %, or about 19 to about 21 %, or about 20 to about 21 .5 %, or about 21 .3 to about 24 % by weight.
  • the present invention has monounsaturated fat present at about 21 .15 % by weight.
  • the present invention has monounsaturated fat present at about 17.5 % by weight.
  • the term "%" is preferably defined as "% by weight” and in this context reflects the total amount of the mono-saturated fat component in the inventive composition.
  • the poly-unsaturated fat is present in the inventive composition in the range of about 0.1 to about 5% by weight, preferably about 1 .8 to about 2.5 %, or about 2.3 to about 2.8 %, or about 2.6 to about 2.9 %, or about 2.8 to about 3 %, or about 2.9 to about 4 %, or about 3 to about 4.5 % by weight.
  • the present invention has polyunsaturated fat pre- sent at about 3.04% by weight.
  • the present invention has polyunsaturated fat present at about 2.6% by weight.
  • the term "%" is preferably defined as "% by weight” and in this context reflects the total amount of the poly-saturated fat component in the inventive composition.
  • the inventive composition comprises or contains an amount about 0 to about 23%, preferably 0.5 to about 23% by weight medium chain triglycerides and/or an amount of about 6 to about 30 % by weight long chain triglycerides.
  • Medium Chain Triglycerides (MCTs) as used herein are typically composed of 6 to 10, or 6 to 1 1 , or 6 to 12 carbon links. Because of their shorter chain length MCTs have a number of unique properties which give them advantages over the more common LCTs.
  • the MCT's employed in the present invention are preferably sourced from fractionated coconut oil, macadamia oil, palm oil, palm kernel oil, etc. and combinations thereof.
  • the medium chain triglycerides which may be present in the inventive composition typically range from about 0.5 to about 23% by weight, preferably about 1 to about 1 .5% or about 1 .2 to about 2%, or about 1 .7 to about 5%.
  • the present invention has medium chain triglycerides present at about 1 .5%, and in a particular embodiment, the present invention has medium chain triglycerides present at about 1 .49% .
  • LCTs Long Chain Fatty acids
  • LCT's employed in the present invention are preferably sourced from sunflower oil, most preferably high oleic sunflower oil, corn oil, soy oil, canola oil, sesame seed oil, safflower oil, walnut oil, evening primrose oil, peanut oil, cottonseed oil, rapeseed oil, olive oil, fish oil (e.g., menhaden oil, sardine oil), palm olein etc. and combinations thereof.
  • the long chain triglycerides which may be present in the inventive composition typically range from about 6 to about 30 % by weight, preferably about 20 to about 24%, preferably about 21 to about 23%, or about 22 to about 24.5%, or about 24 to about 25.5%, or about 25 to about 26.5%, or about 26 to about 28% by weight.
  • the present invention has long chain triglycerides present at about 25.5% by weight.
  • the present invention has long chain triglycerides present at about 22% by weight.
  • the carbohydrate source as contained in the inventive composition typically may be selected from any suitable carbohydrate source which preferably also functions as a sweetener.
  • the carbohydrate source employed in the inventive composition may preferably be selected from the group consisting of sucrose, preferably castor sugar, fructose, maltodextrin, fibers, corn syrup, high fructose corn syrup, corn starch, lactose, glucose, dextrose, maltose and combinations thereof, etc. and the like either alone or in combination.
  • carbohydrate For the purposes of the inventive composition about 5 to about 15% by weight carbohydrate is employed, more preferably about 5.5 to about 8.5%, or about 7 to about 9%, or about 7.5 to about 10%, or about 8 to about 1 1 .5%, or about 1 1 to about 13.5%, or about 12.5 to about 14%. According to one preferred embodiment, he present invention preferably has a carbohydrate content of about 13.4 % by weight.
  • sweetener may also be present, which may be a combination of a high dextrose equivalent sweetener, an artificial sweetener and a highly concentrated sweetener.
  • the sweetener or combination of sweeteners may be crystalline fructose, aspartame, corn syrup, sucrose, glucose, sucralose, maltodextrin, and/or stevia.
  • Sweeteners include, but are not limited to, dextrose, crystalline fructose, high fructose corn syrup 90%, high fructose corn syrup 55%, and high fructose corn syrup 42%.
  • Other complementary sweeteners that may also be used in the optional sweetener blend include, but are not limited to fructose, sucrose, glucose, lactose, maltose, dextrose, honey, invert sugar, corn syrup, rice syrup, grain syrup, maltodextrin, polydextrose, oligodextrin, cane based sweeteners, beet based sweeteners etc.
  • artificial sweeteners, sugar substitutes and non-nutritive sweeteners may also be used and include, but are not limited to, edible saccharin salts, aspartame, saccharine, alitame, acesulfame K, tagatose, L-sugars, neo- phesperidin, thaumatin, dihydrochalchones, cyclamates, steviosides, glycyr- rhizins, synthetic alkoxy aromatics, such as dulcin, sucralose, suosan, miraculin, monellin, sorbitol, xylitol, talin, cyclohexylsulfamates, synthetic sulfamic acids, ox- imes, aspartyl malonates, succanilic acids, amino acid based sweeteners, and carboxylates such as 3-hydroxy-4-alkyloxyphenyl aliphatic carboxylates.
  • carboxylates such
  • Said optional sweetener blend is preferably selected according to the desired sweetness. For instance, it is well known that fructose in its pure crystalline form has a perceived sweetness of about 160 to 180, typically reported as 173, compared to sucrose at a value of 100. Hence, if the optional sweetener blend comprises fructose, other sweeteners may not be required or may only be utilized in relatively small amounts.
  • the optional sweetener blend is also selected in order to compliment the energy requirements of the inventive composition. To this end, in some compositions the artificial sweetener saccharin may be particularly preferred since saccharin has no calories and no nutritional value. Sucralose is a further preferred non-caloric sweetener, since this is about 600 times sweeter than the sugar sucrose.
  • digestible and/or non-digestible sweeteners may be employed in the present invention either alone or in combination.
  • sweeteners are present in the inventive compositions in the ranges as indicated herein for carbohydrates.
  • emulsifiers may also be present, which include, but are not limited to, mono- and diglycerides, distilled mono- glycerides, soy lecithin, egg yolk and egg lecithin, which may be present either alone or in combination.
  • Said optional emulsifiers may be present in an amount between about 0.05 to about 1 %, preferably about 0.1 to about 0.2 %, or about 0.15 to about 0.3 %, or about 0.18 to about 0.4 %, or about 0.35 to about 0.5 %, or about 0.45 to about 0.65 %, or about 0.55 to about 0.8 %, or about 0.7 to about 0.9 % by weight of the inventive composition.
  • starch refers to a complex carbohydrate (polysaccharide) composed of chains of glucose molecules, which plants use to store food energy.
  • the fibre source if employed in the inventive composition may be either soluble or insoluble fibre which can be present alone or in combination which may be selected from the group consisting of inulin, oat fibre, gum acacia (i.e., Gum Arabic), corn fiber, wheat bran, oat bran, corn bran, whole corn flour, whole oat flour, fruc- tooligosaccharides (from Inulin), pea fibre, partially hydrolyzed guar gum and mixtures thereof, etc. and the like either alone or in combination.
  • fibre may be present.
  • the fibre content in the inventive composition typically ranges from about 0.5 to about 2.5% by weight.
  • fibre is utilized in about 1 % by weight, preferably about 0.7 to about 1 %, or about 0.8 to about 2%, or about 0.9 to about 1 .5%, or about 1 to about 1 .2%.
  • fibre is present in about 1 %. In some embodiments it is preferable that no fibre is present in the inventive composition.
  • the inventive composition typically comprises about 4 to about 12% by weight protein, about 5 to about 15% by weight carbohydrate and about 25 to about 38% by weight fat. Most preferably, the composition contains about 0.5 to about 23% by weight medium chain triglycerides and/or about 6 to about 30 % by weight long chain triglycerides. Furthermore, it is also particularly preferred that the inventive composition does not contain or comprise DHA, DPA and/or ARA.
  • 0.4 to 2.0% by weight of the fat in the inventive composi- tion is eicosapentaenoic acid (EPA).
  • EPA eicosapentaenoic acid
  • the term "%" is preferably defined as "% by weight” and in this context reflects the total amount of the preferred EPA component used in the inventive composition.
  • said inventive composition may contain no eicosapentaenoic acid (EPA).
  • the ratio of fat: protein: carbohydrate in the inventive composition is about 4.2: 1 : 2, wherein preferably each of the values for said ratio for fat: protein: carbohydrate may vary by +/- 0.3. Accordingly, in some aspects ratios of 3.9: 0.7: 1 .7 to 4.5: 1 .3: 2.3 may be utilized. For instance, one such ratio comprised in the composition of the present invention is 4.1 : 0.9: 2.2. According to another preferred embodiment, the ratio of fat: protein: carbohydrate in the inventive composition is about 3.1 : 1 : 1 .7, wherein preferably each of the values for said ratio for fat: protein: carbohydrate may vary by +/- 0.3. Accordingly, in some aspects ratios of 2.8: 0.7: 1 .4 to 3.4: 1 .3: 2.0 may be utilized.
  • the weight ratio of fat to the sum of proteins and carbohydrates in the inventive composition is 4.2: 3, which may vary by +/- 0.3.
  • the weight ratio of fat to the sum of pro- teins and carbohydrates, preferably digestible carbohydrates is 3.9: 2.7 to 4.5: 3.3.
  • said ratio could be 4.1 : 3.2; which could consist of 4.1 fat and 1 protein and 2.2 carbohydrate.
  • the ratio of fat to the sum of proteins and carbohydrates may be about 3.1 : 2.7
  • the inventive composition utilizes no artificial additives and/or utilizes whole protein. Having said this, in a preferred embodiment the composition does not utilize whole milk protein in a ratio of 80:20 casein protein to whey protein. It is also preferable that intact proteins are comprised in the inventive composition and further preferred that casein is not present.
  • the inventive composition may also utilize linoleic acid or a-linoleic acid either alone or in combination.
  • linoleic acid or a- linoleic acid preferably may be contained in the inventive composition in amounts of about 1079 mg and about 48.2 mg respectively or about 2742 mg and about 61 .8 mg respectively per 100g.
  • the present invention contains linoleic acid in about 1000 mg to about 3000 mg per 100g, preferably about 2500 to about 2600 mg, or about 2550 to about 2700 mg, or about 2560 to about 2750 mg, or about 2710 to about 2800mg.
  • the present invention contains a-linoleic acid in about 52 to about 58 mg or about 56 to about 62 mg, or about 60 to about 65 mg.
  • Acids may also be employed in the inventive composition, preferably citric acid and/or malic acid and/or ascorbic acid and/or lactic acid and/or succinic acid and/or acetic acid.
  • the Acid can be added in liquid or dry form, such as in hy- drated or anhydrous form and the like.
  • the inventive composition which is preferably a semi-liquid/semi-solid composition, most preferably a liquid composition is adjusted to a pH of less than about 4.3, preferably about 3.5 to about 4.5, more preferably about pH3.5 to pH 4.3, preferably about pH3.5 to about pH4.2, such as around pH4, as defined herein for the inventive composition and inventive process.
  • Said inventive composition may also comprise micronutrients selected from vitamins, minerals and trace elements, which may be present either alone or in com- bination. Alternatively, for some embodiments the inventive compositions may also not contain any micronutrients.
  • vitamin refers to any of various organic substances essential in minute quantities to the nutrition of most animals act especially as coenzymes and precursors of coenzymes in the regulation of metabolic processes. Vitamins have diverse biochemical functions, including function as hormones (for example, vitamin D), antioxidants (for example, vitamin C and vitamin E), and mediators of cell signalling, regulation of cell growth, tissue growth and differentiation (for example, vitamin A).
  • the B complex vitamins which is the largest in number, function as precursors for enzyme cofactor biomolecules (co-enzymes) that help act as catalysts and substrates in metabolism. For instance Vitamin B 6 and Vitannin Bi 2 .
  • Other Vitamins which may be present include Vitamin K, Thiamin, Riboflavin, Niacin, Folic Acid, Biotin and Pantothenic Acid.
  • the inventive composition preferably comprises the following vitamins per 100 kcal:
  • Vitamin A in about 20 to about 180 [ ⁇ g per 100 kcal, preferably about 35 to about 180 ig per 100 kcal, preferably at about 40 to about 80 [ig, or about 70 to about 1 10 g, or about 85 to about 140 g, or about 100 to about 150 g, or about 135 to about 170 [ig per 100 kcal.
  • Vitamin D in about 0.5 to about 3 [ig per 100 kcal, preferably at about 0.9 [ig to about 1 .5 [ig, or about 1 .3 [ig to about 1 .9 [ig, or about 1 .7 g to about 2.2 g, or about 2 to about 2.6 [ig, or about 2.3 [ig to about 2.8 [ig per 100 kcal.
  • Vitamin K in about 3.5 to about 20 [ ⁇ g per 100 kcal, preferably at about 5 to about 9 [ig, or about 7 to about 12 g, or about 10.5 to about 15 [ig, or about 13 to about 18 pg per 100 kcal.
  • Vitamin C in about 2.25 to about 22 mg per 100 kcal, preferably at about 5 to about 10 mg, or about 8 to about 14 mg, or about 1 1 to about 15 mg, or about 13 to about 18 mg per 100 kcal.
  • Riboflavin in about 0.07 to about 0.5 mg per 100 kcal, preferably in about 0.08 to about 0.5 mg per 100 kcal, preferably at about 0.07 to about 0.15 mg, preferably at about 0.13 to about 0.19 mg, or about 0.17 to about 0.23 mg, or about 0.20 to about 0.29 mg, or about 0.27 to about 0.36 mg, or about 0.33 to about 0.40 mg, or about 0.37 to about 0,45 mg per 100 kcal.
  • Vitamin B 6 in about 0.07 to about 0.5 mg per 100 kcal, preferably in about 0.08 to 0.5 mg per 100 kcal, preferably at about 0.07 to about 0.15 mg, or at about 0.13 to about 0.19 mg, or about 0.17 to about 0.24 mg, or about 0.21 to about 0.30 mg, or about 0.27 to about 0.34 mg, or about 0.30 mg to about 0.38 mg, or about 0.36 to about 0.42 mg, or about 0.39 to about 0.46 mg per 100 kcal.
  • Niacin in about 0.7 to about 3 mg per 100 kcal preferably about 0.9 to 3 mg per 100 kcal, preferably at about 0.7 to about 1 .5 mg, or at about 1 .3 to about 1 .9 mg, or about 1 .7 to about 2.2 mg, or about 2.0 to about 2.5 mg, or about 2.2 to about 2.8 mg per 100 kcal.
  • Folic acid in about 10 to about 50 ⁇ ig per 100 kcal, preferably at about 14 to about 20 ⁇ ig, or about 18 to about 24 g, or about 21 to about 28 ⁇ ig, or about 25 to about 32 [ig, or about 29 to about 34 g, or about 31 to about 38 ⁇ ig, or about 35 to about 41 or about 38 to about 45 [ig per 100 kcal.
  • Vitamin Bi 2 in about 0.07 to about 0.7 [ ⁇ g per 100 kcal, preferably at about 0.1 to about 0.18 [ig, or about 0.14 to about 0.22 g, or about 0.19 to about 0.25 [ig, or about 0.23 to about 0.30 [ig, or about 0.28 to about 0.38 [ig, or about 0.35 to about 0.43 [ig, or about 0.40 to about 0.48 [ig, or about 0.43 to about 0.52 g, or about 0.49 to about 0.58 [ig, or about 0.54 to about 0.62 pg, or about 0.59 to about 0.65 [ig, or about 0.62 to about 0.67 pg per 100 kcal.
  • Pantothenic acid in about 0.15 to about 1 .5 mg per 100 kcal, preferably at about 0.4 to about 0.9 mg, or about 0.7 to about 1 .1 mg, or about 0.9 to about 1 .3 mg, or about 1 .1 to about 1 .4 mg per 100 kcal.
  • Biotin in about 0.75 to about 7.5 g per 100 kcal preferably at about 1 .0 to about 1 .9 ig, or about 1 .7 to about 2.5 g, or about 2.3 to about 3.1 g, or about 2.8 to about 3.6 [ig, or about 3.4 to about 4.2 pg, or about 3.9 to about 4.7 pg, or about 4.4 to about 5.2 pg, or about 4.9 to about 5.6 g, or about 5.2 to about 6.3 g, or about 5.9 to about 6.5 g, or about 6.2 to about 7.0 g per 100 kcal .
  • Vitannin E in about 0.5 to about 3 mg per 100 kcal, preferably at about 0.8 to about 1 .4, or about 1 .1 to about 1 .8, or about 1 .5 to about 2.1 , or about 1 .7 to about 2.5, or about 1 .9 to about 2.8 mg per 100 kcal.
  • vitamin E is present in 0.5mg/g of polyunsaturated fatty acids, preferably expressed as linoleic acid but most preferably in no case less than 0.5 mg per 100 available kcal.
  • micronutrient refers to vitamins and minerals that are required in the human diet in very small amounts.
  • Dietary minerals are chemical elements other than carbon, hydrogen, nitrogen, and oxygen that are required to sustain the health of living organisms.
  • dietary minerals can include calcium, magnesium, phosphorus, potassium, sodium, and sulphur.
  • inventive composition as described herein also preferably comprises the following minerals per 100 kcal:
  • Sodium in about 30 to about 175 mg per 100 kcal preferably at about 70 to about 1 10 mg, or about 90 to about 130 mg, or about 1 10 to about 150 mg, or about 135 to about 155mg, or about 140 to about 165 mg per 100 kcal .
  • Potassium in about 70 to about 295 mg per 100 kcal preferably about 80 to about 295 mg per 100 kcal, preferably at about 70 to about 120mg, or about 1 10 to about 150 mg, or about 125 to about 180 mg, or about 160 to about 210 mg, or about 190 to about 240 mg, or about 220 to about 270 mg per 100 kcal.
  • Phosphorus in about 30 to about 80 mg per 100 kcal preferably at about 39 to about 55 mg, or about 44 to about 60 mg, or about 57 to about 65 mg, or about 61 to about 69 mg, or about 66 to about 72 mg, or about 71 to about 76 mg per 100 kcal.
  • Magnesium in about 7.5 to about 25 mg per 100 kcal preferably at about 10 to about 14 mg, or about 12 to about 18 mg, or about 16 to about 20 mg, or about 19 to about 23 mg per 100 kcal.
  • Calcium in about 50 to about 250 mg per 100 kcal preferably at about 90 to about 130 mg, or about 1 10 to about 150 mg, or about 130 to about 170 mg, or about 160 to about 190 mg, or about 180 to about 210 mg, or about 200 to about 230 mg per 100 kcal.
  • the composition of the present invention may comprise or contain calcium, most preferably in an amount of about 100 to about 245 mg per 100 g and/or lecithin, even more preferably in an amount of about 0.1 to about 2%.
  • calcium is present in the present invention at about 120 to about 150 mg, or about 135 to about 190 mg, or about 185 to about 200 mg, or about 195 to about 210 mg, or about 205 to about 215 mg, or about 213 to about 220 mg per 100g.
  • calcium is present at about 217 mg. According to another preferred embodiment it is preferable that calcium is present at about 197 mg per 100g.
  • calcium lactate is present in the present invention in the range of about 0.5 to about 3% by weight. More preferably, in about 0.6% to about 1 .7%, or about 1 .5% to about 1 .8%, or about 1 .6% to about 2%, or about 1 .9% to about 2.5%. Particularly preferable is that calcium lactate is present in 1 .83% by weight.
  • magnesium lactate is present in the present invention in the range of about 0.2 to about 2% by weight. More preferably, in about 0.3 to about 0.5%, or about 0.4 to about 0.6%, or about 0.55 to about 0.8%, or about 0.7 to about 1 .2%, or about 1 to about 1 .5%. Particularly preferable is that magnesium lactate is pre- sent in about 0.61 % by weight.
  • vitamins and minerals in the inventive composition may be determined by one of skill in the art.
  • minerals that are needed in relatively small quantities may be referred to as trace elements, for example, chromium, cobalt, copper, chloride, fluorine, iodine, iron, manganese, molybdenum, selenium, and zinc.
  • inventive composition as described herein also preferably comprises the fol- lowing trace elements per 100 kcal:
  • Copper in about 60 to about 500 g per 100 kcal preferably at about 90 to about 130 g, or about 1 15 to about 150 g, or about 135 to about 170 g, or about 155 to about 200 pg, or about 180 to about 230 pg, or about 210 to about 280 pg, or about 250 to about 330 pg, or about 310 to about 390 pg, or about 375 to about 450 pg per 100 kcal.
  • Chloride in about 30 to about 175 mg per 100 kcal preferably at about 70 to about 1 10 mg, or about 90 to about 130 mg, or about 1 10 to about 150 mg, or about 135 to about 165 mg, or about 155 to about 170 mg per 100 kcal .
  • Iodine in about 6.5 to about 35 g per 100 kcal preferably at about 10 to about 16 pg, or about 13 to about 18 pg, or about 16 to about 20 pg, or about 19 to about 25 pg, or about 22 to about 29 pg, or about 27 to about 33 pg per 100 kcal.
  • Selenium in about 2.5 to about 10 g per 100 kcal preferably at about 3.5 to about 5 pg, or about 4 to about 6 pg, or about 5.5 to about 8 pg, or about 7 to about 9 [ig per 100 kcal.
  • Manganese in about 0.05 to about 0.5 mg per 100 kcal preferably at about 0.1 to about 0.15 mg, or about 0.13 to about 0.19 mg, or about 0.16 to about 0.23 mg, or about 0.21 to about 0.26 mg, or about 0.22 to about 0.3 mg, or about 0.28 to about 0.35 mg, or about 0.32 to about 0.4 mg, or about 0.37 to about 0.45 mg per 100 kcal.
  • Molybdenum in about 3.5 to 18 g per 100 kcal preferably at about 4 to about 6 [ig, or about 5 to about 8 pg, or about 7 to about 9 pg, or about 8 to about 12 pg, or about 10 to about 13, or about 12 to about 16 pg per 100 kcal.
  • Fluoride in about 0 to about 0.2 mg per 100 kcal preferably at about 0.05 to about 0.09 mg, or about 0.07 to about 0.12 mg, or about 0.10 to about 0.14 mg, or about 0.12 to about 0.18 mg per 100 kcal.
  • the inventive composition as described herein can include any combination of vitamins, minerals and trace elements that is useful in providing appropriate nutrition to the patient.
  • the vitamins, minerals and trace elements may be used in the form of a mixture or formulation. It is more preferable that the lecithin is present in the present invention at about 0.3 to about 0.7%, or about 0.5 to about 0.9%, or about 0.8 to about 1 %, or about 0.95 to about 1 .3%, or about 1 .1 to about 1 .5%, or about 1 .4 to about 1 .8%.
  • the inventive composition may also comprise starch, preferably tapioca starch in amounts of about 1 .5% by weight, more preferably about 1 .3% by weight, most preferably about 0.5 to about 2.5%, or about 1 to about 1 .5%, or about 1 .3 to about 2% by weight.
  • starch preferably tapioca starch in amounts of about 1 .5% by weight, more preferably about 1 .3% by weight, most preferably about 0.5 to about 2.5%, or about 1 to about 1 .5%, or about 1 .3 to about 2% by weight.
  • starch preferably tapioca starch in amounts of about 1 .5% by weight, more preferably about 1 .3% by weight, most preferably about 0.5 to about 2.5%, or about 1 to about 1 .5%, or about 1 .3 to about 2% by weight.
  • starch preferably tapioca starch in amounts of about 1 .5% by weight, more preferably about 1 .3% by weight, most preferably about 0.5 to about 2.5%,
  • compositions may comprise or contain an anti- foaming agent, preferably selected from lecithin and/or MCT oil, and/or silicone antifoamers, more preferably in an amount of about 0.5 to 23 % by weight.
  • an anti- foaming agent preferably selected from lecithin and/or MCT oil, and/or silicone antifoamers, more preferably in an amount of about 0.5 to 23 % by weight.
  • the MCT oil then preferably not only acts an antifoaming agent, its presence is furthermore nutritionally required.
  • lecithin and/or MCT oil either separately or in combination are present in the present invention at about 0.5 to 5% by weight, preferably at about 0.6 to about 0.89%, or about 0.7 to about 1 .1 %, or about 1 .0 to about 1 .3%, or about 1 .2 to about 1 .6%, or about 1 .4 to about 2.0%, or about 1 .8 to about 2.38%, or about 2.2 to about 2.6%, or about 2.5 to about 3% by weight.
  • MCT oil preferably sourced from fractionated coconut oil is present at about 1 .49% by weight and Lecithin is present at about 0.89 % by weight.
  • the present invention has an energy content per 100g of about 1397 KJ (about 334 Kcal)
  • Vitamin premix which preferably contains or comprises Vitamin A, Vitamin D, Vitamin E, Vitamin C, Vitamin K, thiamin, riboflavin, niacin, Vitamin B 6 , folic acid, Vitamin Bi2, biotin and pantothenic acid, preferably in a combined amount of about 22.5 mg per 100g.
  • Other vitamins may also be present as defined herein above.
  • Minerals which preferably contains or comprises sodium, potassium, calcium, phosphorus and magnesium, preferably in a combined amount of about 943 mg per 100g. Other minerals may also be present as defined herein above.
  • Trace element mix which preferably contains or comprises chloride, iron, copper, zinc, manganese, iodine, molybdenum, selenium and chromium, preferably in a combined amount of about 255.1 mg per 100g.
  • Other trace elements may also be present as defined herein above.
  • the inventive composition comprises the following ingredients: water, vegetable oil (fractionated coconut oil and high oleic sunflower oil), sucrose; which is preferably caster sugar, whey protein isolate; which is preferably acidified whey protein isolate, calcium lactate, emulsifier (soya lecithin, e.g. E322), dietary fibre which is preferably a mixture of inulin and oat fibre (e.g.
  • White Star AOF 200 magnesium lactate, tri potassium citrate, sodium chloride, choline bitartrate, vitamin premix, trace element mix, dipotassium phosphate, tri sodium citrate, lemon oil (e.g. lemon oil 121 16), taurine (e.g. JP8), L-carnitine L-tartrate, citric acid and citric acid anhydrous.
  • lemon oil e.g. lemon oil 121 16
  • taurine e.g. JP8
  • L-carnitine L-tartrate citric acid and citric acid anhydrous.
  • compositions as described herein are preferably either liquids or semi liq- uids/semi solids, although liquids are particularly preferred, wherein the viscosity can be tailored as desired, preferably by applying pressures as outlined herein in a process for preparing the inventive composition, which may be supplemented e.g. by adding starch as defined herein.
  • viscosity refers to the measure of the thickness or resistance of a fluid to flow. Liquids with a high viscosity such as semi-liquids or semi-solids are usually very thick and flow very slowly, while low viscosity liquids generally are thin and flow quickly.
  • a homogenization pressure of about 86 to about 240 bar, preferably about 86 to about 220 bar, preferably about 86 to about 195 bar, preferably about 90 to about 100 bar, or about 95 to about 120 bar, or about 1 10 to about 140 bar, or about 130 to about 160 bar, or about 150 to about 180 bar, or about 170 to about 190, or about 180 to about 210 bar can be used to give a semi-liquid or semi-solid viscosity.
  • lower homogenization pressures such as about 1 to about 85 bar, preferably about 10 to about 30 bar, or about 20 to about 45 bar, or about 40 to about 65 bar, or about 55 to about 80 bar can be used in order to give a more liquid viscosity.
  • inventive composition with a liquid viscosity, most preferably a homogenization pressure of about 70 bar is used.
  • the present inventive composition preferably encompass products as described herein having preferably liquid, semi-liquid or semi-solid viscosities defined in cen- tipose (cP) of about 1 to about 40,000 cP, preferably about 1000 to about 40,000 cP.
  • cP cen- tipose
  • Viscosities described herein were measured at 25°C using a Brookfield DV-E Vis- cometer (LV model). Alternatively, viscosities can also be measured by other methods known in the art. As used herein, the viscosity terms semi-solid and semi-liquid can be used interchangeably. Having said this, generally speaking, a product with a semi-solid viscosity as described herein is generally more viscous than a product with a semi-liquid viscosity.
  • the inventors have found that this is typically from about 1000 to about 4700 cP, preferably about 1 100 to about 1400 cP, or about 1350 to about 1600 cP, or about 1500 to about 1750 cP, or about 1650 to about 2000 cP, or about 1900 to about 2300 cP, or about 2100 to about 2600 cP, or about 2500 to about 2900 cP, or about 2800 to about 3100 cP, or about 3000 to about 3200 cP, or about 3150 to about 3500 cP, or about 3400 to about 3900 cP, or about 3800 to about 4200 cP, or about 4100 to about 4600 cP.
  • a liquid can also be further described as being honey-like which is about 351 to about 1750 cap
  • honey-like refers to liquids that have been thickened to honey consistency. The liquid flows off a spoon in a rib- bon, just like actual honey.
  • a semi-liquid typically has a viscosity from about 4500 cP to about 25,000 cP, preferably about 4600 to about 5000 cP, or about 4800 to about 5400 cP, or about 5200 to about 5800 cP, or about 5700 to about 6500 cP, or about 6200 to about 7000 cP, or about 6900 to about 10,000 cP, or about 9,000 to about 14,000 cP, or about 12,000 to about 16,000 cP, or about 14,000 to about 20,000 cP, or about 19,000 to about 22,000 cP.
  • a semi-solid typically has a viscosity from about 18,000 to about 40,000 cP, preferably about 19,000 to about 22,000 cP, or about 21 ,000 to about 25,000 cP, or about 24,000 to about 30,000 cP, or about 26,000 to about 32,000 cP, or about 31 ,000 to about 35,000 cP, or about 34, 000 to about 37,000 cP, or about 36,000 to about 39,000 cP.
  • the viscosity of the inventive composition can also preferably be selected depending on the processing conditions utilized such as homogenization pressure, single or multistage homog- enization (such as first stage followed by a second stage), pasteurization tem- perature, the presence or exclusion of starch, amount of protein employed and the type of sealable packaging used etc... Wherein said processing conditions can be selected either alone or in combination.
  • the abovementioned descriptive and/or measured viscosities correspond to the viscosities as determined at the start of the shelf-life as defined herein for the inventive process.
  • the inventive composition which is preferably a liquid or semi liquid/semi solid composition, most preferably a liquid composition, may be adjusted to a pH of less than about 4.3, preferably to a range of about 3.5 to about 4.5, preferably about pH 3.5 to about pH 4.3, Most preferably the pH of the inventive composition is in such a range, more preferably about 4.2 or about 4.
  • the inventive composition provides an energy content of about 300 to about 380 kcal, preferably about 300 to about 360 kcal, most preferably, about 334 Kcal per 10Og, preferably per unit or dose for administration.
  • a unit or dose for administration may be a bottle, pot, stickpack sachet with tear top / tear top tube or a pouch, which is preferably a Guala pack etc.
  • a unit or dose for administration exhibits a weight of about 30 to 200 g of the inventive composition, more preferably a weight of about 30 to 150 g, even more preferably a weight of about 70 to 1 10 g.
  • Most preferably such a unit or dose for administration comprises e.g.
  • the unit or dose for administration as described herein can also be expressed in terms of ml_ rather than g. Hence, if desired 30 to 200 ml_ of the inventive composition can be em- ployed.
  • the total amount of energy to be administered by the inventive composition per day is preferably in range of about 300 to about 635 kcal, most preferably about 300 to about 600 kcal.
  • the inventive composition may be in form of a supplement (and may be packaged accordingly), preferably providing a unit or dose for administration as defined before, e.g. an amount as described above, e.g. an amount of about 1 to about 2 x 100 g pouches a day or for instance of about 1 to about 2 x 90 g, or for instance of about 1 to about 2 x 50 g pouches a day.
  • a unit or dose for administration e.g. an amount as described above, e.g. an amount of about 1 to about 2 x 100 g pouches a day or for instance of about 1 to about 2 x 90 g, or for instance of about 1 to about 2 x 50 g pouches a day.
  • the total amount of energy to be administered per day is be- tween about 300 to about 635 Kcal, most preferably about 300 to about 600 Kcal a day, preferably if used as a supplement.
  • the inventive composition may preferably be used and packaged as a sole source of nutrition (e.g. as a whole meal), preferably providing a unit or dose for administration as defined before, e.g. an amount as described above, e.g. an amount of about 4 to about 8 x 10Og pouches a day, or for instance of about 4 to about 8 x 90g, or for instance of about 4 to about 8 x 50g pouches a day.
  • the total amount of energy administered using the inventive composition per day is typically in the range of about 1200 to about 2500 Kcals a day, preferably if used as a sole source of nutrition (e.g. as a whole meal).
  • compositions as detailed herein are also suitable for use in dietary modification or manipulation involving the intake of fat, protein and carbohydrate, in isolation or combination, for therapeutic effect and benefit.
  • the composition of the present invention could be obtained by any process suitable for a skilled person. More preferably, the inventive composition may be obtained or is obtainable by a method for preparing a composition as defined herein. Such a composition and any composition obtained or obtainable by such a method for preparing a composition may be used for treatment of a dis- ease or disorder as defined herein, particularly preferably for use in treating epilepsy, preferably refractory epilepsy in children.
  • such a composition is for use in treating disorders selected from neurodegenerative diseases, and improvement of brain function or of cognitive skills, Alzheimer disease/cognitive impairment, Parkinson's disease, neurological diseases, Amyo- trophic lateral sclerosis, Traumatic brain injury, Hypoxic/ischemic brain injury, Autism, ADHD (Attention Deficit Hyperactivity Disorder), Depression, Headaches, Migraine Headaches, Narcolepsy, GLUT-1 deficiency, Pyruvate Dehydrogenase (PDH) deficiency, phosphofructokinase (PFK) deficiency, Glycogenosis type V (McArdle disease), Cardiac ischemia, Rett syndrome, Tuberous Sclerosis, Diabe- tes and Cancer (astrocytomas, prostate, gastric, renal, head and neck).
  • disorders selected from neurodegenerative diseases, and improvement of brain function or of cognitive skills, Alzheimer disease/cognitive impairment, Parkinson's disease, neurological diseases, Amyo- trophic lateral sclerosis,
  • the object underlying the present invention is preferably also solved by a process for preparing a composition, preferably a composition as defined herein.
  • the present invention hence describes a composi- tion as described above, preferably a composition obtained or obtainable according to a process for preparing such a composition as defined herein.
  • said process may contain or comprise any of the amounts and ingredients as defined for the inventive composition.
  • the object underlying the pre- sent invention is solved by a process for the preparation of a composition, more preferably a composition as described herein, comprising the following steps: Mixing about 4 to about 12% by weight protein, about 5 to about 15% by weight carbohydrate and about 25 to about 38% by weight fat with water;
  • step (a) or (b) Homogenizing the mixture obtained according to step (a) or (b) at a temperature of about 86 to about 100°C, preferably about 86 to about 92°C, preferably at a pressure of about 30 to about 150 bar.
  • Packaging the mixture into a package which is, preferably a seal- able package, which is preferably a pouch, bottle, tear top tube or pot, which is preferably a unit or dose suitable for administration;
  • any of the steps, in particular, steps (a) to (c) can be repeated as necessary - either independently or in combination.
  • a first step (a) of the inventive process about 4 to about 12% by weight protein, about 5 to about 15% by weight carbohydrate and about 20 to about 38% fat, preferably about 25 to about 38% by weight fat are mixed with water.
  • a mixture preferably comprises proteins, fats and/or carbohydrates as defined herein, preferably as defined herein for the inventive composition, more preferably in the preferred ranges as defined herein.
  • ingredients including those as defined herein are added at step (a). In other words, it is most preferred that no further ingredients are added in steps (b) to (f).
  • steps (a), (b) and/or (c), and optionally further steps as defined herein may be repeated at least once, allowing further addition of ingredients as defined herein, preferably in the preferred ranges as defined herein, preferably during such a repeated step (a).
  • the homogenized product is sent to a filler head prior to packing step (d).
  • Step (c) can also be viewed as a first stage pasteurization, since said step also involves heat treatment of the mixture from step (a) or (b) using pasteurization conditions.
  • step (e) which is carried out on the packaged mixture can also be seen as a second stage pasteurization step. Having said this, since step (e) is preferably followed by cooling step (f), step (e) is deemed the main pasteur- izing step of the inventive process.
  • pasteurization is a heat treatment step carried out at between about 73 to about 93°C, preferably at a time of about 2 to about 10 minutes, preferably followed by cooling immediately.
  • pasteurization is carried out as described herein.
  • pasteurization has the effect of inhibiting microbial growth in the inventive compositions and process thereof.
  • pasteurization does not kill all micro-organisms in the composition, but instead reduces the number of via- ble pathogens and hence greatly reducing the likelihood of any pathogens present causing disease.
  • compositions it may alternatively be preferable to carry out a sterilization step instead of the most preferred pasteurization step.
  • high temperatures are used, preferably at least above about 93°C, more preferably above about 94°C.
  • Sterilization may preferably also be carried out at high temperatures of about 94 to about 140°C, more preferably at about 95 to about 105°C, or about 98 to about 1 10°C, or about 105 to about 120°C, or about 1 10 to about 130°C, or about 120 to about 135°C.
  • sterilization can only potentially be achieved by heat sterilization, wherein high temperatures are employed as de- scribed herein above.
  • time and pressures used for sterilization are as defined herein for pasteurization.
  • step (d) it is particularly preferable that said packaging step also involves sealing said packaged mixture prior to pasteurization step (e), wherein preferably sealing is achieved by capping the packaged mixture.
  • the package or sealable package is a bottle, pot, tear top tube or a pouch, wherein said pouch is most preferably a Gua- la pack and the like. It is also preferable that the package or the sealable package is a tetra pack.
  • the product of the present invention is preferably further treated to avoid browning by methods known in the art by the skilled person, including purging with an inert gas such as nitrogen and/or CO 2 either alone or in combination and/or the process being vacuum sealed.
  • Said treatment can be performed at the end of the inventive process or directly before, during or after any step or steps (a) to (f) throughout said inventive process. Preferably, such treatment is carried out in step (d).
  • step (a) it is particularly preferable that if degassing/vacuuming is undertaken that this oc- curs at step (a), and/or before step(b) of the inventive process. Furthermore, it is also preferable that any purging with inert gas occurs at step (d) of the inventive process.
  • the mixture is a composition as defined herein for the in- ventive composition.
  • the protein, the fat and/or the carbohydrate is/are derived from at least two differ- ent sources. It may be also desirable that the carbohydrate source as used herein also functions as a sweetener as defined for the inventive composition.
  • the mixture formed or obtained according to step (a) of the process of the present invention may contain or comprise any of the ingredients defined above for the inventive composition, preferably in the defined amounts and ratios as defined herein.
  • the inventive process utilizes no artificial addi- tives and/or utilizes whole protein. Having said this, in a preferred embodiment the process does not utilize whole milk protein in a ratio of 80:20 casein protein to whey protein.
  • said mixture formed or obtained according to step (a) does not comprise soy protein and/or does not comprise olive oil or canula oil.
  • said mixture formed or obtained according to step (a) does not contain or comprise DHA, DPA and/or ARA. It is particularly preferable that in the process of the present invention, said mixture formed or obtained according to step (a) that 0.4 to 2.0% by weight of the fat is eicosapentaenoic acid (EPA). According to an alternative, such inventive process may contain no eicosapentaenoic acid (EPA). It is also preferable that in the process of the present invention, said mixture formed or obtained according to step (a) contains emulsifiers and/or fibre as defined herein above for the inventive composition.
  • EPA eicosapentaenoic acid
  • EPA eicosapentaenoic acid
  • said mixture formed or obtained according to step (a) contains emulsifiers and/or fibre as defined herein above for the inventive composition.
  • inventive process may also utilize linoleic acid or a-linoleic acid either alone or in combination as defined for the inventive composition.
  • linoleic acid or a-linoleic acid preferably may be contained in the mixture or compositions of the inventive process in amounts of about 2742 mg and about 61 .8 mg respectively per 100g.
  • the mixture of step (a) is adjusted to a pH of less than about 4.3, preferably about 3.5 to about 4.5, more preferably to a pH of about 3.7 to about 4.1 or about pH 3.8 to about 4.3.
  • the pH adjustment as described herein is achieved using citric acid and/or malic acid and/or lactic acid and/or succinic acid and/or acetic acid or the like, and/or mixtures thereof.
  • Acids can be added in liquid or dry form such as in hydrated or anhydrous form and the like. Compositions obtained by the present invention may consequently also exhibit a pH as defined before.
  • the product obtained or the mixture prepared or obtained according to step (a) of the process of the present invention additionally contains about 0.5 to about 23% by weight medium chain triglycerides and/or about 6 to about 30 % by weight long chain triglycerides as already defined for the inventive composition.
  • the mixture formed or obtained according to step (a) of the process of the present invention contains or comprises fat at about 2 to about 30% by weight saturates, about 1 to about 25% by weight mono- unsaturates and about 0.1 to about 5% by weight poly-unsaturates. These percentages are preferably defined with regard to the entire amount of the mixture.
  • the protein employed in step (a) of the inventive process is as defined herein for the inventive composition, preferably a whey protein, more preferably a whey protein isolate and even more preferably an acidified whey protein isolate.
  • step (a) of the inventive process con- tains an antifoaming agent as defined above, preferably selected from lecithin and/or MCT oil, and/or silicone antifoamers, more preferably in an amount of about 0.5 to about 23 % by weight, most preferably in amounts of about 1 to about 5 % by weight or as defined earlier.
  • an antifoaming agent as defined above, preferably selected from lecithin and/or MCT oil, and/or silicone antifoamers, more preferably in an amount of about 0.5 to about 23 % by weight, most preferably in amounts of about 1 to about 5 % by weight or as defined earlier.
  • MCT oil not only acts as an anti-foaming agent, but is also nutritionally required.
  • the inventors found that in the absence of said antifoaming agents, whey protein or the like present may be prone to being aerated and during the mixing phase this may result in excessive foaming which can lead to processing difficulties in terms of pumping and homogenising the product.
  • the fat source used in the inventive process can be a 100% LCT or 100% MCT fat source, which can be employed either alone or in combination. Accordingly, the inventive process preferably may provide compositions containing a mixture of MCT and LCT as defined herein. Alternatively, if for instance solely a MCT fat source is utilized, this provides compositions which may lack an LCT component. If for instance solely a LCT fat source is utilized, this provides compositions which may lack an MCT component.
  • Said mixture in step (a) and compositions prepared by the present process also preferably comprise micronutrients selected from vitamins, minerals and trace elements, which may be present either alone or in combination as defined for the inventive composition herein.
  • micronutrients selected from vitamins, minerals and trace elements, which may be present either alone or in combination as defined for the inventive composition herein.
  • the terms and ranges for the vitamins, minerals and trace elements and the like as applicable for the inventive process have already been described herein for the inventive composition.
  • Said mixture in step (a) also preferably comprises calcium as defined before, most preferably in an amount of about 100 to about 245 mg per 100 g. Furthermore, the inventors also found that by preferably using magnesium and calcium lactate in the mixture formed or obtained according to step (a) of the process of the present invention, the protein stability of the product may be signifi- cantly improved.
  • step (a) of the inventive process mixing is carried out in step (a) of the inventive process.
  • mixing speeds are employed, which typically range from about 320 rpm to about 800 rpm, pref- erably about 377 to about 725 rpm, or about 360 to about 700 rpm, or about 370 to about 750 rpm, or about 374 to about 740 rpm, or about 380 to about 730 rpm.
  • slow mixing speeds which are preferably of about 320 to about 400 rpm, preferably about 360 to about 380 rpm, or about 370 to about 390 rpm.
  • medium mixing speeds of preferably about 401 to about 550 rpm, or about 410 to about 430 rpm, or about 420 to about 450 rpm, or about 440 to about 490 rpm, or about 460 to about 500 rpm.
  • medium-fast mixing speeds preferably of about 551 to about 800 rpm, or about 510 to about 550 rpm, or about 530 to about 580 rpm, or about 560 to about 640 rpm, or about 600 to about 700 rpm, or about 660 to about 750 rpm.
  • stepwise mixing speeds of about 725 rpm followed by about 377 rpm or about 435 rpm followed by about 435 rpm followed by about 580 rpm, followed by about 435 rpm, followed by about 580 rpm, followed by about 725 rpm or the like are employed. Furthermore, combinations around stepwise mixing speeds using the aforesaid slow, medium and medium-high ranges may also be employed.
  • the pH is then checked to ensure that this is less than 4.3, and if necessary said mixture is adjusted with citric acid to obtain a pH of less than 4.3, preferably a pH between 3.5 and 4.2.
  • step (a) of the process of the present invention if slow mixing was not employed during step (a) of the process of the present invention this may result in excessive aeration, which in turn may lead to problems in the homogeni- zation step, namely a highly aerated product may not run through the homogeniz- er.
  • step (a) of the process of the present invention is conducted with a twin impeller agitator and/or using a Jex mixing tank.
  • a Jex mixing tank any low sheer/low agitation mixing tank (with variable speed agitation) would be suitable. It is most preferred that if a Jex mixing tank is used in the process as described herein that this preferably has the following dimensions:
  • step (a) of the process of the present invention is carried out at about 10 to about 15°C, or about 13 to about 19°C, or about 18 to about 26°C, or about 25 to about 32°C, or about 30 to about 36°C, or about 34 to about 43°C, or about 15 to about 25°C, or about 12 to about 20°C, or about 18 to about 30°C or more preferably at about 17 to about 23°C.
  • the aforementioned temperature ranges can also be used for any preheating if carried out.
  • the order of reagent addition is preferably water, lecithin and starch (although most preferably starch is not added), protein - which is preferably acidified whey protein, coconut oil, most preferably fractionated coconut oil, sunflower oil, most preferably high oleic sunflower oil, fibre, vitamins, minerals, and trace elements, sugar, antioxidants vitamin E and C and finally lemon oil. Further components may be added as defined for the inventive process or the inventive compositions as described herein. It is preferable that the pH is then checked to ensure that this is less than about 4.3.
  • the temperature is preferably kept in one of the temperature ranges as listed above for mixing step (a), although it is more preferred that several of the abovementioned temperature ranges are employed for mixing step (a) during reagent addition. For instance, 34 to about 40°C, or 35 to about 43°C for the mixing in of water, lecithin and starch, followed by about 37 to about 43°C, most preferably at about 35 to about 40°C for instance for the mixing in of acidified whey protein.
  • step (a) of the inventive process is acidified whey protein this leads to an improved viscosity and taste compared to when standard whey protein isolates are employed.
  • inventive process is most preferably carried out as a con- tinuous process although said inventive process can also preferably be carried out as a batch process.
  • water may be added to a mixing tank, which is preferably a Jex mixing tank or the like, preferably at 20°C +/- 3°C , wherein mixing is typically conducted with a twin impeller agitator.
  • a mixing tank which is preferably a Jex mixing tank or the like, preferably at 20°C +/- 3°C , wherein mixing is typically conducted with a twin impeller agitator.
  • lecithin and starch are then added to the tank, and the mixer speed is preferably set at about 725 rpm, most preferably mixing for about 5 minutes.
  • a protein most preferably acidified whey protein is then added, and the mixer speed preferably reduced to about 435 rpm, followed preferably by further mixing for about 30 minutes.
  • fractionated coconut oil and high oleic sunflower oil is then added, followed by preferably increasing the mixer speed to about 580rpm for about 5 minutes. After said mixing it is also preferable that the mixer speed is reduced to about 435 rpm, and most preferably mixed for a further 30 minutes.
  • fibre is then added and mixed for 15minutes at 580rpm.
  • any further ingredients such as vitamins, minerals and trace elements are then added, wherein preferably the mixer speed increases to about 580 rpm, preferably mixing for about 10 minutes.
  • sugar, preferably castor sugar is then added, wherein the mixer speed preferably increased to about 725 rpm, preferably mixing for about 20 minutes.
  • the lemon oil and antioxidants such as vitamin C and vitamin E are then added, followed by mixing for about 10 minutes at about 725rpm
  • the pH is then checked to ensure that this is less than about 4.3, preferably in the range of about 3.5 to about 4.5, and then preferably adjust as is necessary with citric acid to fall within said limits.
  • the product is left to degas at a mixing speed of about 725 rpm or higher for about 12 minutes, wherein optionally the product is processed to a Specific Gravity of about 1 .01 at 20°C +/- 3°C or of about 1 .05 at 20°C +/- 3°C.
  • the mixture obtained according to step (a) is optionally preheated.
  • Preheating may be carried out at a temperature range of about 10 to about 35°C, or about 15 to about 25°C, or about 12 to about 20°C, or of about 18 to about 30°C or more preferably at a temperature range of about 17 to about 23°C.
  • step (c) of the inventive process preferably the mixture obtained according to step (a) or (b) is homogenized at a temperature range of about 86 to about 100°C, preferably about 86 to about 92°C, preferably at a temperature range of about 80 to about 88°C, or about 77 to about 91 °C, or about 84 to about 92°C, or about 86 to 89°C, or about 87 to about 91 °C, or about 90 to about 94°C.
  • Homogenizing is preferably is carried out at pressures of 15 to about 240 bar, preferably about 15 to about 220 bar, preferably about about 15 to about 195 bar, preferably at about 20 to about 185 bar, or about 30 to about 170 bar, or about 40 to about 150 bar, or about 50 to about 135 bar, or about 80 to about 120 bar, or about 100 and about 140 bar, or about 18 to 22 bar, or about 25 to about 45 bar, or about 40 to about 65 bar, or about 50 to about 70 bar, or about 60 to about 75 bar, or about 90 to about 1 15 bar, or about 1 10 to about 120 bar.
  • Said preferable homogenization step employs homogenizers known in the art, particularly preferable homogenizers include Tetra Alex S15, APV or Nitro Homogenizers.
  • the mixture is optionally passed through an inline sieve.
  • This (sub-) step is preferably followed by heating the mixture to about 86 to about 100°C, preferably about 86 to about 92°C, preferably for a minimum of about 2 minutes. The heated mixture is then typically homogenized using a homogenizer as known to a skilled person applying the de- fined temperatures and pressures.
  • the inventors have also surprisingly found that by adjusting the homogenization pressure that the viscosity of the product can be controlled.
  • viscosity we refer back to the inventive composition as described herein above.
  • a homogenization pressure of about 86 to about 220 bar, preferably about 86 to about 195 bar, preferably about 90 to about 100 bar, or about 95 to about 120 bar, or about 1 10 to about 140 bar, or about 130 to about 160 bar, or about 150 to about 180 bar, or about 170 to about 190 bar, or about 180 to about 210 bar, or about 200 to about 240 bar, can be used to give a semi-liquid or semi-solid viscosity.
  • lower homogenization pressures such as about 1 to about 85 bar, preferably about 10 to about 30 bar, or about 20 to about 45 bar, or about 40 to about 65 bar, or about 55 to about 80 bar can be used in order to give a more liquid viscosity.
  • a homogenization pressure of about 70 bar is used.
  • the present inventive process and composition thereof preferably encompass products as described herein having liquid, semi-liquid or semi-solid viscosities defined in centipose (cP) of about 1 to about 40,000 cP, preferably about 1000 to about 40,000 cP.
  • cP centipose
  • Viscosities described herein were measured at 25°C using a Brookfield DV-E Viscometer (LV model). Alternatively, viscosities can also be measured by other methods known in the art. As used herein, the viscosity terms semi-solid and semi-liquid can be used interchangeably. Having said this, generally speaking, a product with a semi-solid viscosity as described herein is generally more viscous than a product with a semi-liquid viscosity.
  • the inventors have found that this is typically from about 1000 to about 4700 cP, preferably about 1 100 to about 1400 cP, or about 1350 to about 1600 cP, or about 1500 to about 1750 cP, or about 1650 to about 2000 cP, or about 1900 to about 2300 cP, or about 2100 to about 2600 cP, or about 2500 to about 2900 cP, or about 2800 to about 3100 cP, or about 3000 to about 3200 cP, or about 3150 to about 3500 cP, or about 3400 to about 3900 cP, or about 3800 to about 4200 cP, or about 4100 to about 4600 cP.
  • a liquid can also be further described as being honey-like which is about 351 to about 1750 cP as already described for the inventive composition.
  • a semi-liquid is typically from about 4500 cP to about 25,000 cP, preferably about 4600 to about 5000 cP, or about 4800 to about 5400 cP, or about 5200 to about 5800 cP, or about 5700 to about 6500 cP, or about 6200 to about 7000 cP, or about 6900 to about 10,000 cP, or about 9,000 to about 14,000 cP, or about 12,000 to about 16,000 cP, or about 14,000 to about 20,000 cP, or about 19,000 to about 22,000 cP.
  • a semi-solid is typically from about 18,000 to about 40,000 cP, preferably about 19,000 to about 22,000 cP, or about 21 ,000 to about 25,000 cP, or about 24,000 to about 30,000 cP, or about 26,000 to about 32,000 cP, or about 31 ,000 to about 35,000 cP, or about 34, 000 to about 37,000 cP, or about 36,000 to about 39,000 cP.
  • the viscosities as described herein can apply for the product after step (c) of the inventive process and/or the product after step (f) of the inventive process.
  • the viscosity at step (c) may differ from that of step (f).
  • the abovementioned descriptive or measured viscosities correspond to the viscosities as determined at the start of the shelf-life, which preferably commences after either the final process step, more preferably final process step (e).
  • the final step of the process of course preferably depending on whether all aforementioned preceding steps are performed.
  • the viscosity is determined within about one minute to about eight hours of said final process step, preferably one minute to about four hours, more preferably one hour to about four hours, most preferably after about two to about four hours, or about three to about six hours, or about five to about seven hours of the final process step.
  • the viscosity may likewise be determined subsequent to the optional cooling step (f), preferably in the aforementioned time ranges.
  • compositions which are preferably either liquids or semi liquids/semi solids, wherein the viscosity can be tailored as desired, preferably by applying pressures as outlined above in a process for preparing a composition, which may be supplemented e.g. by adding starch as defined herein.
  • step (c) of the inventive process when step (c) of the inventive process is repeated this can yield a product having an increased viscosi- ty than if step (c) were only conducted once.
  • step (c) could first be carried out with the homogenizer set at 70 bar pressure, denoted herein as first stage ho- mogenization. This may then be followed by repeating step (c), denoted herein as second stage homogenization, wherein for instance the homogenizer is set at about 18 bar pressure or at a pressure as defined herein.
  • step (c) denoted herein as second stage homogenization, wherein for instance the homogenizer is set at about 18 bar pressure or at a pressure as defined herein.
  • step (c) denoted herein as second stage homogenization
  • second stage homogenization wherein for instance the homogenizer is set at about 18 bar pressure or at a pressure as defined herein.
  • a third or fourth stage homogenization may also be desirable.
  • Preferably during second stage homogenization lower
  • the inventive process as described herein includes at least a first and second stage homogenization step.
  • the inventive process preferably also includes starch along with a second stage homogenization step. Furthermore, preferably by employing protein at the higher range as described herein also tends to lead to products with a higher viscosity.
  • the inventive process herein and/or the product thereof of said process has a water content of about 40 % to about 65 % by weight, more preferably about 41 to about 43 %, or about 42 to about 45 %, or about 43 to about 46 %, or about 45.5 to about 47.5 %, or about 46.5 to about 49 %, or about 48 to about 52 %, or about 50 to about 55 %, or about 53 to about 59 %, or about 57 to about 61 %, or about 60 to about 63.5 % by weight. It is most preferred that the inventive product herein and/or the product of said process has a water content of 46 % by weight.
  • step (c) the product prior to the homogenization step and obtained according to step (a) or (b) is processed at Specific Gravity 1 .01 at 20°C +/- 3°C or of about 1 .05 at 20°C +/- 3°C prior to carrying out homogenization in step (c).
  • the mixture is preferably packed into a package, which is preferably a sealable package which is preferably a unit or dose for administration as described herein, more preferably into a pot, bottle, tear top tube or into a pouch such as a Guala pack.
  • a package which is preferably a sealable package which is preferably a unit or dose for administration as described herein, more preferably into a pot, bottle, tear top tube or into a pouch such as a Guala pack.
  • a pouch or foil stick pack sachet with tear top is particularly preferred since this advantageously allows to pasteurize the mixture in the unit or dose for administration without the risk of damaging the package. It is also preferred that the pouch is most preferably a cheerpack, pillow bag or stand-up pouch, which is most preferably a Guala pack.
  • the pouch or stickpack is particularly preferable since this is complementary to the viscosity of the inventive compositions.
  • the product may thicken too much to be consumed directly from the pack. More specifically, since thickening of the inventive composition occurs inside said packaging this allows for higher protein addition and hence if desired a more viscous semi-solid inventive composition can be produced.
  • step (e) of the inventive process as described herein pasteurizing the packaged mixture is carried out preferably at a temperature of about 60 to about 96°C, preferably at a time of about 2 to about 10 minutes.
  • the pasteurization temperature is about 60 to about 96°C, preferably about 73 to about 93°C or about 65 to about 80°C, or about 70 to about 85°C, or about 76 to about 90°C, or about 82 to about 94°C.
  • the pasteurization time is of about 2.5 to about 3.5 minutes, or about 3 to about 4.5 minutes, or about 4 to about 6 minutes, or about 5 to about 8 minutes.
  • pasteurization as described in the process herein is conducted at about 80°C to about 93°C, preferably at about 80°C to about 90°C, or at about 85°C to about 92°C, or at about 87°C to about 91 °C, preferably 89°C for about 2 minutes, in the scrape surface heat exchanger and then held at about 73°C to about 93°C, or at about 73°C to about 79°C, or at about 76°C to about 80°C, or at about 77 to about 93°C, or at about 78°C to about 82°C, preferably 80°C for about 3 minutes, preferably less than 5 minutes.
  • pasteurizing is prefera- bly followed by carrying out pasteurization into a package, preferably a sealable package, preferably as a unit or dose for administration as described herein, particularly preferable is a pot, bottle, tear top tube or a pouch, wherein said pouch is most preferably a Guala pack or the like, typically at conditions as described above, e.g. at about 73 to about 93°C for 3 minutes +/- 30 seconds.
  • step (e) of the inventive process is also particularly preferable for step (e) of the inventive process as described herein if the mixture prepared or obtained according to step (a) or (b) contains starch, preferably tapioka starch, as defined herein for the inventive composition.
  • starch preferably tapioka starch
  • starch as defined herein is a further
  • a highly viscous product when for instance a first and second stage homogenization step is conducted by repeating step (c) of the inventive process herein, preferably starch is not employed since this tends to result in a lowering of the viscosity.
  • starch is not employed since this tends to result in a lowering of the viscosity.
  • the inventors have also surprisingly found that in the present invention if the protein employed is acidified whey protein this leads to an improved viscosity and taste compared to when standard whey protein isolates are employed. Furthermore, the inventors also found that by also employing magnesium and calcium lactate in the invention as described herein, this improved the protein stability of the product.
  • calcium lactate is present in the present invention in the range of about 0.5 to about 3% by weight. More preferably, in about 0.6% to about 1 .7%, or about 1 .5% to about 1 .8%, or about 1 .6% to about 2%, or about 1 .9% to about 2.5%. Particularly preferable is that calcium lactate is present in 1 .83% by weight.
  • magnesium lactate is present in the present invention in the range of about 0.2 to about 2% by weight. More preferably, in about 0.3 to about 0.5%, or about 0.4 to about 0.6%, or about 0.55 to about 0.8%, or about 0.7 to about 1 .2%, or about 1 to about 1 .5%. Particularly preferable is that magnesium lactate is present in 0.61 % by weight.
  • step (f) of the inventive process this is then pref- erably followed by cooling in a cooling bath in order to obtain a product which is preferably less than 30°C at the end of cooling.
  • said cooling step is conducted at between about 0 and about 10°C, preferably about 5 to about 15°C, or about 12 to about 20°C, or about 18 to about 25°C, or about 22 to about 29°C.
  • the product is then packed into boxes.
  • said cooling step (f) is conducted over less than about 10 minutes, or over less than about 5 minutes or over less than about 2 minutes. Most preferably said cooling step is carried out over about 1 to about 5 minutes, or about 3 to about 8 minutes or about 6 to about 10 minutes.
  • the inventive process as described herein has a flow rate which depends on the sealable package size along with the filling rate. For instance, when a 100g seal- able package, preferably a pouch is employed as described herein, it is preferable that when using one filler about 85 pouches per minute are filled, which amounts to a flow rate of about 510 litres per hour (Iph). Wherein said filler or fillers is/are placed directly before said sealable package.
  • the flow rate doubles and hence increases to about 1020 Iph.
  • the inventive process may also have a flow rate of about 250 to about 3500 Iph, preferably about 350 to about 600 Iph, or about 450 to about 700 Iph, or about 650 to about 850 Iph, or about 750 to about 950 Iph, or about 800 to about 1300 Iph, or about 1200 to about 1600 Iph, or about 1400 to about 1800 Iph, or about 1700 to about 2100 Iph, or about 1900 to about 2500 Iph, or about 2300 to about 3000 Iph, or about 2800 to about 3250 Iph.
  • the pasteurized packaged mixture is a liquid or a semi liquid/semi solid, particularly pref- erable is a liquid.
  • compositions produced thereof have a ratio of fat: protein: carbohydrate of about 4.2: 1 : 2, wherein preferably each of the values for said ratio for fat: protein: carbohydrate may vary by +/- 0.3 as defined above.
  • the weight ratio of fat to the sum of proteins and carbohydrates in the inventive process is 4.2: 3, which may vary by +/- 0.3 as defined above.
  • the energy content of the pasteurized packaged mixture is about 300 to about 380 kcal, preferably about 300 to about 360 kcal per 100g.
  • Said pasteurized packaged mixture may then be administered once daily, preferably twice daily, more preferably three times daily, wherein each dose preferably comprises a 30g, 50 g pouch or a 100 g pouch, most preferably a 90 g pouch.
  • the total amount of energy contained and suitable to be administered per day is about 300 to about 635 kcal, preferably about 300 to about 600 kcal.
  • the inventive process leads to a composition as defined before, preferably comprising as ingredients water, vegetable oil (fractionated coconut oil and high oleic sunflower oil), sucrose; which is preferably caster sugar, whey protein isolate; which is preferably acidified whey protein isolate, calcium lactate, emulsifier (soya lecithin, e.g. E322), dietary fibre which is preferably a mixture of inulin and oat fibre (e.g. White Star AOF 200), magnesium lactate, tri potassium citrate, sodium chloride, choline bitartrate, vitamin premix, trace element mix, dipotassium phosphate, tri sodium citrate, lemon oil (e.g . lemon oil 121 16), taurine (e.g. JP8), L-carnitine L-tartrate, citric acid and citric acid anhydrous.
  • vegetable oil fractionated coconut oil and high oleic sunflower oil
  • sucrose which is preferably caster sugar
  • whey protein isolate which is preferably acidified w
  • the inventors have found that the processing of high protein, high fat compositions, especially wherein they contain added calcium and micronutri- ents can present difficulties during heat treatment using the methods as described in the prior art.
  • Products containing high levels of protein, fat, carbohydrate and micronutrients can often present processing difficulty in retort and pasteurization and/or sterilization due to: 1 ) High viscosity during mixing phases: poor homogeneity, difficult to pump, homogenize and heat process particularly in steam injection plate heat exchangers.
  • a scrape surface heat exchanger in tubular system are also employed since this keeps the product moving and therefore reduces risk of protein fouling so higher protein addition possible.
  • a protein such as an acidified whey protein as a protein source
  • employing antifoaming agents such as lecithin and/or MCT oil and/or silicone antifoamers - which result in the reduc- tion of foaming and increased processability.
  • preferably slow mixing especially during protein addition is also beneficial for the inventive process.
  • the package or sealable package as used herein is a bottle, pot, pouch, stickpack sachet wit tear top / tear top tube and the like.
  • a Guala pack and the like is particularly preferable since this is complementary to the viscosity of the inventive com- positions.
  • the product may thicken too much to be consumed directly from the pack. More specifically, since thickening of the inventive composition occurs inside said packaging this allows for higher protein addition and hence if desired a more viscous, semi solid/semi liquid inventive composition, particularly a liquid can be produced.
  • inventive compositions as described herein are contemplated.
  • inventive composition is particularly suitable for the use in the dietary management of diseases or disorders as defined herein, such as malnutrition, malabsorption states and other conditions requiring fortification with energy, protein and micronutrients.
  • slaughter means to supplement or add nutrients to the inventive composition, preferably during the inventive process as described herein that may be lacking in the overall diet.
  • nutrients include, but are not limited to folate, vitamins A and D, and calcium.
  • composition is also advantageously suitable for the treatment of various states of oncology, cystic fibrosis, elderly (dementia), neuro-disabilities, improve- ment of brain function or of cognitive skills, neurological diseases, neurodegenerative diseases, dysphasia, pre- and post operative surgery, ADHD (Attention Deficit Hyperactivity Disorder), GLUT-1 deficiency, Pyruvate Dehydrogenase (PDH) deficiency, phosphofructokinase (PFK) deficiency, stroke, liver disease, Cancer (renal, head and neck) or may be suitable for use in treatment of neuro- logical diseases, such as for treating epilepsy, preferably refractory epilepsy in children.
  • ADHD Application Deficit Hyperactivity Disorder
  • PDH Pyruvate Dehydrogenase
  • PFK phosphofructokinase
  • the present invention can also be used for the treatment of Dravet Syndrome (severe myoclonic epilepsy) and Doose Syndrome (myoclonic astatic epilepsy), epileptic syndromes and seizures, myoclonic jerk, tumor, obesity, Diabetes, gut motility disorders including constipation, Gastro Intestinal, allergy, anti- aging and psychiatric disorders.
  • Dravet Syndrome severe myoclonic epilepsy
  • Doose Syndrome myoclonic astatic epilepsy
  • epileptic syndromes and seizures myoclonic jerk
  • tumor obesity
  • Diabetes astatic epilepsy
  • gut motility disorders including constipation, Gastro Intestinal, allergy, anti- aging and psychiatric disorders.
  • the inventive composition can also be used for treating a disorder or a disease treatable with the ketogenic diet and selected from neurodegenerative diseases, and improvement of brain function or of cognitive skills, Alzheimer dis- ease/cognitive impairment, Parkinson's disease, neurological diseases, Amyotrophic lateral sclerosis, Traumatic brain injury, Hypoxic/ischemic brain injury, Autism, ADHD (Attention Deficit Hyperactivity Disorder), Depression, Headaches, Migraine Headaches, Narcolepsy, GLUT-1 deficiency, Pyruvate Dehydrogenase (PDH) deficiency, phosphofructokinase (PFK) deficiency, Glycogenosis type V (McArdle disease), Cardiac ischemia, Rett syndrome, Tuberous Sclerosis, Diabetes and Cancer (astrocytomas, prostate, gastric, renal, head and neck).
  • a disorder or a disease treatable with the ketogenic diet and selected from neurodegenerative diseases, and improvement of brain function or of cognitive skills, Alzheimer dis- ease
  • a disorder or "a disease” refers to any derangement or abnormality of function; a morbid physical or mental state. See Dorland's lllustrat- ed Medical Dictionary, (W.B. Saunders Co. 27th ed. 1988).
  • Treatment of such diseases or disorders is preferably accomplished by administering a therapeutically effective amount of a composition according to the present invention to a subject in need thereof.
  • a composition is to be administered once daily, preferably twice daily, more preferably three times daily, wherein during administration preferably at least one unit or dose for administration is provided, as defined herein.
  • the total amount of energy to be administered per day is as defined before.
  • the term "subject" refers to an animal.
  • the animal is a mammal.
  • a subject also refers to for example, primates (e.g., humans), cows, sheep, goats, horses, dogs, cats, rabbits, rats, mice, fish, birds and the like.
  • the subject is a human.
  • therapeutically effective amount of a composition of the present invention refers to an amount of the compound of the present invention that will elicit the biological or medical response of a subject, or ameliorate symptoms, slow or delay disease progression, or prevent a disease, etc.
  • a “therapeutically effective amount” is a packaged dose or unit as obtained as described herein.
  • the inventive compositions as described herein, either as described initially or as obtained or obtainable according to the inventive process are preferably suitable for use in children from the age of 1 , in other words the inventive compositions typically may be not deemed suitable for use in infants.
  • the present invention is however also suitable for use by adults.
  • the present invention is directed towards a method of treating a disease or disorder as defined herein, e.g. epilepsy, prefera- bly refractory epilepsy in children, comprising administering a patient in need thereof a composition as defined herein, typically comprising about 4 to about 12% by weight protein, about 5 to about 15% by weight carbohydrate and about 25 to about 38% by weight fat.
  • a disease or disorder as defined herein e.g. epilepsy, prefera- bly refractory epilepsy in children, comprising administering a patient in need thereof a composition as defined herein, typically comprising about 4 to about 12% by weight protein, about 5 to about 15% by weight carbohydrate and about 25 to about 38% by weight fat.
  • the present invention also includes a method of treatment for dietary management of malnutrition, malabsorption states and other conditions requiring fortification with energy, protein and micronutrients by administering a patient in need thereof a composition as defined herein, typically comprising about 4 to about 12% by weight protein, about 5 to about 15% by weight carbohydrate and about 25 to about 38% by weight fat.
  • Said other conditions including areas such asvari- ous states of oncology, cystic fibrosis, elderly (dementia), neuro-disabilities, improvement of brain function or of cognitive skills, neurological diseases, neurodegenerative diseases, dysphasia, pre- and post operative surgery, ADHD (Attention Deficit Hyperactivity Disorder), Pyruvate Dehydrogenase (PDH) deficiency, phosphofructokinase (PFK) deficiency, stroke, liver disease, Cancer (renal, head and neck) or may be suitable for use in treatment of neurological diseases, such as for treating epilepsy, preferably refractory epilepsy in children.
  • ADHD Application Deficit Hyperactivity Disorder
  • PDH Pyruvate Dehydrogenase
  • PFK phosphofructokinase
  • the present invention also includes a method of treatment for the treatment of Dravet Syndrome (severe myoclonic epilepsy) and Doose Syndrome (myoclonic astatic epilepsy), epileptic syndromes and seizures, myoclonic jerk, tumor, obesity, Diabetes, gut motility disorders including constipation, Gastro Intestinal, allergy, anti-aging and psychiatric disorders.
  • Dravet Syndrome severe myoclonic epilepsy
  • Doose Syndrome myoclonic astatic epilepsy
  • epileptic syndromes and seizures myoclonic jerk
  • tumor obesity
  • Diabetes astatic epilepsy
  • gut motility disorders including constipation, Gastro Intestinal, allergy, anti-aging and psychiatric disorders.
  • the present invention also includes a method of treatment for treating disorders treatable with the ketogenic diet and selected from neurodegenerative diseases, and improvement of brain function or of cognitive skills, Alzheimer disease/cognitive impairment, Parkinson's disease, neurological diseases, Amyotrophic lateral sclerosis, Traumatic brain injury, Hypoxic/ischemic brain injury, Autism, ADHD (Attention Deficit Hyperactivity Disorder), Depression, Headaches, Migraine Headaches, Narcolepsy, GLUT-1 deficiency, Pyruvate Dehydrogenase (PDH) deficiency, phosphofructokinase (PFK) deficiency, Glycogenosis type V, (McArdle disease), Cardiac ischemia, Rett syndrome, Tuberous Sclerosis, Diabetes and Cancer (astrocytomas, prostate, gastric, renal, head and neck), typically comprising administering a patient in need thereof a composition as defined herein, typically comprising about 4 to about 12% by weight protein, about 5 to about 15% by weight carbohydrate
  • the method of treatment of the present invention contains or comprises about 0.5 to about 23% by weight medium chain triglycerides and/or about 6 to about 30 % by weight long chain triglycerides.
  • the method of treatment of the present invention furthermore comprises micronutrients selected from vitamins, minerals and trace elements as defined herein. More preferably, the inventive method of treatment contains or comprises calcium, preferably in an amount of about 100 to about 245 mg per 100 g. It is further preferred that compositions utilized in the inventive method of treatment contains or comprises about 0.5 to about 2.5% by weight fibre.
  • the inventive method of treatment contains or comprises no fibre.
  • compositions utilized in the method of treatment as described herein contains or comprises lecithin, preferably in an amount of about 0.1 to about 2%. It is also desirable that in the method of treatment herein, that the fat in the utilized composition contains or comprises about 2 to about 30% by weight saturates, about 1 to about 25% by weight mono-unsaturates and about 0.1 to about 5% by weight polyunsaturates. It is also desirable that in compositions utilized in the method of treatment herein, 0.4 to 2.0% by weight of the fat is eicosapentaenoic acid (EPA).
  • EPA eicosapentaenoic acid
  • the protein employed is a whey protein, most preferably acid- ified whey protein isolate. It is also preferable if the protein, the fat and/or the carbohydrate is/are derived from at least two different sources.
  • compositions utilized in the inventive method of treatment of the present invention is a liquid or a semi liquid/semi solid, even more preferable is a liquid.
  • compositions utilized in the inventive method of treatment of the present invention has a viscosity of about 1 to about 40,000 cP as defined herein.
  • the ratio of fat: protein: carbohydrate is about 4.2: 1 : 2 and/or that preferably the energy content of the composition is about 300 to about 380 kcal, preferably about 300 to about 360 kcal per 100g.
  • the composition is administered once daily, preferably twice daily, more preferably three times daily, wherein preferably each dose comprises a 30g, 50 g or a 100 g pouch, most preferably a 90 g pouch and/or that the total amount of energy administered per day is about 300 to about 635 kcal, preferably about 300 to about 600 kcal.
  • Said inventive method of treatment is preferably used as a supplement.
  • said method of treatment is preferably used as a sole source of nutrition as defined herein, most preferably wherein the total amount of energy administered per day is between about 1200 to about 2500 Kcals a day.
  • composition utilized in the inventive method of treatment herein does not comprise soy protein and/or comprise olive oil or canula oil and/or does not contain whole milk protein in a ratio of 80:20 casein protein to whey protein.
  • the composition utilized in the inventive method of treatment herein employs intact proteins and particularly preferred that casein is not present in said method.
  • the composition which is preferably a semi-liquid/semi-solid composition, most preferably a liquid composition is adjusted to a pH of less than about 4.3, preferably about 3.5 to about 4.3, preferably less than 4,.
  • the composition furthermore comprises an antifoaming agent, preferably se- lected from lecithin and/or MCT oil, and/or silicone antifoamers more preferably in an amount of about 0.5 to about 23 % by weight.
  • preferred embodiment means “preferred em- bodiment of the present invention”.
  • variant embodiments and “another embodiment” means “various embodiments of the present invention” and “another embodiment of the present invention”, respectively.
  • Figure 1 shows a schematic for the process as described herein
  • Example 1 Exemplary composition of the present invention
  • Vitamin premix preferably consists of Vitamin A, Vitamin D, Vitamin E, Vitamin C, Vitamin K, thiamin, riboflavin, niacin, Vitamin B 6 , folic acid, Vitamin Bi 2 , biotin and pantothenic acid.
  • Other vitamins may also be present as defined herein above.
  • Minerals preferably consist of sodium, potassium, calcium, phosphorus and magnesium. Other minerals may also be present as defined herein above.
  • Trace element mix preferably consists of chloride, iron, copper, zinc, manganese, iodine, molybdenum, selenium and chromium. Other trace elements may also be present as defined herein above.
  • the ingredients which can be used to make said composition are by example wa- ter, high oleic sunflower oil, fractionated coconut oil, caster sugar, whey protein isolate; preferably acidified whey protein isolate obtained from Volac International Ltd (Volactive Hydrapro), calcium lactate, soya lecithin E322 (Emulpur IP), mag- nesium lactate, sodium chloride, dipotassium phosphate, citric acid, tri sodium citrate, vitamin premix , trace element mix, tri potassium citrate, lemon oil 121 16, potassium chloride (with 0.5% magnesium carbonate), L-ascorbic acid, Vitamin E (from Nutrabiol).
  • Example 2 Exemplary composition of the present invention
  • Vitamin premix preferably consists of Vitamin A, Vitamin D, Vitamin E, Vitamin C, Vitamin K, thiamin, riboflavin, niacin, Vitamin B 6 , folic acid, Vitamin Bi 2 , biotin and pantothenic acid.
  • Other vitamins may also be present as defined herein above.
  • Minerals preferably consist of sodium, potassium, calcium, phosphorus and magnesium. Other minerals may also be present as defined herein above.
  • Trace element mix preferably consists of chloride, iron, copper, zinc, manganese, iodine, molybdenum, selenium and chromium. Other trace elements may also be present as defined herein above.
  • the ingredients which can be used to make said composition are by example water, high oleic sunflower oil, fractionated coconut oil, caster sugar, whey protein isolate; preferably acidified whey protein isolate obtained from Volac International Ltd (Volactive Hydrapro), calcium lactate, soya lecithin E322 (Emulpur IP), magnesium lactate, sodium chloride, dipotassium phosphate, citric acid, tri sodium citrate, vitamin premix , trace element mix, tri potassium citrate, lemon oil 121 16, potassium chloride (with 0.5% magnesium carbonate), L-ascorbic acid, Vitamin E (from Nutrabiol).
  • Example 3 Exemplary way of carrying out the process as described herein. (Step (a))
  • Lecithin and optionally starch are added to the tank, mixer speed set at about 725 rpm, mixed for about 5 minutes
  • Acidified Whey Protein is added, mixer speed is reduced to about 435 rpm, mixed for about 30 minutes. 4. Fractionated Coconut Oil and High Oleic Sunflower Oil is added then increase mixer speed to about 580 rpm, mixed for about 5 minutes.
  • mixer speed remains at about 580 rpm, mixed for about 10 minutes.
  • Sugar is then added, mixer speed increased to about 725 rpm, mixed for about 20 minutes.
  • Lemon oil,Vitamin C and Vitamin E are then added, followed by mixing at about 725rpm for about 10 minutes.
  • pH checked to ensure is less than about 4.3, preferably about 3.5 to about 4.5 then adjust as is necessary with citric acid.
  • the product is processed at Specific Gravity of about
  • Pasteurised in pouch at about 73 to about 93°C, preferably about 76 to about 93°C for 3 minutes +/- 30 seconds

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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mycology (AREA)
  • Nutrition Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pediatric Medicine (AREA)
  • Botany (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne des compositions, de préférence des compositions diététiques appropriées pour le traitement d'états de malnutrition, de malabsorption et d'autres états nécessitant une vitaminisation en énergie, protéine et micronutriments pour un soutien nutritionnel. D'autres compositions décrites dans la présente invention sont également appropriées pour être utilisées, par exemple, dans le traitement de maladies neurologiques et dans le traitement de maladies métaboliques ou d'autres maladies. Les compositions décrites dans la présente invention concernent en particulier de nouveaux régimes et compositions appropriés. D'autres compositions décrites dans la présente invention sont également appropriées pour être utilisées dans la modification ou manipulation alimentaire impliquant la consommation de graisse, de protéine et de glucide, en isolation ou en combinaison, pour un effet et un bienfait thérapeutiques. La présente invention concerne également un procédé de préparation de telles compositions et l'utilisation de telles compositions.
PCT/EP2013/066988 2012-08-14 2013-08-14 Compositions diététiques pour le traitement de malnutrition, de maladies neurologiques et de maladies métaboliques WO2014027022A1 (fr)

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EP0843972A1 (fr) * 1996-11-20 1998-05-27 N.V. Nutricia Composition nutritionnelle comprenant des graisses pour le traitement du syndrome métabolique
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* Cited by examiner, † Cited by third party
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CN106535919A (zh) * 2014-07-23 2017-03-22 般财团法人粮食研究会 改善脑功能的药剂和预防或治疗认知功能障碍的药剂
EP3173089A4 (fr) * 2014-07-23 2018-04-04 The Food Science Institute Foundation Agent d'amélioration de fonction cérébrale, et agent prophylactique ou thérapeutique pour dysfonctionnement cognitif

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