HK1132433B

HK1132433B - Nutritional supplement containing long-chain polyunsaturated fatty acids

Info

Publication number: HK1132433B
Application number: HK09105299.8A
Authority: HK
Inventors: Joshua C. Anthony; Catherine A. Peterson; Kevin A. Sims; Deborah Diersen-Schade; Monjur Hossen; Priscilla Samuel
Original assignee: Mjn U.S. Holdings Llc
Priority date: 2005-12-16
Filing date: 2006-12-14
Publication date: 2013-06-14

Description

Nutritional supplement comprising long chain polyunsaturated fatty acids

Cross reference to related patents and patent applications

This application is a continuation-in-part application of U.S. patent application serial No. 11/303,374 filed on 16.12.2005 and claiming priority from that U.S. patent application.

Background

(1) The invention belongs to the field of the following:

the present invention relates to nutritional supplements (nutritional supplements) for patients suffering from chronic diseases, trauma or failure to thrive, as meal replacement or snack, or as nutrition, comprising a unique lipid blend comprising a level of DHA supplement and a lower ratio of omega-6: omega-3 fatty acids relative to a typical western diet, such that health benefits may be provided and/or adverse health consequences prevented.

(2) Description of related art:

young children and children in developed countries are famous pickers. These eating habits coupled with poor parental food selection often result in children not receiving adequate levels of key nutrients important for optimal growth and development. One such nutrient is omega-3 long-chain polyunsaturated fatty acid (LCPUFA) docosahexaenoic acid (DHA).

DHA has been shown to be important for cognitive and visual development and to accumulate rapidly in the developing brain for at least the first two years of life. To date, no nutritionally complete product containing a suitable level of DHA supplement is available for children 1-12 years old. This is partly due to the limited information on LCPUFA intake in weaned infants and young children, or the potential benefits of eating diets containing omega-3 LCPUFA in this age group.

However, a recent survey of dietary intake in US children 1-12 years old reported that DHA intake was below 30 mg/day. Extrapolation of existing recommendations for infants or adults to children of this age group suggests that an intake of DHA of 40-179 mg/day may be desirable to provide levels that show health-promoting benefits, including optimal brain and cardiovascular health and function in other age groups.

These results indicate that in young children there may be a "gap" of up to 150 mg/day between typical DHA intake levels and supplemental levels that may be considered desirable. Furthermore, for some of these age groups, the level based on efficacy may be as high as 500 mg/day, depending on the particular benefit. This is particularly important when one considers the DHA levels recommended in neonates and adults to be designed to optimize brain and cardiovascular health and function. However, to date, no product has been marketed specifically designed for children 1-12 years old to address this gap in DHA intake.

A nutritionally complete product supplemented with suitable levels of DHA combined with a suitable edible oil blend may also help address other growing health concerns. One of these concerns is the increasing level of omega-6 fatty acids relative to omega-3 fatty acids in the diet.

Currently, the ratio of omega-6 to omega-3 fatty acids in the western diet exceeds 15: 1. This excessive intake of omega-6 polyunsaturated fatty acids (PUFAs) resulting in a very high omega-6 to omega-3 ratio of fatty acid consumption changes is implicated in the pathogenesis of a variety of diseases including cardiovascular, cancer, inflammation and autoimmune diseases. In children, a number of behavioral problems, predisposition to splenic qi, sleep problems, learning impairment and health problems have been reported in subjects with low total omega-3 fatty acid concentrations, which underscores the need for adequate omega-3 fatty acid nutrition in children.

There is increasing scientific evidence that lower ratios of omega-6 to omega-3 fatty acids have many health benefits, including immune function, cardiovascular, bone and mental health benefits. In particular, several studies suggest that ratios below 6: 1 of omega-6 to omega-3 may be associated with health benefits, while ratios above 10: 1 may be associated with adverse health effects. Several federal and scientific organizations are focusing on increasing omega-3 fat in the diet.

Available nutritionally complete children products are currently used to supplement nutrients, meal replacements or snacks, or for the chronic illness, injury, trauma or failure to thrive in young children. These products are generally prescribed, focusing on providing full nutrition in a pleasant tasting formulation to help promote patient acceptance and compliance. For example, EnfamilKindercal(Mead Johnson, Evansville, IN) is used to provide nutrition to children aged 1-10 years who need supplemental nutrients, meal replacements or snacks, or to provide total nutrition to children who are chronically ill, injured or unable to thrive. Kindercal currently on the marketThe omega-6 to omega-3 ratio in the supplement is about 5: 1, but no DHA is present. Pediacure(Ross Products Division, Abbott Laboratories, Columbus, OH) were designed for children 1-10 years of age with increased nutritional needs or malnutrition due to illness or poor appetite. Likewise, PediasureAnd no DHA. However, PediasureThe ratio of medium omega-6 to omega-3 fatty acids is about 10.8: 1.

Although each of these products is designed to supplement the diet of a child who is a picky food, or to maintain a chronic pediatric patient, there is an opportunity to improve the composition of these formulations by optimizing lipid composition to provide evidence-based DHA levels and appropriate oil blends to maintain low omega-6: omega-3 fatty acid ratios for optimal brain development and function, in favor of cardiovascular health.

Because of the problems associated with current nutritional products, improvements have been sought in several reported nutritional supplements. However, these supplements are not sufficient to address all health issues in the diet due to the absence of LCPUFAs and/or high ratios of omega-6 fatty acids to omega-3 fatty acids.

For example, WO 2003043445 to Cary et al discloses a processed infant food product comprising a mixture of linoleic acid and alpha-linolenic acid, which supplements the diet of children with precursors of synthetic arachidonic acid and DHA. Since the supplement incorporates only LCPUFA precursors, there is no DHA. The invention also specifically recites relatively high omega-6 to omega-3 fatty acid ratios of 7: 1 to 12: 1.

WO 200215719 to Fuchs et al discloses a composition for nutritional supplementation of patients having a lipid source providing at least 18% of the total calories. The ratio of omega-6 to omega-3 fatty acids in the lipid source is about 1: 1 to about 10: 1. However, the supplement has no DHA.

U.S. patent application nos. 20030000391 and 20030185941 to Highman et al disclose organic nutritional beverages containing at least one of eicosapentaenoic acid (EPA) and DHA. According to the invention, arachidonic acid and linolenic acid (omega-6 fatty acid) are also useful fatty acids in the beverage. The application does not disclose any specific omega-6: omega-3 fatty acid ratio present in the beverage.

WO 2001047377 to Myhre discloses a nutrient solution preparation containing oil mixed with water in order to improve the freshness of the product. The nutritional liquid also has a high omega-6 to omega-3 fatty acid ratio.

U.S. patent No. 5,902,797 to Bell et al discloses a nutritional supplement containing sugar, protein and fat for use in appetite-suppressed individuals. DHA is not disclosed as part of the supplement.

From the foregoing, it can be seen that there is a need for an improved nutritional supplement comprising protein, sugar and a lipid source, while the lipid source needs to contain significant DHA levels, yet have a low overall ratio of omega-6 fatty acids to omega-3 fatty acids. Likewise, nutritional compositions that provide health benefits and/or prevent adverse health outcomes in children would also be desirable. Finally, compositions that provide special nutritional needs for children suffering from chronic diseases, injuries, trauma, or failure to thrive would also be desirable.

Summary of The Invention

Briefly, the present invention is directed to a novel nutritional composition comprising a protein component, a carbohydrate component, and a fat or lipid component further comprising a source of DHA, wherein the ratio of omega-6: omega-3 fatty acids in the supplement is about 6: 1 or less.

Another aspect of the invention relates to a method of providing nutrition to a subject comprising administering to the subject a nutritional supplement comprising a protein component, a carbohydrate component, and a fat or lipid component further comprising a source of DHA, wherein the ratio of omega-6: omega-3 fatty acids in the supplement is about 6: 1 or less.

In certain embodiments, the nutritional supplement is a total nutritional supplement. For example, the nutritional supplement may be suitable as the sole source of caloric intake by the subject, or it may optionally be initially supplemented with animal milk, human milk, and/or other infant milk powder, and/or later supplemented with solid food or beverages.

The lipid blend of the present invention provides an improvement in the ratio of omega-6 to omega-3 fatty acids compared to conventional nutritional supplements and current total nutritional supplements. For example, in certain embodiments, the invention disclosed herein comprises a unique lipid mixture comprising a DHA-rich oil source, canola oil (canola oil), high oleic sunflower oil (high oleic sunflower oil), corn oil, soybean oil, and Medium Chain Triglyceride (MCT) oil that provides suitable DHA supplementation levels and lower omega-6: omega-3 fatty acid ratios relative to typical western diets such that health benefits may be provided and/or adverse health consequences prevented.

Accordingly, the present invention provides an improved nutritional supplement comprising protein, sugar and a lipid source, whereas the lipid source comprises meaningful DHA levels, yet with a lower overall ratio of omega-6 fatty acids to omega-3 fatty acids. As such, the present invention provides nutritional supplements that provide health benefits in children and/or prevent adverse health consequences. Finally, the present invention provides methods and compositions that are capable of providing specific nutritional needs to children suffering from chronic diseases, injuries, trauma, or the inability to thrive.

Detailed description of several preferred embodiments

Reference will now be made in detail to embodiments of the invention, one or more examples of which are set forth below. Each example is provided by way of illustration of the invention and is not intended to be limiting. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope and spirit thereof. For instance, features illustrated or described as part of one embodiment, can be used on another embodiment to yield a still further embodiment. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents. Other objects, features and aspects of the present invention are disclosed in or are apparent from the following detailed description. It is to be understood by one of ordinary skill in the art that the present discussion is a description of exemplary embodiments only, and is not intended as limiting the broader aspects of the present invention.

In accordance with the present invention, it has been found that a pediatric nutritional supplement may be provided in a ready-to-use, nutritionally complete form by combining protein, lipid and sugar in proportions suitable for children to make a composition. For example, in one embodiment, the present invention provides a nutritional supplement comprising a protein component, a carbohydrate component, and a lipid component comprising a source of DHA, wherein the ratio of omega-6: omega-3 fatty acids in the supplement is about 6: 1 or less.

In certain embodiments, the nutritional supplement is a full nutritional pediatric supplement. The terms "pediatric" and "child" as used herein refer to human subjects between the ages of 9 months and 13 years, and in certain embodiments, more specifically, children between the ages of 1 year and 12 years. In a particular embodiment, the child is between 1-10 years of age.

The term "nutritionally complete" as used herein refers to a nutritional supplement that can be used as the sole source of nutrition and should provide a subject with substantially all of the daily requirements for vitamins, minerals, and/or trace elements, as well as proteins, sugars, and lipids.

Advantageously, the present invention provides an advantage over conventional nutritional supplements in that the combination of the lipid blend and meaningful DHA levels results in a ratio of omega-6: omega-3 fatty acids of about 6: 1 or less. For example, such as PediaSereThe ratio of omega-6 to omega-3 in the conventional product is about 11: 1. Although not intended to be limiting, it is believed that nutritional intake with a lower overall omega-6: omega-3 fatty acid ratio may provide certain health benefits including, but not limited to, immune function improvement, cardiovascular improvement, prevention or treatment of asthma, as well as other respiratory diseases, bone strength, and various mental health benefits.

While not wishing to be bound by this or any other theory, it is believed that the present invention may have additional benefits over conventional nutritional supplements in that it relates to its effect on intracellular Phosphatidylserine (PS) concentrations. PS is a phospholipid essential for the functionality of all cells of the body, but is particularly concentrated in the brain. PS has been shown to be of particular benefit for intelligence and memory enhancement. DHA is believed to modulate PS levels in vivo and in vitro, as PS levels have been shown to be directly related to DHA content in neuronal cells. Akbar, Mohammed et al, Docosahexaenoic Acid: a Positive Modulator of Akt Signaling in neuronal Survival (docosahexaenoic acid: a Positive regulator of Akt Signaling in surviving neurons), PNAS 102 (31): 10858 + 10863 (8 months 2005). The regulation of PS by DHA seems to be a unique mechanism, considering that the widely accepted view that altered phospholipid ratios are not easily introduced. The same goes out as above.

Traces of PS may be present in lecithin. In certain embodiments of the invention, the nutritional supplement comprises both lecithin and DHA. In this embodiment, it is possible for DHA to increase the intracellular concentration of PS. Thus, the present invention may be particularly useful for improving brain function, memory, language ability, mood, social ability, stress, attention deficit disorder and/or hyperactivity disorder.

In one embodiment, the nutritional profile of the present invention may be primarily designed for pediatric subjects who cannot or will not ingest sufficient nutrients through traditional dietary sources. For example, the nutritional supplement may be used as a pediatric nutritional supplement for children who are "spotters" as replacement meals (e.g., nutritionally complete) or snacks, or to provide special nutritional needs for children who suffer from chronic diseases, injury, trauma, or are unable to thrive. Likewise, the nutritional supplements described herein may be used as nutritional supplements for children who are recovering from illness or surgical recovery, children with limited appetite, children with anorexia, children with bulimia, and children with impaired ability to digest other nutritional sources.

The nutritional supplement may also include vitamins and minerals in amounts sufficient to provide daily nutritional needs to children between 1 and 13 years of age, and in certain embodiments, the amounts may be selected according to FDA guidelines. The nutritional supplement may also contain other ingredients such as antioxidants, emulsifiers, stabilizers, preservatives, fibers, colorants, flavors such as sweeteners, and other dietary supplements.

In one embodiment, the invention also includes a method of providing nutrition to a subject comprising administering to the subject a nutritional supplement comprising a protein component, a carbohydrate component, and a lipid component comprising a source of DHA, wherein the ratio of omega-6: omega-3 fatty acids in the nutritional supplement is about 6: 1 or less. In certain embodiments, the subject is a pediatric subject.

The variation of suitable sugars, lipids and proteins can be very large and is well known to those skilled in the art of pediatric nutritional supplement preparation. The beneficiated ingredient or ingredients described herein may be a material that is preferred by the formulation design or the consumer and end user. For convenience, some of the ingredients suitable for use in the methods and compositions of the present invention are described in further detail below. However, the invention should not be construed as limited to any one of the specific ingredients listed herein, as one of ordinary skill in the art will readily appreciate that many suitable ingredients other than those described herein may be used in addition to or in place of those described herein.

One component of the methods and compositions of the present invention is one or more sugars. The term "saccharide" as used herein refers to simple sugars (i.e., monosaccharides and disaccharides) and complex sugars (i.e., polysaccharides).

The nutritional supplements of the present invention comprise any carbohydrate source, whether natural, synthetic or developed by genetically manipulating organisms, whether such new source is now known or later developed. For example, sugar sources suitable for use in the methods and compositions of the present invention may include, but are not limited to, corn syrup dry powder; maltodextrin; sugars such as glucose, fructose, dextrose, lactose, galactose, saccharides, sucrose and maltose; sugar alcohols such as sorbitol, mannitol and xylitol; syrups, such as maltitol, corn syrup, rice syrup, and high fructose corn syrup; and mixtures thereof.

Commercial sources of the sugars listed above are readily available and known to those skilled in the art. For example, corn syrup solids are available from Cerestar USA, inc. Glucose and rice-based syrups are available from Natural Products, Lathrop, Calif. Various corn syrups and high fructose corn syrups are available from Cargil, Minneapolis, Minn. Fructose is available from a.e. staley, Decatur, Ill.

In addition to the sugars described above, the nutritional supplements described herein may also include artificial sweeteners such as sucralose, saccharin, cyclamate, aspartame, acesulfame potassium, and/or sorbitol. These artificial sweeteners may be required if the nutritional supplement is intended for overweight patients or type II diabetics who are prone to hyperglycemia. The nutritional supplements of the present invention comprise artificial sweeteners from any source, whether natural, synthetic or developed by genetically manipulating organisms, whether such new source is now known or later developed.

Another component in the methods and compositions of the present invention is one or more proteins. The term "protein" as used herein refers to an organic compound comprising amino acids linked together by peptide bonds.

The nutritional supplements of the present invention comprise proteins of any origin, whether natural, synthetic or developed by genetically manipulating organisms, whether such new sources are now known or later developed. For example, protein sources suitable for use in the methods and compositions of the present invention may include, but are not limited to, any suitable protein for use in nutritional formulations, including milk protein, milk protein concentrate, whey protein concentrate, whey powder, lactalbumin (lactabumen), egg protein (e.g., albumin), soy protein isolate, rice protein, beef collagen, pea protein, potato protein, casein, caseinates (e.g., sodium caseinate, sodium calcium caseinate, potassium caseinate), animal (e.g., bovine and fish) protein, and mixtures thereof.

Proteins suitable for use in the methods and compositions of the present invention may also include hydrolyzed proteins. The term "hydrolyzed protein" or "protein hydrolysate" as used herein refers to a protein that is processed or treated in a manner that serves to break one or more peptide (amide) bonds. These hydrolyzed peptide fragments and free amino acids are more easily digested. Cleavage of the amide bond can occur unintentionally or accidentally during production, for example due to heating or shearing.

Suitable protein hydrolysates include, but are not limited to, soy protein hydrolysate, casein hydrolysate, whey protein hydrolysate, rice protein hydrolysate, potato protein hydrolysate, fish protein hydrolysate, egg white protein hydrolysate, gelatin protein hydrolysate, combinations of animal and vegetable protein hydrolysates, and mixtures thereof.

In certain embodiments, the protein may also be provided in the form of free amino acids. In addition to the protein component, free amino acids may be added to the supplement. Examples of suitable free amino acids include, but are not limited to, histidine, isoleucine, leucine, lysine, methionine, cysteine, phenylalanine, tyrosine, threonine, tryptophan, valine, alanine, arginine, asparagine, aspartic acid, glutamic acid, glutamine, glycine, proline, serine, carnitine, taurine, and mixtures thereof. In other embodiments, small amino acid peptides may be included as proteins of the invention. Such small amino acid peptides may be natural or synthetic.

In certain aspects of the invention, the protein component of the invention comprises a milk protein concentrate, which is a mixture of casein and whey protein. In certain embodiments, the protein component comprises a mixture of casein and whey, wherein the ratio of casein to whey is about 8: 2.

Another component in the methods and compositions of the present invention is one or more lipids. The term "lipid" as used herein refers to a fatty or oily organic compound. The term "lipid" encompasses all fatty acid-type compounds. Lipids can be classified as saturated, polyunsaturated or monounsaturated.

Lipid sources suitable for use in the methods and compositions of the present invention include, but are not limited to, coconut oil, fish oils (e.g., menhaden oil, sardine oil), nut oils (e.g., hazelnut oil, walnut oil, brazil nut oil, chestnut oil, peanut oil), pumpkin seed oil, rice bran oil, sesame oil, soybean oil, corn oil, safflower oil, evening primrose oil, rapeseed oil, olive oil, flax (linseed) oil, cottonseed oil, high oleic safflower oil, palm stearin, soybean lecithin, macadamia nut oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm olein, palm kernel oil, rape oil, butter (e.g., milk fat, butter, cow germ oil), whole grain oil (hole grain oil), and mixtures thereof.

In certain embodiments of the invention, the lipid component comprises a mixture of several different types of lipids. For example, the nutritional supplement may comprise a mixture of at least one source of linoleic acid (omega-3 fatty acids) and at least one source of alpha-linolenic acid (omega-6 fatty acids). At least one source of DHA (omega-3 fatty acids) is also present in the nutritional supplement of the present invention.

In certain aspects of the invention, the lipid type and lipid content in the mixture may be selected such that the ratio of omega-6: omega-3 fatty acids in the nutritional supplement is about 6: 1 or less, about 5: 1 or less, about 4: 1 or less, about 3: 1 or less, about 2: 1 or less, or about 1: 1 or less. In certain embodiments, the ratio of omega-6: omega-3 fatty acids in the nutritional supplement may be only about 6: 1 or less. In other embodiments, the ratio of omega-6: omega-3 fatty acids in the nutritional supplement may be some value between about 1: 1 to 6: 1 or between about 3: 1 to about 6: 1. In other embodiments, the ratio of omega-6: omega-3 fatty acids in the nutritional supplement may be between about 5: 1 to 6: 1. In other embodiments, the ratio of omega-6: omega-3 fatty acids in the nutritional supplement may be about 6: 1. In other embodiments, the ratio of omega-6 to omega-3 fatty acids in the nutritional supplement may be about 5: 1.

For example, in certain aspects of the invention, the nutritional supplement comprises a mixture of: 1) at least one source of omega-3 fatty acid linoleic acid, 2) at least one source of alpha-linolenic omega-6 fatty acid, and 3) at least one source of DHA of omega-3 fatty acids, wherein the ratio of the amount of total omega-6 fatty acids to the amount of total omega-3 fatty acids is less than about 6: 1.

Suitable sources of linoleic acid-rich oil include, but are not limited to, sunflower oil, cottonseed oil, walnut oil, soybean oil, whole grain cereal oil, wheat germ oil, chestnut oil, pumpkin oil, sesame oil, brazil nut oil, peanut oil, safflower oil, corn oil, animal fats and mixtures thereof.

Suitable sources of alpha-linolenic acid-rich oil include, but are not limited to, linseed oil (or linseed oil), rape oil, soybean oil, walnut oil, wheat germ oil, and mixtures thereof.

Suitable sources of DHA include, but are not limited to, dairy products such as eggs (e.g., egg yolk oil) and tallow; marine or fish oils such as cod, salmon, herring, sardine, tuna and many others; brain fat, animal fat (e.g., beef and chicken fat), animal organs, lard, tallow; and microbial oils such as fungal oils and algal oils as described in detail in U.S. Pat. Nos. 5,347,657, 5,550,156, and 5,658,767. Each of the foregoing U.S. patents is incorporated herein by reference in its entirety.

DHA suitable for use in the present invention may be isolated from any single cell organism containing significant amounts of DHA. This shall include a variety of oleaginous fungi, a variety of algae (especially members of the class Dinophyceae (Dinophyceae), the class Diatomycetes (Bacillariophyceae), the class Chlorophyceae (Chlorophyceae), the class Geotrichum (Prymnesiophyceae) and the class Euglenophyceae (Euglenophyceae)) and organisms of indeterminate taxonomic state, such as Thraustochytrium (Thraustochytrium) or Schizochytrium (Schizochytrium). Suitable methods for producing DHA-containing lipids using Thraustochytrium or Schizochytrium are provided in U.S. Pat. No. 5,130,242, which is incorporated herein by reference in its entirety.

Algae oils, e.g. dinoflagellates (din) from the class Dinophyceaeof ofaellalites), particularly those of the algae species Crypthecodinium cohnii (Crypthecodinium cohnii) as the nitrogen source, may be a suitable source of DHA (including DHASCO)^TMAnd DHASCO-S^TM) As taught in U.S. patent nos. 5,397,591, 5,407,957, 5,492,938 and 5,711,983, which are all hereby incorporated by reference in their entirety. For example, nitrogen sources have been operated to produce very high levels of DHA from crypthecodinium cohnii. The organism can be cultivated in large scale, and the biomass can be used for producing DHA-containing oil. Suitable methods for producing DHA-containing biomass from crypthecodinium cohnii as a nitrogen source are provided in U.S. patent nos. 5,397,591 and 5,492,938, each of which is incorporated herein by reference in its entirety.

The nutritional supplement of the present invention also comprises any new source of DHA, which may be developed synthetically or by genetically manipulating organisms such as vegetables and/or oil-producing plants. For example, desaturase and elongase genes have been identified from many organisms and can be engineered into plants or other host cells so that they produce large quantities of DHA-containing lipids at low cost. Thus, the present invention relates to the use of these synthetic or recombinant DHA-containing lipids.

In certain aspects of the invention, the nutritional supplement comprises a mixture of lipid sources comprising two or more of the following oils: rape oil, soybean oil, high oleic sunflower (HoSun) oil, Medium Chain Triglyceride (MCT) oil, corn oil, in certain aspects of the invention the mixture comprises a mixture of all 5 of these oils. In other aspects, a mixture of a lipid source comprising a mixture of canola oil, soybean oil, high oleic sunflower oil, Medium Chain Triglyceride (MCT) oil, and corn oil, plus DHA oil provides a nutritional supplement having a ratio of omega-6: omega-3 fatty acids of about 6: 1 or less.

In certain aspects of the invention, the nutritional supplement may comprise other ingredients, such as one or more vitamins, minerals, antioxidants, fibers, flavorings, colorants, preservatives, emulsifiers, and other food additives and mixtures thereof, in addition to the sugars, proteins, lipids, and DHA previously described.

The methods and compositions of the present invention may optionally comprise one or more of the following vitamins or derivatives thereof, including but not limited to biotin, vitamin B₁Thiamine, thiamine pyrophosphate, vitamin B₂Riboflavin, flavin mononucleotide, flavin adenine dinucleotide, pyridoxine hydrochloride, thiamine mononitrate, folic acid, vitamin B₃Nicotinic acid, nicotinamide (nicotinamide), nicotinamide (niacinamide), nicotinamide adenine dinucleotide, tryptophan, biotin, pantothenic acid, vitamin B₆Vitamin B₁₂Cobalamin, methylcobalamin, desoxyadenosylcobalamin, cyanocobalamin, calcium pantothenate, pantothenic acid, vitamin C, ascorbic acid, vitamin A, retinol, retinal, retinoic acid, beta-carotene, vitamin D₃Calciferol, cholecalciferol, dihydroxyvitamin D, 1, 25-dihydroxycholecalciferol, 7-dehydrocholesterol, choline, vitamin E acetate, vitamin K, menadione, menaquinones, phylloquinone, naphthoquinone and mixtures thereof.

The methods and compositions of the present invention may optionally comprise one or more of the following minerals or derivatives thereof: including but not limited to phosphorus, potassium, sulfur, sodium, docusate sodium, chloride, manganese, magnesium stearate, magnesium carbonate, magnesium oxide, magnesium hydroxide, magnesium sulfate, copper sulfate, iodide, boron, zinc oxide, chromium, molybdenum, iron, carbonyl iron, ferric iron, ferrous fumarate, polysaccharide iron, fluoride, selenium, molybdenum, calcium phosphate or acetate, potassium phosphate, magnesium sulfate or oxide, sodium chloride, potassium chloride or acetate, iron orthophosphate, alpha-tocopherol acetate, zinc sulfate or oxide, copper gluconate, chromium chloride or picolinate, potassium iodide, sodium selenate, sodium molybdate, phylloquinone, cyanocobalamin, sodium selenite, copper sulfate, inositol, potassium iodide, cobalt, and mixtures thereof. Non-limiting representative derivatives of inorganic compounds include salts, basic salts, esters, and chelates of any inorganic compound.

Minerals may be added in the form of salts, such as calcium phosphate, calcium glycerophosphate, sodium citrate, potassium chloride, potassium phosphate, magnesium phosphate, ferrous sulfate, zinc sulfate, copper sulfate, manganese sulfate, and sodium selenite. Other vitamins and minerals may be added as is known in the art.

The methods and compositions of the present invention may optionally include one or more of the following flavorings, including but not limited to spice extracts, volatile oils, cocoa or chocolate flavorings, peanut butter flavorings, cookie crumbs, vanilla or any commercially available flavoring. Examples of useful flavoring agents include, but are not limited to, pure anise extract, banana essence (animation banana extract), cherry essence (animation cherry extract), chocolate extract, pure lemon extract, pure orange extract, pure mint extract, pineapple essence (animation apple extract), rum (animation rum extract), strawberry essence (animation strawberry extract), or vanilla essence; or volatile oil such as Melissa oil (palm oil), laurel oil, bergamot oil, cedar oil, cherry oil, cinnamon oil, clove oil, or peppermint oil; peanut butter, chocolate flavoring, vanilla cookie crumb, butterscotch, toffee, and mixtures thereof. The amount of flavoring agent used may vary considerably depending on the flavoring agent used. The type and amount of flavoring agent can be selected as is known in the art.

The methods and compositions of the present invention may optionally comprise one or more emulsifiers, which may be added for stability of the final product. Examples of suitable emulsifiers include, but are not limited to, lecithin (e.g., from egg or soy), and/or mono-and diglycerides and mixtures thereof. Other emulsifiers will be apparent to those skilled in the art, and the selection of a suitable emulsifier will depend in part on the formulation and end product.

The methods and compositions of the present invention may optionally include one or more preservatives that may be added to the nutritional supplement to extend the shelf life of the product. Suitable preservatives include, but are not limited to, potassium sorbate, sodium sorbate, potassium benzoate, sodium benzoate, and calcium disodium EDTA, and mixtures thereof.

The methods and compositions of the present invention optionally may comprise one or more fiber sources including, but not limited to, soy fiber, pea hull fiber, soy hull fiber, gum arabic, and mixtures thereof. The nutritional supplements of the present invention comprise fiber of any origin, whether natural, synthetic or developed by genetically manipulating organisms, whether such new sources are now known or later developed.

The methods and compositions of the present invention optionally may comprise one or more stabilizers. Suitable stabilizers for use in the methods and compositions of the present invention include, but are not limited to, gum arabic, gum ghatti, gum karaya, gum tragacanth, agar, furcellaran, guar gum, gellan gum, locust bean gum, pectin, low methoxyl pectin, gelatin, microcrystalline cellulose, CMC (sodium carboxymethylcellulose), methylcellulose hydroxypropyl methylcellulose, hydroxypropyl cellulose, DATEM (diacetyl tartaric acid esters of mono-and diglycerides), dextran, carrageenan, and mixtures thereof.

In addition to the amount of omega-3 and omega-6 fatty acids, a variety of amounts of the foregoing ingredients that can be added to the nutritional supplement of the present invention can be selected as known in the art.

For example, the sugar content in the nutritional supplement of the present invention may range from about 1 gram (g)/100 kilocalories (kcal) to about 50g/100 kcal. In other embodiments, the sugar content may range from about 5g/100kcal to about 25g/100 kcal. In still other embodiments, the sugar content may be in the range of about 10g/100kcal to about 15g/100 kcal. In certain embodiments, the sugar content in the nutritional supplement of the present invention may be about 12.8g/100 kcal.

The protein content in the nutritional supplement of the present invention may range from about 0.1g/100kcal to about 20g/100 kcal. In other embodiments, the protein content may range from about 0.5g/100kcal to about 10g/100 kcal. In still other embodiments, the protein content may be in the range of about 1g/100kcal to about 5g/100 kcal. In certain embodiments, the protein content in the nutritional supplement of the present invention may be about 2.8g/100 kcal.

The lipid content in the nutritional supplement of the present invention may range from about 0.1g/100kcal to about 50g/100 kcal. In other embodiments, the lipid content can range from about 1g/100kcal to about 20g/100 kcal. In still other embodiments, the lipid content can be in the range of about 2g/100kcal to about 10g/100 kcal. In certain embodiments, the lipid content in the nutritional supplement of the present invention may be about 4.2g/100 kcal.

When the lipid source comprises linoleic acid, the linoleic acid content in the nutritional supplement of the present invention may range from about 0.1g/100kcal to about 20g/100 kcal. In other embodiments, the linoleic acid content may range from about 0.5g/100kcal to about 5g/100kcal, or the content may range from about 0.75g/100kcal to about 2g/100 kcal. In still other embodiments, the linoleic acid content may be about 1g/100 kcal.

When the lipid source comprises alpha-linolenic acid, the alpha-linolenic acid content in the nutritional supplement of the invention can range from about 0.01g/100kcal to about 10g/100 kcal. In other embodiments, the alpha-linolenic acid content can be in the range of about 0.05g/100kcal to about 1g/100kcal, or the content can be in the range of about 0.1g/100kcal to about 0.2g/100 kcal. In still other embodiments, the alpha-linolenic acid content can be about 0.16g/100 kcal.

The DHA content in the nutritional supplement of the present invention may range from about 0.1 milligrams (mg)/100kcal to about 1g/100 kcal. In other embodiments, the DHA content may be in the range of about 1mg/100kcal to about 200mg/100kcal, or the content may be in the range of about 5mg/100kcal to about 50mg/100 kcal. In still other embodiments, the DHA content may be in the range of about 7.5mg/100kcal to about 25mg/100 kcal. In certain aspects of the invention, the DHA content may be about 17mg/100 kcal. The DHA content of the nutritional supplement of the present invention may vary over a wide range based on the caloric content of the supplement.

In certain embodiments, the amount of DHA present in the nutritional supplements and methods described herein may comprise a meaningful level of DHA. The term "meaningful level" as used herein refers to an amount of DHA that can provide a health benefit, however slight, to at least one patient described herein. Such health benefits may include, but are not limited to, increased dietary intake, enhanced physical growth, improved brain and/or eye development, improved immune health and function, and improved cardiovascular health and function.

In other aspects of the invention, the nutritional supplement may comprise a mixture of lipid sources comprising from about 10% to about 50% canola oil, from about 5% to about 40% soybean oil, from about 5% to about 40% high oleic sunflower oil, from about 5% to about 40% Medium Chain Triglyceride (MCT) oil, from about 1% to about 20% corn oil, and from about 0.1% to about 10% DHA source as weight/weight percent of the total lipid component. In one embodiment, the ratio of omega-6: omega-3 fatty acids in the nutritional supplement is less than about 6: 1.

As used herein, the term "weight percent" and the abbreviation "wt.%" or "w/w" refer to the weight percent based on the total weight of any of the components of the nutritional supplement specified, or the weight percent will be based on the final form of the nutritional supplement of all the ingredients that have been added.

In still further aspects of the invention, the nutritional supplement of the invention may comprise a mixture of lipid sources comprising about 29.3% canola oil, about 20.7% soybean oil, about 20.5% high oleic sunflower oil, about 19.8% medium chain triglyceride oil, about 8.8% corn oil, and about 0.9% DHA source as weight/weight percent of total lipid components. In another embodiment, the ratio of omega-6: omega-3 fatty acids in the nutritional supplement is less than about 6: 1.

When vitamin A is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 1 μ g/100kcal to about 500 μ g/100 kcal. More advantageously, the vitamin A content of the methods and/or compositions of the present invention may be about 70 μ g/100 kcal.

When vitamin D is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1 μ g/100kcal to about 100 μ g/100 kcal. More advantageously, the vitamin D content of the methods and/or compositions of the present invention may be about 1.24 μ g/100 kcal.

When vitamin E is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1mg to about 100 mg. More advantageously, the vitamin E content of the methods and/or compositions of the present invention may be about 2.36 mg.

When vitamin K is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1 μ g/100kcal to about 100 μ g/100 kcal. More advantageously, the vitamin K content of the methods and/or compositions of the present invention may be about 5.4 μ g/100 kcal.

When vitamin B is present in the methods and/or compositions of the invention₁When used, it is advantageously present in an amount ranging from about 0.01mg/100kcal to about 10mg/100 kcal. More advantageously, vitamin B is present in the methods and/or compositions of the present invention₁May be present in an amount of about 0.16mg/100 kcal.

When vitamin B is present in the methods and/or compositions of the invention₂When used, it is advantageously present in an amount ranging from about 0.01mg/100kcal to about 10mg/100 kcal. More advantageously, vitamin B is present in the methods and/or compositions of the present invention₂May be present in an amount of about 0.2mg/100 kcal.

When vitamin B is present in the methods and/or compositions of the invention₆When used, it is advantageously present in an amount ranging from about 0.01mg/100kcal to about 10mg/100 kcal. More advantageously, vitamin B is present in the methods and/or compositions of the present invention₆May be present in an amount of about 0.2mg/100 kcal.

When vitamin B is present in the methods and/or compositions of the invention₁₂When used, it is advantageously present in a range of about 0.01 μ g/100kcal to about 10 μ g/100 kcal. More advantageously, vitamin B is present in the methods and/or compositions of the present invention₁₂May be present in an amount of about 0.56. mu.g/100 kcal。

When present, niacin (niacin) is advantageously present in the methods and/or compositions of the present invention in an amount ranging from about 0.1mg/100kcal to about 100mg/100 kcal. More advantageously, the niacin content of the methods and/or compositions of the present invention may be about 2.45mg/100 kcal.

When folic acid is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1 μ g/100kcal to about 500 μ g/100 kcal. More advantageously, the folic acid content of the methods and/or compositions of the invention can be about 20 μ g/100 kcal.

When pantothenic acid is present in the methods and/or compositions of the invention, it is advantageously present in an amount ranging from about 0.1mg/100kcal to about 100mg/100 kcal. More advantageously, the methods and/or compositions of the present invention can have a pantothenate content of about 1.24mg/100 kcal.

When biotin is present in the methods and/or compositions of the invention, it is advantageously present in an amount ranging from about 0.1 μ g/100kcal to about 100 μ g/100 kcal. More advantageously, the biotin may be present in the methods and/or compositions of the present invention in an amount of about 15.2 μ g/100 kcal.

When vitamin C is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.01mg/100kcal to about 1g/100 kcal. More advantageously, the vitamin C content of the methods and/or compositions of the present invention may be about 23.2mg/100 kcal.

When choline is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1mg/100kcal to about 500mg/100 kcal. More advantageously, the choline content of the methods and/or compositions of the invention may be about 25.2mg/100 kcal.

When inositol is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1mg/100kcal to about 500mg/100 kcal. More advantageously, the amount of inositol in the methods and/or compositions of the invention may be about 6.8mg/100 kcal.

When taurine is present in the methods and/or compositions of the invention, it is advantageously present in an amount ranging from about 0.1mg/100kcal to about 500mg/100 kcal. More advantageously, taurine can be present in the methods and/or compositions of the invention in an amount of about 6mg/100 kcal.

When carnitine is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1mg/100kcal to about 500mg/100 kcal. More advantageously, the carnitine may be present in the methods and/or compositions of the present invention in an amount of about 6mg/100 kcal.

When calcium is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1mg/100kcal to about 1g/100 kcal. More advantageously, the calcium may be present in the methods and/or compositions of the invention in an amount of about 96mg/100 kcal.

When phosphorus is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1mg/100kcal to about 1g/100 kcal. More advantageously, the phosphorus content of the methods and/or compositions of the present invention may be about 80mg/100 kcal.

When magnesium is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1mg/100kcal to about 500mg/100 kcal. More advantageously, the magnesium may be present in the methods and/or compositions of the present invention in an amount of about 14mg/100 kcal.

When iron is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1mg/100kcal to about 100mg/100 kcal. More advantageously, the iron content of the methods and/or compositions of the present invention may be about 1mg/100 kcal.

When zinc is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1mg/100kcal to about 100mg/100 kcal. More advantageously, the zinc content of the methods and/or compositions of the invention may be about 1mg/100 kcal.

When manganese is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.01mg/100kcal to about 10mg/100 kcal. More advantageously, the manganese content of the methods and/or compositions of the present invention may be about 0.16mg/100 kcal.

When copper is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1 μ g/100kcal to about 1mg/100 kcal. More advantageously, the copper content of the methods and/or compositions of the present invention may be about 80 μ g/100 kcal.

When iodine is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1 μ g/100kcal to about 100 μ g/100 kcal. More advantageously, the iodine content of the methods and/or compositions of the present invention may be about 12 μ g/100 kcal.

When selenium is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.01 μ g/100kcal to about 1mg/100 kcal. More advantageously, the amount of selenium in the methods and/or compositions of the present invention may be about 3 μ g/100 kcal.

When sodium is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1mg/100kcal to about 500mg/100 kcal. More advantageously, the sodium content of the methods and/or compositions of the present invention may be between about 55-60mg/100 kcal.

When potassium is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1mg/100kcal to about 1g/100 kcal. More advantageously, the potassium may be present in the methods and/or compositions of the present invention in an amount of about 180mg/100 kcal.

When chloride is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 0.1mg/100kcal to about 1g/100 kcal. More advantageously, the chloride content of the methods and/or compositions of the present invention may be about 70mg/100 kcal. The sodium, potassium and chloride content of the nutritional supplement of the present invention can vary widely based on the caloric content of the supplement.

When chromium is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 1 μ g/100kcal to about 500 μ g/100 kcal.

When molybdenum is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 1 μ g/100kcal to about 500 μ g/100 kcal.

When fluoride is present in the methods and/or compositions of the present invention, it is advantageously present in an amount ranging from about 1mg/100kcal to about 500mg/100 kcal.

When a fiber source is present in the methods and/or compositions of the present invention, the fiber content can range from about 0.01g/100kcal to about 100g/100 kcal. In other embodiments, the fiber content may be in the range of about 0.1g/100kcal to about 10g/100kcal, or the content may be in the range of about 0.5g/100kcal to about 1g/100 kcal. In still other embodiments, the fiber content may be about 0.6g/100 kcal.

The nutritional supplement of the present invention may also contain one or more prebiotics (prebiotics). The term "prebiotic" refers to a food ingredient that is not digestible but is capable of stimulating the growth and/or activity of probiotics (probiotics). Any prebiotic known in the art is acceptable in this embodiment. Prebiotics of the invention may include lactulose (lactulose), galacto-oligosaccharides, fructo-oligosaccharides, isomalto-oligosaccharides, soy-oligosaccharides, lactosucrose (lactosucrose), xylo-oligosaccharides, inulin, polydextrose and gentio-oligosaccharides.

The nutritional supplement of the present invention may also be administered to a subject in combination with human or animal milk (e.g., bovine or goat milk).

In certain embodiments, the liquid nutritional supplement comprises about 250kcal per serving. In other embodiments, the liquid nutritional supplement comprises less than about 200kcal per serving. In another embodiment, the liquid nutritional supplement comprises about 150-. In yet another embodiment, the liquid nutritional supplement comprises about 160-. In yet another embodiment, the liquid nutritional supplement comprises about 170kcal per serving.

In certain embodiments, the present invention is designed to deliver about 7-20mg DHA per 100kcal per serving of a liquid nutritional supplement containing 250 kcal. Thus, providing 2-4 supplements daily to 1-10 year old children should achieve about 35mg to about 200mg of supplemental DHA per day, thus addressing some gaps between DHA intake in this age group relative to the desired level of DHA intake based on current recommendations.

In other embodiments, the present invention is designed to deliver about 7-75mg DHA/100kcal per serving of a liquid nutritional supplement containing less than 200 kcal. In yet another embodiment, the present invention is designed to deliver 7-75mg DHA/100kcal per serving of a liquid nutritional supplement containing about 150-. In a specific embodiment, the present invention is designed to deliver 7-75mgDHA/100kcal per serving of a liquid nutritional supplement containing about 160-180 kcal. In another embodiment, the present invention is designed to deliver 7-75mg DHA/100kcal per serving of a liquid nutritional supplement containing about 170 kcal.

In certain other embodiments, the liquid nutritional supplement comprises less than about 200kcal per serving and is free of artificial sweeteners. In yet another embodiment, the liquid nutritional supplement comprises about 150-. In yet another embodiment, the liquid nutritional supplement comprises about 160-. In yet another embodiment, the liquid nutritional supplement comprises about 170kcal per serving and is free of artificial sweeteners.

The nutritional supplements of the present invention may be provided in any form suitable for administration to a subject. For example, the nutritional supplement may be prepared in a form such as: liquid formulations, powders, liquid/powder concentrates, ready-to-eat forms, caplets, tablets, pills, capsules, puddings, chewable tablets, fast dissolving tablets, effervescent tablets, reconstitutable powders, elixirs, solutions, suspensions, emulsions, multi-layer tablets, bi-layer tablets, soft gelatin capsules, hard gelatin capsules, lozenges, chewable lozenges, beads (beads), granules, microgranules, dispersible granules, cachets, implants, depot implants, ingestion (ingestibles), injections, infusions, bar health foods (health bars), cookies, candies, animal feeds, cereals, cereal panning (cereal coating), food products, soups and purees, nutritional foods, functional foods, and combinations thereof.

However, in certain aspects of the invention, the nutritional supplement is provided in liquid form. The above dosage forms can be prepared as known in the art.

The nutritional supplements of the present invention may be produced using techniques well known to the skilled artisan. For example, there are a variety of processing techniques for producing powdered, ready-to-drink, and liquid supplements.

Typically, these techniques involve forming a slurry from one or more solutions that may include water and one or more of the following: sugars, proteins, lipids, stabilizers, vitamins and minerals. The pH of the slurry may be checked and, if desired, adjusted to a relatively neutral pH, i.e., about 6.5 to about 7.5, preferably about 7.0. Any acid or base compatible with the compositions of the present invention, preferably citric acid, potassium hydroxide or sodium dihydrogen phosphate, may be used to adjust the pH as desired.

The slurry is then emulsified, homogenized and cooled. Various other solutions may be added to the slurry before processing, after processing, or at both times. In certain aspects of the invention, the liquid nutritional supplement is sterile. In those embodiments, the supplement is sterilized under aseptic conditions and can be diluted for ready-to-use or stored as a liquid or powder. Homogenization and sterilization can be accomplished using standard equipment known to the skilled artisan.

If the nutritional supplement is obtained as a ready-to-drink liquid or concentrate, an appropriate amount of water may be added prior to sterilization. If the nutritional supplement is obtained as a powder, the slurry is heated and dried to obtain a powder. The dried powder may be dry mixed with other ingredients, if desired. The nutritional supplements may be packaged as needed for distribution and sale using standard equipment known in the art.

Variations on any of these production methods are known or will be apparent to those skilled in the art. It is not intended that the present invention be limited to any particular method of manufacture.

The following examples describe various embodiments of the invention. Other embodiments within the scope of the claims herein will be apparent to one skilled in the art from consideration of the specification or practice of the invention as disclosed herein. It is intended that the specification, together with the examples, be considered exemplary only, with the scope and spirit of the invention being indicated by the claims which follow the examples. In the examples, all percentages are given on a weight basis unless otherwise indicated.

Example 1

This example illustrates one embodiment of a liquid nutritional supplement composition of the present invention. Table 1 lists the ingredients and their amounts present in embodiments of the liquid nutritional supplement of the present invention, expressed in grams (g)/liter (L) or milligrams (mg)/liter (L). Table 2 lists the amounts of basic nutrients (protein, fat and sugar) and vitamin and mineral nutrients present in an 8 fluid ounce embodiment of the liquid nutritional supplement of the present invention. For the present compositions, an 8 fluid ounce embodiment of the liquid nutritional supplement of the present invention has a caloric content of about 250 kcal.

Table 1: composition information and concentration (per liter)

Component (a) and unit	Per litre (per litre)
		Sucrose, g	115.27
Maltodextrin, DE15, g	55.00
		Milk protein concentrate, g	35.00
Nutritional oil blend, g	25.50

(rape oil, corn oil and high oleic sunflower oil)
		Soybean oil, g	9.00
MCT oil, g	8.65
		Natural and artificial flavors, g	3.83
Potassium citrate, g	2.00
		Ascorbic acid sodium salt, mg	719.60
Corn syrup dry powder, mg	404.28
		Inositol, mg	104.72
Taurine, mg	76.16
		Nicotinamide, mg	29.68
Ground biotin, mg	22.82
		Calcium pantothenate, mg	22.12
Vitamin B₁₂，mg	9.48
		Pyridoxine hydrochloride, mg	4.34
Thiamine hydrochloride, mg	3.25
		Riboflavin, mg	3.08
Folic acid, mg	0.28
		Potassium iodide, mg	0.20
Potassium dihydrogen phosphate, mg	1300.00
		Magnesium chloride, mg	1280.00
Calcium orthophosphate, mg	1250.00
		Sodium chloride, mg	540.00
Lecithin, mg	440.00
		Single cell DHA oil, mg	430.00
Choline chloride, mg	400.00
		Carrageenan K-100, mg	125.00
Tocopheryl acetate, mg	48.65
		Rape oil, mg	36.56
Palmitic acid vitamin A, mg	1.35
		Cholecalciferol concentrate, mg	0.83
Vitamin K₁Liquid plant menadione, mg	0.11
		Carnitine, mg	80.00

Ferrous sulfate, mg	63.00
		Zinc sulfate monohydrate, mg	33.51
Qian powder of corn syrup, mg	11.52
		Manganese sulfate monohydrate, mg	5.63
Copper sulfate, mg	4.79
		Chromium chloride hexahydrate, mg	0.31
Sodium molybdate dihydrate, mg	0.15
		Sodium selenite, mg	0.08

Table 2: nutrient information

Nutrients, units	Every 8 fluid ounces
		Protein, g	7.1
Fat, g	10.5
		Saturated fat, g	3
Cholesterol, mg	＜5
		Linoleic acid, g	2.5
Alpha-linolenic acid, g	0.4
		DHA，mg	43
Sugar, g	32
		Vitamin A, IU	420
Vitamin D, IU	125
		Vitamin E, IU	8.8
Vitamin K, μ g	14
		Thiamine (vitamin B)₁)，mg	0.4
Riboflavin (vitamin B)₂)，mg	0.5
		Pyridoxine, mg	0.5
Vitamin B₁₂，μg	1.4
		Nicotinic acid, mg	4.9
Folic acid, ug	50
		Pantothenic acid, mg	3.1
Biotin, μ g	38
		Choline, mg	63

Vitamin C, mg	58
		Calcium, mg	240
Phosphorus, mg	200
		Magnesium, mg	40
Sodium, mg	88
		Potassium, mg	310
Chloride, mg	175
		Iodine, μ g	30
Iron, mg	2.5
		Zinc, mg	2.5
Manganese, mg	0.4
		Copper, mg	0.2
Selenium, μ g	7.5
		Mu.g of chromium	12.5
Molybdenum, μ g	12.5
		Taurine, mg	15
L-carnitine, mg	15
		Inositol, mg	20

Table 3 lists the concentrations of the relevant components in the nutritional supplement of example 1, expressed in grams/liter.

Table 3: component concentration (per liter)

Component(s) and unit(s)	Per litre (per litre)
		Protein, g	30
Sugar, g	135
		Lipid g	44
Linoleic acid, g	10.6
		Alpha-linolenic acid, g	1.7
Docosahexaenoic acid, g	0.18

The caloric profile of the nutritional supplement of example 1 is shown in table 4.

Table 4: heat distribution

Components	Percentage of Heat
		Protein	11％
Lipid	38％
		Candy	51％

Table 5 below lists the LCPUFA content in the nutritional supplement of example 1.

Table 5: LCPUFA information

LCPUFA	% total lipid (weight/weight)	% of the Total Heat
			Linoleic Acid (LA)	24.1％	9.06％
Alpha-linolenic acid (ALA)	3.9％	1.47％
			Docosahexaenoic acid (DHA)	0.41％	0.154％

Example 2

This example illustrates another embodiment of the liquid nutritional supplement composition of the present invention. Table 6 lists the ingredients present in embodiments of the liquid nutritional supplement of the present invention and their amounts, expressed as weight percent of the total weight of the nutritional supplement. Table 7 lists the levels of basic nutrients (protein, fat and sugar) and vitamin and mineral nutrients present in an 8 fluid ounce embodiment of the liquid nutritional supplement of the present invention. In this example, the caloric content in an 8 fluid ounce embodiment of the liquid nutritional supplement of the present invention is about 170 kcal.

Table 6: composition information and concentration (per liter)

Component (b) g	Per litre (per litre)
		Condensed skim milk	170
Sucrose	42.0
		Fructose, crystal	35.0
Nutrition oil mixture (rape oil, corn oil and high oleic sunflower oil)	31.3
		Cocoa powder	9.0

Whey protein concentrate	5.0
		Casein sodium salt	3.0
Single cell DHA oil	1.45
		Orthophosphoric acid calcium salt	1.10
Natural and artificial flavoring agent	0.50
		Lecithin concentrates	0.50
Guar gum	0.35
		Mono-and diglycerides	0.30
Ascorbic acid sodium salt	0.15
		Corn syrup dry powder	0.08
Nicotinamide	0.03
		Ground biotin	0.02
Calcium pantothenate	0.004
		Pyridinol hydrochloride	0.002
Thiamine hydrochloride	0.002
		Riboflavin	0.0007
Folic acid	0.0003
		Carrageenan K-100	0.25
Sodium chloride	0.25
		Magnesium phosphate dihydrate	0.15
Zinc sulfate	0.02
		Manganese sulfate monohydrate	0.007
Copper sulfate	0.005
		Corn syrup dry powder	0.002
Pyrophosphoric acid iron	0.03
		Soybean oil	0.02
Tocopheryl acetate, DL-alpha	0.004
		Palmitic acid vitamin A	0.003
Cholecalciferol concentrates	0.0002

TABLE 7 nutrient information

Nutrients, units	Every 8 fluid ounces
		Heat, kcal	170
Protein, g	6
		Fat, g	5
Saturated fat, g	0.7
		Cholesterol, mg	0
Linoleic acid, g	1.0
		Alpha-linolenic acid, g	0.2
DHA，mg	130
		Sugar, g	25
Vitamin A, IU	820
		Vitamin D, IU	48
Vitamin E, IU	2.7
		Thiamine (vitamin B)₁)，mg	0.32
Riboflavin (vitamin B)₂)，mg	0.36
		Pyridoxine, mg	0.36
Vitamin B₁₂，μg	0.2
		Nicotinic acid, mg	5.8
Folic acid, ug	70
		Pantothenic acid, mg	1.3
Biotin, μ g	30
		Vitamin C, mg	10
Calcium, mg	270
		Phosphorus, mg	210
Magnesium, mg	38
		Sodium, mg	95
Potassium, mg	320
		Chloride, mg	180
Iodine, μ g	70
		Iron, mg	2.7
Zinc, mg	2.5

Manganese, mg	0.79
		Copper, mg	0.3

Table 8 lists the concentrations of the relevant components in the nutritional supplement of example 2, expressed in grams/liter.

Table 8: component concentration (per liter)

Component(s) and unit(s)	Per litre (per litre)
		Protein, g	25.3
Sugar, g	105
		Lipid g	21.1

The caloric profile of the nutritional supplement of example 2 is shown in table 9.

Table 9: heat distribution

Components	Percentage of Heat
		Protein	14％
Candy	59％
		Lipid	27％

Example 3

This example illustrates a method of producing an embodiment of the nutritional supplement of the present invention.

Compositions of embodiments of the present invention can be seen in the list of components in table 1. In this embodiment, the protein source comprises a milk protein concentrate, which is a mixture of casein and whey proteins in a ratio of 8: 2. The lipid source comprises a weight/weight mixture of the following based on total lipid content: 29.3% rape oil, 20.7% soybean oil, 20.5% high oleic sunflower oil, 19.8% medium chain triglyceride oil, 8.8% corn oil and 0.9% DHA oil. The composition has a DHA content of about 17mg/100 kcal. The sugar source comprises a mixture of maltodextrin and sucrose. The composition also comprises a suitable amount of carrageenan and a flavoring agent.

The method according to which the liquid nutritional supplement of example 1 can be produced comprises the following steps:

1. the protein mixture and the sugar mixture can be dispersed in water at room temperature with good stirring.

2. The pH of the dispersion can then be adjusted to about 7 with potassium hydroxide.

3. All vitamins and minerals can be dissolved in water and pre-heated at about 170 ℉ to obtain a solution which can be added to the protein/sugar dispersion.

4. The pH can then be readjusted to about 7.

5. The lipid mixture may be pre-heated to about 160 ° f and then added to the sugar/protein/vitamin and mineral suspension with good agitation. Any optional ingredients may also be added at this point.

6. The mixture may then be heated to 225 ° f for 45 seconds with direct steam injection and then rapidly cooled to 160 ° f.

7. The mixture can then be homogenized twice using a two-stage homogenizer at a total pressure of 3000psig, 2500psig in the first stage and 500psig in the second stage.

8. The mixture can then be sterilized under aseptic conditions at 268 ° f, 2000psig for 5 seconds and then packaged using a Dole aseptic canning apparatus model 1305.

All references mentioned in this specification, including but not limited to all papers, publications, patents, patent applications, briefs, texts, reports, manuscripts, manuals, books, internet mail, journal articles, periodicals, and the like, are incorporated herein by reference in their entirety.

The discussion of the references herein is intended merely to summarize the assertions made by their authors and no admission is made that any reference constitutes prior art. Applicants reserve the right to challenge the accuracy and pertinence of the cited references.

Although preferred embodiments of the invention have been described using specific terms, devices, and methods, such description is for illustrative purposes only. The words used are words of description rather than of limitation. It is to be understood that changes and variations may be effected by one of ordinary skill in the art without departing from the spirit or scope of the invention as set forth in the following claims. Additionally, it should be understood that aspects of the various embodiments may be interchanged both in whole or in part.

Claims

1. A nutritional supplement for administration to a child, the nutritional supplement comprising:

a protein component;

a sugar component; and

a lipid component comprising a source of docosahexaenoic acid, wherein the nutritional supplement comprises docosahexaenoic acid in an amount between 5mg/100kcal supplement and 50mg/100kcal supplement, the supplement has a ratio of omega-6: omega-3 fatty acids of 6: 1 or less, and the sugar component comprises maltodextrin.

2. The nutritional supplement of claim 1, wherein the supplement is a liquid.

3. The nutritional supplement of claim 1, wherein the sugar component comprises a mixture of maltodextrin and sucrose.

4. The nutritional supplement of claim 1, wherein the protein component comprises a milk protein concentrate.

5. The nutritional supplement of claim 1, wherein the lipid component comprises a mixture of at least one linoleic acid source and at least one alpha-linolenic acid source.

6. The nutritional supplement of claim 1, wherein the lipid component comprises a mixture of canola oil, soybean oil, high oleic sunflower oil, medium chain triglyceride oil, and corn oil.

7. The nutritional supplement according to claim 1, wherein the nutritional supplement comprises docosahexaenoic acid in an amount between 0.1mg/100kcal of supplement and 1g/100kcal of supplement.

8. The nutritional supplement according to claim 1, wherein the nutritional supplement comprises docosahexaenoic acid in an amount between 7.5mg/100kcal of supplement and 25mg/100kcal of supplement.

9. The nutritional supplement according to claim 1, wherein the nutritional supplement comprises docosahexaenoic acid in an amount of 17mg/100kcal of supplement.

10. The nutritional supplement of claim 1, further comprising at least one prebiotic.

11. The nutritional supplement of claim 10, wherein the prebiotic is selected from the group consisting of lactulose, galacto-oligosaccharide, fructo-oligosaccharide, isomalto-oligosaccharide, soy oligosaccharide, lactosucrose, xylo-oligosaccharide, inulin, polydextrose, and gentio-oligosaccharide.

12. The nutritional supplement according to claim 1, wherein the supplement comprises 250kcal per serving.

13. The nutritional supplement of claim 1, wherein the supplement comprises 160-180kcal per serving.

14. A nutritional supplement for administration to a child, the nutritional supplement comprising:

a protein component;

a sugar component; and

a lipid component comprising, as a weight/weight percentage of the total lipid component:

from 10% to 50% rape oil;

5% to 40% soybean oil;

5% to 40% high oleic sunflower oil;

5% to 40% medium chain triglyceride oil;

1% to 20% corn oil; and

0.1% to 10% of a source of docosahexaenoic acid.

15. The nutritional supplement of claim 14, wherein the lipid component comprises, as a weight/weight percentage of the total lipid component:

29.3% rape oil;

20.7% soybean oil;

20.5% high oleic sunflower oil;

19.8% medium chain triglyceride oil;

8.8% corn oil; and

0.9% of a source of docosahexaenoic acid.