MXPA99011693A - Palatable elemental medical food - Google Patents

Abstract

This invention relates to a palatable elemental nutritional formula that is nutritionally complete for humans with specialized dietary needs. The nutritional of the present invention uses specific free amino acids to provide the source of amino nitrogen (protein equivalents) and a special blend of fats that provides 38 to 50%of the total calories in a pleasant tasting formula. The nutritionally complete formula of this invention is useful for children having multiple protein allergies, short gut syndrome, sick gut, diarrhea and the like. More specifically, the nutritional product, in accordance with this invention, utilizes L-asparagine monohydrochloride and L-glutamine in place of L-aspartic acid and L-glutamic acid, respectively. In addition, the source of fat comprises soy, fractionated coconut oil (medium chain triglycerides), high oleic safflower oil and esterified glycerol emulsifiers. The level of fat calories is about 38 to 50%of total calories, which produces a product having a low osmolarity and provides required energy requirements in a small volume.

Description

NUTRIENT ELEMENTARY MEDICAL FOOD TO TASTE Field of the Invention This invention relates to improved oral, hypoallergenic nutrient formulas and more particularly to hypoallergenic formulas that taste good. In addition, the nutritional product of this invention provides a nutritionally complete hypoallergenic food for individuals with multiple food allergies, short bowel syndrome, cystic fibrosis, pancreatic disease, gastroenteritis, inflammatory bowel disease, intractable diarrhea, malnutrition, poor digestion of proteins, infectious diseases or for patients with hypermetabolism, such as victims of burns and trauma or patients with cancer. BACKGROUND OF THE INVENTION Hypoallergenic formulas or compositions that are also referred to as elemental formulas, are characterized in that they contain hydrolysates of immunologically unreactive proteins or free amino acids. Protein hydrolysates comprise fragments of short peptides and / or free amino acids in place of the intact protein found, for example, in formulas based on cow's milk and soy protein. It has been found that these fragments of short peptides and free amino acids are less immunogenic or allergenic than intact proteins. In addition, for protein hydrolysates and free amino acids, elemental or hypoallergenic nutritionally balanced formulas contain carbohydrates, lipids, vitamins and minerals to provide a nutritionally complete formula. These formulas are used to feed infants, children and as who have allergies or sensitivities to intact protein and are often used medically in the treatment of cystic fibrosis, chronic diarrhea, small bowel resection, steatorrhea and protein-calorie malnutrition. A well-known problem in the preparation of elemental or hypoallergenic formulas is product instability. Extensive hydrolysis of the protein by acids, or enzymes, is necessary to provide the short peptides and amino acids used in the formulas to render said formulas hypoallergenic. These widely digested proteins or free amino acids have undesirable characteristics such as bad taste and loss of ability to emulsify fats and thus do not form physically stable emulsions that do not show phase separation. The Patent of E.U.A. No. 4,414,238 to Schmidt, et al., Discloses an elemental diet composition comprising carbohydrates, amino acids and / or peptides and low molecular weight lipids. The elemental diet of this patent has a lipid component in the form of an emulsion consisting of lipids, an emulsifier selected from the group consisting of mono and diglycerides and a starch modified with succinic anhydride. The Patent of E.U.A. No. 4,670,268, by Mahmoud discloses a whole nutritional hypoallergenic formula that uses a starch modified by octenyl succinic anhydride, which is used as the sole lipid emulsifier, to provide a nutritionally well-balanced dietary formula that has excellent physical stability. Patent No. 5,411,751 to Crissinger discloses formulas for infants containing no more than the free, long chain fatty acid (C? 6-C22) riser levels and triglycerides thereof. This patent teaches that the triglyceride digestion products, in particular, long chain fatty acids and monoglycerides, can damage the intestinal epithelium of children and could mediate the onset of disorders such as necrotising enterocolitis. This patent does not suggest or describe a taste-friendly elemental or hypoallergenic medical food that is essentially free of L-glutamic acid and L-aspartic acid. The Patent of E.U.A. DO NOT. 5,234,702 to Katz, et al., Discloses a powdered nutritional product that uses an antioxidant system to protect the oil component comprising ascorbic palmitate, beta carotene and / or mixed tocopherols and citrate. The teachings of this patent are incorporated herein by reference. The Patent of E.U.A. No. Re. 35,233, describes a method for treating atrophy of skeletal muscle and intestinal mucosa comprising administering enterally glutamine or a functional derivative thereof on a scale of 0.4 to 3.0 g / kg / day. The nutritional formula according to this invention has been carefully formulated to provide a nutritional product that may be the only source of nutrition for patients who consume it. To provide effective nutrition for infants, children and adults, the present invention, in its more specific modalities, carefully considers the bioavailability for trace minerals and ultratrace and the dietary interactions involving trace elements. Therefore, the teachings of Forbes, and others, Bioavailability of Trace Mineral Elements, Ann. Rev. Nutr. 1985, 5: 173-193, are incorporated herein by reference. The Patents of E.U.A. Nos. 5,326,569 and 5,550,146, by Acosta et al., Describe a generic powder base, rich in fats, carbohydrates, vitamins, minerals and trace elements that are mixed with specific amino acids to produce several different therapeutic products that are used in the nutritional support of adults and children who have several inherited metabolic diseases. These patents do not suggest or describe the nutritionally complete hypoallergenic formulas of this invention that are essentially free of L-glutamic acid and L-aspartic acid. It has been shown that the etiology of a certain number of gastrointestinal conditions are caused in some cases by food protein allergens. One of said gastrointestinal conditions is eosinophilic gastroenteritis. Administration of an elemental hypoallergenic diet may be required for rapid recovery such as extensively uniform hydrolyzed casein-based formulas such as Alimentum® Iron Protein Hydrolyzate Formula (Ross Products Divison, Abbott Laboratories, Columbus, Ohio) contains enough peptide fragments. great to avoid an allergic reaction in the most sensitive allergic individuals. The Patent of E.U.A. do not. 5,492,899 to Masor et al. Describes an enteral nutrient formula containing ribonucleotides at specific levels. The formula of this patent comprises carbohydrates, lipids, proteins, vitamins and minerals and four (4) specific nucleotides at specific levels and ratios. A preferred embodiment of the present invention includes the presence of nucleotides in the hypoallergenic elemental medical food. The teachings of the U.S. Patent. 5,492,899 are incorporated herein by reference. The Patent of E.U.A. No. 5,340,603, by Neylan et al., Refers to a hypercaloric formula that provides nutritional support for human infants who have chronic lung disease. The formula of this patent has a caloric density of at least 800 kcal per liter of formula and wherein not less than 56% of the total calories in the formula are derived from fats. In addition, the hypercaloric formula of this reference contains no more than 15% of the total calories derived from a high-quality protein source and from approximately 20 to 27% of total calories from a carbohydrate source. The formula of this patent also includes L-inositol at a concentration of at least 50 mg per liter of formula.

The Patent of E.U.A. 5,411,757, by Buist et al., Refers to a balanced, taste-pleasing medical diet for the treatment of patients with congenital errors of essential amino acid metabolism. The diet of this patent uses L-amino acids at specific weights and ratios. More specifically, this patent describes a taste-friendly medical diet wherein the protein equivalent of L-amino acids was formed by the acetylation or esterification of the L-amino acids. In contrast, the present invention uses L-amino acids to supply the amino nitrogen (equivalent protein) except for the replacement of L-asparagine for aspartic acid and L-glutamine for glutamic acid. A currently available product known as Vivonex® Pediatric, contains 100% free amino acids and has an osmolality normal dilution of 1 kcal / ml of 490 mOsm / kg H2O. This product derives 25% of the total calories from fat with 68% of the chain triglyceride calories by. Neocate® One + marketed by Scientific Hospital Supplies, Inc. (SHS) North America, Gaithersburg, Maryland, is a pediatric elemental nutrition that is marketed in liquid and powdered forms designed for children around one year of age. This liquid product contains 100% of its amino nitrogen in the form of free L-amino acids and has an osmolality at normal dilution (100 kcal / 100 ml) of 835 mOsm / kg H2O. These products contain 3.5 grams of fat per 100 ml at a caloric density of 100 kcal / 100 ml. Neocate®, also marketed by SHS in the UK, Scandanavia and USA, uses maltodextrin as the source of carbohydrates containing 11.4% of calories from free L-amino acids and 44.3% of calories from fats where fat is a mixture of refined butter , peanut oil and coconut oil. In general, the elemental or hypoallergenic formulas of the prior art suffer from poor taste (organoleptic properties), high osmolarity and low caloric density. In contrast, the present invention has acceptable organoleptic properties thereby facilitating oral consumption by the patient which also has increases in patient compliance with dietary restrictions. The improved organoleptic properties were achieved in part, by the essential exclusion of L-glutamic acid and L-aspartic acid from the formula and replacing them with L-glutamine monohydrate and L-asparagine. Furthermore, the present invention differs from the prior art in that it contains a higher Caloric content of fat which helps to improve the organoleptic properties, reduces osmolality and increases the overall caloric density. In addition, the specific fat blend of the invention provides a balance of linoleic and a-linoleic essential fatty acids in a readily absorbable form. SUMMARY OF THE INVENTION The present invention relates to an improved elemental formula comprising carbohydrates, lipids, free amino acids, vitamins and minerals. The invention is based, in part, on the discovery that the use of chain triglycerides by (TCM) or fractionated coconut oil, soybean oil, esterified glycerol emulsifiers and sunflower oil with high oleic content as the lipid component , in combination with the use of L-asparagine monohydrate instead of L-aspartic acid and L-glutamine instead of L-glutamic acid, greatly improves the organoleptic properties of the hypoallergenic formula. The present invention also uses a high level of fat to result in a product that has a low osmolarity and also provides the necessary energy requirements in a small volume. One aspect of the present invention relates to the preparation of an elemental medical food that is essentially free of L-glutamic acid and L-aspartic acid. In the present invention, L-glutamic acid (C5H9NO, mol weight 147.13) is replaced with L-glutamine (C5H? 0N2O3), mol weight. 146.15) the monoamide of glutamic acid and L-aspartic acid (C H7NO4, mol weight 133.10) is replaced with L-asparagine monohydrate (C H8N2O3 »H2O, mol weight 150.13), the monoamide of aspartic acid with a molecule of Water. As used herein and in the claims, the phrase "to be essentially free of L-glutamic acid and L-aspartic acid" means that less than 5 mg of each acid shall be present in 100 grams of powdered product (less 50 ppm). The present invention also relates to a complete pediatric hypoallergenic formula for feeding to children in allergen-free diets. The formula according to this invention uses the free L-amino acids as the amino nitrogen source and complies with the recommended dietary premises (PDR) for children from 1 to 3 years of age in 100 kcal and for children aged 4 to 6 years of age in 1500 kcal. As used herein and in the claims, the term "protein equivalent" means the amount of amino nitrogen in grams present in the formulation multiplied by 6.25. An elementary medical food is described for administration to a human being comprising a) a carbohydrate component comprising 36-56% of the total caloric content of said food; b) a lipid composition comprising 38-50% of the total caloric content of said food and wherein the lipid component is a mixture of high oleic sunflower oil, fractionated coconut oil (medium chain triglycerides), soybean oil and esterified glycerols; and c) an amino acid component comprising 10-20% of the total caloric content of said food and wherein the amino acid component is essentially free (less than 5 mg per 100 g of powdered product) of L-glutamic acid and acid L-aspartic. The term "essentially free" means that each of the amino acids is at concentrations less than 5 mg per 100 gm (50 ppm) of powder product. Also disclosed is a method for providing nutrition support for a human being suffering from a malaise selected from the group consisting of multiple food allergies, short bowel syndrome, cystic fibrosis, pancreatic disease, gastroenteritis, inflammatory bowel disease, intractable diarrhea , malnutrition, poor protein digestion, infectious diseases such as HIV, hypermetabolism, trauma, eosinophilic gastroenteritis and gastroesophageal reflux, said method comprises administering to said human being a hypoallergenic formula according to the present invention. More specifically, this invention relates to an elemental medical food and a method for its use wherein the carbohydrate component comprises from 38 to 56% of the total caloric content of the composition and wherein the lipid component comprises from 38 to 50% of the total caloric content of the composition and wherein the amino acid or equivalent component of protein comprises from 10 to 20% of the total caloric content of the composition. In a more preferred embodiment, the lipid component comprises 38-46% of the total caloric content of the composition. The lipid component of this invention supplies 2-8% by weight of the powdered product as linoleic acid (5-15% of calories) and from 0.4 to 1.0% by weight of the powdered product as a-linolenic acid (0.8- 2% of total calories). Preferably, the carbohydrate component of this invention consists essentially of corn syrup solids at a dextrose equivalent (ED) of 23 or less.

A stabilizer system is used in the formula of this invention and can be a single component or a mixture of known stabilizers. As previously mentioned, a major confrontation to develop an elemental nutritional is physical stability. Physical stability refers to the oil and water emulsion of the formula. Those skilled in the art understand that free amino acids and hydrolyzed proteins do not produce emulsions that are stable over time. It is important that the elementary medical foods of this invention have acceptable physical stability as the separation of the emulsion in the water and oil phases greatly decreases the palatability of the formula and may result in inadequate nutrition.

The inventors of the present invention have evaluated numerous emulsion stabilizers and have determined that esterified glycerol emulsifiers such as diacetyltartaric esters of monoglycerides are very useful in the present invention. The diacetyltartaric acid esters of monoglycerides (hereinafter "DATEM") are commercially available and are generally considered safe for human consumption by the USFDA. Representative DATEM emulsion stabilizers useful in the present invention include the line Panodan® of emulsion stabilizers sold by Grinsted Products, Inc. of Kansas, E.U.A. Panodan® is made from edible refined vegetable fat.

In one embodiment of the present invention, the DATM emulsion stabilizer is the only emulsion stabilizer and is present in the elemental medical food of this invention at a level of up to 8% by weight of the lipid. DATEM is grouped into the lipid component since, when ingested, the stearases separate the fatty acid portion from the tartaric acid moiety. The fatty acid is then absorbed and metabolized while the tartaric acid eliminates the non-metabolized body. The profile of the Panodan® emulsion stabilizer sold by Grinsted is as follows: Component Fatty Acids% by Weight 14: 0 0.1 16: 0 6.6 18: 0 54.5 18: 1 0.3 20: 0 0.4 Diacetyltartaric Acid 38.1 Another important aspect of the present invention relates to the use of an antioxidant system to decrease the oxidation of the lipid component. Those skilled in the art will appreciate that the use of unsaturated oils in an elemental powder product presents special problems. To overcome the oxidation (decomposition) of the oils in the powder product, the present invention, in a preferred embodiment, uses an anti-oxidant system comprising ascorbyl palmitate, beta carotene and citrate. The teachings of the U.S. Patent. 5,234,702, Katz et al., Entitled: ANTIOXIDANT SYSTEM FOR POWDERED NUTRITIONAL PRODUCTS, are incorporated herein by reference. Detailed Description of the Invention All the components of the formulation of the invention are commercially available from numerous sources. For example, the carbohydrate source which is preferably corn syrup solids with an ED less than 23, is available from Grain Processing Corporation, Muscatina, IA. The amino acids are available from Kyowa Hakko, Ajinomoto and Tanabe from Japan, and Degusa from Germany. Lipids are available from Stepan Co. Maywood, N.J. and California Oliz, Richmond, CA. The l-glutamine component is available from Kyowa Hakko of Japan and the L-asparagine monohydrate is available from Degussa. According to this invention, the osmolality of the formula can vary from 300 to 400 mOsm / kg H2O, and more preferably from 350 to 375 mOsm / kg H2O when 4.2 g of said powder composition is added to the water to give 29.57 ml of formula. As one skilled in the art will appreciate, the osmolality of the formula will vary with the concentration of doric density of the formula. For example, at a caloric density of 68 kcal / 100 ml, the osmolality of the LPA formula (ready to be fed), can vary from 350-375 mOsm / kg H2O. At a caloric density of 135 kcal / 100 ml, the osmolality of the formula can vary from 850-900 mOsm / kg H2O.

One aspect of the present invention resides in the use of corn syrup solids for the carbohydrate source. It is important to use a carbohydrate source that will not adversely affect (increase to a high value) the osmolality of the final product particularly when the l-amino acids supply the protein equivalent, since they are small molecules that greatly increase osmolality. Those skilled in the art will appreciate that high osmolalities (ie, above about 450 mOsm / kg H2O for infants and about 750 mOsm / kg H2O for children) in a liquid nutrition product can cause gastric discomfort and diarrhea. Therefore, the use of types of carbohydrates, such as dextrose and sucrose, which could increase osmolality above about 400 mOsm / kg H2O for infants and about 750 mOsm / kg H2O for children, is discouraged. In a preferred embodiment, the carbohydrate used in the present invention has an ED (dextrose equivalent) not greater than 23 and corn syrup solids. The use of carbohydrates with an ED greater than 23 in combination with L-amino acids will provide an osmotic pressure in the intestine which can lead to inflammation, diarrhea and dehydration. These are conditions that should be avoided in patients who already suffer from gastrointestinal problems. The medical food according to this invention provides a good balance of caloric density and acceptable osmolality. As those skilled in the art will appreciate, as the ED of the carbohydrate increases, the osmolality of the formula also increases.

The preferred source of carbohydrates is corn syrup solids with an ED of 23 or less. Also in this invention is contemplated an elemental medical food which is given flavor. Flavors and sweeteners (preferably other than sucrose or glucose) known in the food industry are acceptable as long as the patients consuming them are not allergic to them and the osmolality of the final product is acceptable. A vanilla-flavored product with the aspartame artificial sweetener (NutraSweet®) was produced based on Example I. The osmolality of the flavored product at 68 kcal / 100 ml was 370 mOsm / kg H2O and 895 mOsm / kg H2O at 135 Kcal / 100 ml. Also disclosed is a lipid component for use in the present invention which comprises a weight percentage of the lipid component, from 35 to 43% sunflower oil with high oleic acid content, from 28 to 35% fractionated coconut oil (MCT) ), from 24 to 30% of soybean oil and from 0.5 to 8% of esterified glycerols. In the lipid component of this invention, the level of linoleic acid can vary from 15 to 22% and the a-linolenic level can vary from 2 to 5% by weight of the total lipid component. a representative blend of 6.4 grams of soybean oil, 9.0 gm of high oleic sunflower oil, 7.6 gm of fractionated coconut oil and 1.4 gm of DATEM were incorporated into the elemental medical food according to this invention and then analyzed for fatty acid content. Table I shows the name of the fatty acid, grams of fatty acid per 100 gm of powder,% of energy and% by weight of fats. TABLE I NAME NO. OF G / 100 G% OF ENERGY% IN CARBON WEIGHT FAT POWDER Caprico C6: 0 0.068 0.129 0.29 Caprílico C8: 0 4.230 8.015 18.00 Caprico C10: 0 3,032 5,745 12.90 Láurico C12: 0 0.042 0.080 0.18 Palmítico C16: 0 0.191 2.257 5.07 Palmitoleic C16: 1n7 0.014 0.027 0.06 Stearic C18: 0 1,159 2,196 4.93 Oleic C18: 1n9 8.342 15.806 35.50 Linoleic C18: 2n6 4.653 8.816 19.80 a-Linoleic C18: 3n3 0.531 1.006 2.26 Araquídico C20: 0 0.067 0.127 0.29 Eicosenoic C20: 1n9 0.046 0.087 0.19 Behenic C22: 0 0.051 0.097 0.22 Lignocérico C24: 0 0.024 0.045 0.10 Nervonic C24: 1n9 0.018 0.034 0.08 TOTALs 23,468 44,467 99.87 Fatty Acids 8.420 15.954 35.83 mono-unsaturated poly-fatty acids 5.184 9.822 22.06 unsaturated Saturated fatty acids 9.864 18.690 41.97 1 Analytical data By analysis, one can not differentiate the fatty acids from Panodan, soybean oil and HO sunflower oil. In a further embodiment of the present invention, a powdered elemental medical food comprising 100 g of powder is disclosed, in Table II.

TABLE II Elemental Medical Food Scale per 100 g of Product Nitrogen, g 2.32 - 2.92 Protein Equivalent, g 14.3 - 17.9 Fat, g 22.6 - 24.5 Humidity, g 1.0 - 2.0 Ashes, g 3.0 - 4.5 Carbohydrates, g 46.7 - 56.0 Calories 475 - 495 Vit.A, Ul 1500 - 2256 Vit.E, Ul 11.6 - 15.1 Vit.D, Ul 260 - 317 Vit.K, mcg 70 - 103 Pyridoxine, mg 0.57 - 0.79 Niacin, mg 9.28 - 12.47 Folico Acid, mcg 177 - 282 Vit.B !, mg 1.42 - 1.95 Riboflavin, mg 0.62 - 0.87 Vit.B-12, mcg 4.06 - 6.46 Pantothenic acid, mg 5.05 - 8.03 Biotin, mcg 50 - 82 Vit.C, mg 200 - 400 Total Hill, mg 36 - 65 Inositol, mg 32 - 42 Calcium, mg 515 - 600 Phosphorous. Mg 385 - 465 Ca / P 1.11 - 1.56 Magnesium, mg 40.0 - 60.0 Iron, mg 8.4 - 11.4 Zinc, mg 5.40 - • 7.1 Manganese, mg 0.50 - 0.70 Copper, mg 0.70 - 0.90 Iodine, mcg 28 - 56 Selenium, mcg 11.0 - 20.0 Cromium, mcg 11.0 - 20.0 Molybdenum, mcg 12.0 - 26.0 Sodium, mg 217-257 Potassium, mg 717-824 Chloride, mg 285-395 Taurus, mg 30-56 L-Carnitine, mg 23-31 Even more specifically, the elemental food according to this invention comprises, based on 100 kcal of said composition, from 2.8 to 3.8 g of equivalent protein, from 4.0 to 5.6 g of fats, from 9.0 to 11.8 g of carbohydrates, 0.4 to 0.8 g of linoleic acid, from 262 to 475 IU of Vitamin A, from 40 to 80 Ul of Vitamin D, from 2.0 to 3.5 IU of Vitamin E, from 5 to 20 mcg of -vitamin K, from 0.11 to 0.42 mg of thiamin, from 0.1 to 0.21 mg of riboflavin, from 0.09 to 0.17 mg of Vitamin B-6 , from 0.40 to 1.36 mcg of Vitamin B-12, from 1.6 to 3.2 mg of niacin, from 28 to 60 mcg of folic acid, from 0.40 to 1.70 mg of pantothenic acid, from 4.0 to 18 mcg of biotin, from 8.6 to 85 mg of Vitamin C, from 7.5 to 14.5 mg of choline, from 4.6 to 9.9 mg of inositol, from 4 to 6.5 mg of L-carnitine, from 103 to 127 mg of calcium, from 76 to 103 mg of phosphorus, from 8.0 to 12.7 mg of magnesium, 1.6 to 2.4 mg of iron, of 1 .0 to 1.7 mg of zinc, from 0.10 to 0.15 mg of manganese, from 0.11 to 0.19 mg of copper, from 6.7 to 11.8 mcg of iodine, from 2.2 to 4.7 mcg of selenium, from 2.2 to 4.7 mcg of chromium, from 2.4 to 5.5 mcg of molybdenum, 40 to 55 mg of sodium, 144 to 174 mg of potassium and 55 to 85 mg of chloride. To convert nutrient values per 100 Kcal. At nutrient values per 100 grams of powdered product, the value of 100 kcal is multiplied by 4.75. The inclusion of nucleotides and / or nucleosides in the elemental feed according to this invention is also contemplated. The teachings of the Patents of E.U.A. 5,492,899 to Masor et al., 3,231,385 to Ziro et al., 4,544,559 to Gil and 4,994,442 to Gil et al., Which refer to the inclusion of nucleotides in nutritional formulas, are incorporated herein by reference. In another embodiment of the present invention, the protein equivalent component of the elemental medical food has an amino acid profile as shown in Table III. TABLE III Amino Acid Profile of Protein Equivalent MINIMUM MAXIMUM MINIMUM ** MAXIMUM ** gm / 100gm * gm / 100gm * L-alanine 2.86 4.23 2.80 4.41 L-arginine 5.17 7.72 5.05 7.93 L-asparagine 8.37 12.42 8.35 13.10 L-cystine 1.10 1.68 1.10 1.72 L-glutamine 10.62 15.85 10.44 16.41 Glycine 2.20 3.29 2.20 3.45 L-histidine 2.20 3.29 2.14 3.38 L-Isoleucine 5.72 8.53 5.60 8.83 L-leucine 9.25 13.83 9.12 14.28 L-lysine 5.17 7.66 5.05 7.93 L-methionine 2.15 3.22 2.09 3.31 L-phenylalanine 4.79 7.12 4.67 7.31 L-proline 2.92 4.16 2.80 4.41 L-serine 2.86 4.23 2.80 4.41 L-threonine 3.80 5.71 3.74 5.86 L-tryptophan 1.49 2.22 1.42 2.28 L-tyrosine 4.79 7.12 4.67 7.31 L-valine 6.55 9.74 6.43 10.07 * of amino acids "as a percentage of protein equivalent The caloric density of the formula of the invention is preferably about 450 to 500 kcal / 100 g of powder. The caloric density of the RTF product, of course, can be adjusted by the dilution rate with water.

This invention relates to improved hypoallergenic, enteral, hypoallergenic formulas and particularly to hypoallergenic formulas that taste good. In addition, the nutritional product of this invention provides a nutritionally complete hypoallergenic food for individuals with multiple food allergies, short bowel syndrome, cystic fibrosis, pancreatic disease, gastroenteritis, inflammatory bowel disease, intractable diarrhea, malnutrition, poor protein digestion, infectious diseases or for patients with hypermetabolism such as victims of burns and trauma or patients with cancer. The present invention also relates to a method of providing nutritional support to a human being suffering from gastrointestinal conditions caused by food protein allergens or severe food allergies. The method comprises enteral administration of the hypoallergenic medical food according to this invention. a human being suffering from a gastrointestinal condition induced by an allergen. The elemental feed according to this invention is for enteral administration and is designed to provide complete nutrition (meets the RDA) in a small volume. For example, when the RDA for energy for age is supplied by instantaneous elemental breath, all nutrients meet the specifications of the USFDA Infant Formula and RDA for age in the volumes noted in Table IV.

TABLE IV Food Add H2O Elemental Age, to form (ml) Fl Oz Kcal / oz 0 < 6 m or 137 800 27 24 6 < 12 mo 179 930 31 27 1 < 4 years 274 1,272 43 30 4 < 7 years 379 1,330 45 40 7 < 11 years 421 1,478 50 40 The following Table V is a representative list of ingredients and is on a weight% scale for each component that can be used to prepare the palatable elemental medical food of this invention. TABLE V List of Materials Ingredients For 30 kg of powder Infant Elemental Base Maltrin M200 15.9 kg Tricalcium Phosphate 0 .39 kg Dipotassium Phosphate 0 .35781 kg Sodium Citrate 0.22353 kg Potassium citrate 0. 2.7774 kg Magnesium chloride 0.102 kg Calcium carbonate 0.05106 kg Sodium chloride 0.10108 kg Potassium iodide 0.0000165 kg Sunflower oil with high oleic content 2 67 kg MCT 2 oil, 25 kg Soybean oil 1. .92 kg Panodan 0 .426 kg Vitamin A, D3, E, K1 Concentrate 0 .01014 kg Refined coconut oil 7.. 86 g Vitamin E acetate 6. 90 g Vitamin A acetate 540 mg Phyloquinone (phytonadione) 26.1 mg Vitamin D3 3., 83 mg Ascorbyl Palmitate 0.00846 kg Beta Carotene 0.00027 kg Ascorbic acid 0.13029 kg L-carnitine 0.00807 kg Vitamin / Mineral / Taurine premix 0.06006 kg Calcium phosphate, dibasic (pre-mix diluent) 25.4 g Taurine 25.0 g m-lnositol 18.4 g Zinc sulphate 7.59 g Niacinamide 5.25 g Ferrous sulfate 2.90 g D-calcium pantothenate 2.84 g Cupric sulfate 1.57 g Thiamin chloride hydrochloride 804 mg Riboflavin 355 mg Pyridoxine Hydrochloride 326 mg Manganese Sulfate 187 mg Folic acid 99.9 mg Biotin 28.7 mg Sodium selenite 14.1 mg Cyanocobalamin 2.29 mg Chloride Choline 0.01752 kg Ferrous sulfate 0.00972 kg Potassium citrate 0.0006 kg Manganese sulphate 0.00033 kg Chromium chloride 0.000015 kg Sodium molybdate 0.000012 kg Amino Acid Premix: 5172 kg L-Glutamine 875.4 g L-Asparagine Monohydrate 780.2 g L-Leucine 762.0 g L-Lysine acetate 598.7 g L-Valina 539.8 g L-lsoleucine 471.7 g L-Arginine 426.4 g L-Phenylalanine 394.6 g L-Tyrosine 394.6 g L-Threonine 313.0 g L-Proline 240.4 g L-Alanine 235.9 g L-Serine 235.9 g Glycine 181.4 g L-Histidine 181.4 g L-methionine 176.9 g L-Cystine Dihydrochloride 122.5 g L-Tryptophan 122.5 g TOTAL 29,997 kg * The values in kilograms are shown in Table VI. A specific embodiment of an elemental formula according to the present invention is shown in Table IV. TABLE VI NUTRIENT PER 100 G DUST Equivalent protein, g 14 .3 Fat, g 22 .6 Carbohydrate, g 46 .7 Linoleic acid, g 2 .85 Linolenic acid, g 0 .48 Calories, kcal 475 Calcium, mg 515 Phosphorous, mg 385 Magnesium, mg 40 Sodium , mEq (mg) 9 .35 (215) Potassium, mEq (mg) 18 .29 (715) Chloride, mEq (mg) 8 .04 (285) Iron, mg 8 .4 Zinc, mg 5 .3 Copper, mg 0 .60 Iodide, mcg 34 Manganese, mg 0 .50 Selenium, mcg 11 Vitamin A, mcg RE (Ul) 390 (1300) Vitamin D, mcg (Ul) 5 (200) Vitamin E, mg a-TE (Ul) 6 .7 (10.0) Vitamin K, mcg 30 Vitamin C, mg 43 Thiamine, mg 1 .0 Riboflavin, mg 0 .5 Vitamin B-6, mg 0 .48 Vitamin B12, mcg 2 Niacin, mg 8 Folic acid, mcg 140 Pantothenic acid, mg 2 Biotin, mcg 20 Hill 38 Inositol, mg 24 Chromium, mcg 11 Molybdenum, mcg 12 Taurus, mg 30 L-carnitine, mg 23 The present invention will now be explained on the basis of some examples of the specific modality , which, however, will be considered as illustrative only. Unless otherwise noted, the concentrations are parts by weight. EXAMPLE 1 General Procedure The teachings of the U.S. Patent. 5,326,569 to Acosta et al., With respect to the preparation of the amino acid mixtures and the process for preparing an elemental formula, are used in the preparation of the elemental formulas according to this invention and are incorporated herein by reference. An enteral formula according to this invention is generally achieved by dry blending a powdered premix base with a premix of amino acids. The production of the premixed base is achieved through the steps outlined below: 1. Preparation of Mother Solutions: a. Preparation of a water-soluble vitamin and trace mineral mixture; b. preparation of a mixture of ascorbic acid; c. preparation of oil mixture containing oil-soluble vitamins; and d. Preparation of a carbohydrate / mineral slurry. 2. Combination in a specific sequence of the Mother Solutions: a. Mix the mixture in oil and carbohydrate / mineral slurry; b. Addition of water-soluble vitamins to the slurry; and c. Addition of ascorbic acid to the slurry. 3. Dry the combined stock solutions to give the powder premix base. 4. Dry mix the powdered premix base, with a premix of amino acids to give the elemental formula according to the present invention. Commercial Scale The clinical product used in Example 2 was produced on a commercial scale. A batch of 1,000 kg was produced using the method described above to ensure the composition of the label over the shelf life as shown in Table VII.

TABLE VII INGREDIENTS Quantity (kg) MCT oil 75,000 64,000 Soybean Oil Sunflower oil with high oleic content 89,000 Premix of soluble oil vitamin 0.338 Panodan 14,200 Sodium Citrate 7.451 Sodium Chloride 0.360 Potassium Citrate 9.258 Potassium iodide 0.0005 Magnesium Chloride 0.340 Dibasic Potassium Phosphate 7.451 Calcium Carbonate 1,702 UmTCP (Ultramicronized Tricalcium Phosphate) 1,300 Maltrina M200 530 Manganese sulfate 0.324 Chloride of hill 2,002 Sodium Molybdate 0.011 Ascorbic acid 0.584 Beta Carotene 0.269 Ascorbyl Palmitate L-Alanine 0.003 L-Asparagine Monohydrate 4.343 Glycine 0.009 L-Arginine 0.282 L-Cystine 2-HC1 5.70 L-GIutamina 19.15 L-Histidine 4.45 L-lsoleucine 11.55 L-Lysine Acetate 14.65 L-Leucina 18.70 9.65 phenylalanine L-Threonine 7.70 L-Tryptophan 3.00 L-Tyrosine 9.65 L-Valina 13.20 L-Methionine 4.30 Proline 5.70 Serina 5.70 TOTAL 1000.06 EXAMPLE 2 A clinical study of the formula of the invention was carried out at The Johns Hopkins Hospital (Baltimore, Maryland) to assess the growth, tolerance and biochemical response of children fed the formula according to the present invention as a primary feeding for four (4) months. Children, while consuming the formula of the invention, were on diets free of food allergens that were known to be sensitive. The primary indicators for evaluating the formula according to the invention were weight, height, consumption, evacuation patterns, blood biochemistry (whole blood count, serum albumin, ferritin, transtieretin, retinol binding protein, retinol, and nitrogen). urea, and plasma amino acids) and evaluation of fecal occult blood. Secondary variables included gastrointestinal symptoms. The study of non-randomized feeding was carried out with fourteen (14) children with eosinophilic gastroenteritis sensitive to proteins or sensitivity of proteins of multiple foods. Each child served as his own control. All subjects before admission to the study were subjected to double-blind, placebo-controlled food comparisons with the current formula of the children and the composition of the invention to determine if any allergic symptoms occurred. Provised medical records, growth history up to more than twelve (12) months, detailed medical and dietary histories, and records of oral confrontation results for each subject were obtained. The elemental product produced in Example 1 was provided as a powder in 350 g cans and reconstituted to meet the individual needs of each child as determined by the research dietician. The formula of the invention was given a taste with approved flavors determined by the researcher. Children were only allowed to eat those foods they could tolerate, the study formula and the flavors approved by the researcher. On Day 1 of the study, blood and stool samples were taken, and subjects were again evaluated on the dates of one (1) and four (4) months after initiation, for development, formula intake, tolerance and Blood and stool parameters (4 months only). The subjects withdrew from the study on the basis of a protocol failure or treatment failure. It was considered that a child did not comply with the protocol if he did not meet the scheduled exams, there was only automatic withdrawal by the parents, if they did not consume enough amounts of the study formula or were withdrawn by the doctor if the doctor thought it was better to children. It was considered that the children did not comply with the treatment if they were not able to consume the study formula due to intolerance or an allergic reaction to the study formula.

Careful measurements were made of weight, height and head circumference when enrolling in the study, at each visit and when leaving the study using normal techniques and equipment. The available weight and height data collected during the one-year period prior to the start of the study were used for historical comparisons.

At the four-month point, the elemental product produced in Example I provided an average of 58% of total calories per day for children, with the remainder being supplied by authorized foods (ie, tolerated foods). In general, the children maintained the growth as long as they were fed with the study formula, only one subject experienced a slight decrease in the growth regime while consuming the study formula and this could have been caused by problems at home (separation of the parents). . The children in the study often had little appetite for solid foods and weight increases would have been improved if energy consumption had been increased to meet the recommended RDA. Hematocrit hemoglobin concentrations in the study subjects were significantly improved during the study period. Other chemical compounds in the blood evaluated were generally maintained at levels similar to those at the beginning. There were insufficient data available at the time of this request to evaluate the effect of the study formula on vitamins in the serum. The data continues to be collected in this study and will be analyzed statistically. Evacuation patterns improved slightly during the study period; In fact, two children were able to train to go to the bathroom after continuing with the formula of the study due to improving their evacuations compared with their previous feeding. In conclusion, the preliminary results of the study support the formula according to the invention is a hypoallergenic formula suitable for use in the management of children with allergies to multiple food or allergic eosinophilic gastroenteritis. The children grew acceptably with the product of the invention when they were provided with most of the energy requirements. The children tolerated the study product well and its taste was found acceptable. Anecdotal comments from parents and staff there had been positive. The data continues to be collected and the statistical analyzes will be carried out until the data collection is completed. EXAMPLE 3 The hypoallergenic formula according to this invention was analyzed for protein efficiency ratio (REP), which is a measure of protein quality using laboratory rats. The REP was determined by dividing the weight gain of the animals by protein consumption. Two groups of ten rats each were fed a 28-day diet of the hypoallergenic formula and a casein-based formula using the AOAC-960.48 method, AOAC Official Methods of Analysis, 15a. Edition, 1990. Every seven days, the rats were weighed and their food consumption recorded. At the end of 28 days, the total weight gain and protein composition of the two groups was calculated. These values were used to calculate the REP. The results of this rat bioassay, shown in Table VII, indicate that the pediatric elementary diet, according to the present invention, has a significantly higher protein efficiency ratio than the conventional casin-based formula. TABLE VIII COMP. OF PEDIATRIC ELEMENTAL CASEIN Body Weights-grams Body Weights-grams Anim. Sari. Sem. Sem. Sem. Sem. Aum. Anim. Sem. Sem. Sem. Sem. Sem. Aum. No. 0 1 2 3 4 Weight No. 0 1 2 3 4 Weight 1 76 86 124 158 199 123 1 71 96 133 184 237 166 2 71 88 130 170 199 128 2 70 93 133 179 245 175 3 72 90 122 150 190 118 3 81 99 137 187 237 156 4 72 86 133 159 201 129 4 75 97 145 207 266 191 82 94 123 153 191 109 5 76 97 133 174 212 136 6 79 107 150 192 232 153 6 67 95 133 187 236 169 7 75 91 125 159 212 137 7 84 111 167 232 293 209 8 78 89 127 158 195 117 8 80 103 144 200 247 167 9 68 85 119 149 197 129 9 73 100 145 190 233 160 74 96 129 163 197 123 10 74 96 145 183 231 157 Med 75 91 128 161 201 127 Med. 75 99 141 192 244 169 DN 4.19 6.52 8.73 12.57 1227 1205 DN 5.3 5.08 10.72 17.19 22.11 20.14 COMPOSITION OF PEDIATRIC ELEMENTAL CASEIN Consumption of food-grams Consumption of food-grams Anim Sem. Sem Sem Sem Prot. Tot. Ani'm. Senri. Sem £ Sem Sem Sem. Tot.

No. 1 2 3 4 REP No. 1 2 3 4 REP 1 62 102 116 133 412 42 2.92 1 81 101 134 144 460 45 3.69 2 78 120 149 133 479 48.9 2.62 2 80 105 129 157 472 46.3 3.78 3 71 94 110 123 399 40.7 2.89 3 79 109 139 166 492 482 3.23 4 62 113 114 139 428 43.7 2.96 4 79 115 150 158 502 49.2 3.89 73 95 104 128 399 40.7 2.67 5 77 97 122 144 439 43.1 3.16 6 90 118 133 138 479 48.8 3.12 6 80 106 137 143 466 45.6 3.70 7 75 104 121 138 438 44.7 3.06 7 90 136 163 162 551 54 3.87 8 62 110 115 133 421 42.9 2.73 8 86 110 146 147 489 48 3.48 9 67 90 109 130 396 40.4 32 9 90 121 131 129 471 46.1 3.45 85 98 124 125 432 44.1 2.79 10 80 113 124 134 450 44.1 3.56 M. 73 104 119 132 428 43.7 29 M. 82.1 111 137 148 479 46.9 3.58 DN 9.74 1039 1323 5.52 30.4 3.1 0.195 DN 4.67 11.1 12.6 1223 31.74 3.11 0.253 EXAMPLE 4 Immunogenicity This experiment was carried out to evaluate the allergenic potential of the elemental medical food of this invention (produced in Example 1) compared to the three commercially available hypoallergenic nutrients. The low immunogenicity demonstrated in this experiment is highly predictable of very low allergenic activity of a nutritional product.

The three commercially available products were Neocate®, Neocate® One + and Vivonex® Pediatric. In this experiment, rabbits were hyperimmunized with the nutrient according to this invention or the commercial products mentioned above using a vigorous immunization protocol using Complete Freund's Adjuvant (CFA) with multiple injections. The enzyme-linked immunosorbent assay (ELISA) was used to measure the immune response specific to systemic antigen (IgG) in rabbits and to define the relative immunogenicity of each product. A more detailed understanding of protein immunogenicity evaluation can be obtained from a review of the following articles: 1) Cordel, et al., "Immunogenicity Evaluation of Protein Hydrolisates for Hypoalegenic Infant Formula", J. of Ped. Gastro and Nut., 13: 270-276 (1991). 2) Cordle, "Control of Food Allergies Using Protein Hydrolysates", Food Technology, Oct. 1994; and 3) Cordle et al., "Evaluation of the immunogenicity of protein hydrolyzate formulas using laboratory animal hyperimmunization", Pediatr. Allergy Immunol, 5: 14-19, (1994). The teachings of the three articles listed are incorporated herein by reference. Samples of each product were mixed with phosphate buffered saline (PBS) to result in a concentration of 5 mg of protein (amino acids) per 1.5 ml (PBS solution). The primary immunization was prepared by emulsifying 1.5 ml of the PGS product solution with 3.0 ml of CFA. The booster immunization was prepared by mixing 1.5 ml of each PBS solution with 1.5 ml of CFA. These samples were administered at a dose of 5 mg of protein equivalent for every two immunizations. The animals were put on a vegetable diet (free of milk, soy and rice) for 14 days before the primary immunization and remained on this diet during the study. Blood samples before immunization were taken from each rabbit on day 0, and then each rabbit was immunized. On day 21, a second immunization was carried out. The animals were sampled on day 35. The serum was collected and stored at -20 ° C until tested. Antibody responses were quantified by an ELISA developed for each antigen in the following manner. The ELISA plates were coated with the immunization formula at an optimum concentration (saturation). Plates were blocked with PBS containing 0.05% egg albumin and 0.1% Tween 20 to eliminate non-specific binding. The test antisera were serially diluted and added to the coated plates. Then they joined the immunogen. The addition of the enzyme substrate (tetramethylbenzidine) caused a color change that was directly proportional to the amount of bound antibody. Antibody titration was defined as the reciprocal of the dilution of serum giving an ELISA optical density of 0.3 to 450 nm 10 minutes after the addition of the enzyme substrate. Five (5) rabbits were immunized with each nutritional product. The data contained in Table IX show the average titration for each group of five rabbits and the standard deviations on day 0 and day 35. TABLE IX FORMULA OF T TIITTUULLAACTIIOONN DN MEDIA Ex. 1 0 21 12 35 199 * 83 Neocate 0 92 24 35 389 * 222 Neocate One + 0 351 111 35 56,000 27, 505 Vivonex 0 304 185 Pediatric 35 .646 * 469 DN = normal deviation * = not significantly different While the titrations of the formula according to this invention were actually lower than those of all commercial products, it can only be concluded that the elemental formula produced in Ex. I was much higher for Neocate One +. It can also be concluded that the formula according to the invention demonstrates very low immunogenicity, indicating that the product, according to the invention, will demonstrate hypoallergenic clinical performance. In addition, these data support the use of the present invention for people who are extremely sensitive to milk proteins or who react to extensively hydrolyzed protein formulas.

EXAMPLE 5 Organoleptic Test An important aspect of this invention resides in the taste of the formula made according to the invention. Most of the elementary medical foods currently available have a highly unpleasant taste and, as such, patients who use these formulas tend less to consume the necessary caloric intake and still do not comply with the therapy. The elementary medical food produced in Example 1 was tested for flavor against four commercially available formulas. The name and sample number of the product for each product evaluated is shown in Table X. TABLE X SAMPLE COMMERCIAL NAME SUPPLIER Ex. 1 Present invention Abbott Laboratories A Vivonex Pediatric Sandoz Nutrition Co. B Neocate SHS C Neocate One + SHS D Elemental 028 SHS All samples were supplied as unflavored powders and reconstituted with water as shown in Table XI.

TABLE XI SAMPLE WEIGHT POWDER WEIGHT I Ex. 1 354 g 1301 g A 194 g 594 g B 342 g 1420 g C 100 g 340 g D 200 g 674 g Fifty-one (51) volunteers were recruited to evaluate the relative acceptance of a formula according to this invention compared to the 4 commercially available medical foods. The procedure for this organoleptic evaluation consisted of a sample of the formula of the invention for each evaluator, flavoring them and then comparing the flavor of the 4 commercial formulas for the taste of the formula of the invention. Each sample was evaluated at 24 ° C and evaluated with the following scale: 9 = Extremely better than Ej.1 4 = Slightly worse than Ej.1 8 = Fairly better than Ej.1 3 = Moderately worse than Ej.1 7 = Moderately better than Ej.1 2 = Quite worse than Ej.1 6 = Slightly better than Ej.1 1 = Extremely worse than Ej.1 5 = Neither better nor worse than Ej.1 The draft data of each evaluator was collected. Means, normal deviations and p-values were calculated. The significance was determined at the 95% confidence level, according to the Turkey Criterion. The comparison of Ex. 1 was considered important if the value of p was < 0.0125, using the Bonferroni Criterion. The results of this organoleptic test were shown in Table XII. TABLE XII SAMPLE MEDIA GROUP P < or > 5 STATISTICAL A 2.63 C 0.000 B 4.16 B 0.000 C 5.08 A 0.6623 D 5.06 A 0.7433 The samples that share a letter under the heading Statistical Group are not significantly different. From the data presented in Table IX, it is evident that commercial products a and B were significantly but that Ex. I. Therefore, the formula according to this invention provides an elemental medical food having highly acceptable taste. INDUSTRIAL APPLICABILITY This invention provides a hypoallergenic / elemental product, of pleasant flavor, for the nutritional maintenance of humans suffering from protein allergies. The medical community is constantly in search of improved formulations for their patients who supply a complete diet in a pleasant taste matrix. As demonstrated in the examples, the formula according to the present invention is easily manufactured and provides acceptable growth and tolerance to the patients who consume them. The embodiments of the present invention can, of course, be carried out in other specific forms than those exhibited herein without departing from the spirit and essential features of the invention. The modalities present, therefore, should be considered in all aspects as illustrated and not restrictive.

Claims (7)

CLAIMS 1. An elementary medical food for administration to a human being comprising: a) a carbohydrate component comprising from 38 to 56% of the total caloric content of said food; b) a lipid component comprising 38 to 50% of the total caloric content of the food and wherein the lipid component is a mixture of sunflower oil with high oleic content, fractionated coconut oil, esterified glycerols and soybean oil; and c) an amino acid component comprising from 10 to 20% of the total caloric content of the food and wherein the amino acid component is essentially free of L-glutamic acid and L-aspartic acid. The elementary medical food according to claim 1, wherein the carbohydrate component comprises from 38 to 56% of the total caloric content of the food and wherein the lipid component comprises from 38 to 50% of the total caloric content of the food and wherein the amino acid component comprises from 10 to 20% of the total caloric content of the food. The elementary medical food according to claim 1, wherein the amino acid component comprises: from 2.3 to 3.2% by weight of L-histidine; from 5.9 to 8.5% by weight of L-isoleucine; from 9.5 to 14.0% by weight of L-leucine; from 6.6 to 9.7% by weight of L-valine; from 5.2 to 7.6% by weight of L-lysine; from 2.2 to 3.2% by weight of L-methionine; from 4.9 to 7.1% by weight of L-phenylalanine; from 3.8 to 5.7% by weight of L-threonine; from 1.4 to 2.2% by weight of L-tryptophan; from 3.0 to 4.2% by weight of L-alanine; from 5.3 to 7.7% by weight of L-arginine; from 8.6 to 12.4% by weight of L-asparagine monohydrate; from 1.1 to 1.9% by weight of L-cystine dihydrochloride; from 11.0 to 15.8% by weight of L-glutamine; from 2.3 to 3.2 wt% glycine; from 3.0 to 4.1% by weight of L-proline; from 3.0 to 4.2% by weight of L-serine; and from 5.0 to 7.1% by weight of L-tyrosine. 4. The elementary medical food according to claim 1, wherein the carbohydrate component consists essentially of corn syrup solids with an ED of 23 or less. 5. The elementary medical food according to claim 1 in powder form. 6. The elementary medical food according to claim 1, wherein about 4 grams of the composition is added to the water to form about 30 ml and has an osmolality of 300 to 400 mOsm / kg H2O. 7. The elementary medical food according to claim 1, wherein the lipid component comprises from 37 to 41% sunflower oil with high oleic content; from 28 to 35% fractionated coconut oil; from 24 to 30% of soybean oil and from 0.5 to 8% of esterified glycerols based on the total weight of the lipid component. 8. The elementary medical food according to claim 1, which additionally comprises at least one element selected from the group consisting of nucleosides, nucleotides, antioxidant system, natural flavor, artificial flavors, artificial sweeteners, trace minerals and major ultra trace, minerals, vitamins and m-inositol. 9. The elementary medical food according to claim 6, wherein the composition has a caloric density of about 0.68 kcalor / ml and an osmolality of 350 to 375 mOsm / kg H2O. 10. The elementary medical food according to claim 1, comprising, based on 100 kcalories of the composition: from 2.8 to 3.8 g of protein equivalent; from 4.0 to 5.6 g of fats, from 9.0 to 11.8 g of carbohydrates; from 0.4 to 0.8 g of linoleic acid; from 262 to 475 Ul of Vitamin A; from 40 to 80 IU of Vitamin D; from 2.0 to 3.5 IU of Vitamin E; from 5 to 20 mcg of Vitamin K; from 0.11 to 0.42 mg of thiamine, from 0.1 to 0.21 mg of riboflavin; from 0.09 to 0.17 mg of Vitamin B-6; from 0.40 to 1.36 mcg of vitamin B-12; from 1.6 to 3.2 mg of niacin; from 28 to 60 mcg of folic acid; from 0.40 to 1.70 mg of pantothenic acid; from 4.0 to 18.0 mcg of biotin; from 8.6 to 85 mg of Vitamin C; from 7.5 to 14.6 mg of choline; from 4.6 to 9.9 mg of inositol; from 4.0 to 18.0 mcg of biotin; from 8.6 to 85 mg of Vitamin C; from 7.5 to 14.6 mg of choline; from 4.6 to 9.9 mg of inositol; from 4.0 to 6.5 mg of L-carnitine; from 103 to 127 mg of calcium; from 76 to 103 mg of phosphorus; from 8.0 to 12.7 mg of magnesium; from

1. 6 to 2.4 mg of iron; from 1.0 to 1.7 mg of zinc; from 0.10 to 0.1 mg of manganese; from 0.11 to 0.19 mg of copper; from 6.7 to 11.8 mcg of iodine; from 2.2 to 4.7 mcg of selenium, from 2.2 to 4.7 mcg of chromium; from 2.4 to 5.5 mcg of molybdenum; from 40 to 55 mg of sodium; from 144 to 174 mg of potassium and from 55 to 85 mg of chloride. 11. The elementary medical food according to claim 5, comprising, based on 100 grams of powder: 14.3 g of protein equivalent; 22.6 g of lipids; 46.7 g of carbohydrates; 2.85 g of linoleic acid; 0.48 g of α-linolenic acid; 515 mg of calcium; 385 mg of phosphorus; 390 mcg of Vitamin; 5 mcg of Vitamin D; 6.7 mg of Vitamin E; 30 mcg of Vitamin K; 1.0 mg of thiamine, 0.50 mg of riboflavin; 0.48 mg of Vitamin B-6; 2.0 mcg of Vitamin B-12; 8.0 mg of niacin; 140 mcg of folic acid; 2.0 mg of pantothenic acid; 20 mcg of biotin; 43 mg of Vitamin C; 38 mg of choline; 24 mg of nositol; 23 mg of L-carnitine; 40 mg of magnesium; 8.4 mg of iron; 5.3 mg of zinc; 0.50 mg of manganese; 0.60 mg of copper; 34 mcg of iodine; 11 mcg of selenium; 11 mcg of chromium; 12 mcg of molybdenum; 9.35 mEq of sodium, 18.29 mEq of potassium and 8.04 mEq of chlorine. 1

2. The elementary medical food according to claim 1, wherein the carbohydrate component is corn syrup solids with an ED of 23 or less; said lipid component comprises from 35 to 41% by weight of sunflower oil with high oleic content, from 28 to 35% by weight of fractionated coconut oil, from 24 to 30% by weight of soybean oil and from 0.5 to 8 Weight% of diacetylartaric acid esters of monoglycerides; and said amino acid component comprises L-asparagine monohydrate and L-glutamine. 1

3. A method for providing nutritional support to a human being suffering from food protein allergens, said method comprising the enteral administration of an elementary medical food comprising: a) a carbohydrate component comprising from 38 to 56% of the caloric content total of said food; b) a lipid component comprising 38 to 50% of the total caloric content of the food and wherein the lipid component is a mixture of sunflower oil with high oleic content, fractionated coconut oil, esterified glycerols and soybean oil; and c) an amino acid component comprising 10 to 20% of the total caloric content of the food and wherein the amino acid component is essentially free of L-glutamic acid and L-aspartic acid. The method according to claim 13, wherein the gastrointestinal condition is selected from the group consisting of eosinophilic gastroenteritis, short bowel syndrome, gastroenteritis, inflammatory bowel disease, uncontrollable diarrhea and gastroesophageal reflux. 15. The method according to claim 13, wherein the medical food comprises, based on 100 kcalories of the composition: from 2.8 to 3.8 g of protein equivalent; from 4.0 to 5.6 g of fats, from 9.0 to 11.8 g of carbohydrates; from 0.4 to 0.8 g of linoleic acid; from 262 to 475 Ul of Vitamin A; from 40 to 80 IU of Vitamin D; from 2.0 to 3.5 IU of Vitamin E; from 5 to 20 mcg of Vitamin K; from 0.11 to 0.42 mg of thiamine, from 0.1 to 0.21 mg of riboflavin; from 0.09 to 0.17 mg of Vitamin B-6; from 0.40 to 1.36 mcg of vitamin B-12; from 1.6 to 3.2 mg of niacin; from 28 to 60 mcg of folic acid; from 0.40 to 1.70 mg of pantothenic acid; from 4.0 to 18.0 mcg of biotin; from 8.6 to 85 mg of Vitamin C; from 7.5 to 14.6 mg of choline; from 4.6 to 9.9 mg of inositol; from 4.0 to 18.0 mcg of biotin; from 8.6 to 85 mg of Vitamin C; from 7.5 to 14.6 mg of choline; from 4.6 to 9.9 mg of inositol; from 4.0 to 6.5 mg of L-carnitine; from 103 to 127 mg of calcium; from 76 to 103 mg of phosphorus; from 8.0 to 12.7 mg of magnesium; from 1.6 to 2.4 mg of iron; from 1.0 to 1.7 mg of zinc; from 0.10 to 0.1 mg of manganese; from 0.11 to 0.19 mg of copper; from 6.7 to 11.8 mcg of iodine; from 2.2 to 4.7 mcg of selenium, from 2.2 to 4.7 mcg of chromium; from 2.4 to 5.5 mcg of molybdenum; from 40 to 55 mg of sodium; from 144 to 174 mg of potassium and from 55 to 85 mg of chloride. 16. A method for the nutritional support of a human being suffering from a malaise selected from the group consisting of severe food allergies, short bowel syndrome, cystic fibrosis, pancreatic disease, gastroenteritis, inflammatory bowel disease, uncontrollable diarrhea, malnutrition, poor protein digestion, necrotizing enterocolitis, infectious diseases, hypermetabolism, trauma, eosinophilic gastroenteritis and gastroesophageal reflux; said method comprising administering to said human being a formula comprising: a) a carbohydrate component comprising from 38 to 56% of the total caloric content of said food; b) a lipid component comprising 38 to 50% of the total caloric content of the food and wherein the lipid component is a mixture of sunflower oil with high oleic content, fractionated coconut oil, esterified glycerols and soybean oil; and c) an amino acid component comprising 10 to 20% of the total caloric content of the food and wherein the amino acid component is essentially free of L-glutamic acid and L-aspartic acid. 17. A hypoallergenic medical food comprising: a) a carbohydrate component comprising 38 to 56% of the total caloric content of said food; b) a lipid component comprising 38 to 50% of the total caloric content of the food and wherein the lipid component is a mixture of sunflower oil with high oleic content, fractionated coconut oil, esterified glycerols and soybean oil; and c) an amino acid component comprising from 10 to 20% of the total caloric content of the food and wherein the amino acid component is essentially free of L-glutamic acid and L-aspartic acid.