CA2212907A1

CA2212907A1 - Low ph antimicrobial food composition

Info

Publication number: CA2212907A1
Application number: CA002212907A
Authority: CA
Inventors: Woodrow C. Monte
Original assignee: Individual
Current assignee: BOATWRIGHT DOYLE W
Priority date: 1995-02-13
Filing date: 1995-02-13
Publication date: 1996-08-22

Abstract

A nutritionally balanced water soluble powdered food composition which, when mixed with water, has a low pH, extended shelf life, high antimicrobial activity, and which includes protein alpha-amino acids in solution or in suspension. The food composition utilizes a binary stabilizer system.

Description

WO96/2~Q54 PCT~US9~/02~26 LOW PH ANTIMICROBIAL FOOD COMPOSITION
This invention relates to nutritionally balanced food compositions for ingestion along the digestive tract of a patient.
More particularly, the invention relates to nutritionally balanced liquid food compositions which have a low pH, extended shelf life, high antimicrobial activity, and which include protein in solution or in suspension.
In a further respect, the invention relates to a liquid food composition including a low pH protein stabilizer system which, when the food composition is heated to a high temperature to be sterilJlzed, maintains its homogeneity.
In another respect, the invention relates to a liquid food composition which includes a low pH protein stabilizer system and exhibits unusually low aerobic and anaerobic bacterial activity for long periods of time at room temperature.
Liquid nutritionally balanced food compositions are known in the art. See, for example, my U. S. Patent No. 4,931,300 for "ANTIMICROBIAL FOOD COMPOSITION".
Liquid nutritionally balanced powdered food compositions like those described in my U. S. Patent No.
4,931,300 have several potential disadvantages. Protein tends to precipitate from liquid solutions which, like the food composition in U. S. Patent No. 4,931,300, have acidic pH values in the range of 2.0 to 5.5. In particular, protein tends to precipitate from such liquid solutions when the solutions are heated to a high temperature to sterilize the solutions. Solutions with low pH values in the range of 2.0 to 5.5 are, however, often preferred because the acidity of the solutions normally provides a high level of W 096t250~4 PCTnUS95/02026 antimicrobial activity. Food compositions like the compositions disclosed in U. S. Patent No. 4,931,300 are an exception and do not provide a high degree of antimicrobial activity. This is evidenced by the fact that the food composition in my U. S. Patent No. 4,931,300 must be refrigerated after it is reconstituted and must then be utilized within about seventy-two hours. Even though the seventy-two hour shelf life of the reconstituted food composition is relatively short, it is still substantially longer than the shelf life of other comparable food compositions. See, for example, U. S. Patent No. 4,112,123 to Roberts, where the shelf life of a comparable reconstituted refrigerated food composition is only about twenty-four hours. Another problem associated with acidic aqueous food compositions of the type described in U. S.
Patent Nos. 4,112,123 and 4,931,300 i8 that identifying an appropriate stAh;l; zer for the food composition is difficult. The stabilizer must be able to act quickly when the food composition is reconstituted as a drink, must not produce a composition which has excessive viscosity, must have an extended shelf life, and must be able to resist degradation due to the acidic nature of the food composition.
Accordingly, it would be highly desirable to provide a liquid food composition which would produce a low viscosity solution which has a pH in the range of about 2.0 to 6.5, has a high antimicrobial activity, has an extended shelf life at room temperature, and which prevents protein from precipitating or settling from solution when the solution is sterilized at high temperature.
Therefore, it is a principal object of the invention to provide an improved food composition.
Another object of the invention is to provide a low pH liquid food composition which includes alpha-amino acids or other protein and which generally prevents protein from precipitating or separating from the liquid food composition.
A further ob~ect of the invention is to provide a , W O 96125054 P ~Vb~ -026 nutritionally balanced li~uid food composition which includes a low pH protein stabilizer system which has a high antim;crobial activity and has an extended shelf life at room temperature.
These and other, further and more specific objects and advantages of the invention will be apparent to those skilled in the art from the following detailed description thereof.
Briefly, I have discovered a food powder composition which has a high ant;~;c~obial activity and extended shelf life. The food composition includes from 6%
to 28% by weight of a water soluble protein; from 4 to 22~
by weight of triglycerides of predom;n~ntly 6 to 26 carbon atoms in the fatty acid chain; from 35% to 78~ by weight of carbohydrates selected from the group consisting of corn syrup solids, trisaccharides, tetrasaccharides, pentasaccharides, hexasaccharides, dextrose, fructose, sucrose, maltose, oligosaccharides and high saccharides;
from 0.01% to 10.0% by weight of an emulsifier; from 0.1% to 8~ by weight of an edible acid; from 0.01% to 6% by weight of an antimicrobial agent selected from the group consisting of sorbic acid, benzoic acid, sodium benzoate, potassium sorbate, sodium sorbate, and potassium benzoate; and, from 0.1% to 20.0%, preferably 0.2% to 5.0% by weight of pectin.
The food composition provides up to about three calories per cubic centimeter of composition. On being reconstituted with water, the composition forms a liquid solution which has an osmolarity of 250 to 650. The pH of the reconstituted food composition is from 2.0 to 6.5, preferably 3.0 to about 5.7.
The water soluble protein is preferably whey protein or any other acid stable protein or peptide. The water soluble protein forms a sol in water. A sol is a fluid colloidal system, i.e., a dispersion of solid particles in a liquid colloidal solution.
The water soluble protein can be a whole protein or can be a partially hydrolized protein such as a protein alpha-P~;no acid. For purposes of the present specification, the term protein alpha-amino acids is defined W 096/25054 PCTrUS95/02026 to include any one or more of (a) monopeptides, dipeptides, tripeptides, and/or oligopeptides prepared by the partial hydrolysis of naturally occurring proteins or of artificially produced proteins, (b) monopeptides, dipeptides, tripeptides, and oligopeptides prepared by synthesis and comparable to such peptides prepared by the partial hydrolysis of natural or artificially produced proteins, and (c) whey protein. Whey protein and other naturally occurring proteins are presently preferred in the practice of the invention because of their ready availability and because they typically produce drinks which taste good. Protein alpha-amino acids do not include amino acids which are not 1 ;nke~ or bonded to at least one other ~;no acid. In addition to or in place of protein, amino acids can be utilized in the food composition of the invention which are separate from one another and are not bonded or l; nke~ together to form protein.
Peptide alpha-amino acids help in reducing the pH
of the food composition, and consequently, in reducing the quantity of ac; ~nl ~nt required in preparing the food composition. A peptide is any of a class of amides that are derived from two or more amino acids by combination of the amino group of one acid with carboxyl group of another, that yield these acids on hydrolysis, that are classified according to the number of component amino acids, and that are obtained by partial hydrolysis of naturally occurring or artificially produced proteins or by synthesis (as from alpha-amino acids or their derivatives). A dipeptide is a peptide that yields two molecules of amino acid on hydrolysis. A polypeptide is a polyamide that yields amino acids on hydrolysis but has a lower molecular weight than a protein and that is obtained by partial hydrolysis of proteins or by synthesis. Peptides are easier to digest than whey and other proteins.
Peptides are prepared from hydrolyzing proteins of any kind, and are commonly prepared by hydrolyzing egg, milk, or soy. The proteins in egg, milk, and soy are examples of naturally occurring proteins.

W096t2~054 PCTrUS95102026 For purposes of the present specification, the term "whey protein" is defined to mean that water soluble or suspendible, essentially lln~en~tured protein fraction derived from cheese whey which protein fraction is, essentially, retained by an ultra-filtration membrane that permits lactose, lactic acid, and soluble salts to pass through the membrane. Whey protein is a naturally occurring protein and is specific and identifiable in terms of its composition and is not necessarily dependant upon a process for production thereof. Whey protein may be obtained by methods other than ultra-filtration, e.g., gel filtration.
The amount of protein alpha-amino acids or other water soluble proteins used in the present powder food composition may vary widely, but for most applications from 4% to 22% on a dry weight basis is suitable, especially between about 15% and 20%.
The protein alpha-amino acids are essentially water soluble or suspendible, and capa~le of being compounded for formulated into stable and pourable form in order to function in the manner required. Further, it is the protein alpha-amino fraction contA;n;ng one or more of the twenty alpha-amino acids, most of which have the general formula RCH (NH2) COOH, that are synthesized in plant and ~n;~l tissues, that are considered the building blocks of 2S proteins, from which they can be obtained by hydrolysis, and that play an important role in metabolism, growth, maintenance and repair of tissue.
Table 1 in U. S. Patent No. 4,112,123 to Roberts shows a typical ~;no acid profile for whey protein used in the present invention.
The alpha-amino acid proteins or whole protein utilized in the practice of the invention are in the form of amino acids each of which is bonded to one or more other , amino acids. Such alpha-amino acids are typically natural proteins, but can be "directly" produced by synthesis. As used herein, natural protein is whole protein found in a plant or is protein produced by hydrolyzing one a whole protein which is found in a plant.

W 096/25054 PCTrUS95/02026 Me~ m-chain triglycerides (MCT's) utilized in the food composition of the invention produce a composition of low viscosity while concomitantly providing high caloric content and easily digestible compositions. The fatty acid ch~;ns of medium-chain triglycerides are predqm;n~ntly between about 6 and 12 carbon atoms, and are preferably utilized in conjunction with long-chain triglycerides (LCT's) in which fatty acid chA;n~ are pr~Ao~;nAtely between about 14 to 26 carbon atoms.
The proportion of LCT's and MCT's in the powder food composition can vary widely, but typically is about 4%
to 22% by weight, with 12~ to 18% being an optimal range.
Any food grade emulsifier is used for present emulsification purposes and combinations for emulsifiers are used if desired. Any of the long fatty acid glycerol emulsifiers can be used, which normally have a C-12 to C-20 esterified chain. Typical among these are glycerol-lactopalmitate or the stearate. Alternately, the propylene derived emulsifiers may be used, such as propylene glycomonosterate, or the oleate, palmitate, and myristate.
Likewise, the "Span" series of emulsifiers may be used.
These are well-known emulsifiers and are fatty acid partial esters of the sorbitol anhydrides (or sorbitan). One well known emulsifier is the "Tween" series of polyoxyethylene derivatives of fatty acid partial esters of sorbitol anhydride. Tween 80 and Atmos 300 are often used in combination. The well known Atmos series of mono and diglycerides may be used. Also, lecithin is a suitable emulsifier. The amount of the emulsifier is chosen to suit the particular powder food composition, and generally ranges from about 0.01% to 10% by weight.
The powder food composition contains from 35~ to 78~ by weight of carbohydrates. The carbohydrates may be any of the digestible carbohydrates such as dextrose, fructose, sucrose, maltose, oligosaccharides, high saccharides, or mixtures thereof, depending on usage.
vit;~m; nS~ minerals, and other trace elements can be used to supplement the food composition and for purposes W 096~25054 ~CTnUS9~J02D26 of total nutritional hAl~nce. These supplements can be varied as desired by are typ;c~lly equal to the RDA or greater based on 2,000 calories. Soy bran, rice bran, or other fiber polys~h~-ides or sources of fiber can be included in the food composition.
The powdered food composition includes 0.1% to 20%, preferably 0.2% to 5.0%, by weight of a complex carbohydrate stabilizer selected from the group consisting of complex carbohydrates and carbohydrate derivatives which function to prevent the precipitation of protein when a food drink composition form~ ted in accordance with the invention is sterilized to kill all microorg~n; ~mC in the food drink composition. The complex carbohydrates and carbohydrate derivatives are typically of plant origin and function as a stabilizer which prevents the coagulation, clustering, and precipitation of protein in high temperature acidic conditions. Complex colloidal carbohydrate derivatives are presently preferred and comprise pectic substances cont~;n;ng a large proportion of units (in excess of 50~ by weight of the pectic substance~ derived from galacturonic acid and subdivided into protopectins, pectins, pectinic acids, and pectic acids. The presently preferred pectic substance is pectin.
Conventional coloring agents, such as the FDA
colors, may be used, as well as conventional preservatives, such as BHT and BHA. BHT and BHA preserve fats.
The food composition is provided in a powdered form having a relatively low moisture content. The moisture content is, as is the case for many powdered formulations, preferably at least below 4% by weight and more preferably below 3~ by weight. Such low moisture content provides a product having a shelf life of at least one year shelf stability at ambient conditions if hermetically sealed.
The powdered form of the food composition may be reconstituted with a liquid. The liquid form of the food composition of the invention need not be pasteurized or stored under refrigerated conditions. However, in one preferred form of the invention, the liquid form is W O 96/25054 PCTrUS95/02026 sterilized at a temperature of a least 200 degrees Fahrenheit. During this sterilization process, a novel low pH protein stabilizer system comprised of a pectic substance and methylcellulose prevents the precipitation of protein from the liquid at high temperatures. This stabilizer system is described in detail later herein.
The dried powder is reconstituted with any desired edible liquid. The powder is ordinarily partially dissolved and partially suspended in the resulting liquid form of the invention. While it is possible to reconstitute the composition with liquid such as alcohol, the reconstituting liquid will ordinarily be principally water. The water may contain additional ingredients such as alcohol, glycerol, propylene glycol, sugars and flavor.
The caloric content of the liquid solutions of the reconstituted food composition of the invention is adjusted to any desired level up to about 3 calories per cubic centimeter. One half to two calories per cubic centimeter is preferred.
The osmolarity of the reconstituted food composition is in the range of 250 to 650, but preferably is in the range of 275 to 350 mOSm per liter of 1 calorie per cubic centimeter food.
The powder food compositions also include 0.1% to 8% by weight edible acidulants such as malic acid, acetic acid, citric acid, lactic, acid, sodium acetate, fumaric acid, or an acidic salt such as sodium acetate in order to adjust the pH within the range of 2 to 6.5, preferably about 3 to 5.7. This pH is critical to the extended shelf life of the invention. Any pH in excess of about 6.5 is not preferred because such allows greater microbial activity and m; n;m; zes the antimicrobial effects of sorbates and benzoates utilized in the invention. A pH greater than 6.5 is totally unacceptable because of the greatly reduced antimicrobial activity of the sorbates and benzoates critical to the invention.
The antimicrobial activity of sorbic and benzoic acid is due primarily to the undissociated acid molecule.

W 096125054 ~CT~u~S5~026 Antimicrobial activity is therefore pH dep~n~ent and the estimated activity at any pH can be estimated as shown below in Table 1.

EFFECT OF pH ON DISSOCIATION
Percent Undissociated Acid PH Sorbic Benzoic 6 6 1.5 7 0.6 0.15 The food composition includes 0.01~ to 6~ by weight of a sorbate or ~enzoate such as sorbic acid, benzoic acid, potassium sorbate, sodium sorbate, potassium benzoate, sodium benzoate, and the like. Such benzoates and sorbates a.e cruci~l because at low p~ values in the range of 2 tG
6.5 they provide significant antimicrobial activity.
A novel low pH protein stabilizer system is utilized in the food composition of the invention. Various conventional protein stabilizer systems will not function properly at the high temperatures used to sterilize the reconstituted food composition and permit the protein to precipitate out of the reconstituted composition. I have discovered a novel low pH protein stabilizer system which effectively stabilizes the protein in the reconstituted food composition of the invention at high temperature. The low pH protein stabilizer food composition of the invention also appears to produce an interactive synergistic effect which causes the bacteria count in the reconstituted food composition to be low when the food composition is permitted to set exposed to the air at room temperature.
The low pH protein stabilizer system in the powder form of the invention includes, as described above, from 4%
to 22~ on a dry weight basis whey protein or other protein alpha-amino acid and from 0.1~ to 20.0~, preferably 0.2% to 5.0%, by dry weight of pectin or another pectic substance.

W 096/25054 PCTrUS95/02026 In addition, .001% to 10.0%, preferably 0.01~ to 4.0%, by weight of sodium carboxymethylcellulose or another methylcellulose is preferably, but not necessarily, utilized with the pectic substance because the carboxymethylcellulose and pectic substance synergistically interact to effectively st~h;l; ~e the aqueous food composition which results when the powder form is reconstituted with water. Utilizing whey protein in the food composition without pectin, with or without carboxymethylcellulose, is not acceptable because the food composition, when reconstituted, does not exhibit the ability to prevent the whey protein from precipitating out of the reconstituted solution at high sterilization temperatures. When, however, whey protein is utilized in combination with pectin and sodium carboxymethylcellulose a reconstituted food composition results which is unusually stable at high temperature and resistant to the growth of aerobic and anaerobic bacteria. Samples of the reconstituted food composition of the invention have been left exposed to the air for ten days and with the detection of fewer than 10 to 20 aerobic bacteria per millimeter of reconstituted food composition. The growth of so few bacteria is highly unusual. Further, when bacteria were ~~ cd" into the reconstituted food composition, the number of such bacteria gradually decreased over time until living bacteria no longer existed.
After the dried powder food composition of the invention is reconstituted it has an extended shelf life at room temperature of several days or more. The ratio of water to composition will vary with the proportion of the ingredients of the composition and with the desired consistency required, as discussed above. By way of example, on a weight/weight basis of composition to water, the dilutions on a 100 gram basis can be:

W O 96125054 PCTnUS90~2D26 To make 100 gramsApproxLmate Calories/ml. solution Viscosity of solutionqms powder*/gms water (centipoises) 0.5 18/82 <100 1.5 32/68 250

2 40/50 500 *Powder of Example 1 below The following examples depict the presently preferred embodiments of the invention for the purposes of illustrating the practice thereof and not by way of limitation of the scope of the invention. In the examples, all proportions are by weight, unless otherwise noted.

The food composition in powder form was prepared by blending a number of ingredients.
Component Pounds SUGAR 1592.000 WHEY PROTEIN CONC., (~Ok~l~IN 35) (1) 660.700 20 CALCIUM LACTATE, PENTAHYDRATE (4)76.100 NON DAIRY C~M~ (CREATIVE CREAMER 829) (2) 54.300 MALTODEXTRIN, M100 (POLYSACCHARIDES) 51.000 CITRIC ACID 43.500 SODIUM CARBOXY~l~YI~C~TTULOSE (3)10.000 25 PECTIN-CITRIC 35.000 EMULSIFIER (BEATREME 358lZ) (2)5.200 SODIUM CITRATE 4.300 BETA CAROTENE, 1% DILUTION CWS 4.300 BIOTIN 0.005 30 CALCIUM PAN~l~O~l~H~ATE 0.180 FERRIC ORTHOPHOSPHATE, DIHYDRATE0.900 FOLIC ACID 0.007 MANGANESE SULFATE, MONOHYDRATE 0.100 NIACTNAMTDE 0.316 35 POTASSIUM SORBATE 4.544 SELENIUM YEAST CONCENTRATE 0.900 VITAMIN B-l MONONITRATE 0.025 VITAMIN B-12 1% DILUTION 0.010 VITAMIN B-2 TYPE S 0.028 W 096125054 PCTrUS95/02026 VITAMIN B--6 HCL 0.040 ~ITAMIN C 3.190 VITAMIN D3, 100 S.D. 0.100 VITAMIN E 50% S.D. 0.990 ZINC SULFATE, MONOHYDRATE 0.700 FLAVOR (Q.S.) 13.000 TOTAL 2561.435 (1) Wisconsin Dairies, Foremost Ingredients Group, Box 111, Baraboo, Wisconsin 53913-0111; (608) 356-8316.
(2) Beatreme Foods, 352 East Grand Avenue, Beloit, Wisconsin 53511; (800) 328-7517.

(3) Aqualon Company, Little Falls Centre One, 2711 Centerville Road, Wilmington, Delaware 19850; (800) 345-8104.

(4) Gallard-Schlesinger Industries, 584 Mineola Avenue, Carle Place, New York 11514; (516) 333-5600.
The approximate percent calories from the various ingredients are carbohydrates 50.0%, fat 10.0%, and protein 40.0~. The carbohydrates included in the powder food composition include sucrose, dextrose, maltose, lactose, trisaccharides, tetrasaccharides, pentasaccharides, hexasaccharides, and higher saccharides. When 25 gm of the food powder composition is reconstituted with 75 gm of water the resulting mixture has a caloric density (Cal/ml) of about 1.0; and, a total Cal/Nitrogen ratio of about 160.
During the blending of the above-listed ingredients of the food composition, agglomeration techniques are preferably employed to make the resulting powder mixture more easily dispersed and soluble in water.

The 2561.435 pounds of the food composition powder of Example 1 is mixed with 6538.000 pounds of water. The resulting drink provides 1.1 calories per cubic centimeter, has a pH of about 4.7, has an osmolarity of 300, has a viscosity of about 90 to 100 centipoise, and has particles each having a size of less than about 100 mesh.

PCrlUS9~1û2r~26 One thousand grams of a food composition in powde_ form is prepared by blending the following ingredients in the proportions noted.
lN~K~vIENT WEI&HT PERCENT
Dry WHEY PROTEIN CONCENTRATE 13.35 ~OK~l~IN 35 (protein alpha-amino acids) CALCIUM LACTATE, PENTAHYDRATE 3.67 CREATIVE CREAMER 829 (fat emulsifier) 5.5 MALTODEXTRIN, M100 (agglomerated) 58.03 CITRIC ACID 2.2 EMULSIFIER, BEATREME 3581Z (fat emulsifier) .22 SODIUM CITRATE .21 VITAMIN PREMIX .22 (vitAm;ns A, D, C, K, etc.) MAGNESIUM OXIDE .18 POTASSIUM SORBATE .46 PECTIN 10.00 WATER .46 100 . 00 The approximate percent calories from the various ingredients are carbohydrates 50%, fat 10%, and protein 40%.
The car~ohydrates included in the powder food composition include sucrose, dextrose, maltose, lactose, trisaccharides, tetrasaccharides, pentasAcchArides, hexasaccharides, and higher saccharides. When 25 gm of the food powder composition is reconstituted with 75 gm of water the resulting mixture has a caloric density (Cal/ml) of about 1.

Two hundred and thirty-seven grams of food composition powder of EXAMPLE 3 is m; ~e~ at 76 degrees F
with 832 m; 1 1; 1; ters of sterile distilled water at 5:00 pm on May 11, 1992. The resulting drink provides about 1 calorie per cubic centimeter, has a pH of about 4.6, has an osmolarity of about 300, has a viscosity of a~out 90 to 100 centipoise, has a total acidity of about 5.85, and has W 096125054 PCT~US9S/02026 particulate each having a size of less than about 100 mesh.
Total acidity equals the milliliters of a one MOL ~aOH
a~ueous solution required to neutralize the acid pH of one liter of the resulting drink. The acid pH of the drink is neutralized when a pH of 7 is obtained while titrating the drink with a one MOL NaOH a~ueous solution. The total acidity of the drink of the invention is increased by utilizing a buffer system which resists any change in the pH
of the drink. In particular, the sodium citrate and citric acid found in the compositions of Examples 1 and 3 increase the total acidity of the compositions. While any desired buffer system can be utilized in the practice of the invention, sodium citrate, citric acid, and/or sodium salts are, by way of example and not limitation, presently preferred. In the practice of the invention the total acidity of the resulting drink is greater than four, preferably is greater than five, and under the most preferred conditions is greater than 5.4. The pH of the resulting drink is equal to or less than about 4.9, is preferably equal to or less than about 4.75, and under the most preferred conditions is less than about 4.5. The combination of a low pH and high total acidity has been found important in providing a drink which has a high antimicrobial capacity. Other comparable prior art compositions do not utilize the pH--total acidity combination of the invention. For example the PRECISION LR
DIET (Trademark) composition marketed by Sandoz has a pH of about 6.8 and a total acidity of about 3.6; the TOLEREX
(Trademark) composition marketed by Norwich-Eaton has a pH
of about 5.5 and a total acidity of about 3.2; the VITAL
HIGH NITROGEN (Trademark) composition marketed by Ross Laboratories has a pH of about 6.7 and a total acidity of about 3.2; and, the VlVON~X (Trademark) composition marketed by Norwich Eaton has a pH of about 5.3 and a total acidity of about 5.1.

One thousand grams of the powder of EXAMPLE 3 is prepared by mixing the ingredients in the proportions noted, W 09612S054 PCTnUS5_J~2n26 ~ 15 ~
except 0.23 grams of potassium sorbate is substituted for the 0.46 grams of potassium sorbate.

Two hundred and thirty seven grams of the food composition powder of EXAMPLE 5 is mixed at 76 degrees F
with 832 milliliters of sterile distilled water at 5:00 pm on May 11, 1992. The resulting drink provides about 1 calorie per cubic centimeter, has a pH of about 4.6, has an osmolarity of about 300, has a viscosity of about 90 to 100 centipoises, has a total acidity of about 5.85/ and has particles of food composition each having a size of less than about 100 mesh.

As soon as the drink (suspension) of EXA~P~E 4 is produced, i.e., as soon as the rehydration of the powder is performed, a plate count is performed to determine the presence of aerobic and anaerobic bacteria. The plate count is performed by transferring one mi 1~; 1 ;ter of the drink to a 10 milliliter enriched Thio. The Thio is incubated at 35~C
for four days to culture for anaerobes. The Thio is then ~m; ned to determine the existence of aerobic and anaerobic bacteria. The forgoing plate count procedure is carried out in accordance with the FDA Bacteriological Analytical Manual, 4th Edition, 1984, Chapter 4, and with the ASM
M~nll~l of Clinical Microbiology, 4th Edition, 1985.
The drink of EXAMPLE 4 is stored at room temperature exposed to the air. A plate count is initiated at 5:00 pm each day for ten consecutive days. As shown below in TABLE II, in each plate count less than ten aerobic microorg~n;~m~ (bacteria) per grams are detected. No anaerobic bacteria are detected during any of the plate counts.
TABLE II
PLATE COUNT RESULTS SHOWING ABSENCE OF
AEROBIC BACTERIA IN SUSPENSION
PLATE COUNT AEROBIC ORGANISMS
FOR DAY NO. DESCRIPTION PER MTTTTTTTER
1 Rehydration, 5:00pm <10 CA 022l2907 l997-08-l2 W O 96/25054 PCTrUS95/02026 2 1 day, 5:00pm <10 3 2 days, 5:00pm <10 4 3 days, 5:00pm <10

5 4 days, 5:00pm <10 5 6 5 days, 5:00pm <10 7 6 days, 5:00pm <10 8 7 days, 5:00pm <10 9 8 days, 5:00pm <10 10 9 days, 5:00pm <10 101110 days, 5:00pm <10 As soon as the drink (suspension) of EXAMPLE 6 is produced, i.e., as soon as the rehydration of the powder is 15 performed, a plate count is performed to determine the presence of aerobic and anaerobic bacteria. The plate count is performed by transferring one milliliter of the drink to a 10 m; 11; 1 ;ter enriched Thio. The Thio is incubated at 35~C
for four days to culture for anaerobes. The Thio is then 20 ~Am;ned to determine the existence of aerobic and anaerobic bacteria. The foregoing plate count procedure is carried out in accordance with the FDA Bacteriological Analytical Manual, 4th Edition, 1984, Chapter 4, and with the ASM
Manual of Clinical Microbiology, 4th Edition, 1985.
The drink of EXAMPLE 6 is stored at room temperature. A plate count is initiated at 5:00pm each day for ten consecutive days. As shown below in TABLE III, in each plate count twenty or less aerobic organisms per gram are detected.
TABLE III
PLATE COUNT RESULTS SHOWING ABSENCE OF
AEROBIC BACTERIA IN S~S~NSION
PLATE COUNT AEROBIC ORGANISMS
FOR DAY NO.DESCRIPTION PER MTTTTTTTER
351Rehydration, 5:00pm 20 2 1 day, 5:00pm <10 3 2 days, 5:00pm <10 4 3 days, 5:00pm <10 CA 022l2907 l997-08-l2 W 096/25054 . ~CTnUSg5J02026 ~ 17 ~

4 days, 5:00pm <10

6 5 days, 5:00pm <10

7 6 days, 5:00pm <10

8 7 days, 5:00pm <10 5 9 8 days, 5:00pm <10

9 days, 5:00pm <10 11 10 days, 5:00pm <10 EX~MPLE 9 Two hundred and thirty seven grams of the food composition powder of EXAMPLE 3 was mixed with 832 m;~l;l; ters of sterile distilled water in a beaker to form a homogenous solution. The solution had a viscosity of about 250 centipoises, The size of food composition particles in suspension in the solution was less than 100 mesh. The solution was allowed to stand for ten days at room temperature. At the end of the ten day period, the solution was still substantially homogeneous and particulate had not settled or separated out of solution form layers of material at the bottom of the beaker.
EX~MPLE lO

Two hundred and thirty seven grams of the food composition powder of EXAMPLE 5 was m;~re~ with 832 milliliters of sterile distilled water in a beaker to form a homogeneous solution. The solution has a viscosity of about 250 centipoises. The size of the food composition particles in suspension in the solution was less than or equal to 100 mesh. The solution was allowed to stand for ten days at room temperature. At the end of the ten day period, the solution was still substantially homogeneous and particulate had not settled or separated out of solution to form layers of material at the bottom of the beaker.
EX~MPLE 11 One thousand grams of the powder of EXA~IPLE 3 is prepared by m;~;ng the ingredients in the proportions noted, except that 8.0 grams of Maltodextrin, M100 and 2.0 grams of whey protein concentrate foretein 35 are utilized in place of the ten grams of pectin.

CA 022l2907 l997-08-l2 W 096125054 PCTrUS95/02026 Two hundred and thirty seven grams of the food composition powder of EXAMPLE 11 is mi ~e~ with 832 milliliters of sterile distilled water in a beaker to form a homogeneous solution. The solution has a viscosity of about 250 centipoises. The size of the food composition particles in suspension in the solution is less than or equal to 100 mesh. The solution is allowed to stand at room temperature. In less than six hours particulate begin settling and separating out of the solution to form a layer of material at the bottom of the beaker.

One thousand grams of the powder of EXAMPLE 3 is prepared by mixing the ingredients in the proportions noted, except that 8.0 grams of Maltodextrin, M100 and 2.0 grams of whey protein concentrate FORETEIN 35 are utilized in place of the ten grams of pectin.

Two hundred and thirty seven grams of food composition powder of EXAMPLE 13 is mixed with 832 mi 11; 1 iters of sterile distilled water in a beaker to form a homogeneous solution. The solution has a viscosity of about 250 centipoises. The size of food composition particles in suspension in the solution is less than or equal to 100 mesh. The solution is heated to and rem~; ns at the temperature of 220 degrees Fahrenheit for five (5) minutes. After the solution had been heated for two minutes, precipitate begins to form and fall to the bottom of the beaker. The precipitate contains whey protein.

Two hundred and thirty seven grams of food composition powder of EXAMPLE 3 is mixed with 832 milliliters of sterile distilled water in a beaker to form a homogeneous solution. The solution has a viscosity of about 250 centipoises. The size of food composition particles in suspension in the solution is less than or equal to 100 mesh. The solution is heated to and r~m~; n~ at the temperature of 220 degrees Fahrenheit for five (5) W 096125054 PCT/Ub5~J~2026 minutes. Precipitate does not form during the time the solution is heated.

Two hundred and thirty seven grams of food composition powder of EXAMPLE 1 is ~;~ with 832 milliliters of sterile distilled water in a beaker to form a homogeneous solution. The solution has a viscosity of about 250 centipoises. The size of food composition particles in suspension in the solution is less than or equal to 100 mesh. The solution is heated to the temperature of 285 degrees Fahrenheit for ten (10) seconds. Precipitate does not form during the time the solution is heated.

Two hundred and thirty seven grams of food composition powder of EXAMPLE 13 is mixed with 832 m;~ ;ters of sterile distilled water in a beaker to form a homogeneous solution. The solution has a viscosity of about 250 centipoises. The size of food composition particles in suspension in the solution is less than or equal to 100 mesh. The solution is heated to and r~m~;n~ at the temperature of 300 degrees Fahrenheit for four (4) seconds. After the solution had been heated for one (1) minutes, precipitate begins to form and fall to the bottom of the beaker. The precipitate contains whey protein.

One thousand grams of the powder of EXAMPLE 1 is prepared by m;~;ng the ingredients in the proportions noted, except that 1.0 gram of Maltodextrin (Polysaccharides) is utilized in place of the one gram of pectin.

Two hundred and thirty seven grams of food composition powder of EXAMPLE 18 i5 mixed with 832 m;ll;l;ters of sterile distilled water in a beaker to form a homogeneous solution. The solution has a viscosity of about 250 centipoises. The size of food composition particles in suspension in the solution is less than or equal to 100 mesh. The solution is heated to and r~m~;ns at the temperature of 300 degrees Fahrenheit for four (4) W O 96t25054 PCTrUS95/02026 seconds. After the solution had been heated for one (1) minute, precipitate begins to form and fall to the bottom of the beaker. The precipitate contains whey protein.

Two hundred and thirty seven grams of food composition powder of EXAMPLE 18 is mixed with 832 m;ll;l;ters of sterile distilled water in a beaker to form a homogeneous solution. The solution has a viscosity of about 250 centipoises. The size of food composition particles in suspension in the solution is less than or equal to 100 mesh. The solution is heated to and rQm~ i n~ at the temperature of 285 degrees Fahrenheit for ten (10) seconds. After the solution has been heated for two (2) minutes, precipitate begins to form and fall to the bottom of the beaker. The precipitate contains whey protein.

Two hundred and thirty seven grams of food composition powder of EXAMPLE 1 is mixed with 832 milliliters of sterile distilled water in a beaker to form a homogeneous solution. The solution has a viscosity of about 250 centipoises. The size of food composition particles in suspension in the solution is less than or equal to 100 mesh. The solution is heated to and r~m~; ns at the temperature of 300 degrees Fahrenheit for four (4) seconds. Precipitate does not form during the time the solution is heated.

One thousand grams of the powder of EXAMPLE 3 is prepared by mixing the ingredients in the proportions noted, except that ten grams of protopectin is utilized in place of the ten grams of pectin.

Two hundred and thirty seven grams of food composition powder of EXAMPLE 22 is mixed with 832 milliliters of sterile distilled water in a beaker to form a homogeneous solution. The solution has a viscosity of about 250 centipoises. The size of food composition particles in suspension in the solution is less than or W 096/25054 PCTnUS9SJ02026 equal to 100 mesh. The solution is heated to and ro~-;nC at the temperature of 285 degrees Fahrenheit for ten (10) seconds. Precipitate does not ~orm during the time the solution is heated.

One thousand grams of the powder of EXAMPLE 3 is prepared by m;~;ng the ingredients in the proportions noted, except that ten grams of pectinic acid is utilized in place of the ten grams of pectin.

Two hundred and thirty seven grams of food composition powder of EXAMPLE 24 is mixed with 832 m;ll;l;ters of sterile distilled water in a beaker to form a homogeneous solution. The solution has a viscosity of about 250 centipoises. The size of food composition particles in suspension in the solution is less than or equal to 100 mesh. The solution is heated to the temperature of 300 degrees Fahrenheit for three (3) seconds.
Precipitate does not form during the time the solution is heated.

Examples 24 and 25 are repeated in sequence, except that in Example 24 the amount of pectinic acid in the powder is reduced to a weight percent sufficient to permit some precipitate con~;n;ng whey protein to form during Example 25.

Example 26 is repeated, except the powder of Example 24 includes 0.40% by weight sodium carboxymethylcellulose. No precipitate is formed during Example 25.

Example 27 is repeated, except in Example 24 ten grams of pectin is substituted for ten grams of pectinic acid. Similar results are obt~;ne~.

Examples 3 and 4 are repeated, except that the amount of potassium sorbate in the ~ood composition prepared W 096/25054 PCTrUS95/02026 in Example 3 iS reduced such that the pH of the resulting drink in Example 4 is about 5.1 instead of about 4.6. The resulting drink still provides one calorie per cubic centimeter, has an osmolarity of about 300, has a viscosity of about 90 to 100 centipoise, and has particles each having a size of less than about 100 mesh. The total acidity of the resulting drink is about 5.05.

As soon as the drink (suspension) of EXAMPLE 29 iS
produced, i.e., as soon as the rehydration of the powder is performed, a plate count is performed to determine the presence of aerobic and anaerobic bacteria. The plate count is performed by transferring one milliliter of the drink to a 10 milliliter enriched Thio. The Thio is incubated at 35~C
for four days to culture for anaerobes. The Thio is then ~m;ned to determine the existence of aerobic and anaerobic bacteria. The forgoing plate count procedure is carried out in accordance with the FDA Bacteriological Analytical Manual, 4th Edition, 1984, Chapter 4, and with the ASM
Manual of Clinical Microbiology, 4th Edition, 1985.
The drink of EXAMPLE 29 iS stored at room temperature exposed to the air. A plate count is initiated at 5:00 pm each day for ten consecutive days following the day on which the drink of EXAMPLE 29 iS formulated by rehydrating the powder food composition powder. In the plate count taken at rehydration and in each of the ten plate counts taken after rehydration, in excess of ten aerobic microorg~n;smq per grams are detected. Anaerobic bacteria are detected during each of the plate counts.

Examples 3 and 4 are repeated, except that the amount of potassium sorbate in the food composition prepared in Example 3 is reduced such that the pH of the resulting drink in Example 4 is about 4.9 instead of about 4.6. The resulting drink still provides 1 calorie per cubic centimeter, has an osmolarity of about 300, has a viscosity of about 90 to 100 centipoise, and has particles each having W ~96125054 PCTnU~9OD2D26 a size of less than about 100 mesh. The total acidity of the resulting drink is about 5.4.

As soon as the drink (suspension) of EXAMPLE 31 is produced, i.e., as soon as the rehydration of the powder is performed, a plate count is performed to determine the presence of aerobic and anaerobic bacteria. The plate count is performed by transferring one ~;ll;l;ter of the drink to a 10 milliliter enriched Thio. The Thio is incubated at 35~C
for four days to culture for anaerobes. The Thio is then ~;ned to determine the existence of aerobic and anaerobic bacteria. The forgoing plate count procedure is carried out in accordance with the FDA Bacteriological Analytical M~n~ 4th Edition, 1984, Chapter 4, and with the ASM
Manual of Clinical Microbiology, 4th Edition, 1985.
The drink of EXAMPLE 31 is stored at room temperature exposed to the air. A plate count is initiated at 5:00 pm each day for ten consecutive days following the day on which the drink of EXAMPLE 31 is formulated by rehydrating the powder food composition powder. In the plate count taken at rehydration and in each of the ten plate counts taken after rehydration, less than ten aerobic organisms per gram are detected. Anaerobic bacteria are not detected during any of the plate counts.

Examples 3 and 4 are repeated, except that the amount of potassium sorbate in the food composition prepared in Example 3 is increased such that the pH of the resulting drink in Example 4 is about 4.0 instead of about 4.6. The resulting drink still provides 1 calorie per cubic centimeter, has an osmolarity of about 300, has a viscosity of about 90 to 100 centipoise, and has particles each having a size of less than about 100 mesh. The resulting drink has a total acidity of about 5.9.

As soon as the drink (suspension) of EXAMPLE 33 is produced, i.e., as soon as the rehydration of the powder is performed, a plate count is performed to determine the W 096/25054 PCTrU~5S~'~2026 presence of aerobic and anaerobic bacteria. The plate count is performed by transferring one m;ll;l;ter of the drink t~
a 10 m; 11; 1 ;ter enriched Thio. The Thio is incubated at 35~C
for four days to culture for anaerobes. The Thio is then ~m;ned to determine the existence of aerobic and anaerobic bacteria. The forgoing plate count procedure is carried out in accordance with the FDA Bacteriological Analytical Manual, 4th Edition, 1984, Chapter 4, and with the ASM
M~nll~l of Cl;n;~l Microbiology, 4th Edition, 1985.
The drink of EXAMPLE 33 is stored at room temperature exposed to the air. A plate count is initiated at 5:00 pm each day for ten consecutive days following the day on which the drink of EXAMPLE 33 is form~ ted by rehydrating the powder food composition powder. In the plate count taken at rehydration and in each of the ten plate counts taken after rehydration, less than ten aerobic microorganisms (bacteria) per gram are detected. Anaerobic bacteria are not detected during any of the plate counts.

Examples 3 and 4 are repeated, except that the amount of potassium sorbate in the food composition prepared in Example 3 is increased such that the pH of the resulting drink in Example 4 is about 3.0 instead of about 4.6. The resulting drink still provides 1 calorie per cubic centimeter, has an osmolarity of about 300, has a viscosity of about 90 to 100 centipoise, and has particles each having a size of less than about 100 mesh. The resulting drink has a total acidity of about 6.10.

As soon as the drink tsuspension) of EXAMPLE 35 is produced, i.e., as soon as the rehydration of the powder is performed, a plate count is performed to determine the presence of aerobic and anaerobic bacteria. The plate count is performed by transferring one m; 1 1; 1; ter of the drink to a 10 m; 11; 1; ter enriched Thio. The Thio is incubated at 35~C
for four days to culture for anaerobes. The Thio is then ~m;ned to determine the existence of aerobic and anaerobic bacteria. The forgoing plate count procedure is carried out W 096125054 PCTnUS95/02026 in accordance with the FDA Bacteriological Analytical Manual, 4th Edition, 1984, Chapter 4, and with the ASM
MAnllAl of Cl; n; CAl Microbiology, 4th Edition, 1985.
The drink of EXAMPLE 35 is stored at room temperature exposed to the air. A plate count is initiated at 5:00 pm each day for ten consecutive days following the day on which the drink of EXAMPLE 35 is formulated by rehydrating the powder food composition powder. In the plate count taken at rehydration and in each of the ten plate counts taken after rehydration, less than ten aerobic organisms per gram are detected. Anaerobic bacteria are not detected during any of the plate counts.
While preparing drinks in accordance with the invention which have a pH in the range of 2 to 6.S helps prevent or min;~; ~e the formation of aerobic and anaerobic bacteria in the drinks, I have discovered that producing a drink with a pH in the range of 2 to about 4.9 is critical in preventing the growth of all or substantially all bacteria in the drink. As used herein, the growth of "substantially all~ microorgAn;~ (bacteria) is prevented if a concentration of no more than ten aerobic organisms per ~;ll;liter results in the drink at room temperature.

Examples 31 and 32 are repeated, except that the quantity of sodium citrate and citric acid in the drink is reduced to lower the total acidity from 5.4 to about 5.00.
Similar results are obtained.

Examples 33 and 34 are repeated, except that the quantity of sodium citrate and citric acid in the drink is reduced to lower the total acidity from 5.9 to about 5.00.
Similar results are obtained.

w Examples 35 and 36 are repeated, except that the quantity of sodium citrate and citric acid in the drink is reduced to lower the total acidity from 6.1 to about 4.5.
Similar results are obtained.

W 096/2~054 PCTnUS9StO2026 The viscosity of the food composition of the invention is important and is, in part, responsible for the difficulty in finding a suitable stabilizer. The viscosity is such that the food composition, when reconstituted with water, can be readily drunk. The viscosity at 68~F of the reconstituted food composition is less than 10,000 centipoises, preferably less than 1000 centipoises. The viscosity of olive oil at 68~F is 1008 millipoises; of sperm oil at 68~F is 420 millipoises; of water at 68~F is 10.02 millipoises; of caster oil at 68~F is 10,272 millipoises; of turpentine at 68~F is 14.87 millipoises; of methyl alcohol at 68~F is 5.93 millipoises; and, of glycerol at 20~C is

10,690 millipoises. The viscosity of glycerol at 20.9~C is 7,776 millipoises. Even at low viscosities of 500 centipoises or less, the food composition of the invention retains its homogeneity. In one embodiment of the invention, the preferred viscosity is less than 500 centipoises.
The size of the particles in the food composition of the invention after the food composition is reconstituted is also important. Particles in the reconstituted food composition generally are each equal to or less than 100 mesh in size. A 20 mesh particle moves through a screen opening of 0.0331 inch; a 50 mesh particle moves through a screen opening of 0.0117 inch; a 100 mesh particle moves through a screen opening of 0.0059 inch; a 200 mesh particle moves through a screen opening of 0.0021 inch; and, a 325 mesh particle moves through a screen opening of 0.0017 inch.
Since particulate in the reconstituted food composition must remain in suspension, the particulate size is small.
The food composition of the invention is ingested at any desired point along the digestive tract, but ordinarily is administered to a patient orally or is tubally fed directly into the patient's stomach. If appropriate, the reconstituted food composition can be tubally directly fed into the intestinal tract or the esophagus. The patient can, as would be appreciated by those of skill in the art, can be a hominid or other appropriate A n; ~1 .

CA 022l2907 l997-08-l2 PCTnUS9~JD2D26 W O 96r25054 Having described my invention in such terms as to enable those skilled in the art to understand and practice it, and having identified the presently preferred embodiments thereof, I Claim:

Claims

- 28 -

1. A food composition for ingestion along the digestive tract of a patient, said food composition consisting of:
(a) from 6% to 28% by weight of natural water soluble protein;
(b) from 4% to 22% by weight of triglycerides of predominantly 6 to 26 carbon atoms in the fatty acid chain;
(c) from 35% to 78% by weight of carbohydrates selected from the group consisting of corn syrup solids, trisaccharides, tetrasaccharides, pentasaccharides, hexasaccharides, dextrose, fructose, sucrose, maltose, oligosaccharides and higher saccharides;
(d) from 0.01% to 10% by weight of an emulsifier;
(e) from 0.1% to 8% by weight of an edible acid for adjusting the pH of the food composition within the range of 2 to about 4.9 when said food composition is hydrated;
(f) from 0.01% to 6% by weight of an antimicrobial agent selected from the group consisting of sorbic acid, benzoic acid, sodium benzoate, potassium sorbate, sodium sorbate, and potassium benzoate;
and, (g) from 1% to 5.0% by weight of a water soluble complex carbohydrate stabilizer selected from the group consisting of complex carbohydrates and complex carbohydrate derivatives, said stabilizer preventing the precipitation of said protein when said food composition is hydrated to form a drink and is sterilized to kill substantially all microorganisms in the drink.

2. The food composition of Claim 1 in liquid form and (a) including water;
(b) providing from 0.4 up to about 3 calories per cubic centimeter of composition;
(c) having an osmolarity from 250 up to about 650;

(d) having a viscosity of less than 500 centipoise;
and, (e) including particulate, substantially all of said particulate being less than about 100 mesh in size.

3. The food composition of Claim 1 wherein said water soluble complex carbohydrate stabilizer is pectin.

4. The food composition of Claim 2 wherein said water soluble complex carbohydrate stabilizer is pectin.

5. A method for preparing a sterile food composition for ingestion along the digestive tract of a patient, said method including the steps of (a) preparing a powder food composition by blending together (i) from 6% to 28% by weight of water soluble protein;
(ii) from 4% to 22% by weight of triglycerides of predominantly 6 to 26 carbon atoms in the fatty acid chain;
(iii) from 35% to 78% by weight of carbohydrates selected from the group consisting of corn syrup solids, trisaccharides, tetrasaccharides, pentasaccharides, hexasaccharides, dextrose, fructose, sucrose, maltose, oligosaccharides and higher saccharides;
(iv) from 0.1% to 10% by weight of an emulsifier;
(v) from 0.1% to 8% by weight of an edible acid for adjusting the pH of the food composition within the range of 2 to about 4.9 when said food composition is hydrated;
(vi) from 0.01% to 6% by weight of an antimicrobial agent selected from the group consisting of sorbic acid, benzoic acid, sodium benzoate, potassium sorbate, sodium sorbate, and potassium benzoate; and, (v) from 1% to 5.0% by weight of a water soluble complex carbohydrate stabilizer selected from the group consisting of complex carbohydrates and complex carbohydrate derivatives, said stabilizer preventing the precipitation of said protein when said food composition is hydrated to form a drink and is sterilized to kill substantially all microorganisms in the drink;
(b) mixing said powder food composition with water to form an aqueous food solution;
(c) heating said aqueous food solution to a sterilization temperature of at least about two hundred degrees Fahrenheit for a time sufficient to kill substantially all microorganisms in said food solution; and, (d) cooling said sterilized food solution.

6. The method of Claim 5 wherein in step (a), from 0.001%
to 4.0% by weight methylcellulose is blended into said powder food composition.

7. The method of Claim 5 wherein in step (a), from 0.001%
to 4.0% by weight sodium carboxymethylcellulose is blended into said powder food composition.

8. The food composition of Claim 1 including from 0.001%
to 4.0% by weight methylcellulose.

9. The food composition of Claim 1 including from 0.001%
to 4.0% by weight sodium carboxymethylcellulose.

10. The method of Claim 6 wherein in step (a) said water soluble complex carbohydrate stabilizer is pectin.

11. The method of Claim 7 wherein in step (a) said water soluble complex carbohydrate stabilizer is pectin.

12. The method of Claim 5 wherein in step (a) said water soluble complex carbohydrate stabilizer is pectin.

13. A food composition for ingestion along the digestive tract of a patient, said food composition consisting of:
(a) from 6% to 28% by weight of water soluble protein;
(b) from 4% to 22% by weight of triglycerides of predominantly 6 to 26 carbon atoms in the fatty acid chain;

(c) from 35% to 78% by weight of carbohydrates selected from the group consisting of corn syrup solids, trisaccharides, tetrasaccharides, pentasaccharides, hexasaccharides, dextrose, fructose, sucrose, maltose, oligosaccharides and higher saccharides;
(d) from 0.01% to 10% by weight of an emulsifier;
(e) from 0.1% to 8% by weight of an edible acid for adjusting the pH of the food composition within the range of 2 to about 4.9 when said food composition is hydrated;
(f) from 0.01% to 6% by weight of an antimicrobial agent selected from the group consisting of sorbic acid, benzoic acid, sodium benzoate, potassium sorbate, sodium sorbate, and potassium benzoate;
and, (g) from 1% to 5.0% by weight of a water soluble complex carbohydrate stabilizer selected from the group consisting of complex carbohydrates and complex carbohydrate derivatives, said stabilizer preventing the precipitation of said protein when said food composition is hydrated to form a drink and is sterilized to kill substantially all microorganisme in the drink.

14. The food composition of Claim 13 wherein said protein is produced by hydrolyzing naturally occurring protein.

15. The food composition of Claim 13 in liquid form and (a) including water;
(b) providing from 0.4 up to about 3 calories per cubic centimeter of composition;
(c) having an osmolarity from 250 up to about 650;
and, (d) including particulate, substantially all of said particulate being less than about 100 mesh in size.

16. A food composition for ingestion along the digestive tract of a patient, said food composition consisting of an aqueous solution including:

(a) protein;
(b) triglycerides of predominantly 6 to 26 carbon atoms in the fatty acid chain;
(c) carbohydrates selected from the group consisting of corn syrup solids, trisaccharides, tetrasaccharides, pentasaccharides, hexasaccharides, dextrose, fructose, sucrose, maltose, oligosaccharides and higher saccharides;
(d) an emulsifier;
(e) an edible acid for adjusting the pH of said solution within the range of 2 to about 4.9;
(f) an antimicrobial agent selected from the group consisting of sorbic acid, benzoic acid, sodium benzoate, potassium sorbate, sodium sorbate, and potassium benzoate; and, (g) a stabilizer;
said solution having a total activity of at least 4Ø

17. A food composition for ingestion along the digestive tract of a patient, said food composition consisting of an aqueous solution including:
(a) protein;
(b) triglycerides of predominantly 6 to 26 carbon atoms in the fatty acid chain;
(c) carbohydrates selected from the group consisting of corn syrup solids, trisaccharides, tetrasaccharides, pentasaccharides, hexasaccharides, dextrose, fructose, sucrose, maltose, oligosaccharides and higher saccharides;
(d) an emulsifier;
(e) an edible acid for ad justing the pH of said solution within the range of 2 to about 4.9;
(f) an antimicrobial agent selected from the group consisting of sorbic acid, benzoic acid, sodium benzoate, potassium sorbate, sodium sorbate, and potassium benzoate; and, (g) a stabilizer;
said solution having a total activity of at least 5Ø

18. A food composition for ingestion along the digestive tract of a patient, said food composition consisting of an aqueous solution including:
(a) protein;
(b) triglycerides of predominantly 6 to 26 carbon atoms in the fatty acid chain;
(c) carbohydrates selected from the group consisting of corn syrup solids, trisaccharides, tetrasaccharides, pentasaccharides, hexasaccharides, dextrose, fructose, sucrose, maltose, oligosaccharides and higher saccharides;
(d) an emulsifier;
(e) an edible acid for adjusting the pH of said solution within the range of 2 to about 4.9;
(f) an antimicrobial agent selected from the group consisting of sorbic acid, benzoic acid, sodium benzoate, potassium sorbate, sodium sorbate, and potassium benzoate; and, (g) a stabilizer;
said solution having a the total activity of at least 5.4.