Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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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
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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
,
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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
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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.
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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.
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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
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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
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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.
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Antimicrobial activity is therefore pH dep~n~ent and the
estimated activity at any pH can be estimated as shown below
in Table 1.
TABLE 1
EFFECT OF pH ON DISSOCIATION
Percent Undissociated Acid
PH Sorbic Benzoic
3 98 94
4 86 60
37 13
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.
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-- 10 --
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:
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To make 100 gramsApproxLmate
Calories/ml. solution Viscosity
of solutionqms powder*/gms water (centipoises)
0.5 18/82 <100
1 25/75 100
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.
EXAMPLE 1
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
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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.
EXAMPLE 2
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.
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EXAMPLE 3
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
SUGAR 5-5
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.
EXAMPLE 4
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
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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.
EXAMPLE 5
One thousand grams of the powder of EXAMPLE 3 is
prepared by mixing the ingredients in the proportions noted,
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~ 15 ~
except 0.23 grams of potassium sorbate is substituted for
the 0.46 grams of potassium sorbate.
EXAMPLE 6
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.
EXAMPLE 7
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
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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
EXAMPLE 8
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
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~ 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.
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EXAMPLE 12
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.
EXAMPLE 13
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.
EXAMPLE 14
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.
EXAMPLE 15
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)
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minutes. Precipitate does not form during the time the
solution is heated.
EXAMPLE 16
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.
EXAMPLE 17
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.
EXAMPLE 18
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.
EXAMPLE 19
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)
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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.
EXAMPLE 20
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.
EXAMPLE 21
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.
EXAMPLE 22
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.
EXAMPLE 23
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
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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.
EXAMPLE 24
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.
EXAMPLE 25
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.
EXAMPLE 26
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 27
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 28
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~.
EXAMPLE 29
Examples 3 and 4 are repeated, except that the
amount of potassium sorbate in the ~ood composition prepared
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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.
EXAMPLE 30
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.
EXAMPLE 31
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
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a size of less than about 100 mesh. The total acidity of
the resulting drink is about 5.4.
EXAMPLE 32
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.
EXAMPLE 33
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.
EXAMPLE 34
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
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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.
EXAMPLE 35
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.
EXAMPLE 36
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
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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.
EXAMPLE 37
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.
EXAMPLE 38
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.
EXAMPLE 39
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.
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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 .
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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:
