FIELD OF THE INVENTION
The present invention relates to a method of providing nutrition to a patient by
compensating the protein loss happened during the ailment process by administering
orally to the said patient a small volume ready-to-drink protein beverage composition
comprising about 8 to 20 g of protein per 150 ml of the composition. The present
invention relates to a hyperprotein supplement which is formulated for patients,
particularly renal dialysis patients undergoing a peritoneal renal dialysis treatment
regimen or critical care patients.
BACKGROUND OF THE INVENTION
Every year, about 80,000 people are afflicted with end stage renal disease (ESRD), the
final stage of renal failure. In ESRD, the kidneys lose the ability to adequately filter the
blood; consequently, wastes accumulate in the body. Several conditions can lead to
ESRD, including diabetes and high blood pressure, as well as several other less-common
causes. Without medical intervention, ESRD is fatal. Patients with ESRD must either be
regularly treated with renal dialysis or receive a kidney transplant to compensate for the
loss of kidney function.
Peritoneal renal dialysis is one of the current medical techniques used in the care of
patients suffering from renal failure. Peritoneal renal dialysis involves pumping a special
fluid into a patient's abdominal cavity. The fluid is balanced in such a manner that waste
materials from the blood cross the peritoneal membrane and into the fluid in the
peritoneum. The abdominal cavity is then evacuated, with the waste materials removed
along with the fluid.
Dialysis typically results in the subject having a poor appetite, altered taste sensation,
and an aversion to high protein foods. During each session (three times a week) of
dialysis, three grams of protein and about 5 to 10 grams of amino acids are lost. This
abrupt fall of amino acids induces an inflammatory state that leads to hyper catabolism
of muscular proteins and blockade of anabolism. These losses are compensated by
administering infusion comprising amino acids. Hence, there is a need wherein a patient
can be given a product orally to compensate the loss.
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The oral products currently on the market are inadequate during dialysis due to several
reasons such as presence of deleterious potential additives such as maltodextrin and
sodium benzoate; presence of caseinates, highly hydrolyzed whey protein or collagen
hydrolyzates as protein source; presence of high levels of sodium, potassium and
phosphates that may disrupt dialysis parameters; poor patient compliance due to
unpalatability and need of reconstitution. None of these products are adapted to
intradialysis as proteins are mixed with vitamins and minerals.
There exists a need in the art to provide a method of providing nutrition to a patient
undergoing dialysis by compensating the protein loss happened during the dialysis
process wherein the composition administered to the patient has a low sodium/calcium
content with high concentration of protein without the presence of other ingredients
(such as vitamins, minerals etc.). As the composition does not comprise any added sugar,
it also suitable for patients having comorbidity related to diabetes and kidney failure.
SUMMARY OF THE INVENTION
The inventor of the present application has developed a ready-to-drink protein beverage
composition that comprises high quality proteins in an amount sufficient to compensate
the amino acid lost during the dialysis process or during aliments leading to critical care.
In one of the aspects, there is provided a method of providing nutrition to a patient by
compensating the protein loss happened during the ailment process by administering
orally to the said patient a small volume ready-to-drink protein beverage composition
comprising about 8 to 20 g of protein per 150 ml of the composition; wherein said protein
comprises a mixture of native micellar casein and partially hydrolysed whey proteins in
the weight ratio of about 75:25 to about 85:15 and native casein provides ≥95% of total
energy intake.
In another aspect, there is provided a method of providing nutrition to a patient by
compensating the protein loss happened during the ailment process by administering
orally to the said patient a small volume ready-to-drink protein beverage composition
comprising of:
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(i) about 8 to 20 g of protein per 150 ml of the composition;
(ii) one or more optional excipients selected from flavoring agent, artificial
sweeteners, or mixtures thereof and
(iii) purified water
wherein said protein comprises a mixture of native micellar casein and partially
hydrolysed whey proteins in the weight ratio of about 75:25 to about 85:15 and native
casein provides ≥95% of total energy intake.
In another embodiment, the ailment is related to critical care patients such as oncology
patients, post-surgery recovery patients, bariatric surgery patients, convulsion patients,
sports injury etc.
In another embodiment, the ailment is related to end stage renal disease or chronic
kidney disease.
In another embodiment, the dose to be administered after dialysis for maintenance is
one can per day. The composition may be administered before, after or between the
dialysis treatments.
In another embodiment, the ailment is related to critical care patients such as oncology
patients, post-surgery recovery patients, bariatric surgery patients, convulsion patients,
sports injury etc. The composition helps the patients to avoid muscle wasting and boost
immunity as required by the physician.
In yet another embodiment, the beverage composition is sugar-free and suitable for
diabetic patients.
In another embodiment, the ailment is related to chronic kidney disease or end stage
renal disease or requires renal peritoneal dialysis.
In another embodiment, the total volume of the composition may vary from 150 mL to
300 mL.
In an embodiment of above aspect, the dose to be administered during dialysis is one can
per session. The composition is suitable for interdialysis as it does not comprise added
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vitamins and minerals. The composition may be administered post dialysis, interdialytic
and intradialytic.
In another embodiment, the patient can drink cold or even warm it and drink instantly.
In yet another embodiment, the beverage composition has a low sodium, phosphorus
and potassium content as required by patients on dialysis. The content of sodium is less
than 0.2 mg/mL of the beverage composition and the content of potassium is less than
0.006 mg/ml of the beverage composition.
In yet another embodiment, the beverage composition has a Protein digestibilitycorrected amino acid score (PDCAAS) of 1. In yet another embodiment, the beverage
composition has a high biological value.
In yet another embodiment, the composition has a slow assimilation for longer effect.
According to another aspect, there is provided a stable small volume ready-to-drink
protein beverage composition comprising of:
(i) about 8 to 20 g of protein per 150 ml of the composition;
(ii) one or more optional excipients selected from flavoring agent, artificial
sweeteners, or mixtures thereof and
(iii) purified water
wherein said protein comprises a mixture of native micellar casein and partially
hydrolysed whey proteins in the weight ratio of about 75:25 to about 85:15 and
native casein provides ≥95% of total energy intake.
In another embodiment, native micellar casein provides about 95 to 100% of total energy
intake.
In another embodiment, native micellar casein and whey proteins are present in the
composition in the weight ratio of about 80:20 to about 90:10 or about 85:15 to about
95:05.
In another embodiment, the ratio of native micellar casein and partially hydrolysed whey
proteins provides solubilisation of proteins in the water.
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In another embodiment, the total protein content is about 80 to 95% by weight of the
composition.
In another embodiment, the beverage composition is substantially free of stabilizing
agent, caseinates and preservatives.
In another embodiment, there is no addition of fats, carbohydrates, glutens, vitamins,
minerals, lactose, soya or emulsifiers, to the composition.
In another embodiment, the composition has a pH in the range of about 6 to about 7.
In a preferred embodiment, the composition has a pH of 6.5. In another embodiment,
the composition has a pH of 6.7.
In another embodiment, the composition comprises 45% of essential amino acids.
In another embodiment, the composition provides essential amino acids selected from
glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine,
tryptophan and valine.
In another embodiment, the composition comprises a high amount of leucine, which
initiates muscle protein synthesis.
In yet another embodiment, the protein in the composition is in the form of spherical
complex structure in liquid form, that gets near 100% assimilated hence doesn’t cause
any gastrointestinal disturbance.
In another embodiment, the artificial sweetener is present in a concentration of about
0.05 to 0.5% by weight of the composition.
DETAILED DESCRIPTION
The term “beverage” as used herein refers to any water-based liquid which can be
ingested orally as a drink, e.g. by sipping, pouring or tube-feeding.
The term “native micellar casein also known as micellar casein”, refers to casein in the
form of micelles. Micellar casein may be provided by milk protein sources, such as Milk
Protein Concentrate (MPC), which is a powder product usually prepared by ultrafiltration with an average protein content of about 80 weight%, Milk Protein Isolate
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(MPI), a powder product usually prepared by precipitation with an average protein
content of more than 75 weight%, and skimmed concentrated milk.
The whey protein can be sourced from whey protein isolate, whey protein concentrate,
whey protein extract, whey protein micelles, intact or native whey protein or partially
hydrolysed whey protein or combinations thereof.
Protein digestibility-corrected amino acid score (PDCAAS) is a method of evaluating
the quality of a protein based on both the amino acid requirements of humans and their
ability to digest it. The PDCAAS rating was adopted by the US FDA and the Food and
Agricultural Organization of the United Nations/World Health Organization (FAO/WHO)
in 1993 as best method to determine protein quality. The highest possible score is one
by comparing the amino acid profile of the specific food protein against a standard amino
acid profile.
Biological value (BV) is a measure of the proportion of absorbed protein from a food
which becomes incorporated into the proteins of the organism's body. When a protein
composition contains the essential amino acids in the right proportion required by
humans, we say that it has high biological value.
The protein beverage composition is provided in a ready-to-use liquid form that does not
require reconstitution or mixing prior to use. The composition according to the invention
can be tube fed or administered orally.
The beverage composition may also include one or more optional excipientsthat provide
the composition desired taste for consumption by the subject.
Suitable artificial sweeteners include but are not limited to artificial, low calorie
sweeteners such as aspartame, cyclamate, sucralose, acesulfame K, neotame, saccharin,
neohesperidin dihydrochalcone or mixtures thereof.
Suitable flavors include but are not limited to fruit-based flavors selected from banana,
pineapple, vanilla, strawberry, apple, lemon, mixed berry, grapefruit, pomegranate,
orange; or other flavors like jasmine tea flavor, coffee flavor, cocoa.
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The following examples are provided to enable one skilled in the art to practice the
invention and are merely illustrative of the invention. The examples should not be read
as limiting the scope of the invention.
Example 1
S. No. Ingredients Qty/ Can Qty./ Batch (kg)
1. Dairy Protein (80%) 13.00 g 54.16 kg
2. Sucralose 50 mg 0.167 kg
3. Coffee flavor 3 ml 10 L
4. Purified Water q.s. to 150ml q.s. to 500 L
Procedure:
1. Purified water was taken in a Batch Pasteurizer at about 50-55°C.
2. Dairy protein powder was dissolved in heated water to make a uniform solution.
3. The remaining excipients (Sucralose and coffee flavor) were added to the solution of
step (2) in the Pasteurizer.
4. The final volume was made and the whole mixture was blended for 30 minutes by
re-circulation.
5. The solution was cooled to around 4°C and filtered using appropriate mesh into a
double jacketed storage tank.
6. The solution was kept in storage tank for around 4 to 8 hours for its hydration.
7. The solution from step 6 was filled into 150 ml cans and sealed.
8. The sealed cans were retorted for 120°C for 20 minutes by sterilization process

CLAIMS
1. A method of providing nutrition to a patient by compensating the protein loss
happened during the ailment by administering orally to the said patient a small
volume ready-to-drink protein beverage composition comprising about 8 to 20 g
of protein per 150 ml of the composition wherein said protein comprises a
mixture of native micellar casein and partially hydrolysed whey proteins in the
weight ratio of about 75:25 to about 85:15 and native casein provides ≥95% of
total energy intake.
2. The method of providing nutrition to a patient according to claim 1 wherein the
patient has a critical care illness or end stage renal disease or chronic kidney
disease or requires renal peritoneal dialysis.
3. The method of providing nutrition to a patient according to claim 2 wherein the
critical care illness patients includes oncology patients, post-surgery recovery
patients, bariatric surgery patients, convulsion patients, sports injury.
4. The method of providing nutrition to a patient according to claim 2 wherein the
chronic kidney disease patients are subjected to dialysis.
5. The method of providing nutrition to a patient according to claim 2 wherein the
end stage renal disease patients are subjected to dialysis.
6. The method of providing nutrition to a patient according to claim 1 the
composition may be administered post dialysis, interdialytic and intradialytic.
7. The method of providing nutrition to a patient according to claim 1 wherein the
composition has a high biological value.
8. The method of providing nutrition to a patient according to claim 1 wherein the
composition has a Protein digestibility-corrected amino acid score (PDCAAS) of
1.
9. The method of providing nutrition to a patient according to claim 1 wherein the
beverage composition has a low sodium, potassium and phosphorous content.
10. The method of providing nutrition to a patient according to claim 9 wherein the
composition has sodium content of less than 0.2 mg/mL and the content of
potassium is less than 0.006 mg/ml of the beverage composition.
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11. The method of providing nutrition to a patient according to claim 1 wherein the
composition is sugar-free and suitable for diabetic patients.
12. The method of providing nutrition to a patient according to claim 1 wherein the
composition is substantially free of stabilizing agent, caseinates and
preservatives.
13. The method of providing nutrition to a patient according to claim 1 wherein the
composition does not comprise additional fats, carbohydrates, glutens, vitamins,
minerals, lactose, soya or emulsifiers, to the composition.
14. The method of providing nutrition to a patient according to claim 1 wherein the
composition does not cause any gastrointestinal disturbances.