A STABLE PROTEIN BEVERAGE COMPOSITION
FIELD OF THE INVENTION
The present invention relates to a stable 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 more than 95% of total energy intake.
BACKGROUND OF THE INVENTION
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 hypercatabolism
of muscular proteins and blockade of anabolism.
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.
International Publication No. WO 02/098242 discloses a liquid oral supplement based on
a (60:40) soy protein isolate/caseinate mixture with a protein level of 9 g/100 ml,
12.25g/100 ml of fat and 19.7 g/100 ml of digestible carbohydrates.
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US Publication No. 2003/099761 discloses a nutritionally complete formula comprising
8g/100ml of intact whey protein using whey protein isolate as a source of whey, acidified
to a pH of 3, ultrahigh temperature (UHT) treated for 5 seconds at 148°C and
subsequently mixed with lipids, carbohydrates, minerals to provide a nutritional
composition.
There exists a need in the art to provide a low volume fluid, low sodium/potassium
hyperprotein composition without the presence of other ingredients (such as vitamins,
minerals etc.) to compensate the amino acids loss during the dialysis process and is
adapted to intradialytic intake.
SUMMARY OF THE INVENTION
The inventor of the present composition has developed a ready-to-drink protein
beverage composition that comprises high quality proteins in an amount sufficient to
compensate the amino acid intradialytic loss or loss in critical care patients. The
composition is a pleasant-taste patient-friendly beverage provided in small-volume to
increase compliance and is free of additives that are otherwise standardized in the
dialysate.
In one of the aspects, there is provided a stable 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.
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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.
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 yet another embodiment, the beverage composition has a low sodium, potassium and
phosphorous 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 another embodiment, the ratio of native micellar casein and partially hydrolysed whey
proteins provides solubilisation of proteins in the water. Protein in the composition
remains completely dissolved in liquid and are passed on to small intestine to be
absorbed through microvilli. Protein is 100% assimilated, thus, patients will not have a
feeling of flatulence & heaviness.
In another embodiment, the total volume of the composition may vary from 150 mL to
300 mL.
In a particular embodiment, the composition is sterilized after packaging in the cans.
In second aspect of the present invention, there is provided a stable ready–to-drink
protein beverage composition consisting of:
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(i) about 10 to 20 g of protein per 150 ml of composition,
(ii) at least one flavor selected from fruit flavor, coffee, cocoa component
or mixtures thereof;
(iii) at least one artificial sweetener and
(iv) purified water;
wherein the said composition is stable on storage under ambient conditions for at least
12 months.
In an embodiment of above aspect, the composition does not comprise any stabilizer.
In another embodiment, the composition comprises about 15 g of protein per 150 ml of
the composition.
In a particular embodiment, the composition comprises about 13 g of protein per 150 ml
of the composition.
In another embodiment, the patient can drink the composition cold or even warm it and
drink instantly.
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 one embodiment, the container for the storage of composition has a volume capacity
of about 180 ml to 360 ml.
In yet another embodiment, the composition has a slow assimilating for longer effect.
In another embodiment, the protein in 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 another embodiment, the composition has an osmolality of 40-60 mOsmol/L.
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In another embodiment, there is no change in the viscosity of the composition
throughout the shelf-life of the product.
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 “about” as used herein refers to ± 10% of the numerical value of the number
with which it is being used.
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
(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.
The term “stable” as used herein refers to stability of more than 6 months under normal
storage conditions, i.e. at room temperature of between 18 and 25°C, and at a relative
humidity of 35%.
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.
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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 butter scotch, jasmine tea flavor, coffee flavor, cocoa.
The packaged protein drink composition may be stored at room temperature for at least
about 6 months.
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
1. Dairy Protein (80%) 13.00 g 54.16 kg
2. Sucralose 50.00 mg 0.17 kg
3. Coffee flavour 3 ml 10 L
4. Purified Water qs to 150 ml qs 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 flavour) 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.
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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 4-8 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.
Stability Studies
The protein beverage composition was prepared as per the procedure given in Example
1 and stability test with varying conditions was done at 0, 1, 2 and 6 months. Results
obtained are as given in Table 1.
Table 1: Stability of the beverage composition under various process parameters
Activities Process Variables Month Of
Start Of
Activity
Month Of
End Of
Activity
Indicators Of
Progress
2 trial batches were
taken with 30 cans in
each trial.
Product was
prepared &
Pasteurized.
0 01 Slight foul smell
with curdy
preparation was
observed in all the
cans within 7 days
of the preparation.
2 trial batches were
taken with 30 cans in
each trial.
Product was
prepared &
Pasteurized. pH was
checked & adjusted.
00 01 pH of the product
was adjusted to
6.5. Again foul
smell with curdy
preparation was
observed within
7days.
5 trial batches were
taken with 30 cans in
each trial.
Product was
prepared &
Pasteurized. pH was
6.8. It was sterilized
for 20 minutes at
120°C.
00 02 By looking at
microbial growth in
product, the
aseptically
processed and
homogenized mix
was subjected to
pasteurization for
30 minutes followed
by sterilization of
the product.
Product was found
to be stable.
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5 trial batches were
taken with 30 cans in
each trial.
3
rd Method was
repeated to check the
consistency.
00 02 The product was
processed in
hygienic
conditions and
sterilization was
done after filling.
This product was
also found as
stable.
2 pilot batches of
300 cans each were
taken to check to
scale up the batch.
Pilot batches were
taken to check for
scale-up.
00 06 Both the batches
were stable.

CLAIMS
1. A stable 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 more than 95% of total energy intake.
2. The protein beverage composition according to claim 1 wherein native micellar casein
provides about 95 to 100% of total energy intake.
3. The protein beverage composition according to claim 1 wherein native micellar casein
and whey proteins are present in the composition in the weight ratio of about 80:20 to
about 90:10.
4. The protein beverage composition according to claim 3 wherein native micellar casein
and whey proteins are present in the composition in the weight ratio of about 85:15 to
about 95:05.
5. The protein beverage composition according to claim 1 wherein the total protein
content is about 80 to 95% by weight of the composition.
6. The protein beverage composition according to claim 1 wherein the beverage
composition is substantially free of stabilizing agent, caseinates and preservatives.
7. The protein beverage composition according to claim 1 wherein the beverage
composition does not comprise any additional fats, carbohydrates, glutens, vitamins,
minerals, lactose, soya or emulsifiers.
8. The protein beverage composition according to claim 1 wherein the beverage
composition has a pH in the range of about 6 to about 7.
9. The protein beverage composition according to claim 8 wherein the beverage
composition has a pH of 6.7.
10. The protein beverage composition according to claim 1 wherein the beverage
composition has an osmolality of 40-60 mOsmol/L.
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11. The protein beverage composition according to claim 1 wherein the artificial sweetener
is present in a concentration of about 0.05 to 0.5% by weight of the composition.
12. The protein beverage composition according to claim 1 wherein the composition does
not cause any gastrointestinal disturbances.
13. The protein beverage composition according to claim 1 wherein the protein in the
composition is in the form of spherical complex structure in liquid form.
14. The protein beverage composition according to claim 1 wherein the beverage
composition has a volume of 150 ml to 300 ml.
15. A stable ready-to-drink protein beverage composition consisting of:
(i) about 10 to 20 g of protein per 150 ml of composition,
(ii) at least one flavor selected from fruit flavor, coffee, cocoa component or
mixtures thereof;
(iii) at least one artificial sweetener and
(iv) purified water;
wherein the said composition is stable on storage at room temperature of 25°C for at
least 12 months.
16. The stable ready-to-drink protein beverage composition according to claim 12 wherein
the composition does not comprise any stabilizing agent or preservative.
17. The stable ready-to-drink protein beverage composition according to claim 12 wherein
there is no change in the viscosity of the composition throughout the shelf-life of the
product