WO2021014467A1 - Composition de boisson prête à boire à base de protéine - Google Patents

Composition de boisson prête à boire à base de protéine Download PDF

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Publication number
WO2021014467A1
WO2021014467A1 PCT/IN2020/050630 IN2020050630W WO2021014467A1 WO 2021014467 A1 WO2021014467 A1 WO 2021014467A1 IN 2020050630 W IN2020050630 W IN 2020050630W WO 2021014467 A1 WO2021014467 A1 WO 2021014467A1
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WO
WIPO (PCT)
Prior art keywords
composition
protein
protein beverage
beverage composition
container
Prior art date
Application number
PCT/IN2020/050630
Other languages
English (en)
Inventor
Satish Chander
Original Assignee
Satish Chander
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Satish Chander filed Critical Satish Chander
Publication of WO2021014467A1 publication Critical patent/WO2021014467A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23J—PROTEIN COMPOSITIONS FOR FOODSTUFFS; WORKING-UP PROTEINS FOR FOODSTUFFS; PHOSPHATIDE COMPOSITIONS FOR FOODSTUFFS
    • A23J3/00—Working-up of proteins for foodstuffs
    • A23J3/04—Animal proteins
    • A23J3/08—Dairy proteins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23J—PROTEIN COMPOSITIONS FOR FOODSTUFFS; WORKING-UP PROTEINS FOR FOODSTUFFS; PHOSPHATIDE COMPOSITIONS FOR FOODSTUFFS
    • A23J3/00—Working-up of proteins for foodstuffs
    • A23J3/04—Animal proteins
    • A23J3/08—Dairy proteins
    • A23J3/10—Casein
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/52—Adding ingredients
    • A23L2/66—Proteins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/19—Dairy proteins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • 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 also 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.
  • the supplement includes small-volume ready-to-drink protein beverage composition comprising about 8 to 20 g of protein per 150ml 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.
  • ESRD end stage renal disease
  • 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.
  • infusion comprising amino acids.
  • 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.
  • compositions administered to the patient have a low sodium/potassium/phosphorous content with high concentration of protein without the presence of other ingredients (such as vitamins, minerals etc.).
  • the composition does not comprise any added sugar, it also suitable for patients having comorbidity related to diabetes and kidney failure.
  • 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 aliment leading to critical care.
  • the composition is a pleasant-taste patient-friendly stable beverage provided in small- volume to increase compliance and is free of additives that are otherwise standardized in the dialysate.
  • the present invention also provides a process of preparation of stable ready-to-drink protein beverage composition comprising about 8 to 20 g of protein per 150 ml of the composition.
  • the composition so produced is stable without phase separation, creaming, gelation and sedimentation, and retain a constant viscosity over time.
  • the present invention also provides a coated container for the storage of the protein beverage, wherein the composition can be stored at ambient temperature of less than 25°C; and no special storage conditions are required.
  • the said container prevents the degradation of beverage composition by coating the interiors with a lacquer, plastic or resin or mixtures thereof, preferably a lacquer.
  • the inner coating of container seals and prevents any chemical reaction between metal and packed beverage composition, thus preserving the flavor and other organoleptic properties of composition.
  • 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.
  • 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:
  • 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.
  • 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 ailment is related to chronic kidney disease or end stage renal disease or requires renal peritoneal dialysis.
  • the total volume of the composition may vary from 150 mL to
  • the dose to be administered during dialysis is one can per session.
  • the composition is suitable for interdialysis as it does not comprise added vitamins and minerals.
  • the composition may be administered post dialysis, interdialytic and intradialytic.
  • the patient can drink cold or even warm it and drink instantly.
  • 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.
  • 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.
  • the beverage composition is sugar-free and suitable for diabetic patients.
  • 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.
  • the beverage composition has a Protein digestibility- corrected amino acid score (PDCAAS) of 1.
  • PDCAAS Protein digestibility- corrected amino acid score
  • the beverage composition has a high biological value.
  • composition has a slow assimilating for longer effect.
  • a stable small volume ready-to-drink protein beverage composition comprising of:
  • 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.
  • a stable ready-to-drink protein beverage composition consisting of:
  • composition is stable on storage under ambient conditions for at least 12 months.
  • the composition does not comprise any stabilizer or preservative.
  • the composition comprises about 15 g of protein per 150 ml of the composition.
  • the composition comprises about 13 g of protein per 150 ml of the composition.
  • the composition has an osmolality of 40-60 mOsmol/L In another embodiment, there is no change in the viscosity of the composition throughout the shelf-life of the product.
  • the artificial sweetener is present in a concentration of about 0.05 to 0.5% by weight of the composition.
  • native micellar casein provides about 95 to 100% of total energy intake.
  • 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.
  • 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.
  • the total protein content is about 80 to 95% by weight of the composition.
  • beverage composition is substantially free of stabilizing agent, caseinates and preservatives.
  • 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 a particular embodiment, the composition is sterilized after packaging in the cans.
  • the composition comprises 45% of essential amino acids.
  • the composition provides essential amino acids selected from glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine.
  • the composition comprises a high amount of leucine, which initiates muscle protein synthesis.
  • 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.
  • the artificial sweetener is present in a concentration of about 0.05 to 0.5% by weight of the composition.
  • step (iii) dissolving the excipients separately in purified water and adding the solution of excipients to the solution of step (ii) and making up the final volume;
  • step (iv) cooling the final solution obtained from step (iii) to about 2 to about 8°C;
  • step iii) optionally, filtering the solution of step iii) through a filter and keeping the solution obtained for 4-8 hrs. in a storage tank for its hydration,
  • step iii) is stirred for a time period of around
  • the sterilization in step vii) is carried out at 100-140°C for 10- 30 minutes.
  • step (iii) dissolving the excipients separately in purified water and adding the solution of excipients to the solution of step (ii) for about 30 minutes and making up the final volume;
  • step (iv) cooling the final solution obtained from step (iii) to about 2-8°C for about 3 to about 7 hrs;
  • step iv) optionally, filtering the solution of step iv) through 60 mesh filter and keeping the solution obtained for 4-8 hrs in a storage tank for its hydration,
  • the water in step i) is heated to about 50°C to about 55°C.
  • the beverage composition is prepared under aseptic processing conditions.
  • processing time between the production and filling is minimized to reduce chances of microbial contamination. In the preferred embodiment, processing time between the production and filling is less than 6 hours.
  • composition is subject to aseptic homogenization at suitable temperatures.
  • beverage composition is substantially free of any stabilizers/emulsifier.
  • beverage composition is stable after storage in pasteurized canned container.
  • a package container containing a ready-to-drink protein beverage composition comprising native micellar casein, hydrolyzed whey proteins and one or more optional excipients, wherein the interior surface of said container is coated.
  • a package container containing a ready-to-drink protein beverage composition comprising native micellar casein, hydrolyzed whey proteins and one or more optional excipients, wherein the interior of said container is coated and container has less than 5% of headspace of the total volume of the container.
  • the container has a volume capacity of about 180 ml to 360 ml.
  • the interior of said container is coated with a lacquer or lacquer based composition so as to avoid interaction between the beverage composition and the container surface.
  • the composition is filled in the container to a surface level so as allowing a headspace above said surface level sufficient to generally minimize spillage of the composition while handling the container without the closure and still the composition is stable to avoid the interaction between the air entrapped in the head space and the composition.
  • the container is selected from bottle or metal cans.
  • the metal cans are formed of materials selected from aluminum, steel, tin or alloys thereof.
  • the can contains single use unit dose.
  • the can provides about 8 to 20 g of protein per 150 ml of the composition.
  • the can is provided with EOE (easy open ends) seamed to the can body.
  • EOE Easy open ends
  • the can in another embodiment, includes double neck on top side and single neck on bottom side that is attached to cylindrical can body by EOE seam.
  • the internal lacquer coating is consistently distributed throughout the inner walls of the container.
  • the lacquer meets the requirements of food safety regulations; in particular the lacquer is food grade.
  • the lacquer is light-colored and imparts a smooth surface finish or polish to the container.
  • container has golden colour coating.
  • the metal cans are coated with acrylic lacquers, oleoresinous lacquers, vinyl lacquers, vinyl organosols, epoxy amines, epoxy phenolics and epoxy based lacquer.
  • the lacquer maintains its integrity without cracking during can processing.
  • the lacquer withstands deformation during the manufacture of the containers and during transportation.
  • the coating layer of the container withstands elevated temperature conditions associated with retort or other sterilization processes.
  • step (a) b) filling the composition of step (a) into lacquer coated aluminum cans and c) sealing the filled cans under aseptic conditions.
  • micellar casein and hydrolyzed whey proteins are present in the weight ratio of about 75:25 to about 85:15
  • protein beverage is cooled to a low temperature before filling into cans.
  • the beverage is pasteurized by batch pasteurization prior to sealing of the cans. In another embodiment, the beverage is pasteurized subsequent to sealing of the cans. In another embodiment, the outer face of the cans may be lacquered to prevent any possible corrosion of the metal surface.
  • the composition is stable in sealed cans on storage at room temperature for about 12 months.
  • a method of producing a hermetically sealed beverage container comprising: sterilizing the protein beverage composition, sterilizing a container body, placing said sterilized protein composition into said sterilized container body, whereby said container has a long shelf life at room temperature.
  • the top of the canned container is hermetically sealed after the addition of beverage.
  • the sealed cans are subject to retort sterilization at temperatures of about 110 to 140°C for about 15 to 30 minutes.
  • the beverage remains stable and does not show gelation or coagulation of proteins at high temperatures during sterilization.
  • the container is flushed with nitrogen before filing the composition into the container or even after filing the composition.
  • beverage refers to any water-based liquid which can be ingested orally as a drink, e.g. by sipping, pouring or tube-feeding.
  • 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 ultra filtration 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.
  • MPC Milk Protein Concentrate
  • MPI Milk Protein Isolate
  • 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 is a measure of the proportion of absorbed protein from a food which becomes incorporated into the proteins of the organism's body.
  • 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 excipients that provide the composition desired taste for consumption by the subject.
  • stable refers to stability of more than 6 months under normal storage conditions, i.e. at an ambient temperature of between 18 and 25°C, and at a relative humidity of 35%.
  • the packaged protein drink composition may be stored at room temperature for at least about 12 months.
  • 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.
  • aseptic processing includes fundamental requirements (1) all product contact equipment and final packaging components to be sterilized using validated cycles, (2) the processes to be carried out in environmentally controlled facilities under approved class area. Aseptic processing involves the processing and packaging of a commercially sterile product into sterilized containers followed by hermetic sealing with a sterilized closure in a manner that prevents viable microbiological recontamination of the sterile product. It provides the benefits of longer shelf life, wider packaging sizes, wider container materials and improved nutritional and sensory properties.
  • composition of the present invention is prepared under controlled conditions of temperature, humidity and microbial load.
  • the processing time between the production and filling (hold time) is kept to minimum possible to decrease the chances of microbial contamination.
  • HTST High Temperature Short Time
  • UHT Ultra High Temperature
  • Sterilization can be done by autoclaving using a modified cycle by F0 based cycle, Modified Temperature, Modified Time. It was surprisingly observed that the position in which the container are kept affect the sterilization process, to ensure effective sterilization, a consistent and smooth heating autoclaving process was followed.
  • can includes a rigid retortable container, e.g., a metal container such as a metal or metal alloy can.
  • easy open end refers to a can end (typically an end of a beverage container) that includes (i) a frangible opening portion and (ii) a riveted portion for attaching a pull tab thereto for purposes of opening the frangible opening portion to access the product housed within a can or container.
  • composition is packaged in low-volume metal cans of the kind which are frequently used in the art, the material of the can is chosen such that there is no interaction between the protein composition and metal surface.
  • lacquers coated on the inner side walls of the can/container are those conventionally used in the industry including acrylic lacquers, oleoresinous lacquers, vinyl lacquers, vinyl organosols, epoxy amines, epoxy phenolics and epoxy based lacquer. Lacquers may be applied by any method known to a person skilled in the art that includes electrophoresis, dipping, spraying or brushing the container with the coating composition.
  • Purified water was taken in a Batch Pasteurizer at about 50-55°C.
  • Dairy protein powder was dissolved in heated water to make a uniform solution.
  • the solution was cooled to around 4°C and filtered using appropriate mesh into a double jacketed storage tank.
  • step 6 The solution from step 6 was filled into 150 ml cans and sealed.
  • the protein beverage composition was prepared as per the procedure given in Example
  • Example 2 The composition of Example 2 was prepared according to composition given in Example 1 and packaged in 180 ml container with 173 ml of the composition. The container is coated internally with double layer epoxy-phenyl coating having a thickness of first layer as 6-8gsm and second layer as 9-12 gsm.

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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Nutrition Science (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Non-Alcoholic Beverages (AREA)

Abstract

La présente invention concerne une composition de boisson prête à boire à base de protéine qui comprend des protéines de haute qualité en une quantité suffisante pour compenser l'acide aminé perdu pendant le processus de dialyse ou lors d'une affection conduisant aux soins intensifs. La composition est une boisson stable sans danger pour le patient et agréable au goût fournie en petit volume pour augmenter la conformité et est exempte d'additifs qui sont autrement normalisés dans le dialysat. L'invention concerne également un procédé de préparation d'une composition stable de boisson à base de protéine prête à boire comprenant environ 8 à 20 g de protéine pour 150 ml de la composition. La composition ainsi produite est stable sans séparation de phase, crémage, gélification et sédimentation, et conserve une viscosité constante dans le temps. La présente invention concerne également un contenant revêtu contenant une boisson à base de protéine, la composition pouvant être stockée à une température ambiante inférieure à 25 °C et aucune condition de stockage particulière n'étant requise.
PCT/IN2020/050630 2019-07-22 2020-07-22 Composition de boisson prête à boire à base de protéine WO2021014467A1 (fr)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
IN201911029380 2019-07-22
IN201911029378 2019-07-22
IN201911029378 2019-07-22
IN201911029381 2019-07-22
IN201911029381 2019-07-22
IN201911029379 2019-07-22
IN201911029380 2019-07-22
IN201911029379 2019-07-22

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WO2021014467A1 true WO2021014467A1 (fr) 2021-01-28

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5998363A (en) * 1995-10-27 1999-12-07 Beth Israel Deaconess Medical Center, Inc. Enteral formulation: low in fat and containing protein hydrolysates
US20190069589A1 (en) * 2015-10-01 2019-03-07 Frieslandcampina Nederland B.V. Liquid nutritional composition comprising micellar casein and hydrolysed whey protein

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5998363A (en) * 1995-10-27 1999-12-07 Beth Israel Deaconess Medical Center, Inc. Enteral formulation: low in fat and containing protein hydrolysates
US20190069589A1 (en) * 2015-10-01 2019-03-07 Frieslandcampina Nederland B.V. Liquid nutritional composition comprising micellar casein and hydrolysed whey protein

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
JONKER, R . ET AL.: "Hydrolyzed casein and whey protein meals comparably stimulate net whole-body protein synthesis in COPD patients with nutritional depletion without an additional effect of leucine co-ingestion", CLINICAL NUTRITION, vol. 33, no. 2, 2014, pages 211 - 220, XP028627410, DOI: 10.1016/j.clnu. 2013.06.01 4 *

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