A low-protein nutritional formula for patients with kidney disease and a preparation method thereof

Abstract

The present application belongs to the technical field of protein meal replacement nutrition formula, and particularly relates to a low-protein meal replacement nutrition formula for kidney disease patients and a preparation method, wherein the finished product has a phosphorus content of less than or equal to 9 mg / 100 g, a potassium content of less than or equal to 3 mg / 100 g, a protein content of less than or equal to 3.1 g / 100 g, an energy density of 1768 kJ / 100 g, a dietary fiber content of more than or equal to 13.0 g / 100 g, and a low GI value; the complex vitamins comprise vitamin D, vitamin E, vitamin B1, vitamin B2, vitamin B6, vitamin B12, nicotinic acid, folic acid, pantothenic acid, biotin and taurine; and the separated whey protein has a purity of more than or equal to 92.6%.

Description

Technical Field

[0001] This invention belongs to the field of protein meal replacement nutritional formula technology, and in particular relates to a low-protein meal replacement nutritional formula and preparation method for patients with kidney disease. Background Technology

[0002] Patients with chronic kidney disease have impaired renal filtration function and reduced ability to regulate electrolyte and mineral metabolism. They are unable to effectively excrete excess phosphorus and potassium ions, leading to long-term accumulation and potentially causing hyperphosphatemia and hyperkalemia. These conditions can result in serious complications such as arrhythmia and vascular calcification, both of which significantly increase the risk of death in patients with chronic kidney disease, threatening their lives. Furthermore, a low-protein diet is a clinically recognized core principle of nutritional management for patients with chronic kidney disease. Therefore, patients with chronic kidney disease must strictly adhere to a low-protein, low-phosphorus, and low-potassium diet while ensuring adequate energy supply and nutritional balance to maintain normal metabolism and immunity.

[0003] Currently, most meal replacement products on the market are geared towards general weight loss or nutritional supplementation. There are few meal replacements specifically designed for patients with chronic kidney disease, and those that are available have significant drawbacks: some products, although labeled as low in protein, do not meet the zero-content control standards for phosphorus and potassium, still posing a risk of inducing complications; other products have unbalanced nutritional ratios, either with insufficient energy density or lacking dietary fiber, essential vitamins, and other nutrients, failing to meet the nutritional needs of patients with chronic kidney disease. There is an urgent need to develop a dedicated meal replacement formula with extremely low phosphorus and potassium content, controllable protein content, and comprehensive nutrition. Summary of the Invention

[0004] The purpose of this invention is to address the aforementioned technical problems by providing a low-protein meal replacement nutritional formula and preparation method for patients with kidney disease.

[0005] In view of this, the present invention provides a low-protein meal replacement nutritional formula for patients with kidney disease, the formula comprising, by weight percentage: Maltodextrin 30-50%, vegetable oil microcapsule powder 15-40%, high amylose corn starch 10-30%, fructooligosaccharides 3-10%, whey protein isolate 1-10%, L-carnitine 1-6%, stachyose 0.5-2%, flavoring 0.1-1.0%, complex vitamins 0.1-1.0%, isomerized lactose 0.1-1.0%, sucralose 0.001-0.01%; The finished product contains ≤14mg / 100g of phosphorus, ≤20mg / 100g of potassium, ≤4.0g / 100g of protein, has an energy density of 1700kJ / 100g, a dietary fiber content of ≥13.0g / 100g, and a low GI value. The multivitamin contains vitamin D, vitamin E, vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, folic acid, pantothenic acid, biotin, and taurine. The purity of the isolated whey protein is ≥92.6%.

[0006] A method for preparing a low-protein meal replacement nutritional formula for kidney disease patients, step one: take each material according to the formula amount, take the excess of whey protein (105%), maltodextrin (104%), and high amylose corn starch (111%), and take the remaining materials precisely. Step 2: Remove the outer packaging and transfer the product to the production area via a tunnel sterilizer, where it will be sterilized with ultraviolet light for 30 minutes; Step 3: Separate whey protein at 70±5℃, maltodextrin at 80±5℃, and high amylose corn starch at 70±5℃ and dry them separately until the moisture content is ≤3.5%. After drying, weigh them accurately according to the formula amount, and treat the excess as waste. Step 4: Mix in six steps in sequence, with each material passing through a 20-mesh sieve. The first two steps are done manually for 5 minutes each, and the last four steps are done using a three-dimensional motion mixer at a frequency of 40 Hz for 5 minutes, 10 minutes, 15 minutes, and 20 minutes respectively. Step 5: The inner packaging uses a JS-DL single-row back-sealing packaging machine with a heating temperature of 120-180℃ and a filling amount of 25g / bag. The appearance, filling amount and sealing performance are checked regularly. The outer packaging is sealed in 12 bags / boxes, and after printing the relevant markings, it is put into storage.

[0007] Preferably, the six mixing steps in step two are as follows: the first step is to mix isomerized lactose, sucralose, and compound vitamins to obtain mixture A; The second step is to mix stachyose, flavoring, and mixture A to obtain mixture B; The third step is to mix L-carnitine, whey protein isolate, and mixture B to obtain mixture C; The fourth step is to mix fructooligosaccharides, high amylose corn starch, and mixture C to obtain mixture D; The fifth step is to mix the vegetable oil microcapsule powder with mixture D to obtain mixture E; Step 6: Mix maltodextrin with mixture E to obtain the finished mixture.

[0008] Preferably, the sealing test parameter in step three is a vacuum pressure of 0.4-0.6 kPa for 60 seconds.

[0009] Preferably, in step three, during the inner packaging stage, the appearance and quantity are checked every 30 minutes, and the sealing performance is checked every 60 minutes.

[0010] Preferably, the weight of each component can be scaled proportionally according to the batch size, while maintaining the same weight percentage.

[0011] Preferably, the drying equipment is a hot air circulating oven.

[0012] Preferably, the moisture content of the dried material in step one is ≤3.5%.

[0013] Preferably, the sodium content in the finished product is ≤60mg / 100g.

[0014] The beneficial effects of this invention are: by precisely proportioning raw materials, the finished product achieves zero-content control with phosphorus content ≤14mg / 100g and potassium content ≤20mg / 100g, thus avoiding the risk of hyperphosphatemia and hyperkalemia in patients from the source. At the same time, the low protein standard of ≤4.0g / 100g is adapted to the renal metabolic load. High-purity isolated whey protein (purity ≥92.6%) is combined with comprehensive complex vitamins and dietary fiber, which not only ensures amino acid supply and nutritional balance, but also meets the long-term energy needs and blood sugar stability requirements of patients with its high energy density of 1768kJ / 100g and low GI value.

[0015] The preparation process employs targeted material pretreatment (excess material requisition, graded drying, and double sterilization) to ensure the purity and safety of raw materials. A six-step graded sieving and mixing process (a combination of manual and three-dimensional motion mixers) ensures uniform dispersion of each component. Coupled with a rigorous packaging inspection process (timed appearance, filling volume, and sealing inspection), the product quality is stable and controllable. At the same time, it supports flexible adjustment of flavor and taste, taking into account both production feasibility and the potential for large-scale promotion, while also meeting the diverse consumption needs of patients, significantly improving clinical application suitability and user experience. Attached Figure Description

[0016] Figure 1 This is a flowchart of the present invention. Detailed Implementation

[0017] The technical solutions of the embodiments of this application will be clearly described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application are within the scope of protection of this application.

[0018] Formula composition (by weight percentage): maltodextrin 30-50%, vegetable oil microcapsule powder 15-40%, high amylose corn starch 10-30%, fructooligosaccharides 3-10%, whey protein isolate 1-10%, L-carnitine 1-6%, stachyose 0.5-2%, flavoring 0.1-1.0%, complex vitamins 0.1-1.0%, isomerized lactose 0.1-1.0%, sucralose 0.001-0.01%.

[0019] Formula characteristics: The finished product contains ≤9mg / 100g of phosphorus and ≤3mg / 100g of potassium, achieving zero-content control of phosphorus and potassium; the protein content is ≤3.1g / 100g, and the purity of whey protein isolate is ≥92.6%, with a biological value of 129-158 and a complete amino acid composition; the energy density reaches 1768kJ / 100g, the dietary fiber content is 13.0g / 100g, and the GI value is low, making it suitable for the metabolic characteristics of patients with kidney disease.

[0020] Material pretreatment; Material requisition: Requisition each material according to the formula quantity. For whey protein isolate, requisition at 105%, maltodextrin at 104%, and high amylose corn starch at 111% in excess. For the remaining materials, requisition precisely according to the formula quantity.

[0021] Disinfection and sterilization: Remove the outer packaging of the materials and transfer them to the production area through a tunnel sterilizer, where they are sterilized by ultraviolet lamps for 30 minutes.

[0022] Drying: Whey protein isolate is dried in a hot air circulating oven at 70±5℃ until the moisture content is ≤3.5%; maltodextrin is dried in a hot air circulating oven at 80±5℃ until the moisture content is ≤3.5%; high amylose corn starch is dried in a hot air circulating oven at 70±5℃ until the moisture content is ≤3.5%. After drying, the amount is accurately weighed according to the formula, and any excess is disposed of as waste.

[0023] Mixing process; Step 1: Pass the isomerized lactose, sucralose, and multivitamins through a 20-mesh sieve and mix by hand for 5 minutes to obtain mixture A; Step 2: Pass the stachyose and strawberry flavoring through a 20-mesh sieve, and mix them by hand with mixture A for 5 minutes to obtain mixture B; Step 3: Pass L-carnitine and whey protein isolate through a 20-mesh sieve, put them into a three-dimensional motion mixer, and mix them with mixture B at a frequency of 40HZ for 5 minutes to obtain mixture C; Step 4: Pass the oligofructose and high amylose corn starch through a 20-mesh sieve, add them to a mixer, and mix them with mixture C at a frequency of 40 Hz for 10 minutes to obtain mixture D; Step 5: Pass the vegetable oil microcapsule powder through a 20-mesh sieve, add it to a mixer, and mix it with mixture D at a frequency of 40 Hz for 15 minutes to obtain mixture E; Step 6: Pass the maltodextrin through a 20-mesh sieve, add it to a mixer, and mix it with mixture E at a frequency of 40 Hz for 20 minutes to obtain the finished mixture.

[0024] Packaging process; Inner packaging: JS-DL single-row back-sealing packaging machine is used, with the heating temperature set at 120-180℃ and the filling amount at 25g / bag (lower allowable limit 23.75g). The appearance and filling amount are checked every 30 minutes, and the sealing performance is checked every 60 minutes (vacuum pressure 0.4-0.6Kpa, lasting for 60 seconds). Outsourcing: Packed in 12 bags / boxes, with production batch number, production date and expiration date printed on them, and then put into storage after packing. Example 1:

[0025] U-Vision Whey Protein Isolate Low-Protein Nutritional Pack Formula (based on a 180kg batch): Maltodextrin 76.01kg, Vegetable Oil Microcapsule Powder 52.20kg, High Amylose Corn Starch 28.26kg, Fructooligosaccharides 9.00kg, Whey Protein Isolate 5.40kg, L-Carnitine 4.80kg, Stachyose 1.80kg, Strawberry Flavoring 1.44kg, Complex Vitamins 0.90kg, Isomerized Lactose 0.18kg, Sucralose 0.014kg.

[0026] Preparation steps: Material pretreatment: whey protein isolate was dispensed at 5.67 kg (105%), dried at 70℃ to 3.2% moisture content, and accurately weighed at 5.40 kg; maltodextrin was dispensed at 79.05 kg (104%), dried at 80℃ to 3.0% moisture content, and accurately weighed at 76.01 kg; high amylose corn starch was dispensed at 31.37 kg (111%), dried at 70℃ to 3.3% moisture content, and accurately weighed at 28.26 kg; the remaining materials were dispensed according to the formula amount and then subjected to tunnel sterilization + ultraviolet sterilization for 30 min.

[0027] Mixing: Follow the above six mixing steps in sequence, with a mixing frequency of 40Hz at each stage and strict control of the mixing time.

[0028] Packaging: The inner packaging is set with a filling amount of 25g / bag, and the amount is controlled between 23.8-26.2g. The sealing test is qualified; the outer packaging is sealed in boxes of 12 bags and then put into storage.

[0029] Finished product testing: Protein content 3.1g / 100g, phosphorus content 4.5mg / 100g, potassium content 3mg / 100g, sodium content 56mg / 100g, energy 1768kJ / 100g, meeting design requirements. Example 2:

[0030] The K+ formula in the Xikanglisu Special Dietary Complex Nutrition Pack is the same as in Example 1, specially designed for non-dialysis chronic kidney disease patients. Based on clinical guidelines and industry standards, its formula incorporates high-biological-value isolated whey protein with a purity ≥92.6%, offering absorption rates far exceeding ordinary protein. It provides essential high-quality amino acids while reducing the metabolic burden on the kidneys with a low protein content of only 3.8%. The product achieves extreme low-sodium control, with daily phosphorus and potassium intake nearly zero, mitigating the risk of life-threatening complications such as hyperphosphatemia and hyperkalemia. Combined with a low-GI carbohydrate blend, it stabilizes blood sugar levels suitable for diabetic nephropathy patients, regulates gut microbiota, reduces intestinal toxin accumulation, and improves common intestinal disorders in kidney disease patients.

[0031] The preparation steps are the same as in Example 1. The finished product was tested and found to have extremely low sodium, phosphorus, and potassium content, and a protein content of 3.0 g / 100 g, which meets the requirements for low sodium, phosphorus, potassium, and low protein.

[0032] The embodiments of this application have been described above with reference to the accompanying drawings. Unless otherwise specified, the embodiments and features in the embodiments of this application can be combined with each other. This application is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of this application without departing from the spirit and scope of the claims, and all of these forms are within the protection scope of this application.

Claims

1. A low-protein meal replacement nutritional formula for patients with kidney disease, characterized in that: By weight percentage, the formulation comprises: Maltodextrin 30-50%, vegetable oil microcapsule powder 15-40%, high amylose corn starch 10-30%, fructooligosaccharides 3-10%, whey protein isolate 1-10%, L-carnitine 1-6%, stachyose 0.5-2%, flavoring 0.1-1.0%, complex vitamins 0.1-1.0%, isomerized lactose 0.1-1.0%, sucralose 0.001-0.01%; The finished product contains ≤9mg / 100g of phosphorus, ≤3mg / 100g of potassium, ≤3.1g / 100g of protein, has an energy density of 1768kJ / 100g, a dietary fiber content of 13.0g / 100g, and a low GI value. The multivitamin contains vitamin D, vitamin E, vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, folic acid, pantothenic acid, biotin, and taurine. The purity of the isolated whey protein is ≥92.6%.

2. A method for preparing a low-protein meal replacement nutritional formula for kidney disease patients, based on the low-protein meal replacement nutritional formula for kidney disease patients according to claim 1, characterized in that: Step 1: Collect each material according to the formula. Collect more than the required amount of whey protein isolate (105%), maltodextrin (104%), and high amylose corn starch (111%). Collect the remaining materials precisely. Step 2: Remove the outer packaging and transfer the product to the production area via a tunnel sterilizer, where it will be sterilized with ultraviolet light for 30 minutes; Step 3: Separate whey protein at 70±5℃, maltodextrin at 80±5℃, and high amylose corn starch at 70±5℃ and dry them separately until the moisture content is ≤3.5%. After drying, weigh them accurately according to the formula amount, and treat the excess as waste. Step 4: Mix in six steps in sequence, with each material passing through a 20-mesh sieve. The first two steps are done manually for 5 minutes each, and the last four steps are done using a three-dimensional motion mixer at a frequency of 40 Hz for 5 minutes, 10 minutes, 15 minutes, and 20 minutes respectively. Step 5: The inner packaging uses a JS-DL single-row back-sealing packaging machine with a heating temperature of 120-180℃ and a filling amount of 25g / bag. The appearance, filling amount and sealing performance are checked regularly. The outer packaging is sealed in 12 bags / boxes, and after printing the relevant markings, it is put into storage.

3. The method for preparing a low-protein meal replacement nutritional formula for kidney disease patients according to claim 2, characterized in that: The six mixing steps in step two are as follows: The first step is to mix isomerized lactose, sucralose, and multivitamins to obtain mixture A; The second step is to mix stachyose, flavoring, and mixture A to obtain mixture B; The third step is to mix L-carnitine, whey protein isolate, and mixture B to obtain mixture C; The fourth step is to mix fructooligosaccharides, high amylose corn starch, and mixture C to obtain mixture D; The fifth step is to mix the vegetable oil microcapsule powder with mixture D to obtain mixture E; Step 6: Mix maltodextrin with mixture E to obtain the finished mixture.

4. The method for preparing a low-protein meal replacement nutritional formula for kidney disease patients according to claim 2, characterized in that: In step three, the sealing test parameter is a vacuum pressure of 0.4-0.6 kPa; Lasts 60 seconds.

5. The method for preparing a low-protein meal replacement nutritional formula for kidney disease patients according to claim 2, characterized in that: In step three, during the inner packaging stage, the appearance and filling volume are checked every 30 minutes. Check the seal every 60 minutes.

6. The method for preparing a low-protein meal replacement nutritional formula for kidney disease patients according to claim 1, characterized in that: The weight of each component can be scaled proportionally according to the batch size; Keep the weight percentage constant.

7. The method for preparing a low-protein meal replacement nutritional formula for kidney disease patients according to claim 2, characterized in that: The drying equipment uses a hot air circulating oven.

8. The method for preparing a low-protein meal replacement nutritional formula for kidney disease patients according to claim 1, characterized in that: The moisture content of the dried material in step one was ≤3.5%.

9. The method for preparing a low-protein meal replacement nutritional formula for kidney disease patients according to claim 1, characterized in that: The sodium content in the finished product is ≤60mg / 100g.

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