Nutritional composition as well as preparation method and application thereof

Abstract

The invention provides a nutritional composition as well as a preparation method and application thereof, and relates to the technical field of functional food preparation, the nutritional composition comprises protein, fat, carbohydrate and dietary fiber, and the energy supply ratios of the protein, the fat, the carbohydrate and the dietary fiber are 15-20%, 20-26%, 52-56% and 1-5% respectively; on the basis of the mass of the protein, the content of phosphorus in the protein is (300-1500) mg / 100g. The nutritional composition provides balanced nutrient substances, can keep the stability of the body mass of a patient, can meet the nutritional requirements of the nephrotic patient, can effectively inhibit or relieve the reduction of the renal function of the nephrotic patient, improves the life quality and prognosis of the nephrotic patient, and is particularly suitable for the nephrodialysis chronic nephrotic patient.

Description

Technical Field

[0001] This invention relates to the field of functional food preparation technology, and in particular to a nutritional composition, its preparation method, and its application. Background Technology

[0002] Nephropathy refers to various acute and chronic kidney diseases, as well as acute and chronic kidney function damage resulting from other systemic diseases, leading to kidney failure. Chronic kidney disease (CKD) is widely defined clinically as kidney damage lasting 3 months or more. End-stage renal disease (ESRD) refers to the terminal stage of various chronic kidney diseases (CKD), commonly known as "uremia." It is generally considered that a diagnosis can be made when the glomerular filtration rate (GFR) drops below 15 mL / min.

[0003] Currently, the global incidence of end-stage renal disease (ESRD) is increasing year by year. The poor prognosis and high treatment costs of ESRD have made it a significant public health problem worldwide. Studies have shown that malnutrition is a crucial factor affecting the prognosis of kidney disease patients. Patients with kidney disease are highly susceptible to malnutrition when their glomerular filtration rate (GFR) is <60 mL / min. Therefore, nutritional management and dietary therapy for CKD patients can effectively improve their quality of life and prognosis.

[0004] Patent CN114365841A discloses a complete nutritional milk suitable for kidney disease patients and its preparation method. The complete nutritional milk contains carbohydrates, fats, dietary fiber, vitamins, minerals, casein, phospholipids, sucrose fatty acid esters, and carrageenan; the mass ratio of casein, phospholipids, sucrose fatty acid esters, and carrageenan is (3.0~5.0):(0.2~0.4):(0.03~0.05):(0.01~0.05). While this nutritional milk can meet the nutritional needs of kidney disease patients, it does not consider the impact on renal metabolism in these patients, and therefore cannot effectively inhibit or alleviate the decline in renal function. Consequently, it cannot effectively improve the physical condition of kidney disease patients (especially those on dialysis) in the long term, thus lowering the prognosis.

[0005] Therefore, this invention is proposed. Summary of the Invention

[0006] This invention provides a nutritional composition, its preparation method, and its application. The nutritional composition provides balanced nutrients, which can maintain the stability of the patient's body weight. It can not only meet the nutritional needs of patients with kidney disease, but also effectively inhibit or alleviate the decline of kidney function in patients with kidney disease, thereby improving the quality of life and prognosis of patients with kidney disease. It is especially suitable for patients with chronic kidney disease undergoing kidney dialysis.

[0007] This invention provides a nutritional composition comprising: protein, fat, carbohydrates, and dietary fiber, wherein the energy contribution ratios of protein, fat, carbohydrates, and dietary fiber are 15-20%, 20-26%, 52-56%, and 1-5%, respectively. Based on the mass of the protein, the phosphorus content in the protein is (300~1500) mg / 100g.

[0008] Among the human organs, the kidneys are responsible for about two-thirds of phosphorus excretion. Patients with CKD stage 4-5 have a reduced glomerular filtration rate, making it difficult to maintain phosphorus balance and easily leading to hyperphosphatemia. Hyperphosphatemia can accelerate the deterioration of kidney disease, induce cardiovascular calcification and other problems, and increase the risk of death in kidney disease patients.

[0009] Based on the metabolic characteristics of kidney disease patients, this invention optimizes the functional ratio of protein, fat, carbohydrates, and dietary fiber, and controls the phosphorus content in protein within the aforementioned range. The resulting nutritional composition is a high-energy-density food that not only provides balanced nutrition for kidney disease dialysis patients but also meets their basic nutritional needs. It can reduce water intake, alleviate the burden on the kidneys of patients with chronic kidney disease, and adjust their metabolic level, thereby improving their quality of life and prognosis. It has significant market value.

[0010] Furthermore, the energy density of the nutritional composition is 1.5~2.0 kcal / mL. Preferably, it is 1.8~2.0 kcal / mL.

[0011] Furthermore, in the fat, the mass ratio of polyunsaturated fatty acids: saturated fatty acids: monounsaturated fatty acids is (1.0~2.0):1:1.

[0012] Abnormal levels of serum triglycerides and cholesterol are common complications in patients with chronic kidney disease. These abnormalities not only accelerate the deterioration of kidney function but also significantly increase the risk of cardiovascular complications. This study found that controlling the mass ratio of polyunsaturated fatty acids, saturated fatty acids, and monounsaturated fatty acids within the specified range helps to inhibit the rise in serum triglyceride and cholesterol levels, thereby suppressing the deterioration of kidney function and reducing the risk of cardiovascular complications in patients with kidney disease.

[0013] Preferably, in the polyunsaturated fatty acids, the mass ratio of linoleic acid (n-6) to linolenic acid (n-3) is (1.0~4.0):1.

[0014] Maintaining the mass ratio of linoleic acid and alpha-linolenic acid within the above range can help kidney disease patients maintain a better metabolic state. At the same time, it can also reduce the inflammatory nature of linoleic acid (n-6) metabolites, thus achieving a better balance between health and metabolism.

[0015] Preferably, the fat is provided by a blend of edible vegetable oils, which includes one or more of rapeseed oil, sunflower oil, flaxseed oil, perilla seed oil, and corn oil.

[0016] Preferably, the blended edible vegetable oil comprises, by weight percentage, 60-90% rapeseed oil, 5-10% sunflower seed oil, and 1-5% corn oil.

[0017] Preferably, the edible vegetable blend oil also includes antioxidants.

[0018] More preferably, the antioxidant is ascorbyl palmitate, and its addition amount is 0.01~0.05% based on the mass of the edible vegetable blend oil.

[0019] Furthermore, the nutritional composition also includes stabilizers and emulsifiers. The stabilizers include one or more of carrageenan, gellan gum, xanthan gum, microcrystalline cellulose, β-cyclodextrin, and sodium carboxymethyl cellulose. The emulsifiers include any one or more of phospholipids, mono- and diglycerides of fatty acids, glycerides of fatty acids of citrate, monoglycerides of succinate, and sodium octenyl succinate starch.

[0020] Preferably, the mass ratio of the protein, fat, carbohydrate, dietary fiber, stabilizer and emulsifier is (4.0~10.0):(3.0~7.0):(20.0~30.0):(2.0~4.0):(0.02~0.2):(0.05~0.6).

[0021] Preferably, the stabilizer is a mixture of carrageenan, microcrystalline cellulose and sodium carboxymethyl cellulose, and the emulsifier is a phospholipid or a mixture of mono- and diglycerides of fatty acids and glycerides of citrate fatty acids.

[0022] To ensure the stability of the nutritional composition system, this invention studies the selection and combination of various stabilizers and emulsifiers, and compares their stability effects. It was found that using a mixture of carrageenan, microcrystalline cellulose, and sodium carboxymethyl cellulose as a stabilizer, and a mixture of phospholipids or mono- and di-fatty acid glycerides and citrate fatty acid glycerides as an emulsifier, the combined use of the two prevents physical instability phenomena such as fat floating, flocculation, aggregation, and phase separation in the nutritional composition system of this invention during storage, which can significantly improve the stability of the nutritional composition and thus enhance its efficacy.

[0023] Preferably, based on the volume of the nutritional composition, the stabilizer contains 0.02-0.05% (w / v) carrageenan, 0.03-0.06% (w / v) microcrystalline cellulose, and 0.02-0.06% (w / v) sodium carboxymethyl cellulose.

[0024] Preferably, the amount of phospholipid added is 0.3~0.6% (w / v) based on the volume of the nutritional composition.

[0025] Preferably, the mass ratio of the mono- and di-fatty acid glycerides to the citrate fatty acid glycerides is (2.0~3.0):1.

[0026] Furthermore, the protein is selected from one or more of casein, sodium caseinate, calcium caseinate, soy protein isolate, and whey protein powder; Casein is a type of phosphorus- and calcium-binding protein found in mammalian milk. It contains eight essential amino acids, has good solubility, and is distributed in dairy products in an ultra-fine colloidal state. It readily associates with itself or with other substances to form a stable polymer network.

[0027] Sodium caseinate and calcium caseinate are casein salts that have emulsifying and stabilizing effects and are widely used in liquid and wet process products. When casein forms a soluble complex with calcium ions, it can effectively prevent calcium from precipitating in the neutral or slightly alkaline environment of the small intestine.

[0028] Soy protein isolate has dispersing, dissolving, stabilizing and emulsifying properties. It has a protein content of over 90%, is lactose-free to avoid lactose intolerance, and is cholesterol-free. It is a low-calorie, high-nutrient, safe and convenient raw material for dairy product processing.

[0029] Whey protein powder has good solubility in liquid products and is almost unaffected by the pH of the solution, making it suitable for use in neutral and acidic emulsion foods. Its good emulsifying properties help maintain the texture of liquid products. For complete nutritional formula foods, which typically contain vegetable oils, vitamins, and minerals, whey protein can adsorb at the oil / water interface to form a stable emulsion.

[0030] And / or, the carbohydrate is selected from one or two of maltodextrin, wheat starch, solid corn syrup and fructose; And / or, the dietary fiber is selected from any one or two of resistant dextrin, inulin, and galactomannan.

[0031] Further, each 100 mL of the nutritional composition comprises 6-10 g of protein, 4-7 g of fat, 22-27 g of carbohydrates, 2-4 g of dietary fiber, 0.05-0.2 g of stabilizer, and 0.05-0.5 g of emulsifier; Preferably, each 100 mL of the nutritional composition comprises 4-11 g of calcium caseinate, 0-5 g of sodium caseinate, 0-2 g of concentrated whey protein powder, 0-6 g of soy protein isolate, 25-30 g of maltodextrin or solid corn syrup, 4-6 g of edible vegetable blended oil, 0-4 g of inulin, 0-4 g of resistant dextrin, 0.02-0.05 g of carrageenan, 0-0.5 g of phospholipids, 0-0.10 g of mono- and diglycerides of fatty acids, 0-0.04 g of citric acid fatty acid glycerides, 0.03-0.06 g of microcrystalline cellulose, and 0.02-0.06 g of sodium carboxymethyl cellulose.

[0032] More preferably, each 100 mL of the nutritional composition comprises 4-11 g of calcium caseinate, 1-6 g of sodium caseinate or concentrated whey protein powder or soy protein isolate, 25-30 g of solid corn syrup or maltodextrin, 4-6 g of edible vegetable blended oil, 0-4 g of inulin, 0-4 g of resistant dextrin, 0.02-0.05 g of carrageenan, 0.3-0.4 g of phospholipids, or 0.08-0.14 g of a mixture of mono- and diglycerides of fatty acids and glycerides of citrate fatty acids in a mass ratio of 2:1, 0.03-0.06 g of microcrystalline cellulose, and 0.02-0.06 g of sodium carboxymethyl cellulose.

[0033] Furthermore, the nutritional composition also includes calcium salt, and the amount of calcium salt added is 0.05~0.3% (w / v) based on the volume of the nutritional composition.

[0034] Preferably, the calcium salt is calcium carbonate.

[0035] Furthermore, the nutritional composition also includes a complex vitamin, and the amount of the complex vitamin added is 0.4~0.6% (w / v) based on the volume of the nutritional composition.

[0036] Preferably, each 1 g of the complex vitamin contains 200-800 μg of vitamin A, 5-15 μg of vitamin D, 8-20 mg of vitamin E, 30-80 μg of vitamin K1, 3-6 mg of vitamin B1, 2-5 mg of vitamin B2, 2-4 mg of vitamin B6, 1-4 μg of vitamin B12, 3-8 mg of niacin, 180-260 μg of folic acid, 4-7 mg of pantothenic acid, 300-600 mg of vitamin C, and 30-70 μg of biotin.

[0037] The compound vitamins of this invention can be sourced from the following raw materials, but are not limited to: Vitamin A: Retinyl palmitate; Vitamin D: Cholecalciferol; Vitamin E: dl-α-tocopherol acetate; Vitamin K1: Menaquinone; Vitamin B1: Thiamine hydrochloride; Vitamin B2: Riboflavin; Vitamin B6: Pyridoxine hydrochloride; Vitamin B12: Cyanocobalamin; Niacin: Nicotinamide; Folic acid: Folic acid; Pantothenic acid: D-calcium pantothenate; Vitamin C: Sodium L-ascorbate; Biotin: D-Biotin.

[0038] Furthermore, the nutritional composition also includes minerals, and the amount of minerals added is 1 to 2% (w / v) based on the volume of the nutritional composition.

[0039] Preferably, each 1 g of the mineral contains 15-30 mg of sodium, 60-100 mg of potassium, 80-150 μg of copper, 15-30 mg of magnesium, 1-3 mg of iron, 1-3 mg of zinc, 150-400 μg of manganese, 35-65 mg of phosphorus, 50-100 μg of iodine, 30-50 mg of chlorine, 10-25 μg of selenium, 120-250 μg of chromium, and 40-80 mg of choline.

[0040] The minerals used in this invention can be sourced from the following raw materials, but are not limited to: Sodium: Sodium chloride; Potassium: Potassium citrate; Copper: Copper sulfate; Magnesium: Magnesium sulfate; Iron: Ferrous sulfate; Zinc: Zinc sulfate; Manganese: Manganese sulfate; Phosphorus: Tricalcium phosphate; Iodine: Potassium iodide; Chlorine: Sodium chloride; Selenium: Sodium selenite; Chromium: Chromium chloride; Choline: Choline tartrate.

[0041] Furthermore, the nutritional composition also includes flavoring, preferably vanilla or fruit flavoring. The addition of flavoring is primarily to appropriately mask unpleasant flavors, enhance palatability for clinical patients, improve the taste defects caused by the main ingredients, and adjust the flavor of the product.

[0042] Preferably, the flavoring is vanilla flavoring, and the amount added is 0.04~0.1% (w / v) based on the volume of the nutritional composition.

[0043] Furthermore, the dosage form of the nutritional composition is an emulsion, powder, oral liquid, tablet, or capsule.

[0044] Preferably, the nutritional composition is an emulsion with a volume average particle size of 0.5 to 1.5 μm and a multiple light scattering stability index (TSI) of 0.5.

[0045] The present invention also provides a method for preparing the above-mentioned nutritional composition, comprising the following steps: (1) The protein, the carbohydrate, the dietary fiber, the stabilizer, the minerals and water are mixed to obtain an aqueous phase; (2) The fat, emulsifier and water are mixed and emulsified to obtain an oil phase; (3) The aqueous phase and the oil phase are mixed and then sheared to obtain the primary emulsion; (4) Add compound vitamins to the colostrum, adjust the pH to 6.5-7.5, and then homogenize and post-process.

[0046] pH primarily affects the conformation, surface hydrophobicity, and particle size of proteins in the interfacial adsorption layer by influencing the charge content within the emulsion system. When the pH approaches the isoelectric point of the protein raw materials, the charge number and electrostatic repulsion in the system decrease, exposing hydrophobic residues of the proteins, thereby causing protein aggregation and leading to system instability. Therefore, the pH should be controlled within the aforementioned range. A pH of 6.8–7.2 is preferred.

[0047] Preferably, in step (1), the water temperature is 50~80 ℃, more preferably 60~70 ℃. Protein hydration and the dissolution of the stabilizer (carrageenan) require a certain temperature. Too high a temperature may cause protein denaturation, while too low a temperature may be detrimental to protein hydration and carrageenan dissolution. Therefore, the water temperature is controlled within the above range.

[0048] Preferably, the emulsification temperature is 60~80 °C, more preferably 65~75 °C. Excessively high emulsification temperatures may lead to emulsifier degradation or system component denaturation, while excessively low temperatures may result in insufficient molecular motion, preventing the formation of a uniform emulsion. Therefore, the emulsification temperature is controlled within the aforementioned range.

[0049] High-pressure homogenization is used to further reduce the particle size of the dispersed phase, resulting in a smoother emulsion texture, a more stable system, and to prevent fat from rising and insoluble particles from settling. Preferably, the homogenization is performed in two stages: the first stage is homogenized at a pressure of 200-400 bar for 2-3 cycles; the second stage is homogenized at a pressure of 300-600 bar for 2-3 cycles.

[0050] More preferably, the first-stage homogenization pressure is 200-300 bar, and the number of cycles is 2-3; the second-stage homogenization pressure is 400-500 bar, and the number of cycles is 2-3.

[0051] Furthermore, the post-processing includes filling and sterilization.

[0052] The sterilization temperature is 121 °C, and the time is 8-15 min.

[0053] In one optional embodiment of the present invention, the nutritional composition is an emulsion, and the preparation method for preparing 500 mL of the nutritional composition includes the following steps: (1) Dispersion: The protein, carbohydrates, dietary fiber, stabilizer and food flavoring in the formula amount are stirred and hydrated in 100~200 mL of water to make the protein material fully absorb water, swell and dissolve fully, which is conducive to the stability of the system and obtain liquid 1; (2) Mineral dispersion: Add the minerals to the liquid 1 and stir evenly to obtain the aqueous phase; (3) Oil phase dispersion: Dissolve and emulsify the fat and emulsifier in 30-70 mL of water to obtain the oil phase; (4) Shearing: The oil phase is added to the aqueous phase and sheared to obtain the primary emulsion; (5) Pre-sterilization: The colostrum is pre-sterilized; (6) Dispersion of compound vitamins: After the sterilized colostrum is cooled, compound vitamins are added to the colostrum, stirred evenly, the pH is adjusted to 6.5~7.5, and the volume is adjusted to 500 mL to obtain solution 2; (7) Homogenization: Homogenize liquid 2 to obtain liquid 3; (8) Filling: Fill liquid 3 into the packaging container and seal it; (9) Sterilization: After filling, the emulsion is sterilized at high temperature to obtain the emulsion.

[0054] Preferably, the pre-sterilization parameters include: a temperature of 72~75 ℃ and a time of 15~20 s.

[0055] The present invention also provides the application of the above-mentioned nutritional composition or the nutritional composition prepared by the above-mentioned method, wherein the nutritional composition is suitable for use by patients with kidney disease to improve their nutritional status, quality of life and prognosis.

[0056] Preferably, the application includes any one of the following a to c: a. Application in the preparation of formulations that improve or maintain the nutritional status, quality of life and prognosis of patients with kidney disease; b. Used to improve kidney function in patients with kidney disease; c. Used to improve the skeletal muscle mass index in patients with kidney disease.

[0057] Preferably, the kidney disease patients include kidney dialysis patients or non-kidney dialysis patients with chronic kidney disease.

[0058] More preferably, the kidney disease patient is a kidney dialysis patient.

[0059] The beneficial effects of the nutritional composition, its preparation method, and its application provided by this invention are as follows: The nutritional composition of this invention contains nutrients such as protein, fat, carbohydrates, and dietary fiber. It is a high-energy-density food that provides balanced nutrition for people undergoing dialysis for kidney disease while reducing water intake, alleviating the burden on the kidneys of patients with chronic kidney disease, and meeting their nutritional needs. Furthermore, it can inhibit or alleviate the decline in kidney function in patients with kidney disease, improve their quality of life and prognosis, and has significant market value. Attached Figure Description

[0060] To more clearly illustrate the technical solutions in this invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0061] Figure 1 The ΔBS test results are for the nutritional composition prepared in Example 1.

[0062] Figure 2 The ΔBS test results are for the nutritional composition prepared in Example 2.

[0063] Figure 3 The ΔBS test results are for the nutritional composition prepared in Example 3.

[0064] Figure 4 The results are the TSI test results of the nutritional composition prepared in Example 1.

[0065] Figure 5 The results are the TSI test results of the nutritional composition prepared in Example 2.

[0066] Figure 6 The results are the TSI test results of the nutritional composition prepared in Example 3. Detailed Implementation

[0067] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this invention. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0068] Where specific techniques or conditions are not specified in the examples, they shall be performed in accordance with the techniques or conditions described in the literature in this field, or in accordance with the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels.

[0069] In the “w / v” described in this invention, w refers to mass in g and v refers to volume in mL.

[0070] All raw materials used in the embodiments of this invention are commercially available products, wherein: Calcium caseinate: Purchased from Friesland Campina DMV, trade name Calcium CaseinateS; Sodium caseinate: purchased from Friesland Campina DMV, trade name Sodium Caseinate S; Maltodextrin: Purchased from Roquette (China) Nutritional Foods Co., Ltd., under the brand name GLUCIDEX 19; Resistant dextrin: purchased from Quantum Hi-Tech (Guangdong) Biotechnology Co., Ltd., model Q-Fiber 90; Heavy calcium carbonate: purchased from Columbia Nutrition (Suzhou) Co., Ltd.; Carrageenan: Purchased from CP Kelco US, inc., model J-DS; Phospholipids: Purchased from Lipoid, Germany, model S 75; Microcrystalline cellulose: purchased from JRS, Germany, model VIVAPUR® MCG 591 P; Sodium carboxymethyl cellulose: purchased from Chongqing Tianrun Food Development Co., Ltd., model FH9; Food flavoring: Purchased from Guangzhou Kaihong Flavoring & Fragrance Co., Ltd., product name: Vanilla Flavoring; Concentrated whey protein powder: purchased from Fonterra, model WPC 550; Solid corn syrup: purchased from Roquette (China) Nutritional Foods Co., Ltd., model number GLUCIDEX 39; Inulin: Purchased from Roquette (China) Nutritional Foods Co., Ltd., product name ST; Mono- and diglycerides of fatty acids: purchased from Riken Vita Chemicals Food (Industrial) Shanghai Co., Ltd., model PV; Citric acid fatty acid glycerides: purchased from Riken Vita Chemicals (Industrial) Shanghai Co., Ltd., model number RIKEMAL KV-30E.

[0071] Soy protein isolate: purchased from Solae LLC, model number SUPRO 787.

[0072] The following information is provided for other raw materials used in the following examples and comparative examples: Multivitamin: Each 1 g of the multivitamin contains 600 μg of vitamin A, 7 μg of vitamin D, 13 mg of vitamin E, 50 μg of vitamin K1, 5 mg of vitamin B1, 4 mg of vitamin B2, 3 mg of vitamin B6, 3 μg of vitamin B12, 5 mg of niacin, 210 μg of folic acid, 5 mg of pantothenic acid, 500 mg of vitamin C, and 50 μg of biotin.

[0073] Minerals: Each 1 g of the minerals described contains 20 mg sodium, 70 mg potassium, 110 μg copper, 16 mg magnesium, 2 mg iron, 2 mg zinc, 260 μg manganese, 45 mg phosphorus, 60 μg iodine, 35 mg chlorine, 15 μg selenium, 200 μg chromium, and 50 mg choline.

[0074] Calcium is added in the form of calcium carbonate compound monomers. The amount of calcium that needs to be added varies depending on the protein source in the formula. Based on the volume of the nutritional composition, the amount of calcium carbonate added is 0.05~0.3% (w / v).

[0075] Example 1 A nutritional composition, which is an emulsion, is provided in Table 1, with the ingredient list and formulation quantities for 500 mL of raw materials.

[0076] Table 1 Ingredients List

[0077] Among them, the blended edible vegetable oil consists of 70% rapeseed oil, 8% sunflower seed oil, and 3% corn oil; The energy contributions from protein, fat, carbohydrates, and dietary fiber were 16%, 25%, 56%, and 3%, respectively. Based on the mass of the protein, the phosphorus content in the protein is 700 mg / 100g.

[0078] The preparation method of the emulsion is as follows: (1) Dispersion: The formula amounts of calcium caseinate, sodium caseinate, maltodextrin, resistant dextrin, carrageenan, microcrystalline cellulose, sodium carboxymethyl cellulose, and food flavoring are stirred in 150 mL of purified water at 65 ℃ until homogeneous. The stirring speed is 600 rpm and the stirring time is 30 min, so that the protein materials can fully absorb water, swell, and dissolve completely, which is beneficial to the stability of the system and yields solution 1. (2) Mineral dispersion: The minerals and heavy calcium carbonate of the formula amount are mixed and added to the liquid 1, and stirred evenly at 600 rpm for 10 min to obtain the aqueous phase; (3) Oil phase dispersion: Dissolve and emulsify the formulated amount of edible vegetable blended oil and phospholipids in 50 mL of purified water at 70 °C for 15 min to obtain the oil phase; (4) Shearing: Add the oil phase to the aqueous phase, stir and shear for 30 min at 3000 rpm to obtain the primary emulsion; (5) Pre-sterilization: The colostrum is pasteurized at 72 ℃ for 15 s; (6) Dispersion of compound vitamins: Cool the pre-sterilized colostrum to below 30 °C, add the formulated amount of compound vitamins to the colostrum, stir at 600 rpm for 10 min, adjust the pH to 7.0 with 10% sodium hydroxide solution, and make up to 500 mL to obtain liquid 2; (7) Homogenization: The liquid 2 is homogenized twice at a pressure of 200 bar, and then homogenized twice at a pressure of 400 bar to obtain liquid 3. (8) Filling: Fill liquid 3 into the packaging container and seal it; (9) Sterilization: The filled sample is sterilized at 121 °C for 8 min to obtain the emulsion.

[0079] Example 2 A nutritional composition, which is an emulsion, has its raw materials listed in Table 2, including the ingredient list and formulation quantities for 500 mL.

[0080] Table 2 Ingredient List

[0081] Edible vegetable blended oil: 70% rapeseed oil, 8% sunflower oil, and 3% corn oil; The energy contributions from protein, fat, carbohydrates, and dietary fiber were 20%, 25%, 52%, and 3%, respectively. Based on the mass of the protein, the phosphorus content in the protein is 850 mg / 100g.

[0082] The preparation method of the emulsion is as follows: (1) Dispersion: Calcium caseinate, concentrated whey protein powder, solid corn syrup, inulin, carrageenan, microcrystalline cellulose, sodium carboxymethyl cellulose, and food flavoring were stirred in 150 mL of purified water at 65 °C until homogeneous. The stirring speed was 600 rpm and the stirring time was 30 min to allow the protein materials to fully absorb water, swell, and dissolve completely, which is beneficial to the stability of the system and yielded solution 1. (2) Mineral dispersion: The minerals and heavy calcium carbonate were mixed and added to the feed solution 1, and stirred at 600 rpm for 10 min to obtain the aqueous phase; (3) Oil phase dispersion: Edible vegetable blended oil and mono- and di-fatty acid glycerides and citrate fatty acid glycerides are dissolved and emulsified in 50 mL of purified water at 65 °C for 15 min to obtain the oil phase; (4) Shearing: Add the oil phase to the aqueous phase, stir and shear for 30 min at 3000 rpm to obtain the primary emulsion; (5) Pre-sterilization: The colostrum is pasteurized at 72 ℃ for 15 s; (6) Dispersion of compound vitamins: Cool the pre-sterilized colostrum to below 30 °C, then add compound vitamins to the colostrum, stir at 600 rpm for 10 min, add 10% sodium hydroxide solution to adjust the pH to 7.0, and make up to 500 mL to obtain liquid 2; (7) Homogenization: The liquid 2 is homogenized twice at a pressure of 200 bar, and then homogenized twice at a pressure of 400 bar to obtain liquid 3. (8) Filling: Fill liquid 3 into the packaging container and seal it; (9) Sterilization: The filled sample is sterilized at 121 °C for 8 min to obtain the emulsion.

[0083] Example 3 A nutritional composition, which is an emulsion, has its raw materials listed in Table 3, including the ingredient list and formulation quantities for 500 mL.

[0084] Table 3 Ingredient List

[0085] Edible vegetable blended oil: 70% rapeseed oil, 8% sunflower oil, and 3% corn oil; The energy contributions from protein, fat, carbohydrates, and dietary fiber were 18%, 25%, 54%, and 3%, respectively. Based on the mass of the protein, the phosphorus content in the protein is 800 mg / 100g.

[0086] The preparation method of the emulsion is as follows: (1) Dispersion: Calcium caseinate, soy protein isolate, maltodextrin, resistant dextrin, carrageenan, microcrystalline cellulose, sodium carboxymethyl cellulose, and food flavoring were stirred in 150 mL of purified water at 65 °C until homogeneous. The stirring speed was 600 rpm and the stirring time was 30 min to allow the protein materials to fully absorb water, swell, and dissolve completely, which is beneficial to the stability of the system and yielded solution 1. (2) Mineral dispersion: Mix the minerals and heavy calcium carbonate and add them to the feed solution 1. Stir at 600 rpm for 10 min to obtain the aqueous phase; (3) Oil phase dispersion: Dissolve and emulsify edible vegetable blended oil and phospholipids in 50 mL purified water at 70 °C for 15 min to obtain the oil phase; (4) Shearing: Add the oil phase to the aqueous phase, stir and shear for 30 min at 3000 rpm to obtain the primary emulsion; (5) Pre-sterilization: The colostrum is pasteurized at 72 ℃ for 15 s; (6) Dispersion of compound vitamins: Cool the pre-sterilized colostrum to below 30 °C, add compound vitamins to the colostrum, stir at 600 rpm for 10 min, add 10% sodium hydroxide solution to adjust the pH to 7.0, and make up to 500 mL to obtain liquid 2; (7) Homogenization: The liquid 2 is homogenized twice at a pressure of 200 bar, and then homogenized twice at a pressure of 400 bar to obtain liquid 3. (8) Filling: Fill liquid 3 into the packaging container and seal it; (9) Sterilization: The filled sample is sterilized at 121°C for 8 min to obtain the emulsion.

[0087] Comparative Example 1 This comparative example is basically the same as Example 2, except that calcium chloride is used instead of heavy calcium carbonate.

[0088] Comparative Example 2 The difference between this comparative example and Example 1 is that the ratio of fatty acids in the blended vegetable oil is changed (the mass ratio of polyunsaturated fatty acids: saturated fatty acids: monounsaturated fatty acids is 2:3:1), while other formulations remain the same.

[0089] Test Example 1 The physicochemical properties of the emulsions prepared in Examples 1-3 and Comparative Examples 1-2 were determined, and the results are shown in Table 4.

[0090] Testing method: The sample shall be tested according to the following method.

[0091] Sensory evaluation: Pour the sample into a clean, transparent, disposable tasting cup and observe its appearance with the naked eye under natural light.

[0092] pH: Calibrate the pH meter using buffer solutions of pH 4.00, 6.86, and 9.18, respectively. Take an appropriate amount of this product, insert the rinsed and dried electrode into the sample solution, and read the data after the data stabilizes.

[0093] Osmotic pressure: The osmotic pressure molality meter was calibrated using standard solutions from the 300 and 600 osmotic pressure molality meter, respectively. At least 100 mL of liquid sample was taken, thoroughly mixed to prepare the sample, and the probe was immersed in the sample and lowered into the instrument's cooling tank. The cooling system was activated, and when the temperature of the test solution dropped below its freezing point, the instrument used a metal probe to induce freezing of the solution. The instrument automatically recorded the temperature at which the freezing point decreased, and the measured value displayed by the instrument was the osmotic pressure molality.

[0094] Particle size: Turn on the laser particle size analyzer and analysis software, operate the automatic test in the software, slowly add the sample into the instrument, the refractive index of the medium is 1.333, add the sample until the shading rate is about 10%, then stop adding the sample, the sample is automatically processed and the data is obtained.

[0095] Table 4. Results of physicochemical properties of emulsions prepared in the examples and comparative examples.

[0096] The nutrient composition of Comparative Example 1 deteriorated after sterilization during preparation, so it was not subjected to further experiments.

[0097] Test Example 2 Stability studies were conducted on the emulsions prepared in Examples 1-3 and Comparative Example 2, and the results are shown in Table 5.

[0098] Testing method: The testing was conducted in accordance with the "Stability Study Requirements for Foods for Special Medical Purposes (Trial) (2017 Revised Edition)".

[0099] Table 5. Stability of the emulsions prepared in Examples and Comparative Example 2

[0100] Test Example 3 Stability test The change in backscattering intensity (ΔBS) and the stability index (Turbiscan Stability Index) of the prepared emulsion were measured using a Turbiscan stability analyzer.

[0101] TSI reflects the droplet migration velocity in an emulsion. A high TSI value (>0.5) indicates a fast droplet migration velocity, suggesting instability and a high probability of phase separation, while a low TSI value (<0.5) indicates a low probability of phase separation (Marianne L, Kai T. Turbiscan as a Tool for Studying the Phase Separation Tendency of Pyrolysis Oil[J]. 2013.). ΔBS represents the change in backscattered light intensity, typically referring to the difference between the backscattered light intensity of a sample at a specific time point or under specific conditions and its initial state (or reference state). Backscattered light intensity is closely related to the concentration, particle size, and distribution of particles in the sample; therefore, ΔBS can be used to characterize changes in the microstructure of the system.

[0102] Figure 1-3 The graph shows the changes in ΔBS values ​​in Examples 1-3 under accelerated 3-month conditions. The larger the absolute value of ΔBS, the more obvious the structural changes of the system. As can be seen from the graph, the changes in ΔBS are all near the baseline, indicating that there is no obvious sedimentation or fat floating phenomenon in the emulsion during storage, indicating that the prepared emulsion is relatively stable. Figure 4-6 The TSI values ​​of Examples 1-3 after 3 months of accelerated processing are all less than 0.5, indicating that the prepared emulsion has good stability.

[0103] Test Example 4 In dialysis facilities, subjects were given oral emulsions of Examples 1-3 and the comparative examples to evaluate the clinical safety, nutritional adequacy, and clinical efficacy for special medical purposes.

[0104] The study included 123 hemodialysis patients from a blood purification center, comprising 65 males and 58 females, aged 20-70 years. They were randomly divided into five groups: a control group (low-sodium, potassium, and phosphorus diet), three observation groups (oral administration of Examples 1-3), and an observation control group (oral administration of Comparative Example 2). Evaluation lasted for one month. Examples 1-3 and Comparative Example 2 were administered orally as partial nutritional supplementation. The daily energy intake of this preparation should be 480-600 kcal, with the preparation itself providing 2.0 kcal / mL. The remaining energy intake should be under the guidance of a clinician. Skeletal muscle mass index, albumin (ALB), and blood urea nitrogen (BUN) were measured before and 30 days after the intervention.

[0105] The detection method is as follows: Skeletal Muscle Mass Index (SMI): This index utilizes two different energies of X-rays to penetrate the human body. Based on the varying degrees of attenuation of X-rays by different tissues (bone, muscle, fat), software automatically separates and calculates skeletal muscle mass. Skeletal Muscle Mass Index = Skeletal Muscle Mass (kg) / Height2 .

[0106] Albumin (ALB): Fasting venous blood was collected from the subject, and serum was separated by centrifugation; working solution was prepared according to the reagent instructions, and the serum sample was mixed with BCG reagent; absorbance was measured at a wavelength of 628 nm, and albumin concentration was calculated by comparison with standard.

[0107] Blood urea nitrogen (BUN): Collect venous blood, centrifuge to separate serum / plasma (avoid hemolysis, as hemolysis will interfere with the results); mix the sample with reagents containing urease, GLDH, α-ketoglutarate, and NADH; the fully automated biochemical analyzer automatically monitors the absorbance changes and outputs the results.

[0108] All data were analyzed using SPSS 26.0 statistical software. Quantitative data, including relevant evaluation indicators, are expressed as mean ± standard deviation. p <0.05 indicates a statistically significant difference.

[0109] Inclusion criteria: 1. The patient's condition is stable, and they have been undergoing maintenance hemodialysis for more than 6 months, with regular dialysis sessions of 2-3 times per week; 2. Subjective Comprehensive Nutrition Assessment (SGA) score <25; 3. Individuals who can tolerate enteral nutrition; 4. Voluntarily participate in clinical trials and sign an informed consent form.

[0110] Exclusion criteria: 1. Intolerant of enteral nutrition; 2. Patients with concurrent diseases of other organs such as the heart, liver, and lungs; 3.2 weeks ago, other nutritional preparations that may have affected the experimental results were used.

[0111] The clinical evaluation results are shown in Table 6.

[0112] Table 6. Clinical trial results of the emulsions prepared in the examples and comparative examples.

[0113] Compared to the control group, after 30 days of intervention, the nutritional compositions (emulsions) prepared in Examples 1-3 by renal dialysis patients all showed an increase in skeletal muscle mass index and white blood cell count, and a decrease in blood urea nitrogen content. This indicates that the nutritional compositions of the present invention can better improve the renal function of patients and help regulate renal metabolism compared to conventional low-sodium, potassium, and phosphorus diets.

[0114] Comparative Example 1: The sample had deteriorated after sterilization and was not included in the clinical trial. Comparative Example 2: Skeletal muscle mass index, ALB, and BUN all improved after intervention compared to before intervention; however, the improvement was slightly less than that in the control group.

[0115] Based on the results of the above clinical evaluation indicators, the products in Examples 1-3 not only provide nutrition for hemodialysis patients, but also improve their renal function, quality of life and prognosis.

[0116] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A nutritional composition, characterized in that, include: The energy content consists of protein, fat, carbohydrates, and dietary fiber, with the energy contribution ratios of protein, fat, carbohydrates, and dietary fiber being 15-20%, 20-26%, 52-56%, and 1-5%, respectively. Based on the mass of the protein, the phosphorus content in the protein is (300-1500) mg / 100g.

2. The nutritional composition according to claim 1, characterized in that, In the fat, the mass ratio of polyunsaturated fatty acids: saturated fatty acids: monounsaturated fatty acids is (1.0~2.0):1:1; Preferably, in the polyunsaturated fatty acids, the mass ratio of linoleic acid to linolenic acid is (1.0~4.0):1; Preferably, the fat is provided by a blend of edible vegetable oils, which includes one or more of rapeseed oil, sunflower oil, flaxseed oil, perilla seed oil, and corn oil. Preferably, by weight percentage, the blended edible vegetable oil comprises 60-90% rapeseed oil, 5-10% sunflower seed oil, and 1-5% corn oil; Preferably, the edible vegetable blend oil also includes antioxidants.

3. The nutritional composition according to claim 1 or 2, characterized in that, The nutritional composition further includes stabilizers and emulsifiers. The stabilizers include one or more of carrageenan, gellan gum, xanthan gum, microcrystalline cellulose, β-cyclodextrin, and sodium carboxymethyl cellulose. The emulsifiers include any one or more of phospholipids, mono- and diglycerides of fatty acids, glycerides of fatty acids of citrate, monoglycerides of succinate, and sodium octenyl succinate starch. Preferably, the mass ratio of the protein, fat, carbohydrate, dietary fiber, stabilizer, and emulsifier is (4.0~10.0):(3.0~7.0):(20.0~30.0):(2.0~4.0):(0.02~0.2):(0.05~0.6). Preferably, the stabilizer is a mixture of carrageenan, microcrystalline cellulose and sodium carboxymethyl cellulose, and the emulsifier is a phospholipid or a mixture of mono- and diglycerides of fatty acids and glycerides of citrate fatty acids; Preferably, based on the volume of the nutritional composition, the stabilizer contains 0.02-0.05% (w / v) carrageenan, 0.03-0.06% (w / v) microcrystalline cellulose, and 0.02-0.06% (w / v) sodium carboxymethyl cellulose. Preferably, the amount of phospholipid added is 0.3~0.6% (w / v) based on the volume of the nutritional composition. Preferably, the mass ratio of the mono- and di-fatty acid glycerides to the citrate fatty acid glycerides is (2.0~3.0):

1.

4. The nutritional composition according to any one of claims 1 to 3, characterized in that, The protein is selected from one or more of casein, sodium caseinate, calcium caseinate, soy protein isolate, and whey protein powder; And / or, the carbohydrate is selected from one or two of maltodextrin, wheat starch, solid corn syrup and fructose; And / or, the dietary fiber is selected from any one or two of resistant dextrin, inulin, and galactomannan.

5. The nutritional composition according to any one of claims 1 to 4, characterized in that, Each 100 mL of the nutritional composition comprises 6-10 g of protein, 4-7 g of fat, 22-27 g of carbohydrates, 2-4 g of dietary fiber, 0.05-0.2 g of stabilizer, and 0.05-0.5 g of emulsifier; Preferably, each 100 mL of the nutritional composition comprises 4-11 g of calcium caseinate, 0-5 g of sodium caseinate, 0-2 g of concentrated whey protein powder, 0-6 g of soy protein isolate, 25-30 g of maltodextrin or solid corn syrup, 4-6 g of edible vegetable blended oil, 0-4 g of inulin, 0-4 g of resistant dextrin, 0.02-0.05 g of carrageenan, 0-0.5 g of phospholipids, 0-0.10 g of mono- and diglycerides of fatty acids, 0-0.04 g of citric acid fatty acid glycerides, 0.03-0.06 g of microcrystalline cellulose, and 0.02-0.06 g of sodium carboxymethyl cellulose. Preferably, each 100 mL of the nutritional composition comprises 4-11 g of calcium caseinate, 1-6 g of sodium caseinate or concentrated whey protein powder or soy protein isolate, 25-30 g of solid corn syrup or maltodextrin, 4-6 g of edible vegetable blended oil, 0-4 g of inulin, 0-4 g of resistant dextrin, 0.02-0.05 g of carrageenan, 0.3-0.4 g of phospholipids, or 0.08-0.14 g of a mixture of mono- and diglycerides of fatty acids and glycerides of citrate fatty acids in a mass ratio of 2:1, 0.03-0.06 g of microcrystalline cellulose, and 0.02-0.06 g of sodium carboxymethyl cellulose.

6. The nutritional composition according to any one of claims 1 to 5, characterized in that, The nutritional composition also includes calcium salt, and the amount of calcium salt added is 0.05~0.3% (w / v) based on the volume of the nutritional composition. Preferably, the calcium salt is calcium carbonate.

7. The nutritional composition according to any one of claims 1 to 6, characterized in that, The nutritional composition also includes a complex vitamin, and the amount of the complex vitamin added is 0.4~0.6% (w / v) based on the volume of the nutritional composition. Preferably, each 1 g of the complex vitamin contains 200-800 μg of vitamin A, 5-15 μg of vitamin D, 8-20 mg of vitamin E, 30-80 μg of vitamin K1, 3-6 mg of vitamin B1, 2-5 mg of vitamin B2, 2-4 mg of vitamin B6, 1-4 μg of vitamin B12, 3-8 mg of niacin, 180-260 μg of folic acid, 4-7 mg of pantothenic acid, 300-600 mg of vitamin C, and 30-70 μg of biotin. Preferably, the nutritional composition further includes minerals, and the amount of minerals added is 1-2% (w / v) based on the volume of the nutritional composition. Preferably, each 1 g of the mineral contains 15-30 mg of sodium, 60-100 mg of potassium, 80-150 μg of copper, 15-30 mg of magnesium, 1-3 mg of iron, 1-3 mg of zinc, 150-400 μg of manganese, 35-65 mg of phosphorus, 50-100 μg of iodine, 30-50 mg of chlorine, 10-25 μg of selenium, 120-250 μg of chromium, and 40-80 mg of choline.

8. The nutritional composition according to any one of claims 1 to 7, characterized in that, The dosage form of the nutritional composition is an emulsion, powder, oral liquid, tablet, or capsule.

9. A method for preparing the nutritional composition according to any one of claims 1 to 8, characterized in that, Includes the following steps: (1) The protein, the carbohydrate, the dietary fiber, the stabilizer, the minerals and water are mixed to obtain an aqueous phase; (2) The fat, emulsifier and water are mixed and emulsified to obtain an oil phase; (3) The aqueous phase and the oil phase are mixed and then sheared to obtain the primary emulsion; (4) Add compound vitamins to the colostrum, adjust the pH to 6.5-7.5, and then homogenize and post-process; Preferably, in step (1), the water temperature is 50~80 ℃; Preferably, the emulsification temperature is 60~80 ℃; Preferably, the homogenization is a two-stage homogenization, with the first stage homogenization pressure being 200~400 bar and the number of cycles being 2~3; the second stage homogenization pressure being 300~600 bar and the number of cycles being 2~3.

10. The application of the nutritional composition according to any one of claims 1 to 8 or the nutritional composition prepared by the method according to claim 9, characterized in that, The nutritional composition is suitable for use by patients with kidney disease to improve their nutritional status, quality of life and prognosis. Preferably, the application includes any one of the following a to c: a. Application in the preparation of formulations that improve or maintain the nutritional status, quality of life and prognosis of patients with kidney disease; b. Used to inhibit or alleviate the decline in renal function in patients with kidney disease; c. Used to improve the skeletal muscle mass index in patients with kidney disease; Preferably, the kidney disease patients include kidney dialysis patients or non-kidney dialysis patients with chronic kidney disease.

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