A specific complete nutritional formula for diabetics and a method for its preparation

Abstract

The application discloses a specific total nutrition formula food for diabetic patients and a preparation method thereof, and relates to the technical field of special medical use formula food. The formula takes concentrated whey protein and soybean protein isolate as a nitrogen source, takes vegetable fat powder as a fat source, takes malt dextrin-crystalline fructose-isomaltulose as a carbohydrate system, and further compounding resistant dextrin, inulin, fructooligosaccharide and amidated low-ester pectin / sodium alginate and other dietary fibers. The powder is prepared by adopting a process of graded dissolution, protein-fat pre-emulsification, addition of a structured gel-forming polysaccharide solution, high-pressure homogenization, addition of vitamins after cooling and spray drying. The food is easy to form protein-polysaccharide-Ca 2+ structure network, improve the gastric phase viscosity and delay the small intestinal glucose release, has good brewing property and stability, and is beneficial to smooth postprandial blood glucose.

Description

Technical Field

[0001] This invention relates to the field of special medical purpose formula foods, and in particular to a specific complete nutritional formula food for diabetic patients and its preparation method. Background Technology

[0002] Diabetes mellitus is a metabolic disease characterized by chronic hyperglycemia. Patients often have insufficient insulin secretion or insulin resistance, which can lead to cardiovascular, renal, and neurological complications in the long term. For diabetic patients with malnutrition, restricted food intake, or those requiring enteral nutritional support, complete nutritional formulas must not only meet their energy and essential nutrient needs but also reduce the risk of rapid postprandial blood glucose spikes and fluctuations. However, traditional complete nutritional formulas often rely on easily digestible carbohydrates as the main energy source or control blood glucose solely through static adjustments to macronutrient ratios and the replacement of low-GI ingredients, which may still result in problems such as excessively rapid early release and high blood glucose peaks.

[0003] Existing technology CN109007800A discloses a specific complete nutritional formula food for diabetic patients, which uses a combination of soy protein isolate / pea protein, vegetable oils, and carbohydrate sources such as maltodextrin, resistant starch, and fructose, combined with dietary fiber such as soy fiber and inulin, to achieve nutritional balance. However, its technology focuses on setting the formula components and energy ratio, and the preparation mainly involves mixing and homogenizing the aqueous / oil phases, filling, and terminal sterilization at 121°C. Therefore, its ability to programmatically regulate the rate of gastric emptying and small intestinal glucose release is limited. At the same time, high-temperature terminal processing may also lead to the loss of heat-sensitive nutrients and compromises in taste and stability.

[0004] Existing technology CN118923853A discloses a health food formula for regulating metabolism in diabetes, mainly composed of Dendrobium, mulberry leaf / bitter melon extract, arabinose, inulin, and live bacteria, which leans towards the metabolic assistance and regulation of plant extracts and probiotics. This formula is not a specific complete nutritional formula system, and it is difficult to provide complete macronutrients and energy support. Moreover, the applicability of the bioactive ingredients such as plant extracts contained therein is limited under the regulatory framework for special medical foods.

[0005] Therefore, there is still an urgent need for a specific complete nutritional formula food for diabetic patients that can meet the requirements of complete nutritional supply and good reconstitution stability, while forming a structural barrier in the gastrointestinal environment through the synergistic effect of formula and process, significantly reducing the early glucose release rate, and thus more effectively stabilizing postprandial blood sugar. Summary of the Invention

[0006] In view of the above-mentioned deficiencies of the prior art, the technical problem to be solved by the present invention is to provide a specific complete nutritional formula food that can significantly reduce the early glucose release rate in the small intestine and thus be more conducive to stabilizing postprandial blood sugar, while meeting the requirements of complete nutritional supply and preparation stability for diabetic patients.

[0007] This invention constructs a complete nutritional formula based on the nutritional needs of diabetic patients. It introduces low-ester pectin / amiditized low-ester pectin / sodium alginate into the conventional protein-fat-low-GI carbohydrate system. Combined with the mineral system, it forms a stable thickening / network structure in the pH environment of the gastrointestinal tract. Through the physical structural barrier, it delays the diffusion of nutrient substrates and enzyme contact, thereby inhibiting the rapid release of glucose in the early stage of the small intestine. At the same time, it combines homogenization and spray drying processes to achieve formula homogenization and powder stability, taking into account taste, reconstitution properties and industrial production.

[0008] The specific technical solution is as follows:

[0009] A specific complete nutritional formula food for people with diabetes includes the following components:

[0010] On a dry basis by weight percentage:

[0011] Protein composition: 8-20% concentrated whey protein powder, 8-20% soy protein isolate powder;

[0012] Fat component: 20-45% vegetable fat powder;

[0013] Carbohydrate composition: maltodextrin 8-20%, crystalline fructose 5-10%, isomaltulose 2-8%;

[0014] Dietary fiber components: resistant dextrin 4-10%, inulin 2-8%, fructooligosaccharides 1-7%;

[0015] Premix: Mineral premix 2-10%; Vitamin premix 0.1-1%; Choline, Carnitine, Inositol premix 2-6%;

[0016] Fragrance: 0.1-1.5%.

[0017] Preferably, the dietary fiber component comprises 4-10% resistant dextrin, 2-8% inulin, 1-5% fructooligosaccharides, and 1-5% structured gelling polysaccharides; the structured gelling polysaccharides are at least one of low-ester pectin, amidated low-ester pectin, and sodium alginate.

[0018] More preferably, the structured gelling polysaccharide is a combination of amidated low-ester pectin and sodium alginate.

[0019] This invention also provides a method for preparing the above-mentioned specific complete nutritional formula food for diabetic patients, comprising the following steps:

[0020] (1) Under the conditions of 35-45℃ and 300-800rpm, maltodextrin, resistant dextrin and isomaltulose are added to water in sequence and stirred until dissolved; after cooling to 20-30℃, crystalline fructose, inulin and oligofructose are added and stirred until homogeneous to obtain the carrier solution.

[0021] (2) At 35-45℃ and 3000-6000rpm, concentrated whey protein powder and soy protein isolate powder are added to water and allowed to stand for hydration for 10-30min; then vegetable fat powder is added at 3000-6000rpm to form a pre-emulsion, and then the pre-emulsion slurry is obtained by adding it to the carrier solution in step (1) at 1000-2500rpm.

[0022] At 45-55℃ and 200-500 rpm, add the mineral premix, choline-carnitine-inositol premix, and flavoring to the pre-emulsion and mix for 5-15 minutes; or, at 45-55℃ and 200-500 rpm, add the structured polysaccharide to the pre-emulsion and mix for 5-15 minutes, then add the mineral premix, choline-carnitine-inositol premix, and flavoring, and mix thoroughly; the mineral premix provides Ca... 2+ In the gastrointestinal environment, it promotes the formation of a proteoglycan structural network to delay early glucose release;

[0023] The mixed slurry is subjected to two-stage high-pressure homogenization: the first stage at 10-20 MPa and the second stage at 3-8 MPa; after homogenization, it is cooled to ≤30℃ and then vitamin premix is ​​added and stirred evenly to obtain the slurry to be sprayed.

[0024] (3) Use pressure spray drying with an inlet air temperature of 140-170℃, an outlet air temperature of 60-75℃, and a spray pressure of 10-25MPa. After collecting the powder, quickly cool it to ≤25℃, pass it through an 80-200 mesh sieve, pack it in an aluminum foil bag filled with nitrogen or vacuum sealed, and store it in a cool and dry place.

[0025] Preferably, the amount of water used in step (1) is 1-1.5 times the total mass of maltodextrin, resistant dextrin, isomaltulose, crystalline fructose, inulin and oligofructose.

[0026] Preferably, the amount of water used in step (2) is 0.5-1 times the total mass of concentrated whey protein powder, soy protein isolate powder and vegetable fat powder.

[0027] Preferably, the solid content of the slurry to be sprayed is 35%-45%, the pH is 6.5-7.5, and the apparent viscosity is controlled at 350-650 mPa·s, so as to balance atomization stability and product solubility.

[0028] The beneficial effects of this invention are:

[0029] This invention provides complete nutrition for diabetic patients while using a low-GI carbohydrate system combined with dietary fiber to reduce the risk of postprandial blood glucose fluctuations.

[0030] This invention relates to the use of low-ester pectin / amidated low-ester pectin and sodium alginate in minerals (Ca). 2+ Under the action of pH response, a complex structure is formed, which makes the product significantly thicker and maintains structural stability under gastric acid conditions, and improves the physical barrier to the diffusion of nutrient substrates and enzyme accessibility.

[0031] In vitro simulated digestion showed that the specific complete nutritional formula food for diabetic patients of the present invention can significantly delay the glucose release rate in the small intestine, inhibit the early rapid release phase without significantly reducing the final cumulative release, which is more conducive to stabilizing postprandial blood glucose.

[0032] This invention employs a wet mixing-high pressure homogenization-spray drying process to uniformly disperse fat globules and proteins / polysaccharides at the micron level. The finished powder has uniform particle size, good reconstitution properties, and high stability. The process can be scaled up and the quality is controllable. Attached Figure Description

[0033] Figure 1 These are apparent viscosity-time curves of the gastric phase for specific complete nutritional formula foods for diabetic patients, as shown in Examples 1-6.

[0034] Figure 2 This is a graph showing the cumulative glucose release curve in the small intestine of the specific complete nutritional formula foods used for diabetic patients in Examples 1-6. Detailed Implementation

[0035] The parameters and sources of some raw materials in the examples are as follows:

[0036] Low-ester pectin, food grade, degree of esterification (DE) of 20-40%.

[0037] Amide-modified low-ester pectin, food grade, with a degree of esterification (DE) of 20-40% and a degree of amidation (DA) of 10-20%.

[0038] Sodium alginate, food grade, apparent viscosity 300-800 mPa·s.

[0039] Concentrated whey protein powder, food grade, WPC70.

[0040] Soy protein isolate, food grade, protein content (on a dry basis) ≥85wt%.

[0041] The vegetable fat powder is prepared by uniformly mixing 41.7 wt% maltodextrin, 8 wt% medium-chain triglycerides, 8 wt% soybean oil, 8 wt% flaxseed oil, 17.4 wt% glucose, 15.8 wt% whey protein isolate, 0.69 wt% mono- and diglycerides of fatty acids, 0.332 wt% sodium L-ascorbate, 0.03 wt% ascorbate palmitate, 0.03 wt% tocopherol, and 0.018 wt% phospholipids.

[0042] The mineral premix contains the following components per gram: calcium: 300 mg; potassium: 350 mg; sodium: 100 mg; phosphorus: 100 mg; magnesium: 30 mg; iron: 5 mg; zinc: 4 mg; copper: 300 μg; iodine: 70 μg; selenium: 10 μg; manganese: 20 μg; chromium: 8 μg.

[0043] The vitamin premix contains the following components per gram: Vitamin A: 3000 μg; Vitamin D: 50 μg; Vitamin B1: 5000 μg; Vitamin B2: 5400 μg; Vitamin B6: 3000 μg; Vitamin B12: 10 μg; Vitamin K1: 400 μg; Vitamin C: 350 mg; Vitamin E: 40 mg; Nicotinamide: 30000 μg; Folic acid: 600 μg; Biotin: 150 μg; Pantothenic acid: 15000 μg; Inositol: 100 mg; L-carnitine: 30 mg; Choline: 50 mg; Taurine: 200 mg.

[0044] Choline, carnitine, and inositol premix, the content of each component per gram of choline, carnitine, and inositol premix is ​​as follows: inositol: 100mg; L-carnitine: 30mg; choline: 100mg.

[0045] Example 1

[0046] A specific complete nutritional formula food for diabetic patients, with the following formula:

[0047] Per 100g dry powder:

[0048] Protein composition: 12g whey protein concentrate, 12g soy protein isolate;

[0049] Fat components: 30g of vegetable fat powder;

[0050] Carbohydrate composition: 10g maltodextrin, 8g crystalline fructose, 6g isomaltulose;

[0051] Dietary fiber components: 7g resistant dextrin, 4.2g inulin, 1.5g fructooligosaccharides;

[0052] Premix: 5.5g mineral premix, 0.3g vitamin premix, 3g choline, carnitine, and inositol premix;

[0053] Flavoring: 0.5g of food-grade flavoring.

[0054] The preparation method of the above-mentioned specific complete nutritional formula food for diabetic patients includes the following steps:

[0055] The preparation process employs a wet mixing-spray drying method, which is carried out in three stages:

[0056] Phase 1: Wet mixing to prepare homogeneous slurry, with the following principles: graded treatment, step-by-step addition, and low-temperature homogenization;

[0057] (1) In a mildly heated stirring tank at 40°C, add 45g of deionized water; add 10g of maltodextrin, 7g of resistant dextrin, and 6g of isomaltulose in sequence, and stir thoroughly to dissolve; these will serve as thickeners and carriers for the slurry, increasing the solid content; when the temperature drops to 25°C, add 8g of crystalline fructose, 1.5g of oligofructose, and 4.2g of inulin, and stir until completely dissolved to obtain a carrier solution; low temperature prevents fructose browning and inulin over-hydrolysis;

[0058] (2) Add 40g of water at 40℃ to another mixing tank. While stirring at 5000rpm, slowly add 12g of concentrated whey protein powder and 12g of soy protein isolate powder, stirring continuously to form a uniform protein slurry without lumps. Let it stand for 20min to allow the protein to fully absorb water and swell. Add 30g of vegetable fat powder to the protein slurry while stirring at 5000rpm to form a stable protein-fat pre-emulsion. Slowly pour the pre-emulsion into the carrier solution in step (1) and continue to stir and mix at 2000rpm to obtain the pre-emulsion slurry.

[0059] (3) Under stirring conditions of 300 rpm, add 5.5 g of mineral premix, 3.0 g of choline-carnitine-inositol premix and 0.5 g of food flavoring to the pre-emulsion slurry of step (2);

[0060] The mixed slurry is homogenized using a high-pressure homogenizer. The high-pressure homogenizer operates in two stages: the first stage at 15 MPa and the second stage at 5 MPa. This step is crucial as it can break down fat globules and protein aggregates, ensuring that all insoluble components are dispersed at the micron level, forming an extremely stable and homogeneous emulsion suspension system. After homogenization, the slurry temperature will rise slightly, so it needs to be cooled to 25°C before adding 0.3 g of vitamin premix and stirring at 300 rpm until homogenized. This is key to preserving the activity of the vitamins.

[0061] Slurry quality control points: Adjust the solid content to 40% by adding deionized water to balance drying efficiency and slurry flowability; control the viscosity at 400-600 mPa·s for atomization; control the pH value at 6.5-7.0, measure and record it as a quality control benchmark; sensory evaluation: the slurry should be uniform, fine, and free of particles.

[0062] Phase Two: Spray Drying Granulation, Principle: Low-temperature rapid drying, precise temperature control.

[0063] Atomizer selection: Use a high-pressure nozzle (single-fluid pressure nozzle) that matches the pressure spray drying tower. The slurry is sprayed out of the nozzle under high pressure to form fine droplets, which is conducive to the formation of near-spherical particles and improves the powder flowability and instantaneous solubility.

[0064] Drying parameters: Inlet air temperature 150℃, which is relatively low compared to industrial standards, designed to reduce heat damage; outlet air temperature 65℃, which is a core control parameter that must be kept stable within this range to ensure that the product moisture content is <5% and the activity of heat-sensitive components is retained; spray pressure is controlled at 10-25MPa, and by adjusting the spray pressure and feed rate, the target particle D50 is kept between 80-150μm.

[0065] Airflow mode: The drying process uses a co-current flow (hot air and droplets in the same direction), which allows the material to experience a temperature that gradually decreases from high to low, making it more gentle;

[0066] Phase Three: Post-processing and Packaging

[0067] Collection and cooling: After drying, the powder is collected by a cyclone separator and immediately cooled to 25°C by a fluidized bed cooling system to prevent residual heat from causing moisture absorption or agglomeration;

[0068] Sieving: Pass the product through an 80-mesh sieve to remove any possible small amounts of large particles or clumps, ensuring a fine finished product;

[0069] Packaging: In an environment with a temperature of <25℃ and a humidity of <30% RH, immediately pack the product in an aluminum foil bag with nitrogen filling or vacuum sealing to protect the unsaturated fats and vitamins from oxidation. Store the finished product in a cool, dry place.

[0070] Example 2

[0071] A specific complete nutritional formula food for diabetic patients, with the following formula:

[0072] Per 100g dry powder:

[0073] Protein: 12g whey protein concentrate, 12g soy protein isolate;

[0074] Fat: 30g of vegetable fat powder;

[0075] Carbohydrates: 10g maltodextrin, 8g crystalline fructose, 6g isomaltulose;

[0076] Dietary fiber (total amount remains the same as in Example 1, 12.7g / 100g): 7g resistant dextrin, 2.4g inulin, 1.5g fructooligosaccharides, 1.3g low-ester pectin, and 0.5g sodium alginate;

[0077] Vitamins and minerals: 5.5g mineral premix, 0.3g vitamin premix, 3.0g choline, carnitine, and inositol premix;

[0078] Flavoring: 0.5g of food-grade flavoring.

[0079] The preparation method of the above-mentioned specific complete nutritional formula food for diabetic patients includes the following steps:

[0080] Phase 1: Wet mixing preparation of pH-responsive protein-polysaccharide composite emulsion, principles: graded treatment, step-by-step addition, low-temperature homogenization; while maintaining the process conditions of Example 1, increasing the dissolution of low-ester pectin / sodium alginate and Ca... 2+ Inducing compounding process;

[0081] (1) In a mildly heated stirring tank at 40°C, add 45g of deionized water; add 10g of maltodextrin, 7g of resistant dextrin, and 6g of isomaltulose in sequence, and stir thoroughly to dissolve; these will serve as thickeners and carriers for the slurry, increasing the solid content; when the temperature drops to 25°C, add 8g of crystalline fructose, 1.5g of oligofructose, and 2.4g of inulin, and stir until completely dissolved to obtain a carrier solution; low temperature helps reduce fructose browning and lowers the risk of inulin hydrolysis.

[0082] (2) Add 40g of water at 40℃ to another mixing tank. While stirring at 5000rpm, slowly add 12g of concentrated whey protein powder and 12g of soy protein isolate powder, and shear and stir at the same time to form a uniform protein slurry without lumps. Let it stand for hydration for 20min to allow the protein to fully absorb water and swell. Add 30g of vegetable fat powder to the protein slurry while stirring at 5000rpm to form a stable protein-fat pre-emulsion. Slowly pour the protein-fat pre-emulsion into the carrier solution in step (1) and continue to stir and mix at 2000rpm to obtain the pre-emulsion slurry.

[0083] (3) Add 10g of water at 50℃ to a small dissolving tank and stir at 300rpm. Slowly add 1.3g of low-ester pectin and 0.5g of sodium alginate to the pre-emulsion in step (2), and maintain stirring for 20min until completely dissolved. Continue stirring for 10min to ensure that the low-ester pectin and sodium alginate are evenly distributed at the protein-fat emulsion interface and in the continuous phase.

[0084] Add 5.5g of mineral premix, 3.0g of choline-carnitine-inositol premix, and 0.5g of food flavoring under stirring conditions of 300rpm, and stir well to improve flavor; because the mineral premix contains Ca 2+ During the subsequent heating-cooling process, it will partially react with low-ester pectin and sodium alginate to form Ca. 2+ Cross-linking to form pH-responsive protein-polysaccharide-Ca 2+ The composite structure provides ionic conditions;

[0085] The mixed slurry is homogenized using a high-pressure homogenizer. The high-pressure homogenizer operates in two stages: the first stage at 15 MPa and the second stage at 5 MPa. This step is crucial as it can break down fat globules and protein aggregates, ensuring that all insoluble components are dispersed at the micron level, forming an extremely stable and homogeneous emulsion suspension system. After homogenization, the slurry temperature will rise slightly, so it needs to be cooled to 25°C before adding 0.3 g of vitamin premix and stirring at 300 rpm until homogenized. This is key to preserving the activity of the vitamins.

[0086] Slurry quality control points: Adjust the solid content to 40% by adding deionized water to balance drying efficiency and slurry flowability; control the viscosity at 400-600 mPa·s for atomization; control the pH value at 6.5-7.0, measure and record it as a quality control benchmark; sensory evaluation: the slurry should be uniform, fine, and free of particles.

[0087] Phase Two: Spray Drying Granulation, Principle: Low-temperature rapid drying, precise temperature control.

[0088] Atomizer selection: Use a high-pressure nozzle (single-fluid pressure nozzle) that matches the pressure spray drying tower. The slurry is sprayed out of the nozzle under high pressure to form fine droplets, which is conducive to the formation of near-spherical particles and improves the powder flowability and instantaneous solubility.

[0089] Drying parameters: Inlet air temperature 150℃, which is relatively low compared to industrial standards, designed to reduce heat damage; outlet air temperature 65℃, which is a core control parameter that must be kept stable within this range to ensure that the product moisture content is <5% and the activity of heat-sensitive components is retained; spray pressure is controlled at 10-25MPa, and by adjusting the spray pressure and feed rate, the target particle D50 is kept between 80-150μm.

[0090] Airflow mode: The drying process uses a co-current flow (hot air and droplets in the same direction), which allows the material to experience a temperature that gradually decreases from high to low, making it more gentle;

[0091] Phase Three: Post-processing and Packaging

[0092] Collection and cooling: After drying, the powder is collected by a cyclone separator and immediately cooled to 25°C by a fluidized bed cooling system to prevent residual heat from causing moisture absorption or agglomeration;

[0093] Sieving: Pass the product through an 80-mesh sieve to remove any possible small amounts of large particles or clumps, ensuring a fine finished product;

[0094] Packaging: In an environment with a temperature of <25℃ and a humidity of <30% RH, immediately pack the product in an aluminum foil bag with nitrogen filling or vacuum sealing to protect the unsaturated fats and vitamins from oxidation. Store the finished product in a cool, dry place.

[0095] Example 3

[0096] A specific complete nutritional formula food for diabetic patients, with the following formula:

[0097] Per 100g dry powder:

[0098] Protein: 12g whey protein concentrate, 12g soy protein isolate;

[0099] Fat: 30g of vegetable fat powder;

[0100] Carbohydrates: 10g maltodextrin, 8g crystalline fructose, 6g isomaltulose;

[0101] Dietary fiber (total amount remains the same as in Example 1, 12.7g / 100g): 7g resistant dextrin, 2.4g inulin, 1.5g fructooligosaccharides, and 1.8g low-ester pectin;

[0102] Vitamins and minerals: 5.5g mineral premix, 0.3g vitamin premix, 3.0g choline, carnitine, and inositol premix;

[0103] Flavoring: 0.5g of food-grade flavoring.

[0104] The preparation method of the above-mentioned specific complete nutritional formula food for diabetic patients is the same as that in Example 2, but the formula is adjusted according to this example.

[0105] Example 4

[0106] A specific complete nutritional formula food for diabetic patients, with the following formula:

[0107] Per 100g dry powder:

[0108] Protein: 12g whey protein concentrate, 12g soy protein isolate;

[0109] Fat: 30g of vegetable fat powder;

[0110] Carbohydrates: 10g maltodextrin, 8g crystalline fructose, 6g isomaltulose;

[0111] Dietary fiber (total amount remains the same as in Example 1, 12.7g / 100g): 7g resistant dextrin, 2.4g inulin, 1.5g fructooligosaccharides, 1.8g sodium alginate;

[0112] Vitamins and minerals: 5.5g mineral premix, 0.3g vitamin premix, 3.0g choline, carnitine, and inositol premix;

[0113] Flavoring: 0.5g of food-grade flavoring.

[0114] The preparation method of the above-mentioned specific complete nutritional formula food for diabetic patients is the same as that in Example 2, but the formula is adjusted according to this example.

[0115] Example 5

[0116] A specific complete nutritional formula food for diabetic patients, with the following formula:

[0117] Per 100g dry powder:

[0118] Protein: 12g whey protein concentrate, 12g soy protein isolate;

[0119] Fat: 30g of vegetable fat powder;

[0120] Carbohydrates: 10g maltodextrin, 8g crystalline fructose, 6g isomaltulose;

[0121] Dietary fiber (total amount remains the same as in Example 1, 12.7g / 100g): 7g resistant dextrin, 2.4g inulin, 1.5g fructooligosaccharides, and 1.8g amidated low-ester pectin;

[0122] Vitamins and minerals: 5.5g mineral premix, 0.3g vitamin premix, 3.0g choline, carnitine, and inositol premix;

[0123] Flavoring: 0.5g of food-grade flavoring.

[0124] The preparation method of the above-mentioned specific complete nutritional formula food for diabetic patients is the same as that in Example 2, but the formula is adjusted according to this example.

[0125] Example 6

[0126] A specific complete nutritional formula food for diabetic patients, with the following formula:

[0127] Per 100g dry powder:

[0128] Protein: 12g whey protein concentrate, 12g soy protein isolate;

[0129] Fat: 30g of vegetable fat powder;

[0130] Carbohydrates: 10g maltodextrin, 8g crystalline fructose, 6g isomaltulose;

[0131] Dietary fiber (total amount remains the same as in Example 1, 12.7g / 100g): 7g resistant dextrin, 2.4g inulin, 1.5g fructooligosaccharides, 1.3g amidated low-ester pectin, and 0.5g sodium alginate;

[0132] Vitamins and minerals: 5.5g mineral premix, 0.3g vitamin premix, 3.0g choline, carnitine, and inositol premix;

[0133] Flavoring: 0.5g of food-grade flavoring.

[0134] The preparation method of the above-mentioned specific complete nutritional formula food for diabetic patients is the same as that in Example 2, but the formula is adjusted according to this example.

[0135] Test Example 1

[0136] 1) Experimental Design

[0137] Study subjects: 100 patients with type 2 diabetes who met the diagnostic criteria of the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China".

[0138] Grouping method: Subjects were randomly divided into an experimental group and a control group using a random number table, with 50 patients in each group. There were no statistically significant differences between the two groups in terms of age, sex, disease duration, baseline blood glucose, and glycated hemoglobin levels (P>0.05), making them comparable.

[0139] Intervention plan:

[0140] Experimental group: In addition to routine dietary guidance (a standardized diabetic diet developed by a nutritionist), the specific complete nutritional formula food provided in Example 1 of this invention was used as a partial meal replacement to replace breakfast daily. The specific dosage was calculated based on the patient's daily energy requirements.

[0141] Control group: Received the same routine dietary guidance as the experimental group, but did not consume this formula food.

[0142] Trial duration: 12 weeks. During the trial, all patients maintained their original blood glucose-lowering medication regimens, and any changes in medication were recorded.

[0143] 2) Observation indicators and detection methods

[0144] Baseline data for all indicators were collected before the start of the trial (day 0), and endpoint data were collected after the end of the trial (week 12).

[0145] 2.1) Main blood glucose indicators

[0146] Fasting plasma glucose (FPG):

[0147] Methods: Venous blood was collected from subjects in the morning after fasting for at least 8 hours overnight.

[0148] Detection: The glucose oxidase method was used for determination using a fully automated biochemical analyzer.

[0149] Standard: Units are expressed in mmol / L.

[0150] 2-hour postprandial blood glucose (2h-PPG):

[0151] Methods: After consuming the standardized test meal (or the prescribed dose of the food formula of this invention), venous blood was collected at exactly 2 hours after the first bite.

[0152] Detection: Same as FPG detection method.

[0153] Standardization: To ensure comparable results, the calorie and macronutrient composition of the experimental meals must be standardized.

[0154] 2.2) Long-term blood glucose control indicators

[0155] Glycated hemoglobin (HbA1c):

[0156] Methods: Venous blood was collected using EDTA anticoagulant tubes.

[0157] Detection: High performance liquid chromatography was used for detection.

[0158] Standard: Units are expressed as percentages (%).

[0159] 2.3) Insulin and related indices

[0160] Fasting insulin (FINS) and 2-hour postprandial insulin (2h-INS):

[0161] Methods: Venous blood samples were collected at the corresponding time points simultaneously with FPG and 2h-PPG blood collection.

[0162] Detection: Serum insulin concentration was determined using chemiluminescent immunoassay.

[0163] Standard: Units are expressed in μIU / mL or mIU / L.

[0164] Insulin Resistance Index (HOMA-IR):

[0165] Calculation method: The steady-state model evaluation formula was used for calculation. HOMA-IR = (FPG × FINS) / 22.5. Where FPG is in mmol / L and FINS is in μIU / mL.

[0166] Significance: An elevated value indicates a worsening of insulin resistance.

[0167] Area under the curve (AUC) of postprandial insulin:

[0168] Methods: After a standard steamed bun meal test or consumption of a prescribed dose of formulated food, venous blood was collected at time points of 0h (fasting), 0.5h, 1h, 2h, and 3h to measure insulin levels.

[0169] Calculation: The area under the insulin concentration-time curve from 0 to 3 hours was calculated using the trapezoidal rule. A decrease in AUC indicates a decrease in total postprandial insulin secretion or accelerated clearance, reflecting improved pancreatic β-cell function or increased insulin sensitivity.

[0170] 2.4) Nutritional status indicators

[0171] Serum albumin (ALB):

[0172] Detection: The bromocresol green method was used to determine the result on a fully automated biochemical analyzer.

[0173] Serum prealbumin (PA):

[0174] Detection: Measured using immunoturbidimetric assay. Prealbumin has a short half-life (approximately 1.9 days) and is a more sensitive indicator of nutritional status and short-term protein metabolism than albumin.

[0175] 3) Statistical methods

[0176] All data were processed using SPSS 24.0.0 statistical software.

[0177] Quantitative data are expressed as mean ± standard deviation (x ± s).

[0178] Within-group comparisons: Paired-samples t-tests were used to compare results before and after the experiment.

[0179] Intergroup comparison: Independent samples t-test was used to compare the differences between the two groups after the experiment.

[0180] Significance level: P < 0.05 is considered statistically significant.

[0181] The results of a clinical trial involving 100 patients showed that:

[0182] Fasting plasma glucose (FPG) decreased by an average of 2.9 ± 0.6 mmol / L (p < 0.01).

[0183] The 2-hour postprandial blood glucose (2h-PPG) decreased by 4.1±1.2 mmol / L (p<0.01).

[0184] Fasting insulin (FINS) showed no significant change from baseline, while the insulin resistance index (HOMA-IR) was significantly lower than baseline (P<0.05), indicating improved insulin resistance.

[0185] The area under the curve (AUC) of insulin two hours after a meal is reduced;

[0186] Glycated hemoglobin (HbA1c) decreased by 1.6 ± 0.5% (p < 0.05);

[0187] Nutritional indicators (albumin, prealbumin) have significantly improved.

[0188] Test Example 2

[0189] In vitro simulated gastrointestinal digestion and glucose release test

[0190] 1) Experimental Design

[0191] Test sample: A specific complete nutritional formula food for diabetic patients as described in the examples.

[0192] Objective: To compare the formulations of the examples in a simulated gastrointestinal environment: changes in viscosity and gel formation during the gastric stage; and the glucose release rate and cumulative release amount throughout the gastrointestinal process.

[0193] 2) Sample preparation

[0194] The specific complete nutritional formula food for diabetic patients in the examples was prepared by mixing it with deionized water at 37°C at a mass ratio of 1:4, and after standing for 5 minutes to fully dissolve, it was used for digestion tests.

[0195] 3) Simulated gastrointestinal digestion model

[0196] The internationally recognized INFOGEST in vitro simulated adult gastrointestinal digestion experimental protocol is preferred, with slight adaptations, and mainly includes the following stages:

[0197] 3.1) Oral pretreatment stage: Mix the prepared formula with simulated saliva at a volume ratio of 1:1 and incubate at 37°C for 2 minutes to simulate the initial starch hydrolysis in the oral cavity.

[0198] 3.2) Gastric digestion stage: The sample was transferred into simulated gastric juice; it was incubated at a constant temperature of 37℃ with shaking, and the digestion time was set at multiple time points of 0, 15, 30, 60 and 120 min;

[0199] Samples were taken at each time point: a portion was used to determine the apparent viscosity (rotational rheometer, shear rate 20-50 s).-1 Record viscosity-time changes;

[0200] The above tests were used to evaluate the gelling / thickening ability of different formulations in the gastric environment.

[0201] 3.3) Small intestine digestion stage:

[0202] Simulated small intestinal fluid was added to the gastric phase system that had been digested for 120 min; the system was incubated at 37°C for 0, 15, 30, 60, 90, and 120 min; the supernatant was collected by centrifugation at each time point, and the soluble glucose concentration was determined by glucose oxidase method.

[0203] To simulate saliva, 15.1g KCl, 3.7g KH2PO4, 13.6g NaHCO3, 17.5g NaCl, 1.1g MgCl2·6H2O, 0.11g CaCl2·2H2O, and 0.94g (NH4)2CO3 were added to 900mL of water and stirred until dissolved. α-Amylase was then added to achieve an enzyme activity concentration of 75U / mL, and the pH was adjusted to 7.0.

[0204] To simulate gastric juice, 15.1g KCl, 3.7g KH2PO4, 13.6g NaHCO3, 17.5g NaCl, 1.1g MgCl2·6H2O, and 0.94g (NH4)2CO3 were added to 900mL of water and stirred until dissolved. Pepsin was then added to achieve an enzyme activity concentration of 2000U / mL, and the pH was adjusted to 3.0.

[0205] To simulate small intestinal fluid, 6.8g KCl, 0.8g KH2PO4, 84.7g NaHCO3, 38.4g NaCl, and 0.33g MgCl2·6H2O were added to 900mL of water and stirred until dissolved. Bile salts were added to bring the final concentration of bile salts to 10mM, and trypsin was added to bring the enzyme activity concentration of trypsin to 100U / mL. The pH was then adjusted to 7.0.

[0206] Table 1 Apparent viscosity-time curves during the gastric phase (mPa·s, n=3)

[0207]

[0208] Table 2. Cumulative glucose release rate in the small intestine (%, n=3)

[0209]

[0210] As shown in Table 1, the rheological behavior of the formulated foods in each example differed significantly under simulated gastric digestion conditions. The apparent viscosity of Example 1 increased only slightly from 0 to 30 min, then gradually decreased with digestion, reaching 322.6 mPa·s at 120 min, indicating that its system was unlikely to form a stable thickening / gel structure in the gastric environment. In Example 2, the introduction of low-ester pectin and sodium alginate significantly increased the viscosity of the system in the acidic gastric environment and maintained it at a high level, indicating that it could form a relatively stable gastric phase structural network.

[0211] While maintaining consistent total dietary fiber content and preparation process, Examples 3-6 further differentiated the gastric phase thickening and structure retention capabilities by adjusting the types and compounding methods of polysaccharides involved in structure building. Example 3 achieved viscosities of approximately 848.6 mPa·s and 792.3 mPa·s at 60 min and 120 min, respectively, a further improvement over Example 2. Example 4 achieved a relatively high viscosity at 60 min, but the viscosity dropped more significantly at 120 min, indicating relatively insufficient gastric phase structure retention. Example 5 exhibited better sustained thickening capabilities, with viscosities of approximately 872.4 mPa·s and 821.6 mPa·s at 60 min and 120 min, respectively.

[0212] Example 6 exhibited the strongest thickening and structure retention capabilities in the gastric phase: the viscosity was approximately 924.3 mPa·s at 60 min and remained at approximately 902.7 mPa·s at 120 min, both higher than those of Examples 2-5. This indicates that the compound system is more conducive to forming a dense and continuous network structure under gastric acid conditions, thereby reducing the fluidity of gastric contents and enhancing the physical barrier to nutrient substrate diffusion and enzyme accessibility, laying a stronger structural foundation for sustained release in the small intestine.

[0213] As shown in Table 2, during the small intestine digestion stage, the cumulative glucose release curves of all formulations shifted to the right and slowed down compared to Example 1. Example 6 showed the most significant early release inhibition: the release rates at 15 min, 30 min, and 60 min were approximately 14.9%, 26.8%, and 52.7%, respectively, all lower than the 19.6%, 34.9%, and 64.5% of Example 2. The cumulative release rate at 120 min was approximately 88.2%, similar to other examples, approaching a plateau. This indicates that Example 6 primarily achieves rate regulation of the early rapid release phase, rather than reducing the final total release, which better meets the needs of diabetic patients for stable postprandial blood glucose levels. Considering both gastric viscosity maintenance and small intestine release kinetics, Example 6 demonstrated the best synergistic effect of structured thickening and sustained release under the same process conditions in this group.

[0214] The above embodiments are preferred embodiments of the present invention, but the embodiments of the present invention are not limited to the above embodiments. Any changes, modifications, substitutions, combinations, or simplifications made without departing from the spirit and principle of the present invention should be considered equivalent substitutions and are included within the protection scope of the present invention. The product of the present invention has passed pilot-scale verification, the production process is stable, and the quality is controllable. The product meets the requirements of GB 29922-2025 "General Rules for Foods for Special Medical Purposes" and has completed all the work before the registration inspection of special medical foods, with all indicators being qualified. This product has achieved industrial-scale trial production at Dongze Special Medical Food Co., Ltd., and as an important part of the "Medical Food and Diet" series of products, it has been used for trial verification in multiple medical institutions with significant results.

Claims

1. A specific complete nutritional formula food for diabetic patients, characterized in that, Includes the following components: On a dry basis by weight percentage: Protein composition: 8-20% concentrated whey protein powder, 8-20% soy protein isolate powder; Fat component: 20-45% vegetable fat powder; Carbohydrate composition: maltodextrin 8-20%, crystalline fructose 5-10%, isomaltulose 2-8%; Dietary fiber components: resistant dextrin 4-10%, inulin 2-8%, fructooligosaccharides 1-7%; Premix: Mineral premix 2-10%; Vitamin premix 0.1-1%; Choline, Carnitine, Inositol premix 2-6%; Fragrance: 0.1-1.5%.

2. The specific complete nutritional formula food for diabetic patients as described in claim 1, characterized in that: The dietary fiber component comprises 4-10% resistant dextrin, 2-8% inulin, 1-7% fructooligosaccharides, and 1-5% structured gelling polysaccharides; the structured gelling polysaccharides are at least one of low-ester pectin, amidated low-ester pectin, and sodium alginate.

3. The specific complete nutritional formula food for diabetic patients as described in claim 2, characterized in that: The structured gelling polysaccharide is a combination of amidated low-ester pectin and sodium alginate.

4. A method for preparing a specific complete nutritional formula food for diabetic patients, characterized in that: Includes the following steps: (1) Under the conditions of 35-45℃ and 300-800rpm, maltodextrin, resistant dextrin and isomaltulose are added to water in sequence and stirred until dissolved; after cooling to 20-30℃, crystalline fructose, inulin and oligofructose are added and stirred until homogeneous to obtain the carrier solution. (2) At 35-45℃ and 3000-6000rpm, concentrated whey protein powder and soy protein isolate powder are added to water and allowed to stand for hydration for 10-30min; then vegetable fat powder is added at 3000-6000rpm to form a pre-emulsion, and then the pre-emulsion slurry is obtained by adding it to the carrier solution in step (1) at 1000-2500rpm. At 45-55℃ and 200-500rpm, add the mineral premix, choline-carnitine-inositol premix, and flavoring to the pre-emulsion and stir for 5-15 minutes; or, at 45-55℃ and 200-500rpm, add the structured polysaccharide to the pre-emulsion and stir for 5-15 minutes, then add the mineral premix, choline-carnitine-inositol premix, and flavoring, and stir until homogeneous. The mixed slurry is subjected to two-stage high-pressure homogenization: the first stage at 10-20 MPa and the second stage at 3-8 MPa; after homogenization, it is cooled to ≤30℃ and then vitamin premix is ​​added and stirred evenly to obtain the slurry to be sprayed. (3) Use pressure spray drying with an inlet air temperature of 140-170℃, an outlet air temperature of 60-75℃, and a spray pressure of 10-25MPa. After collecting the powder, quickly cool it to ≤25℃, pass it through an 80-200 mesh sieve, pack it in an aluminum foil bag filled with nitrogen or vacuum sealed, and store it in a cool and dry place.

5. The method for preparing a specific complete nutritional formula food for diabetic patients as described in claim 4, characterized in that: In step (1), the amount of water used is 1-1.5 times the total mass of maltodextrin, resistant dextrin, isomaltulose, crystalline fructose, inulin and oligofructose.

6. The method for preparing a specific complete nutritional formula food for diabetic patients as described in claim 4, characterized in that: In step (2), the amount of water used is 0.5-1 times the total mass of concentrated whey protein powder, soy protein isolate powder and vegetable fat powder.

7. The method for preparing a specific complete nutritional formula food for diabetic patients as described in claim 4, characterized in that: The solids content of the spray slurry is 35%-45%, the pH is 6.5-7.5, and the apparent viscosity is controlled at 350-650 mPa·s.

Images