Specific total-nutrient formula food applied to diet-restricted diabetes mellitus group

Abstract

The invention provides a specific full-nutrient formula food applied to diet-restricted diabetes mellitus groups, and belongs to the technical field of formula foods for special medical purposes. According to the product, marine active substances and medicinal and edible traditional Chinese medicine extracts are innovatively compounded, and a multi-probiotic microencapsulation technology is combined, so that a specific full-nutrition formula with the functions of regulating blood sugar, improving insulin resistance and protecting target organ functions is formed. The formula comprises marine active ingredients such as marine collagen tripeptide, a sea cucumber saponin extract and fucoidan as well as medicinal and edible traditional Chinese medicine extracts such as mulberry leaves, rhizoma polygonati and radix puerariae, and oligopeptide, amino acid, multivitamins and mineral substances in a specific proportion are matched. Probiotics are protected by adopting a three-layer microencapsulation technology to pass through a gastric acid environment, active ingredients are reserved by utilizing a low-temperature enzymolysis and molecular directed extraction technology, and the nutritional status and blood sugar control of diabetic patients can be remarkably improved through clinical verification. The product conforms to the GB 29922-2013 special medical purpose formula food standard, can be used as a single nutrition source for diabetics, and meets the special nutrition requirements of the diabetics.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of special medical purpose formula food, and particularly relates to a specific whole-nutrition formula food serving a diet-restricted diabetes group, in particular, a compound formula combining marine active substances and medicinal and edible Chinese herbal medicine extracts, which is suitable for diabetes patients in need of medical nutrition therapy. BACKGROUND

[0002] Diabetes is a global epidemic chronic metabolic disease, and the number of diabetes patients in China has exceeded 140 million. Diet management is the basis of diabetes treatment, but traditional diabetes diet has problems such as unbalanced nutrition, poor taste and low compliance. Special medical purpose formula food (FSMP) as an important carrier of medical nutrition therapy plays an increasingly important role in diabetes management.

[0003] The existing diabetes special medical food mainly has the following technical defects: 1) single protein source, mostly whey protein or soy protein, with low bioavailability; 2) simple carbohydrate regulation means, mostly adding dietary fiber, lacking systematic blood glucose regulation strategy; 3) simple superposition of functional ingredients, lacking synergistic compounding technology; 4) low survival rate of probiotics, large number of inactivation in gastric acid environment; 5) ignoring the unique value of marine active substances.

[0004] Marine organisms produce a large number of bioactive substances with unique structure and significant activity due to their special living environment. Studies have shown that marine collagen tripeptide has the effect of improving insulin sensitivity; sea cucumber saponin can significantly reduce blood glucose and blood lipids; brown algae polysaccharide has the functions of regulating intestinal flora and enhancing immunity. The synergistic effect of these active ingredients and traditional medicinal and edible Chinese herbal medicine has not been fully applied in diabetes special medical food.

[0005] Based on years of research, the research and development team innovatively combines marine active substances with traditional medicinal and edible Chinese herbal medicine, and through specific proportioning and advanced technology, develops a diabetes specific whole-nutrition formula food with multiple regulation mechanisms, solving the technical bottlenecks of existing products. SUMMARY

[0006] The purpose of the present application is to provide a medical and food worry-free specific whole-nutrition formula food applied to a diet-restricted diabetes group, which has the following innovative points: 1. The first synergistic formula system of marine active substances and medicinal and edible Chinese herbal medicine, regulating glucose metabolism through multiple targets; 2. Development of three-layer microencapsulated probiotic protection technology, greatly improving the survival rate in gastric acid environment; 3. Application of low-temperature enzymatic decoupling and molecular directional extraction technology to maximize the retention of active ingredients; 4. Establishing a steady-state technology of protein-polysaccharide-plant active ingredients to improve product stability.

[0007] The main technical scheme of the formula of the present application is as follows: 1. Marine active substance combination: four marine-derived active ingredients, marine collagen tripeptide, sea cucumber saponin, fucoidan and sea star saponin, are selected and compounded in a specific ratio to play a synergistic role in reducing blood sugar, improving insulin resistance and protecting target organ function; 2. TCM formula of food and medicine: based on the records in "Compendium of Materia Medica" and modern pharmacological research, six food and medicine TCMs, mulberry leaf, yellow ginseng, radix puerariae, bitter gourd, polygonatum and psoralea, are selected and extracted at low temperature to retain effective ingredients, and the TCM theory of "nourishing yin, clearing heat, invigorating spleen and kidney" is followed; 3. Probiotic microencapsulation technology: a self-developed three-layer protein-polysaccharide-lipid complex microcapsule technology is used to achieve high survival rate (≥95%) of probiotics in gastric acid environment and intestinal targeting release (≥90%); 4. Nutrient matrix design: soybean protein isolate peptide and whey protein peptide double protein system are selected, combined with medium-chain triglycerides and resistant dextrin, to achieve the nutritional characteristics of low GI (≤35) and high protein utilization rate (≥90%).

[0008] The beneficial effects of the present application include: 1. Multiple mechanisms for blood sugar regulation: synergistic blood sugar reduction through inhibition of alpha-glucosidase, improvement of insulin sensitivity, and protection of beta cells; 2. Comprehensive and balanced nutrition: meets the special nutritional needs of diabetic patients and can be used as a single source of nutrition; 3. Intestinal microecological regulation: high-activity probiotics and prebiotics work synergistically to improve intestinal barrier function; 4. Target organ protection: marine active ingredients have unique cardiovascular and kidney protection effects; 5. Convenient to use: various dosage forms are designed to meet the needs of different use scenarios. DETAILED DESCRIPTION

[0009] The present application will be further described below in conjunction with examples, but the scope of protection of the present application is not limited thereto. Example 1

[0010] Powder formula (parts by weight): - marine collagen tripeptide 20 parts, sea cucumber saponin extract 10 parts, fucoidan 15 parts; - mulberry leaf extract 15 parts, yellow ginseng extract 12 parts, radix puerariae extract 15 parts; - microencapsulated bifidobacterium 80 parts, microencapsulated lactobacillus 80 parts; - Soybean protein isolate peptides 50 parts, whey protein peptides 30 parts; - Complex vitamins 10 parts, complex minerals 10 parts; Preparation method: 1) Mix marine active substances with traditional Chinese medicine extracts, add 5% β-cyclodextrin inclusion; 2) Enzymatically hydrolyze the protein peptide matrix with a complex enzyme (papain: flavor protease = 1:2) at 45°C for 3 hours; 3) Mix all components and low-temperature spray dry at 60°C; 4) Add microencapsulated probiotics under sterile conditions; 5) Package as 15g / bag aluminum foil packaging. Example 2

[0011] Liquid formula (parts by weight): - Marine collagen tripeptide 25 parts, sea star saponin 8 parts; - Bitter gourd polypeptide P10 parts, Anemarrhena asphodeloides extract 8 parts; - Microencapsulated probiotic complex 120 parts; - Resistant dextrin 25 parts, medium-chain triglyceride 20 parts; - Complex vitamins 12 parts; Preparation method: 1) Use ultra-high pressure extraction technology to prepare active ingredients; 2) Use nano-emulsification technology to process fat-soluble ingredients; 3) Sterile fill as 100ml / bottle liquid dosage form; 4) Store at 4°C. Example 3

[0012] Solid energy bar formula (parts by weight): - Brown algae polysaccharide 18 parts, Cortex Lycii extract 8 parts - Microencapsulated probiotics 100 parts - Protein peptide complex 60 parts - White kidney bean extract 5 parts, mulberry polysaccharide 8 parts Preparation method: 1) Use low-temperature forming technology, processing temperature ≤ 50°C; 2) Add microencapsulated probiotics; 3) Make 15g / branch solid energy bars. Clinical trials.

[0013] According to the results of 100 clinical trials in Shenzhen People's Hospital: - The average fasting blood glucose decreased by 2.8±0.7mmol / L (p<0.01); - 2 hours postprandial blood glucose decreased by 4.2 ± 1.1 mmol / L (p < 0.01); - Glycated hemoglobin decreased by 1.5 ± 0.4% (p < 0.05); - The number of intestinal bifidobacterium increased by 3-5 orders of magnitude; - Nutritional indicators (albumin, prealbumin) were significantly improved. Industrial applicability

[0014] The product of the present application has been verified by pilot test, the production process is stable, and the quality is controllable. The product meets the requirements of GB 29922-2013 "General Principles for Special Medical Purpose Formulated Foods", and has completed all work before special medical food registration test, and all indicators are qualified. The product has realized industrialization trial production in Tianjin Bainabio Technology Co., Ltd., as an important part of "Medical Food Good Diet" series products, and has provided trial verification work in many medical institutions, with remarkable effect. Brief description of the drawings

[0015] Figures 1-4 : Figure 1 is a schematic diagram of the formula composition of the present application, Figure 2 is a schematic diagram of the structure of the three-layer microencapsulated probiotics, Figure 3 is a process flow diagram for product preparation, Figure 4 is a blood glucose change curve chart for clinical test. Notes

[0016] The present application has completed 9 months of uninterrupted comprehensive animal experiments in the National Animal Laboratory of Shenzhen People's Hospital, and has passed the gene detection work of Huada Gene. After the completion of the clinical test, it is planned to apply for registration to the national special medical food registration management unit. The project has won the gold award of the China International University Students Innovation Contest (2024) Shanxi Innovation Contest, and its specific whole-nutrient formula diabetic food has been applied in the "Medical Food Worry-Free", "Medical Food Good Diet" and other product series of Tianjin Bainabio Technology Co., Ltd., and has fully possessed the industrialization basis.

Claims

1. A specific nutritionally complete formula for use in a diet-restricted diabetic population, characterized in that The raw material components include the following components by weight: - Marine active substances: marine collagen tripeptide 15-30 parts, sea cucumber saponin extract 5-15 parts, brown alga polysaccharide 8-20 parts, sea star saponin 3-10 parts; - Medicinal and edible Chinese medicine extract: mulberry leaf extract 10-20 parts, yellow ginseng extract 8-18 parts, radix puerariae extract 10-20 parts, bitter gourd polypeptide P 5-15 parts, polygonatum extract 5-12 parts, cortex lycii extract 5-10 parts; - Probiotic compound: microencapsulated bifidobacterium (Bifidobacterium longum, Bifidobacterium lactis, Bifidobacterium infantis) 50-100 parts, microencapsulated lactobacillus (Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus plantarum) 50-100 parts; - Nutrient matrix: soybean protein isolate peptide 30-60 parts, whey protein peptide 20-40 parts, medium-chain triglyceride 10-25 parts, resistant dextrin 15-30 parts; - Vitamin and mineral compound: complex vitamins (vitamins A, D, E, K, B group, C) 5-15 parts, complex minerals (chromium, zinc, magnesium, selenium, calcium) 5-15 parts.

2. The specific nutritionally complete formula according to claim 1, characterized in that The marine collagen tripeptide has a molecular weight of ≤1000 Da, the saponin content of the sea cucumber saponin extract is ≥40%, and the fucoidan content of the brown alga polysaccharide is ≥30%.

3. The specific nutritionally complete formula according to claim 1, characterized in that The medicinal and edible Chinese medicine extract is prepared by low-temperature enzymatic coupling molecular directional extraction technology, the extraction temperature is ≤50℃, and the retention rate of effective components is ≥90%.

4. The specific nutritionally complete formula according to claim 1, characterized in that The probiotic compound is embedded by three-layer protein-polysaccharide-lipid complex microcapsule technology, the survival rate in gastric acid environment is ≥95%, and the intestinal release rate is ≥90%.

5. The specific nutritionally complete formula according to claim 1, characterized in that It also includes the following functional components: white kidney bean extract (α-amylase inhibitor) 2-8 parts, mulberry polysaccharide 3-10 parts, L-arabinose 1-5 parts.

6. The method for the preparation of a specific nutritionally complete formula according to claim 1, characterized in that It includes the following steps: a) Mix marine active substances and medicinal and edible Chinese medicine extract according to the proportion, add β-cyclodextrin for molecular inclusion; b) Perform low-temperature enzymatic treatment on the nutrient matrix components, the enzymatic temperature is 40-45℃, and the time is 2-4 hours; c) Mix the vitamin and mineral compound with the products of steps a and b uniformly, and perform low-temperature spray drying; d) Mix the microencapsulated probiotic compound with the product of step c under sterile conditions; e) Sterilize and package to make powder, liquid or solid forms.

7. The method of claim 6, wherein The low-temperature spray drying inlet air temperature is ≤60℃, the material temperature is ≤45℃, and the moisture content is ≤5%.

8. Use of the specific complete nutritional formula of claim 1 in the preparation of a medical food for improving the nutritional status of diabetic patients and regulating blood glucose metabolism.

9. The specific nutritionally complete formula according to claim 1, characterized in that It has a glycemic index (GI) of ≤35 and a protein utilization rate of ≥90%, and can be used as a single nutritional source for diabetic patients.

10. Packaged form of a specific nutritionally complete formula according to claim 1, characterized in that It includes 10-20g of small bagged powder, 50-100ml of bottled liquid, or 10-15g of solid energy bar.

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