New mode development and applicable group application of special dietary food under special medical core technology

Abstract

The invention discloses new modal development and applicable group application of special dietary foods under a special medical core technology, and belongs to the technical field of formula foods for special medical purposes. According to the product, active peptide of Huainan spotted-brown chicken is creatively combined with a marine brown algae polysaccharide compound, and a special dietary food system with a triple metabolism regulation mechanism (inhibiting fat synthesis, promoting energy consumption and regulating intestinal flora) is formed. The core formula comprises 20%-30% of spotted-brown chicken active peptide (the molecular weight is smaller than or equal to 1500 Da), 15%-25% of a fucoidan-chitosan compound, 10%-20% of a folium mori-radix puerariae-rhizoma polygonati three-phase extract, 10%-15% of medium-chain triglyceride nano-emulsion and 3%-5% of compound probiotics (lactobacillus plantarum CGMCC No.1258 and lactobacillus rhamnosus ATCC 53103). And low-temperature directional enzymolysis, microencapsulation targeted delivery and ultrahigh-pressure nano-emulsification technologies are adopted, so that the bioavailability of the active ingredients is ensured. Clinical tests prove that the product can significantly improve the body fat rate (averagely reduced by 8.2 + / -2.5% in 12 weeks) of people suffering from obesity and prediabetes mellitus, meets the daily basic nutritional requirements, and conforms to the GB 29922-2013 special medical purpose formula food standard.

Description

Technical Field

[0001] The present invention belongs to the technical field of the intersection of special medical purpose formula foods and functional foods, and specifically relates to a special dietary food system based on Huainan Ephedra chicken and marine active ingredients, which is particularly suitable for nutritional intervention and health management of people with metabolic abnormalities such as obesity and prediabetes. Background Art

[0002] Traditional weight loss products suffer from three major technical flaws: 1) nutritional imbalance, leading to muscle loss with long-term use; 2) limited functionality, focusing solely on caloric deficit while ignoring metabolic regulation; and 3) poor palatability and low user compliance. Existing patent CN112546133A utilizes a traditional Chinese medicine formula but lacks precise nutritional design; CN112674325A focuses on protein supplementation but fails to address metabolic regulation; and CN108450930A's ultrafine grinding technology provides insufficient protection for the active ingredients.

[0003] The muscle carnosine content of Huainan Ephedra chicken is 2-3 times higher than that of other chicken breeds, demonstrating significant antioxidant and metabolic regulatory potential. Combined with the gut microbiota-regulating effects of marine fucoidan, this creates a unique "animal-plant" dual-source active system. However, existing technologies have yet to achieve a stable combination and efficient delivery of these two active ingredients.

[0004] Based on the concept of "medicine and food have the same origin, and medicinal diet is integrated", this research and development team innovatively combines local specialty ingredients with modern biotechnology to develop a special dietary food system that has both cultural attributes and health functions, solving the technical bottleneck in the field of metabolic intervention foods. Summary of the Invention

[0005] The core innovations of the present invention include: 1. The first stable composite system of Huainan Ephedra Chicken active peptide and fucoidan, forming a sustained-release carrier through molecular self-assembly; 2. Develop a three-phase extraction technology of mulberry leaves, kudzu root, and polygonatum to achieve the triple effects of α-glucosidase inhibition, insulin sensitization, and mitochondrial activation; 3. Design a probiotic-polysaccharide-peptide synergistic delivery system to increase intestinal colonization efficiency by 3-5 times; 4. The application of ultra-high pressure nano-emulsification technology increases the bioavailability of medium-chain triglycerides by 80%.

[0006] The main technical solutions of the present invention's formula are as follows: 1. Animal active ingredient module: Huainan Ephedra chicken is used for targeted enzymatic hydrolysis to obtain active peptides with a molecular weight of ≤1500Da. These peptides are rich in carnosine (≥5%) and anserine (≥3%), and have a unique effect on activating fat oxidation. 2. Plant active system: Fucoidan (fucose content ≥35%) and chitosan are electrostatically self-assembled to form a complex that selectively promotes the proliferation of Bifidobacterium (increase by 2-3 orders of magnitude) while delaying gastric emptying (extending by 30-40 minutes); 3. Traditional Chinese Medicine Formula: Based on the records in the Compendium of Materia Medica, three traditional Chinese medicines with medicinal and edible properties were carefully selected: mulberry leaves (containing 1-deoxynojirimycin), kudzu root (containing puerarin), and polygonatum (containing polygonatum polysaccharides). Supercritical CO2 extraction was used to preserve the intact active sites. 4. Energy supply system: Medium-chain triglycerides (C8-C12 ≥90%) are homogenized at 150MPa ultra-high pressure to form a nanoemulsion (particle size ≤200nm), combined with resistant dextrin (degree of polymerization 10-30) to provide sustained energy without causing blood sugar fluctuations.

[0007] The beneficial effects of the present invention include: 1. Metabolic regulation with multiple targets: Simultaneously acting on three key links: lipase (inhibiting ACC activity by ≥60%), energy expenditure (activating the AMPK pathway), and intestinal flora (increasing bifidobacteria by 2-3 orders of magnitude); 2. Nutritionally complete: Protein potency (PER) reaches 2.8, essential amino acid index (EAAI) ≥ 0.9, meeting DRIs standards; 3. Outstanding cultural attributes: Deeply integrated with Huainan food culture, user acceptance increased by 40%; 4. Safety assurance: Acute toxicity test (LD50>15g / kg) and teratogenicity test confirmed no adverse reactions. DETAILED DESCRIPTION

[0008] The present invention is described in detail below with reference to the embodiments, but the protection scope of the present invention is not limited thereto.

[0009] Example 1: Instant powder dosage form Formula composition (weight percentage): - Huainan Ephedra Chicken Active Peptide 25%; - Fucoidan-chitosan complex 20%; - Mulberry leaf, Pueraria root and Polygonatum sibiricum triphasic extract 15%; - Medium chain triglyceride nanoemulsion 12%; - Complex probiotics 4%; - Resistant dextrin 8%; - Multivitamin mineral premix 4%; - Other auxiliary materials 12%; Preparation process: 1) Active peptides were obtained from ephedra chicken breast meat through compound enzymatic hydrolysis and ultrafiltration; 2) Fucoidan and chitosan formed a complex at 50°C; 3) Mulberry leaves, Pueraria root, and Polygonatum sibiricum are extracted with supercritical CO2 and then molecularly distilled; 4) preparing nanoemulsions of medium-chain triglycerides by high-pressure homogenization at 150 MPa; 5) After mixing the components, use a three-fluid nozzle to spray dry at low temperature; 6) Add microencapsulated probiotics and then fill with nitrogen for packaging; Example 2: Ready-to-drink liquid Formula composition (weight percentage): - Huainan Ephedra Chicken Active Peptide 20%; - Fucoidan-chitosan complex 15%; - Mulberry leaf, Pueraria root and Polygonatum sibiricum triphasic extract 10%; - Medium chain triglyceride nanoemulsion 15%; - Complex probiotics 3%; - Other components 37%; Process characteristics: 1) Ultra-high pressure homogenization (180 MPa) was used to treat the lipid phase; 2) Add 0.1% gellan gum as a stabilizer; 3) Aseptic filling after UHT sterilization (137℃ 4s); Example 3: Ready-to-eat energy bar; Formula composition (weight percentage): - Huainan Ephedra Chicken Active Peptide 30%; - Fucoidan-chitosan complex 25%; - Functional excipients 5%; - Other components 40%; Process characteristics: 1) Low temperature molding (≤50℃) to maintain activity; 2) applying a cocoa butter-based coating on the outside; 3) Independent nitrogen-filled packaging. clinical trials

[0010] A randomized controlled trial (n=150) conducted by the Aerospace Hospital showed that: - Body fat percentage: average reduction of 8.2±2.5% over 12 weeks (p<0.01); - Waist circumference: average reduction of 7.5±2.8cm (p<0.01); - Fasting blood glucose: decreased by 1.2±0.5mmol / L (p<0.05); - The number of intestinal bifidobacteria: increased by 2-3 orders of magnitude; - Muscle mass: remains stable (change rate ≤ 3%); Industrial Applicability

[0011] A demonstration production line for this product, developed in collaboration with an ephedra chicken manufacturer in Huainan, is planned, with an estimated annual production capacity of 500 tons. The product complies with the requirements of GB 29922-2013, "General Rules for Formulated Foods for Special Medical Purposes," and has passed a six-month accelerated stability test. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] (1) Figure 1 The invention demonstrates a four-fold mechanism of action: 1) Ephedra chicken active peptide activates the AMPK pathway; 2) Fucoidan regulates intestinal flora; 3) Mulberry leaf extract inhibits glycosidase; 4) Medium-chain triglycerides rapidly provide energy; (2) Figure 2 Scanning electron microscope image (×10000) of the Ephedra chicken active peptide-fucoidan complex is shown, showing the formed nano-network structure; (3) Figure 3 This is a confocal microscopic image of three-layer microencapsulated probiotics (live bacteria stained green), showing the complete capsule structure and bacterial distribution; (4) Figure 4 The body fat percentage change curve of the clinical trial (12-week data) is presented, and the experimental group is significantly lower than the control group (p<0.01). Remarks

[0013] This invention has completed 9 months of uninterrupted comprehensive animal experiments in the National Animal Laboratory of Shenzhen People's Hospital and has passed the genetic testing of BGI.

Claims

1. A special dietary food, characterized in that Contains the following components in weight percentage: - Huainan Ephedra Chicken Active Peptide (molecular weight ≤ 1500Da) 20-30%; - Fucoidan-chitosan complex (fucose content ≥35%) 15-25%; - Mulberry leaf-Kuai root-Polygonatum triphasic extract (containing 1-deoxynojirimycin ≥5%, puerarin ≥8%, Polygonatum polysaccharide ≥10%) 10-20%; - Medium-chain triglyceride nanoemulsion (C8-C12 ≥90%, particle size ≤200nm) 10-15%; - Composite probiotics (Lactobacillus plantarum CGMCC No. 1258 + Lactobacillus rhamnosus ATCC 53103, viable count ≥ 1 × 10^10 CFU / g) 3-5%; - Resistant dextrin (degree of polymerization 10-30) 5-10%; - Multivitamin mineral premix 3-5%.

2. The special dietary food according to claim 1, characterized in that The Huainan Ephedra chicken active peptide is prepared by the following method: Huainan Ephedra chicken breast is selected, enzymatically hydrolyzed with a composite enzyme (flavor protease: neutral protease = 2:1) at 45°C for 4 hours, and ultrafiltration is performed to obtain an active peptide segment with a molecular weight of ≤1500Da, with a peptide yield of ≥85%.

3. The special dietary food according to claim 1, characterized in that The fucoidan-chitosan complex is prepared by the following method: fucoidan (from Sargassum, with a fucose content of ≥35%) and chitosan (with a deacetylation degree of ≥90%) are mixed in a ratio of 5:1, 0.3% citric acid is added as a cross-linking agent, and the mixture is reacted at 50°C for 2 hours to form a complex.

4. The special dietary food according to claim 1, characterized in that The mulberry leaf-kudzu root-polygonatum three-phase extract is prepared by supercritical CO2 extraction combined with low-temperature molecular distillation technology, and contains 1-deoxynojirimycin (content ≥5%) in mulberry leaves, puerarin (content ≥8%) in kudzu root, and polygonatum polysaccharide (content ≥10%) in polygonatum, with an average particle size of ≤50μm.

5. The special dietary food according to claim 1, characterized in that The medium-chain triglyceride nanoemulsion is prepared by ultra-high pressure homogenization technology (pressure ≥150 MPa), contains C8-C12 medium-chain triglycerides, lecithin and β-cyclodextrin (weight ratio 8:1:1), and has an average particle size of ≤200 nm.

6. The method for preparing the special dietary food according to claim 1, characterized in that The following steps are involved: a) premixing Huainan Ephedra Chicken active peptide and fucoidan-chitosan complex at 40-45°C; b) dry-mixing the mulberry leaf-kudzu root-polygonatum three-phase extract with resistant dextrin and then adding the mixture from step a); c) homogenizing the medium-chain triglyceride nanoemulsion and the multivitamin and mineral premix in an emulsifier; d) mixing the products of steps b) and c) and spray drying them at low temperature using a three-fluid nozzle (inlet air temperature ≤ 60°C); e) Finally, add the microencapsulated compound probiotics, mix and package in an environment with a relative humidity of ≤30%.

7. The preparation method according to claim 6, characterized in that The microencapsulated composite probiotics adopt a three-layer encapsulation technology: the outer layer is a calcium alginate-chitosan composite film (thickness 50-100nm), the middle layer is a whey protein isolation layer, and the inner layer is a probiotic-oligogalactose (1:1) complex. The survival rate in the gastric acid environment is ≥95%, and the intestinal targeted release rate is ≥90%.

8. Use of the special dietary food according to claim 1 in the preparation of a medical food for improving the body composition of patients with metabolic syndrome, wherein the metabolic syndrome includes central obesity, insulin resistance and dyslipidemia.

9. The special dietary food according to claim 1, characterized in that Its glycemic index (GI) is ≤28, protein digestibility-corrected amino acid score (PDCAAS) is ≥0.92, every 100g provides 280-320kcal of energy, and the fat energy supply ratio is ≤30%. It can be used as a single source of nutrition for people with metabolic abnormalities.

10. The product form of the special dietary food according to claim 1, characterized in that include: - 20g instant powder (packed in aluminum foil composite film and nitrogen filling); - 250ml ready-to-drink liquid (sterile filling in HDPE bottles); - 50g ready-to-eat energy bars (with a cocoa butter-based coating); - 100g of pre-made dishes (vacuum packed for freshness).

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