Composition as well as preparation method and application thereof

Abstract

The invention provides a composition as well as a preparation method and application thereof, the composition comprises radix puerariae, radix polygonati officinalis and lucid ganoderma, and the mass ratio of the radix puerariae to the radix polygonati officinalis to the lucid ganoderma is (2-5): (2-4): 1. The composition has a relatively low glycemic index, and is helpful for regulating and controlling blood sugar.

Description

Technical Field

[0001] The present invention relates to the technical field of food and medicine, and in particular to a composition, a preparation method and an application thereof. Background Art

[0002] Blood sugar is the body's primary source of energy. Stable blood sugar levels not only help maintain a steady energy supply but also contribute to overall metabolic health. Diet is a key factor influencing blood sugar levels. Choosing the right foods and nutrient combinations can help maintain healthy blood sugar levels. Foods with a low glycemic index (GI) are often recommended to help control blood sugar because they cause less fluctuation in blood sugar after consumption. For example, a variety of foods are already on the market that claim to help regulate blood sugar, including high-fiber foods, whole-grain products, protein-rich foods, and foods containing healthy fats. These foods generally help regulate blood sugar by slowing the absorption of carbohydrates or improving insulin sensitivity.

[0003] Although there are many compositions in the prior art that help control blood sugar, there are still problems such as poor effects.

[0004] Therefore, developing a composition that can effectively regulate blood sugar has important research significance. Summary of the Invention

[0005] The present invention provides a composition, a preparation method and an application thereof, which can effectively regulate blood sugar.

[0006] The invention provides a composition comprising kudzu root, polygonatum odoratum and ganoderma lucidum, wherein the mass ratio of the kudzu root, polygonatum odoratum and ganoderma lucidum is (2-5):(2-4):1.

[0007] Optionally, the mass ratio of the Pueraria root, Polygonatum odoratum and Ganoderma lucidum is 2:2:1.

[0008] The present invention provides a method for preparing the composition, comprising: mixing the kudzu root, polygonatum and ganoderma lucidum to obtain the composition.

[0009] The present invention provides a product comprising the composition as described above.

[0010] Optionally, the product includes at least one of food, medicine, health food, and special medical purpose formula food, wherein the food includes one or more of milk powder, milk tablets, and yogurt.

[0011] Optionally, in the product, the mass percentage of the composition described above is 0.03%-0.07%.

[0012] Optionally, the product further comprises resistant dextrin and inulin, and in the product, the mass percentage of the resistant dextrin is 0-15%, and the mass percentage of the inulin is 0-15%.

[0013] Optionally, the product further comprises one or more of milk mineral salts, lactoferrin, and bifidobacteria, and in the product, the mass percentage of the milk mineral salts is 0-1%, the mass percentage of the lactoferrin is 0-2%, and the mass percentage of the bifidobacteria is 0-4%; and / or the product further comprises vitamins and minerals.

[0014] Optionally, the product comprises, by mass percentage, 16.5% to 30.0% protein, 1.0% to 26.0% fat, 0% to 15.0% dietary fiber, and 30% to 69% carbohydrates.

[0015] The present invention provides a method for preparing the product as described above, comprising: mixing a raw material system including the composition as described above to obtain the product.

[0016] The present invention provides a composition, a preparation method, and an application thereof. In terms of blood sugar regulation, kudzu root, polygonatum odoratum, and ganoderma lucidum exhibit a synergistic effect, achieving an effect of 1+1+1>3. Furthermore, by controlling the mass ratio of kudzu root, polygonatum odoratum, and ganoderma lucidum to (2-5):(2-4):1, the synergistic blood sugar regulation effect of the three ingredients is more pronounced, resulting in the composition having a lower glycemic index (GI). The composition is effective in maintaining and improving fasting blood sugar, postprandial blood sugar regulation, glucose tolerance, and other aspects, and has a good blood sugar-lowering effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following is a brief introduction to the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0018] Figure 1 Graph showing the blood sugar response of glucose and the formula milk powder of Example 2;

[0019] Figure 2 It is the area under the blood glucose curve of glucose and the formula milk powder of Example 2. DETAILED DESCRIPTION

[0020] In order to enable those skilled in the art to better understand the scheme of the present invention, the present invention is further described in detail below. The specific embodiments listed below are only for describing the principles and features of the present invention. The examples are only used to explain the present invention and are not intended to limit the scope of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without making creative efforts are within the scope of protection of the present invention.

[0021] Although there are many compositions in the prior art that help control blood sugar, there are still problems such as poor effects.

[0022] In order to overcome the defects in the prior art, in a first aspect, an embodiment of the present invention provides a composition comprising Pueraria lobata, Polygonatum odoratum and Ganoderma lucidum, wherein the mass ratio of Pueraria lobata, Polygonatum odoratum and Ganoderma lucidum is (2-5): (2-4):1.

[0023] Research and analysis show that Pueraria root, Polygonatum odoratum, and Ganoderma lucidum exhibit a synergistic effect in regulating blood sugar, achieving a 1+1>2 effect. Furthermore, controlling the mass ratio of Pueraria root, Polygonatum odoratum, and Ganoderma lucidum to (2-5):(2-4):1 significantly enhances the synergistic effect, resulting in a lower glycemic index (GI) for the composition. This composition is effective in maintaining and improving fasting blood sugar, postprandial blood sugar regulation, and glucose tolerance, demonstrating a favorable blood sugar-lowering effect.

[0024] Preferably, the mass ratio of Pueraria root, Polygonatum odoratum, and Ganoderma lucidum is (close to) 2:2:1. By controlling the mass ratio of Pueraria root, Polygonatum odoratum, and Ganoderma lucidum to meet the above preferred range, the glycemic index of the composition is lower, and the composition has a better effect in maintaining and improving fasting blood sugar, postprandial blood sugar regulation, and glucose tolerance, and has a better effect in assisting in lowering blood sugar.

[0025] In a second aspect, an embodiment of the present invention provides a method for preparing the above-mentioned composition, comprising: mixing Pueraria lobata, Polygonatum odoratum and Ganoderma lucidum to obtain the composition.

[0026] It is understandable that the above-mentioned mixing conditions should not affect the performance of Pueraria lobata, Polygonatum odoratum and Ganoderma lucidum, ensuring that the three can play a synergistic role in regulating blood sugar.

[0027] The preparation method of the composition is simple to operate.

[0028] In a third aspect, an embodiment of the present invention further provides a product, which includes the above-mentioned composition.

[0029] Based on the composition, the above-mentioned product has a low glycemic index. The composition has a good effect on maintaining and improving fasting blood sugar, postprandial blood sugar regulation, and glucose tolerance, and has the effect of lowering blood sugar.

[0030] In some specific embodiments, the above-mentioned product includes at least one of food, medicine, health food, and special medical purpose formula food.

[0031] The food may include one or more of milk powder, milk tablets, and yogurt.

[0032] In some specific embodiments, the mass percentage of the above composition in the product is 0.03%-0.07%.

[0033] Illustratively, in the product, the mass percentage of the above composition may be 0.03%, 0.04%, 0.05%, 0.06%, 0.07% or a range consisting of any two thereof.

[0034] By controlling the mass percentage of the composition in the product to meet the above range, the glycemic index of the product is made lower, and the composition has a better effect in maintaining and improving fasting blood sugar, postprandial blood sugar regulation, and glucose tolerance, and has a better effect in lowering blood sugar.

[0035] Furthermore, the above product also includes resistant dextrin and inulin. Research has found that in terms of blood sugar regulation, resistant dextrin and inulin synergize with the above combination, making the product have a lower glycemic index. The combination has a better effect in maintaining and improving fasting blood sugar, postprandial blood sugar regulation, and glucose tolerance, and has a better blood sugar-lowering effect.

[0036] In addition, the weight percentage of resistant dextrin and inulin in the above product can be 0-15%, and the weight percentage of inulin can be 0-15%. The synergistic effect of resistant dextrin and inulin with the above composition is more obvious, making the product have a lower glycemic index. The composition has a better effect in maintaining and improving fasting blood sugar, postprandial blood sugar regulation, and glucose tolerance, and has a better blood sugar-lowering effect.

[0037] Illustratively, in the product, the mass percentage of resistant dextrin can be 0, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15% or a range consisting of any two of them, and the mass percentage of inulin can be 0, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15% or a range consisting of any two of them.

[0038] In some embodiments, the product further comprises one or more of milk mineral salts, lactoferrin, and bifidobacteria.

[0039] In the product, the mass percentage content of milk mineral salt can be 0-1%, for example, 0, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1% or a range consisting of any two thereof, and the mass percentage content of lactoferrin can be 0-2%, for example, 0, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%. , 1.6%, 1.7%, 1.8%, 1.9%, 2% or a range consisting of any two thereof, the mass percentage of Bifidobacterium can be 0-4%, for example, 0, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2%, 2.5%, 3%, 3.5%, 4% or a range consisting of any two thereof.

[0040] Additionally, the product may include vitamins and minerals.

[0041] In some specific embodiments, the product includes 16.5% to 30.0% protein, 1.0% to 26.0% fat, 0% to 15.0% dietary fiber, and 30% to 69% carbohydrates in terms of mass percentage.

[0042] In some specific embodiments of the present invention, the above-mentioned product includes at least one of milk powder and modified milk powder (milk powder).

[0043] The following takes milk powder (or modified milk powder) as an example to explain its composition in detail.

[0044] The nutritional composition of milk powder (or modified milk powder) is as follows: every 100g of milk powder (or modified milk powder) includes 16.5-30.0g of protein, 1.0-26.0g of fat, 0-15.0g of dietary fiber, and 30-69g of carbohydrates.

[0045] Milk powder (or formula milk powder) with the above-mentioned nutritional composition can not only meet normal nutritional needs, but also has a lower glycemic index (GI), and has a good effect in maintaining and improving fasting blood sugar, postprandial blood sugar regulation, glucose tolerance, etc., and has a good effect in lowering blood sugar.

[0046] The source of protein may include one or more of raw milk, skimmed milk powder, demineralized whey powder, whole milk powder, and skimmed milk.

[0047] The present invention does not specifically limit the ratio and specific amount of each protein source in the product, as long as the protein content of the product is satisfied. For example, based on 1000 parts by weight of milk powder (or formula milk powder, modulated milk powder), its raw materials may include: 0-6000 parts by weight of raw cow's milk, 25-735 parts by weight of skim milk powder, and 0-500 parts by weight of desalted whey powder; based on 1000 parts by weight of milk powder (or modulated milk powder), its raw materials include: 0-500 parts by weight of desalted whey powder and 25-735 parts by weight of skim milk powder.

[0048] In specific applications, part or all of raw milk and skimmed milk powder can be replaced by whole milk powder or skimmed milk with an equivalent amount of protein.

[0049] The source of fat may include at least one of raw cow's milk, whole milk powder, skimmed milk powder, demineralized whey powder, vegetable oil (sunflower oil) and phospholipids.

[0050] The embodiment of the present invention does not specifically limit the proportion and specific amount of each fat source in the product, as long as the fat content of the product is satisfied. For example, based on 1000 parts by weight of milk powder (or modified milk powder), its raw materials include 0-6000 parts by weight of raw cow's milk, 25-735 parts by weight of skim milk powder, 0-500 parts by weight of desalted whey powder, 0-50 parts by weight of vegetable oil, and 1-5 parts by weight of phospholipids; based on 1000 parts by weight of milk powder, its raw materials include 25-735 parts by weight of skim milk powder, 0-50 parts by weight of vegetable oil, and 1-5 parts by weight of phospholipids.

[0051] The source of carbohydrates may include a basic raw material containing lactose, such as at least one of milk, whole milk powder, and skimmed milk powder.

[0052] The present invention does not impose any particular restrictions on the ratio and specific amount of each carbohydrate source in the product, as long as the carbohydrate content of the product is satisfied. For example, based on 1000 parts by weight of milk powder (or modified milk powder), raw cow's milk can be used in an amount of 0-6000 parts by weight, and skim milk powder can be used in an amount of 25-735 parts by weight.

[0053] Sources of dietary fiber may include resistant dextrins and / or inulin.

[0054] In a specific embodiment of the present invention, based on 1000 parts by weight of milk powder (or modified milk powder), the amount of resistant dextrin is 0-150 parts by weight, and the amount of inulin is 0-150 parts by weight.

[0055] The raw materials of the product may also include one or more of milk mineral salts, lactoferrin, and probiotics.

[0056] In some embodiments, based on 1000 parts by weight of milk powder (modulated milk powder), the raw materials include: 0-10 parts by weight of milk mineral salt, 0-2 parts by weight of lactoferrin, and 0-0.4 parts by weight of probiotics.

[0057] Furthermore, the above-mentioned probiotics may include Bifidobacterium.

[0058] The bifidobacterium includes, but is not limited to, one or more of Bifidobacterium animalis subsp. lactis HN019, Bifidobacterium animalis subsp. lactis Bb-12, and Bifidobacterium animalis subsp. lactis BL-99.

[0059] Based on 1000 parts by weight of milk powder (modified milk powder), the added amount of bifidobacteria can be 0-0.4 parts by weight, preferably 0.1-0.4 parts by weight, and more preferably 0.15-0.25 parts by weight.

[0060] More preferably, the number of viable bifidobacteria per weight portion of bifidobacterium powder is 3×10 10 CFU or more, such as 3×10 10 CFU / g.

[0061] In addition, the raw materials of the product may also include compound nutrients containing vitamins and minerals.

[0062] Preferably, based on 1000 parts by weight of milk powder (modulated milk powder), the raw materials include: 7-22 parts by weight of complex nutrients containing vitamins and minerals.

[0063] The compound nutrients are a combination of nutrients that meet national standards, and the amount to be added can be determined according to the product formula.

[0064] Specifically, each gram of vitamins (vitamin nutrition package) can include vitamin A: 2050-2550 μg RE, vitamin D: 36.5-46.5 μg, vitamin E: 58-72 mg α-TE, vitamin B6: 4800-6100 μg, folic acid: 1440-1800 μg, taurine: 150-180 mg, vitamin C: 288-352 mg; each gram of minerals (mineral nutrition package 1) can include iron: 24-30 mg, zinc: 10.1-12.3 mg, magnesium: 90-120 mg, selenium: 54-69 mg; each gram of minerals (mineral nutrition package 2) can include calcium 368-434 mg. It is understandable that calcium is generally added to minerals or products in the form of calcium powder such as calcium carbonate.

[0065] In some embodiments, based on 1000 parts by weight of milk powder (or formula milk powder), the added amount of the above vitamins (vitamin nutrition package) is 1-4 parts by weight, the added amount of mineral nutrition package 1 is 1-4 parts by weight, and the added amount of mineral nutrition package 2 is 2-16 parts by weight.

[0066] The base material of each of the above-mentioned nutritional packages preferably includes lactose or L-ascorbic acid.

[0067] In one specific embodiment, in 1 ton of milk powder, the weight of the vitamin nutrient package is 2.5 kg, and its base material includes lactose; the weight of the mineral nutrient package 1 is 3.5 kg, and its base material includes lactose; the weight of the mineral nutrient package 2 is 16 kg, and its base material includes L-ascorbic acid.

[0068] It is understood that the content of each component of the above-mentioned compound nutrients does not include the content of the corresponding nutrient components introduced by other raw materials in milk powder (or modified milk powder), and is a scientifically designed addition amount for strengthening the corresponding nutrient components in the product. Taking the calcium powder (calcium carbonate) in the mineral nutrient package 2 as an example, the calcium content in every 1000 kg of milk powder is 1300-1600g. The calcium content introduced by the mineral nutrient package 2 refers to the amount of calcium added based on the weight of the calcium element in the mineral nutrient package 2 (such as calcium carbonate) of 1300-1600g based on the weight of the calcium element in the 1000 kg of milk powder, which is only for strengthening the calcium element in the product.

[0069] In some specific embodiments of the present invention, the raw materials of 1000 parts by weight of milk powder (or formula milk powder) include 0-6000 parts by weight of raw cow's milk, 25-735 parts by weight of skimmed milk powder, 0-500 parts by weight of desalted whey powder, 0-150 parts by weight of resistant dextrin, 0-150 parts by weight of inulin, 0-50 parts by weight of vegetable oil, 1-5 parts by weight of phospholipids, 7-22 parts by weight of complex nutrients including vitamins and minerals, 0.2-5 parts by weight of polygonatum powder, 0.2-5 parts by weight of kudzu root powder, 0.1-5 parts by weight of ganoderma lucidum powder, and 0-0.4 parts by weight of bifidobacteria.

[0070] The milk powder (or modified milk powder) of the present invention has a GI value of 13.3 (≤55), making it a low-GI food. Compared with ordinary milk powder, it can play a better role in maintaining and improving fasting blood sugar, postprandial blood sugar regulation, and glucose tolerance, and has a blood sugar regulation function. In addition, the milk powder of the present invention can effectively improve problems such as hard stools and difficulty in defecation.

[0071] It is understood that the specific amount of each raw material in the product of the present invention should meet the corresponding national standards and relevant standards and regulations.

[0072] In a fourth aspect, an embodiment of the present invention further provides a method for preparing the above-mentioned product, comprising: mixing a raw material system including the above-mentioned composition to obtain the product.

[0073] In some embodiments, the above-mentioned product includes milk powder (formulated milk powder), and its preparation method specifically includes: batching, homogenization, concentration and sterilization, spray drying, and dry mixing to obtain milk powder.

[0074] During the specific implementation process, the source (raw material) of protein, the source (raw material) of fat, the source (raw material) of carbohydrates, and the compound nutrients can be mixed first to obtain a mixed liquid, and then the mixed liquid is filtered, homogenized, cooled, concentrated and sterilized, spray-dried, and fluidized bed dried and cooled to obtain dry milk powder, and then the dry milk powder is mixed with raw materials such as polygonatum powder, kudzu root powder, ganoderma lucidum powder, and probiotics, and the above-mentioned milk powder is obtained after screening.

[0075] Specifically, the mixed liquid can be prepared in a vacuum mixing tank.

[0076] During the homogenization of the mixed liquid, the first-level pressure of the homogenization process may be 105±5 bar, and the second-level pressure may be 32±3 bar.

[0077] In addition, the above-mentioned concentration and sterilization process can adopt a double-effect concentration process. Preferably, the sterilization temperature can be ≥83°C and the sterilization time can be about 25 seconds. More preferably, the discharge concentration is 48%-52% dry matter (dry matter is the portion remaining after removing water from the material).

[0078] The inlet air temperature of the spray drying can be 165-180°C, the exhaust air temperature can be 75-90°C, the high-pressure pump pressure can be 160-210 bar, and the tower negative pressure can be -4 mbar to -2 mbar.

[0079] The fluidized bed drying and cooling process may include two drying and cooling steps, and the temperature of the milk powder after the second drying and cooling step may be 25-30°C.

[0080] When the raw material system of the milk powder also includes lecithin, the above preparation method may further include: mixing the lecithin with the carrier, heating to 60-65° C., and uniformly dispersing the mixture on the surface of the milk powder under the action of compressed air.

[0081] In a specific embodiment of the present invention, the preparation process of milk powder comprises the following specific steps:

[0082] 1) Milk coarse filtration: After the milk is coarsely filtered and degassed in the balance tank, it is preheated by a plate heat exchanger and then separated from impurities by a separator.

[0083] 2) Milk homogenization and sterilization: After removing impurities, part of the milk enters the homogenizer for homogenization, and the other part is not homogenized. The homogenized milk and the non-homogenized milk are mixed and then enter the sterilization system for sterilization. The sterilized milk enters the mixing tank.

[0084] 3) Powder addition: Various powder raw materials are measured according to the formula and added into the powder mixing tank through the air delivery system for storage.

[0085] 4) Vacuum powder suction: The various powder raw materials in the powder mixing tank are sucked into the mixing tank through the vacuum system.

[0086] 5) Dissolve and add compound nutrients (compound nutrient enhancers): Add the vitamin nutrient package, mineral nutrient package 1, and mineral nutrient package 2 (compound carbon calcium nutrient package) separately. Specifically, use 100-200 kg of pure water to dissolve the vitamin nutrient package, mineral nutrient package 1, and mineral nutrient package 2 (compound carbon calcium nutrient package) respectively, and then add them into the mixing tank. After each nutrient package is added, rinse the addition tank and pipeline with 100 kg of pure water.

[0087] 6) Add small ingredients: Add lecithin and vegetable oil into the small hopper and pump them into the mixing tank.

[0088] 7) Filtration: Mix the various raw materials in a mixing tank, and filter the mixed liquid through a filter to remove physical impurities that may be introduced into the raw materials.

[0089] 8) Homogenization: The mixed liquid is homogenized by a homogenizer with a first-stage pressure of 105±5 bar and a second-stage pressure of 32±3 bar. The fat globules are mechanically treated and dispersed into uniform fat globules.

[0090] 9) Cooling and storage: The homogenized liquid enters the plate heat exchanger for cooling, cools to below 20°C, and is temporarily stored in a pre-storage tank. It enters the next process within 6 hours, and the agitator is turned on according to the set requirements.

[0091] 10) Concentration and sterilization: Double-effect concentration is used during production, the sterilization temperature is ≥83°C, and the sterilization time is 25 seconds; the discharge concentration is 48%-52% dry matter.

[0092] 11) Concentrated Milk Storage, Preheating, Filtration, and Spray Drying: The concentrated milk is temporarily stored in a concentrated milk balance tank; it is preheated to 60-70°C in a scraper preheater. After preheating, the material is filtered through a 1mm pore filter and pumped into a drying tower for spray drying using a high-pressure pump. The fine powder is agglomerated at the tower top or in a fluidized bed as required. The inlet air temperature is 165-180°C, the exhaust air temperature is 75-90°C, the high-pressure pump pressure is 160-210 bar, and the tower negative pressure is -4 mbar to -2 mbar.

[0093] 12) Fluidized bed drying and cooling: The milk powder coming out of the drying tower is dried again in a fluidized bed (primary stage) and then cooled to 25-30°C in a fluidized bed (secondary stage). At the same time, the lecithin is mixed with the carrier and heated to 60-65°C. Under the action of compressed air, the lecithin is evenly dispersed on the surface of the milk powder, causing the powder particles to agglomerate and increase its particle size and solubility.

[0094] 13) Packaging: According to the recipe requirements, weigh the polygonatum powder, kudzu root powder, ganoderma lucidum powder, and probiotics (such as bifidobacteria) and seal the bags for packaging.

[0095] 14) Dry mixing: Mix the weighed polygonatum powder, kudzu root powder, ganoderma lucidum powder, probiotics (such as bifidobacteria) and milk powder in a dry mixer.

[0096] 15) Powder screening: Use a vibrating screen to make the particle size of the milk powder uniform and discard the powder residue.

[0097] 16) Powder discharge: Collect the powder in a sterilized powder collection box and transport it from the powder discharge room to the powder loading room.

[0098] 17) Powdering: Pour the milk powder into the powder storage tank on the large and small packaging machines according to the packaging requirements.

[0099] 18) Packaging: Different specifications are packed with nitrogen by automatic packaging machines; the oxygen content during nitrogen filling is less than 1-5%.

[0100] 29) Packing: Put the packaged sachets into the carton and add the powder spoon, then seal the carton with a carton sealing machine.

[0101] 20) Finished product inspection: Sampling inspection shall be carried out on the packaged products according to the inspection plan.

[0102] 21) Storage: Products that have passed the inspection must be stored in the warehouse at room temperature with humidity ≤ 65%.

[0103] In the embodiments of the present invention, kudzu root powder is an aqueous extract obtained from the root of kudzu root through extraction, concentration, drying and other processes; polygonatum odoratum powder is an aqueous extract obtained from the dried rhizome of polygonatum odoratum through extraction, concentration, drying and other processes; ganoderma lucidum powder is an aqueous extract obtained from the dried fruiting bodies of red ganoderma or ganoderma lucidum through extraction, concentration, drying and other processes; resistant dextrin is a dietary fiber obtained from corn starch through a dextrinization reaction under acidic conditions; and inulin is obtained from chicory root through processes such as spray drying after removing protein and minerals.

[0104] In addition, raw materials such as kudzu root powder, polygonatum powder, ganoderma lucidum powder, resistant dextrin, inulin, etc. can be purchased.

[0105] The present invention is further described below by way of specific examples and comparative examples. Unless otherwise specified, the reagents, materials, and instruments used below are all conventional reagents, materials, and instruments, all of which are commercially available, and the reagents and materials involved can also be synthesized by conventional synthesis methods.

[0106] Bifidobacterium: including Bifidobacterium animalis subspecies lactis HN019 and Bifidobacterium animalis subspecies lactis Bb-12, with a viable cell count of 3×10 10 CFU / g; also includes Bifidobacterium lactis subspecies BL-99, with a viable count of 1.5×10 11 CFU / g.

[0107] Each gram of vitamin nutrition package meets the following standards: Vitamin A: 2050-2550μgRE, Vitamin D: 36.5-46.5μg, Vitamin E: 58-72mgα-TE, Vitamin B6: 4800-6100μg, Folic acid: 1440-1800μg, Taurine: 150-180mg, Vitamin C: 288-352mg.

[0108] Each gram of minerals (mineral nutrition package 1) meets the following standards: iron: 24-30mg, zinc: 10.1-12.3mg, magnesium: 90-120mg, selenium: 54-69mg.

[0109] Each gram of calcium carbonate (mineral nutrient package 2) meets the following standards: 368-434 mg of calcium.

[0110] Example 1

[0111] This embodiment provides a formula milk powder, the raw materials of which include, by weight, 1700 parts of raw cow's milk, 525 parts of skim milk powder, 120 parts of desalted whey powder, 70 parts of resistant dextrin, 45 parts of vegetable oil (sunflower oil), 20 parts of inulin, 2 parts of phospholipids, 16 parts of calcium carbonate (mineral nutrient package 2), 3.5 parts of minerals (mineral nutrient package 1), 2.5 parts of vitamin nutrient package, 0.25 parts of kudzu root powder, 0.20 parts of polygonatum powder, 0.05 parts of ganoderma lucidum powder, and 0.18 parts of bifidobacteria.

[0112] The formula milk powder prepared with the above ingredients contains 23.3g / 100g of protein, 11.2g / 100g of fat, 51.0g / 100g of carbohydrates, 6.5g / 100g of dietary fiber, 0.025g / 100g of kudzu root powder, 0.02g / 100g of polygonatum root powder, and 0.005g / 100g of ganoderma lucidum powder. The protein sources are raw milk, skim milk powder, and demineralized whey powder, with a mass ratio of kudzu root powder, polygonatum root powder, and ganoderma lucidum powder of 5:4:1. Dietary fiber sources are resistant dextrin and inulin.

[0113] Example 2

[0114] This embodiment provides a formula milk powder, the raw materials of which include, by weight, 1700 parts of raw cow's milk, 525 parts of skim milk powder, 120 parts of desalted whey powder, 70 parts of resistant dextrin, 45 parts of vegetable oil (sunflower oil), 20 parts of inulin, 2 parts of phospholipids, 16 parts of calcium carbonate (mineral nutrient package 2), 3.5 parts of minerals (mineral nutrient package 1), 2.5 parts of vitamin nutrient package, 0.20 parts of kudzu root powder, 0.20 parts of polygonatum powder, 0.10 parts of ganoderma lucidum powder, and 0.18 parts of bifidobacteria.

[0115] The formula milk powder prepared with the above raw materials has a protein content of 23.3g / 100g, a fat content of 11.2g / 100g, a carbohydrate content of 51.0g / 100g, a dietary fiber content of 6.5g / 100g, kudzu root powder of 0.02g / 100g, odoratum powder of 0.02g / 100g, and ganoderma lucidum powder of 0.01g / 100g; wherein, the protein sources are raw cow's milk, skimmed milk powder and desalted whey powder, the mass ratio of kudzu root powder, odoratum powder and ganoderma lucidum powder is 2:2:1, and the dietary fiber sources are resistant dextrin and inulin.

[0116] Comparative Example 1

[0117] This comparative example provides a formula milk powder, the raw materials of which include, in parts by weight: 6000 parts of raw cow's milk, 25 parts of skim milk powder, 90 parts of desalted whey powder, 70 parts of resistant dextrin, 45 parts of vegetable oil (sunflower oil), 20 parts of inulin, 2 parts of phospholipids, 16 parts of calcium carbonate (mineral nutrient package 2), 3.5 parts of minerals (mineral nutrient package 1), 2.5 parts of vitamin nutrient package, 0.50 parts of kudzu root powder, and 0.18 parts of bifidobacteria.

[0118] The formula milk powder prepared with the above raw materials has a protein content of 19.2g / 100g, a fat content of 25.7g / 100g, a carbohydrate content of 40.6g / 100g, a dietary fiber content of 6.5g / 100g, and kudzu root powder of 0.05g / 100g; among them, the protein sources are raw cow's milk, skimmed milk powder and desalted whey powder, and the dietary fiber sources are resistant dextrin and inulin.

[0119] Comparative Example 2

[0120] This comparative example provides a formula milk powder, the raw materials of which include, in parts by weight: 3500 parts of raw cow's milk, 325 parts of skimmed milk powder, 100 parts of desalted whey powder, 70 parts of resistant dextrin, 45 parts of vegetable oil (sunflower oil), 20 parts of inulin, 2 parts of phospholipids, 16 parts of calcium carbonate (mineral nutrient package 2), 3.5 parts of minerals (mineral nutrient package 1), 2.5 parts of vitamin nutrient package, 0.50 parts of polygonatum powder, and 0.18 parts of bifidobacteria.

[0121] The formula milk powder prepared with the above raw materials has a protein content of 21.8g / 100g, a fat content of 17.3g / 100g, a carbohydrate content of 46.4g / 100g, a dietary fiber content of 6.5g / 100g, and a polygonatum powder content of 0.05g / 100g. The protein sources are raw cow's milk, skimmed milk powder and desalted whey powder, and the dietary fiber sources are resistant dextrin and inulin.

[0122] Comparative Example 3

[0123] This comparative example provides a formula milk powder, the raw materials of which include, in parts by weight: 4500 parts of raw cow's milk, 300 parts of skimmed milk powder, 70 parts of resistant dextrin, 45 parts of vegetable oil (sunflower oil), 20 parts of inulin, 2 parts of phospholipids, 16 parts of calcium carbonate (mineral nutrient package 2), 3.5 parts of minerals (mineral nutrient package 1), 2.5 parts of vitamin nutrient package, 0.50 parts of polygonatum powder, and 0.18 parts of bifidobacteria.

[0124] The formula milk powder prepared with the above raw materials has a protein content of 22.8g / 100g, a fat content of 20.7g / 100g, a carbohydrate content of 42.0g / 100g, a dietary fiber content of 6.5g / 100g, and a polygonatum powder content of 0.05g / 100g; among them, the protein source is raw cow's milk and skimmed milk powder, and the dietary fiber source is resistant dextrin and inulin.

[0125] Comparative Example 4

[0126] This comparative example provides a formula milk powder, the raw materials of which include, in parts by weight: 5,300 parts of raw cow's milk, 100 parts of skim milk powder, 105 parts of desalted whey powder, 70 parts of resistant dextrin, 45 parts of vegetable oil (sunflower oil), 20 parts of inulin, 2 parts of phospholipids, 16 parts of calcium carbonate (mineral nutrient package 2), 3.5 parts of minerals (mineral nutrient package 1), 2.5 parts of vitamin nutrient package, 0.50 parts of Ganoderma lucidum powder, and 0.18 parts of bifidobacteria.

[0127] The formula milk powder prepared with the above raw materials has a protein content of 19.8g / 100g, a fat content of 23.3g / 100g, a carbohydrate content of 42.4g / 100g, a dietary fiber content of 6.5g / 100g, and a Ganoderma lucidum powder content of 0.05g / 100g. The protein sources are raw cow's milk, skimmed milk powder and desalted whey powder, and the dietary fiber sources are resistant dextrin and inulin.

[0128] Test Example 1 Animal Function Verification Test

[0129] 1.1 Experimental Animals: Wild-type AB strain zebrafish were bred by natural pair mating; zebrafish were 3 days post-fertilization (dPf), with 30 fish per parallel group; all zebrafish were maintained at 28°C in aquaculture water (water quality: 200 mg of instant sea salt per liter of reverse osmosis water, conductivity of 450-550 μS / cm; pH of 6.5-8.5; hardness of 50-100 mg / L CaCO3).

[0130] 1.2 Model establishment: Feeding normal zebrafish with a high-sugar, high-fat diet can rapidly increase the glucose content in the zebrafish blood, thereby establishing a zebrafish hyperglycemia model.

[0131] 1.3 Experimental Grouping: There were 9 experimental groups in total, including a normal (blank) control group, a model control group, a positive control group (taking pioglitazone hydrochloride), Example 2, and Comparative Examples 1-5.

[0132] 1.4 Administration: The test samples were the formula milk powders of the Examples and Comparative Examples, and were administered to hyperglycemic zebrafish by dissolving the test samples in water. The intervention doses (test sample concentrations in the unit culture water) for each group are shown in Table 1.

[0133] 1.5 Experimental method: After the test article treatment, 30 zebrafish were collected from each experimental group and the glucose level was measured using a blood glucose meter.

[0134] 1.6 Statistical Analysis: GraphPad Prism 8 software was used to analyze the data between groups using ANOVA and Tukey's test. Results are expressed as mean ± standard deviation (mean ± SD). Different letters indicate statistical significance between groups (P < 0.05).

[0135] 1.7 Test Results: As shown in Table 1, the glucose levels of the model control group in each example group were significantly lower than those in the control group (P < 0.05), indicating that each experimental group has blood sugar regulation function. The glucose level of Example 2 was significantly lower than that of the positive control group, and the glucose level of Example 3 was higher than that of Example 2, but the difference was not significant, and significantly lower than that of the other experimental groups (P < 0.05). This shows that the milk powder combination of Pueraria lobata + Polygonatum odoratum + Ganoderma lucidum has a better blood sugar regulation function, has a synergistic effect, and is superior to other groups in blood sugar regulation.

[0136] Table 1 Intervention doses and blood glucose levels in each experimental group

[0137]

[0138] Note: Data are expressed as mean ± standard deviation (mean ± SD) (n = 30). Different superscript letters in glucose levels indicate statistical differences (P ≤ 0.05) between data from different sample groups under the same culture environment.

[0139] Test Example 2: Clinical Function Verification and Safety Verification Test

[0140] 2.1 Experimental Purpose: Based on the experimental results of Experimental Example 1, taking the formula milk powder of Example 2 as an example, the formula milk powder of the embodiment of the present invention is used to study the regulatory effect of postprandial blood sugar and the improvement effect of glucose metabolism on middle-aged and elderly people with type 2 diabetes, as well as the safety of the subjects.

[0141] The results of other examples are similar to those of Example 2.

[0142] 2.2 Experimental method: This experiment is a multicenter, randomized, controlled, parallel, double-blind, superior efficacy trial, which was carried out in the General Hospital of the Chinese People's Liberation Army, the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, and Tianjin Hospital in Tianjin. The 88 subjects of this study will be randomly divided into the formula milk powder group of Example 2 and the ordinary milk powder group of Comparative Example 5, with 44 subjects in each group. While receiving dietary guidance, the formula milk powder group of Example 2 and the ordinary milk powder group of Comparative Example 5 will take 50g of the formula milk powder prepared by Example 2 and 48g of the ordinary formula milk powder (ordinary middle-aged and elderly formula milk powder) prepared by Comparative Example 5 daily. The subjects will consume the formula milk powder of Example 2 or the ordinary middle-aged and elderly formula milk powder of Comparative Example 5 for 84 days (12 weeks) continuously. During this period, the fasting blood glucose value, standard postprandial blood glucose value, standard postprandial blood glucose curve increase area (iAUC), blood glucose curve area (AUC), glycated albumin, glycated hemoglobin, and insulin resistance index detected during the visit will be collected to observe the effect of the formula milk powder of Example 2 on human blood glucose metabolism. The safety of the formula milk powder of Example 2 to the human body was observed and evaluated by measuring the subjects' physical indicators, blood pressure, blood routine, blood biochemistry (including blood lipids), urine routine and other safety indicators before and after the intervention.

[0143] 2.3 Test results:

[0144] (1) Increased area under the blood glucose curve (iAUC): Compared with the baseline, the mean iAUC of the Example 2 formula milk powder group decreased slightly by 6.4% (P>0.05) at 2 weeks of intervention, while the mean iAUC of the regular milk powder group increased significantly by 33.7% (P<0.05); the mean iAUC of the Example 2 formula milk powder group increased slightly by 13.5% (P>0.05) at 4 weeks of intervention, while the mean iAUC of the regular milk powder group increased significantly by 58.1% (P<0.05); the mean iAUC of the Example 2 formula milk powder group decreased significantly by 36.5% (P<0.05) at 12 weeks of intervention, while the mean iAUC of the regular milk powder group decreased slightly by 4.7% (P>0.05). Compared with the baseline, the mean iAUC changes of the Example 2 formula milk powder group at 2 weeks, 4 weeks, and 12 weeks were significantly lower than those of the regular milk powder group, and the differences between the groups were statistically significant (P<0.05).

[0145] (2) Area under the blood glucose curve (AUC): Compared with the baseline, the mean AUC of the Example 2 formula milk powder group decreased slightly by 3.2% (P>0.05) at 2 weeks of intervention, while the mean AUC of the regular milk powder group increased by 8.1% (P>0.05); the mean AUC of the Example 2 formula milk powder group increased slightly by 1.4% (P>0.05) at 4 weeks of intervention, while the mean AUC of the regular milk powder group increased by 9.3% (P>0.05); the mean AUC of the Example 2 formula milk powder group increased slightly by 4.3% (P>0.05) at 12 weeks of intervention, while the mean AUC of the regular milk powder group increased significantly by 25.5% (P<0.05). Compared with the baseline, the mean AUC change of the Example 2 formula milk powder group at 12 weeks was significantly lower than that of the regular milk powder group, and the difference between the groups was statistically significant (P<0.05).

[0146] (3) Fasting blood glucose: Compared with baseline, the mean fasting blood glucose levels of the Example 2 formula milk powder group and the regular milk powder group decreased slightly by 2.0% and 0.8%, respectively, at 2 weeks of intervention (P>0.05); the mean fasting blood glucose levels of the Example 2 formula milk powder group and the regular milk powder group decreased slightly by 2.8% and 7.8%, respectively, at 4 weeks of intervention (P>0.05); the mean fasting blood glucose levels of the Example 2 formula milk powder group increased by 6.7% (P>0.05), while the mean fasting blood glucose levels of the regular milk powder group increased significantly by 20.6% (P<0.05). Compared with baseline, the changes in fasting blood glucose levels of the Example 2 formula milk powder group and the regular milk powder group were not statistically significant between the two groups (P>0.05).

[0147] (4) Blood glucose 1 hour after meal: Compared with baseline, the blood glucose 1 hour after meal of the Example 2 formula milk powder group decreased slightly by 3.9% (P>0.05) at 2 weeks of intervention, while the blood glucose 1 hour after meal of the regular milk powder group increased significantly by 12.0% (P<0.05); the blood glucose 1 hour after meal of the Example 2 formula milk powder group increased slightly by 1.9% (P>0.05) at 4 weeks of intervention, while the blood glucose 1 hour after meal of the regular milk powder group increased significantly by 17.0% (P<0.05); the blood glucose 1 hour after meal of the Example 2 formula milk powder group increased slightly by 1.7% (P>0.05) at 12 weeks of intervention, while the blood glucose 1 hour after meal of the regular milk powder group increased significantly by 26.5% (P<0.05). Compared with baseline, the mean changes in blood glucose 1 hour after meal of the Example 2 formula milk powder group at 2 weeks, 4 weeks, and 12 weeks were significantly lower than those of the regular milk powder group, and the differences between the groups at 2 weeks and 12 weeks were statistically significant (P<0.05).

[0148] (5) Blood glucose 2 hours after meal: Compared with the baseline, the blood glucose 2 hours after meal of the Example 2 formula milk powder group decreased slightly by 2.4% (P>0.05) at the 2nd week of intervention, while the blood glucose 2 hours after meal of the regular milk powder group increased slightly by 6.4% (P>0.05); the blood glucose 2 hours after meal of the Example 2 formula milk powder group increased slightly by 2.3% (P>0.05) at the 4th week of intervention, while the blood glucose 2 hours after meal of the regular milk powder group increased slightly by 5.5% (P>0.05); the blood glucose 2 hours after meal of the Example 2 formula milk powder group increased slightly by 8.1% (P>0.05) at the 12th week of intervention, while the blood glucose 2 hours after meal of the regular milk powder group increased significantly by 26.7% (P<0.05). Compared with the baseline, the mean changes in blood glucose 2 hours after meal of the Example 2 formula milk powder group at 2 weeks, 4 weeks, and 12 weeks were significantly lower than those of the regular milk powder group, and the difference between the groups at 12 weeks was statistically significant (P<0.05).

[0149] (6) Glycated hemoglobin, glycated albumin, and insulin resistance index: After 4 and 12 weeks of intervention, there was no significant difference in the changes in glycated hemoglobin, glycated albumin, and insulin resistance index between the formula milk powder group and the ordinary milk powder group (P>0.05).

[0150] (7) Defecation: After 12 weeks of intervention, the formula milk powder group of Example 2 could soften the stool of people with defecation difficulties compared with the ordinary milk powder group (P<0.05); it could improve the defecation difficulties of people with dry and hard stools (P<0.05); and it could comprehensively improve the defecation situation of people with dry and hard stools and defecation difficulties (P<0.05).

[0151] (8) Instantaneous blood glucose monitoring data:

[0152] ●The increased area under the blood glucose curve (iAUC) of the formula milk powder group in Example 2 at 60 minutes, 90 minutes, and 120 minutes after breakfast on the 71st day was significantly lower than that of the ordinary milk powder group (P<0.05), approximately 60.9%, 66.9%, and 70.8% of that of the ordinary milk powder group.

[0153] ●The increased area under the blood glucose curve (iAUC) of the formula milk powder group in Example 2 at 60 minutes, 90 minutes, and 120 minutes after breakfast on the 76th day was significantly lower than that of the ordinary milk powder group (P<0.05), approximately 63.8%, 69.4%, and 75.1% of that of the ordinary milk powder group.

[0154] ●The increased area under the blood glucose curve (iAUC) of the formula milk powder group in Example 2 at 60 minutes, 90 minutes, and 120 minutes after breakfast on the 77th day was significantly lower than that of the ordinary milk powder group (P<0.05), approximately 61.2%, 64.5%, and 69.2% of that of the ordinary milk powder group.

[0155] ● The increased area under the blood glucose curve (iAUC) of the formula milk powder group in Example 2 at 60 minutes and 90 minutes after breakfast on the 80th day was significantly lower than that of the ordinary milk powder group (P<0.05), which was approximately 65.6% and 70.0% of the ordinary milk powder group.

[0156] ● Compared with the first day, the iAUC at 90 minutes after the meal on the 15th day in the formula milk powder group of Example 2 increased by 7.6%, and the iAUC at 120 minutes after the meal increased by 6.9%. While the iAUC at 90 minutes after the meal on the 15th day in the conventional milk powder group increased significantly by 49.4%, and the iAUC at 120 minutes after the meal increased significantly by 48.9%. The increase in iAUC in the formula milk powder group of Example 2 was significantly lower than that in the conventional milk powder group, and the difference between the groups was statistically significant (P<0.05).

[0157] Compared with day 1, the iAUC at 60 minutes after breakfast in the formula milk powder group of Example 2 on the 71st day decreased by 7.1%, the iAUC at 90 minutes decreased by 2.3%, and the iAUC at 120 minutes decreased by 2.0%. However, the iAUC at 60 minutes after breakfast in the regular milk powder group on the 71st day increased by 69.4%, the iAUC at 90 minutes increased by 61.1%, and the iAUC at 120 minutes increased by 54.1%. The iAUC of the formula milk powder group of Example 2 decreased, while the iAUC of the regular milk powder group increased significantly, and the difference between the groups was statistically significant (P<0.05).

[0158] Compared with day 1, the iAUC at 60 minutes after breakfast in the Example 2 formula milk group on the 76th day decreased by 12.6%, the iAUC at 90 minutes decreased by 9.7%, and the iAUC at 120 minutes decreased by 6.2%. In the conventional milk powder group on the 76th day, the iAUC at 60 minutes after breakfast increased by 32.5%, the iAUC at 90 minutes increased by 30.8%, and the iAUC at 120 minutes increased by 28.2%. The iAUC of the Example 2 formula milk group decreased slightly, while the iAUC of the conventional milk powder group increased significantly. The differences between the groups were statistically significant (P<0.05).

[0159] Compared with the first day, the blood glucose level at 60 minutes after breakfast in the formula milk powder group of Example 2 on the 77th day decreased by 0.1%, the blood glucose level at 90 minutes decreased by 2.5%, the AUC at 60 minutes increased by 2.8%, the AUC at 90 minutes increased by 1.3%, the AUC at 120 minutes increased by 0.7%, the iAUC at 60 minutes decreased by 16.6%, the iAUC at 90 minutes decreased by 18.1%, and the iAUC at 120 minutes decreased by 17.5%. The blood glucose level at 60 minutes after breakfast in the ordinary milk powder group on the 77th day increased by 20.2%, the blood glucose level at 90 minutes increased by 15.8%, the AUC at 60 minutes decreased by 1.0%, the AUC at 120 minutes decreased by 0.7%, the iAUC at 60 minutes decreased by 16.6%, the iAUC at 90 minutes decreased by 18.1%, and the iAUC at 120 minutes decreased by 17.5%. The blood glucose levels at 60 and 90 minutes after the meal in the formula milk powder group of Example 2 decreased, while those in the conventional milk powder group increased. The increase in AUC in the formula milk powder group of Example 2 was significantly smaller than that in the conventional milk powder group. The iAUC in the formula milk powder group of Example 2 decreased, while the iAUC in the conventional milk powder group increased significantly. The differences between the groups were statistically significant (P<0.05).

[0160] Compared with day 1, the iAUC at 60 minutes after breakfast in the formula milk powder group of Example 2 on the 80th day decreased by 27.8%, the iAUC at 90 minutes decreased by 19.8%, and the iAUC at 120 minutes decreased by 12.0%. However, the iAUC at 60 minutes after breakfast in the regular milk powder group on the 80th day increased by 18.5%, the iAUC at 90 minutes increased by 25.9%, and the iAUC at 120 minutes increased by 30.5%. The iAUC of the formula milk powder group of Example 2 decreased slightly, while the iAUC of the regular milk powder group increased significantly. The differences between the groups were statistically significant (P<0.05).

[0161] ● Postprandial blood glucose fluctuation (monitoring): On the first day, there was no significant difference in the increase in blood glucose after breakfast between the formula milk powder group of Example 2 and the ordinary milk powder group; on the 71st day, the increase in blood glucose 60 minutes after meal in the formula milk powder group of Example 2 was significantly lower than that in the ordinary milk powder group (P=0.009<0.05), and the increase was approximately 64.8% of the increase in the ordinary milk powder group; on the 76th day, the increase in blood glucose 60 minutes after meal in the formula milk powder group of Example 2 was significantly lower than that in the ordinary milk powder group (P=0.043<0.05), and the increase was approximately 70.6% of the increase in the ordinary milk powder group; on the 77th day, the increase in blood glucose 60 minutes after meal in the formula milk powder group of Example 2 was significantly lower than that in the ordinary milk powder group (P=0.005<0.05), and the increase was approximately 62.2% of the increase in the ordinary milk powder group.

[0162] During the intervention period, the blood glucose increase at 60 and 90 minutes after breakfast in the Example 2 formula milk powder group showed a downward trend, while that in the regular milk powder group showed an upward trend; the blood glucose increase at 120 minutes after breakfast in both the Example 2 formula milk powder group and the regular milk powder group showed a slight upward trend, with the rate of increase in the Example 2 formula milk powder group being lower than that in the regular milk powder group.

[0163] ●Compared with the first day, the blood glucose increase at 60 minutes and 90 minutes after breakfast on the 15th day in the formula milk powder group of Example 2 was slightly increased by 6.4% and 6.5%, respectively, while the blood glucose increase at 60 minutes and 90 minutes after breakfast in the ordinary milk powder group was significantly increased by 56.5% and 53.0%, respectively. The increase in the formula milk powder group of Example 2 was significantly lower than that in the ordinary milk powder group, and the difference was statistically significant (P<0.05).

[0164] ● On the 71st day, the blood sugar increase rate of the formula milk powder group in Example 2 60 minutes and 90 minutes after breakfast slightly decreased by 6.2% and slightly increased by 1.4%, respectively, while the blood sugar increase rate of the ordinary milk powder group 60 minutes and 90 minutes after breakfast significantly increased by 56.4% and 41.9%, respectively. The decrease or increase range of the formula milk powder group in Example 2 was significantly lower than that of the ordinary milk powder group, and the difference was statistically significant (P<0.05).

[0165] ● On the 76th day, the blood sugar increase rate at 60 minutes and 90 minutes after breakfast in the formula milk powder group of Example 2 decreased slightly by 6.7% and 5.8%, respectively, while the blood sugar increase rate at 60 minutes and 90 minutes after breakfast in the ordinary milk powder group increased significantly by 48.1% and 35.4%, respectively. The formula milk powder group of Example 2 showed a decrease while the ordinary milk powder group showed a significant increase, and the difference was statistically significant (P<0.05).

[0166] ● On the 77th day, the blood sugar increase rate at 60 minutes and 90 minutes after breakfast in the formula milk powder group of Example 2 decreased slightly by 14.5% and 18.8%, respectively, while the blood sugar increase rate at 60 minutes and 90 minutes after breakfast in the regular milk powder group increased significantly by 53.8% and 29.8%, respectively. The blood sugar increase rate at 60 minutes and 90 minutes after breakfast in the formula milk powder group of Example 2 decreased while that in the regular milk powder group increased significantly, and the difference was statistically significant (P<0.05).

[0167] ● On the 80th day, the blood sugar level of the formula milk powder group in Example 2 decreased by 16.8% 60 minutes after breakfast, while the blood sugar level of the regular milk powder group increased by 33.6% 60 minutes after breakfast. The blood sugar level of the formula milk powder group in Example 2 decreased while that of the regular milk powder group increased, and the difference was statistically significant (P<0.05).

[0168] ● Long-term monitoring results showed that the area under the blood glucose curve after breakfast, the increased area under the blood glucose curve, and the blood glucose increase 60 minutes after breakfast of the formula milk powder group of Example 2 showed a significant downward trend, while the ordinary milk powder group showed a significant upward trend; the changing trend of the blood glucose increase 90 minutes and 120 minutes after breakfast of the formula milk powder group of Example 2 was not as obvious as the change in the blood glucose increase 60 minutes after breakfast, but was still lower than that of the ordinary milk powder group.

[0169] (9) Safety indicators: There was no statistically significant difference in the changes in body weight, body fat percentage, body mass index (BMI), fat-free body mass, and calf circumference between the formula milk powder group and the regular milk powder group after intervention. After 4 weeks of intervention, the waist circumference and waist-to-hip ratio of the formula milk powder group in Example 2 decreased significantly, while the waist circumference and waist-to-hip ratio of the regular milk powder group increased, and the difference between the groups was statistically significant (P < 0.05). No significant differences were observed in blood pressure, blood routine, blood biochemistry (including blood lipids), and urine routine indicators before and after intervention between the formula milk powder group and the regular milk powder group in Example 2.

[0170] 2.4 Test conclusion:

[0171] (1) The results of blood glucose testing after a standard meal and long-term monitoring of transient blood glucose showed that the milk powder of Example 2 was more effective than ordinary milk powder in maintaining and improving fasting blood glucose, postprandial blood glucose regulation, and glucose tolerance. Drinking the milk powder of Example 2 for 2 weeks can effectively stabilize postprandial blood glucose levels. Through 12 weeks of long-term observation, it was found that there was a significant improvement in postprandial blood glucose fluctuations. The milk powder of Example 2 can be used as a high-quality nutritional supplement for long-term consumption by diabetic patients.

[0172] (2) The effects of milk powder in Example 2 on glycosylated hemoglobin, glycosylated albumin, and insulin resistance have not been confirmed.

[0173] (3) The milk powder of Example 2 can effectively improve the problems of hard stool and difficulty in defecation in diabetic patients.

[0174] (4) The milk powder of Example 2 has no significant effect on the blood pressure, blood routine, blood biochemistry (including blood lipids), and urine routine indicators of diabetic patients, and is a safe nutritious food.

[0175] (5) The milk powder of Example 2 has no significant effect on the body weight, body fat ratio and other physical indicators of diabetic patients, and long-term use does not cause obesity or weight loss in diabetic patients.

[0176] Test Example 3 Glycemic Index (GI Value) Measurement Test

[0177] The glycemic index (GI) of a food is an indicator that describes the physiological parameters of food, expressing the concept that different types of carbohydrates have different effects on blood sugar. With the glucose GI value being 100, carbohydrate-rich foods can be classified into different levels based on their GI value. Foods with a GI below 55 are considered low-GI foods, those between 55 and 70 are medium-GI foods, and those above 70 are high-GI foods. Studies have shown that low-GI foods are absorbed slowly and release energy continuously, helping to maintain blood sugar homeostasis and prevent diabetes. The definition and application of the glycemic index of foods have also been recognized and recognized by the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO).

[0178] 3.1 Purpose of the Test: Based on WS / T652-2019 "Method for Determining the Glycemic Index of Foods", the changes in blood sugar levels of volunteers after consuming the formula milk powder of Example 2 were studied and tested, and its GI value was obtained to evaluate the glycemic index of the formula milk powder of Example 2.

[0179] 3.2 Test Method: Fifteen healthy volunteers were selected and their fasting blood glucose levels were measured. They were then fed the formula milk powder of Example 2 and glucose from the same available carbohydrates. Their blood glucose levels were measured at different time points within 2 hours after the meal. Changes in the blood glucose response curves of the two test substances were observed. Calculation of GI: A blood glucose response curve was constructed with time as the abscissa and the blood glucose values at each time point as the ordinate. The area under the blood glucose curve was calculated using the Wolever method. The GI value of the formula milk powder of Example 2 was calculated, with the GI of the reference food glucose as 100.

[0180]

[0181] 3.3 Test Results: Using glucose as the reference food, blood glucose levels showed statistically significant differences at 15, 30, 45, and 60 minutes after the meal (P<0.05). The blood glucose levels of the two test substances gradually decreased and stabilized after the 90th minute, returning to normal fasting blood glucose levels. After 90 minutes, the blood glucose level of the formula milk powder of Example 2 decreased more slowly than that of glucose, which is beneficial for regulating blood glucose balance in the human body. The GI value of the formula milk powder of Example 2 was calculated to be 13.3.

[0182] 3.3.1 Postprandial blood glucose response

[0183] According to the blood glucose response curve (such as Figure 1As shown in the figure, within 120 minutes, the blood glucose response curve of edible glucose rises within the first 30 minutes, and then continues to decline to a stable state of fasting blood glucose; the blood glucose response curve of the formula milk powder in Example 2 rises gently within the first 30 minutes, and then declines. The overall fluctuation is significantly stable compared with glucose, and the effect on blood glucose is relatively small. The absolute increase in blood glucose after a meal is significantly lower than that of glucose.

[0184] According to the statistical analysis results (Table 2), the fasting blood glucose (0 min) of the two test groups was within the normal range, and there was no statistical difference between the two (P = 0.441). From 15 minutes to 60 minutes after consumption, the blood glucose level of the glucose group was higher than that of the formula milk powder of Example 2. There was a statistical difference at 15 minutes, 30 minutes, 45 minutes, and 60 minutes after the meal (P < 0.05). Both test substances reached a peak at the 30th minute, but the peak blood glucose response of the formula milk powder of Example 2 was significantly lower than that of glucose. The blood glucose levels of the two test substances then gradually decreased, tending to stabilize after the 90th minute, and both returned to normal fasting blood glucose levels. At 120 minutes, the blood sugar level of the formula milk powder in Example 2 was significantly higher than that of glucose, and there was a statistically significant difference between the two time points (P<0.05). This indicates that although both tended to stabilize after 90 minutes, the blood sugar level of the formula milk powder in Example 2 decreased more slowly than that of glucose, which stabilized the blood sugar level in the human body. In contrast, the blood sugar level of glucose in the human body rises and falls rapidly. Therefore, the formula milk powder in Example 2 is more conducive to regulating blood sugar balance in the human body.

[0185] Table 2 Glucose at each time point and blood sugar response analysis results of formula milk powder in Example 2

[0186]

[0187] Note: * indicates statistically significant difference compared with the glucose value at the same time (P<0.05).

[0188] 3.3.2 Area under the blood glucose curve

[0189] The area under the blood glucose curve (AUC) is a comprehensive indicator that describes the blood glucose response over a specific time period. Analysis of the AUC reveals significant differences in the blood glucose responses induced by the formula milk powder in Example 2 and glucose, with the postprandial blood glucose change in the formula milk powder in Example 2 being smaller than that in glucose.

[0190] The Wolever method was used to calculate the blood glucose area under the curve after consuming glucose and the formula milk powder of Example 2. Figure 2As shown in Table 3, analysis of variance revealed statistically significant differences in the blood glucose area under the curve (AUC) between the glucose ingestion group and the formula milk powder of Example 2 at 15, 30, 45, 60, 90, and 120 minutes (P < 0.05). This indicates a significant difference in the blood glucose response after glucose ingestion compared to the formula milk powder of Example 2.

[0191] Table 3 Results of variance analysis of the area under the glucose response curve at each time point and the formula milk powder of Example 2

[0192]

[0193] Note: * indicates statistically significant difference compared with the glucose value at the same time (P<0.05).

[0194] 3.3.3GI value

[0195] The GI value of glucose is 100. Verified by the GI test, the GI value of Yili Xinhuo Shu Sugar Diet Base Formula Milk Powder measured with glucose as a reference substance = (area under the postprandial blood glucose curve of formula milk powder in Example 2 / area under the postprandial blood glucose curve of glucose) × 100.

[0196] The GI of the formula milk powder of Example 2 was calculated based on the area under the blood glucose curve 2 hours after the meal. The average value was calculated for each volunteer and the GI value was 13.26±10.87. Since the GI value is ≤55, the formula milk powder of Example 2 is low GI.

[0197] 3.4 Test Conclusion: Based on the evaluation methods and procedures recommended in WS / T 652-2019, blood glucose levels were measured in healthy adult subjects within 2 hours of consuming the formula milk powder of Example 2. The GI value of the formula milk powder of Example 2 was evaluated by calculating the area under the blood glucose curve (AUC) using the GI value of glucose as a reference. The results showed that, using glucose as the reference food (GI is 100), the GI value of the formula milk powder of Example 2 was 13.3. According to the GI grading standard, the formula milk powder of Example 2 has a GI of ≤55, which is a low GI food and can better control blood glucose.

[0198] According to the test results of Example 2, the formula milk powder of Example 1 should also be a low GI food in theory.

[0199] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the above embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A composition, characterized in that The invention comprises kudzu root, polygonatum odoratum and ganoderma lucidum, and the mass ratio of kudzu root, polygonatum odoratum and ganoderma lucidum is (2-5): (2-4):

1.

2. The composition according to claim 1, characterized in that The mass ratio of the kudzu root, polygonatum and ganoderma lucidum is 2:2:

1.

3. A method for preparing the composition according to claim 1 or 2, characterized in that: include: The kudzu root, polygonatum and ganoderma lucidum are mixed to obtain the composition.

4. A product, characterized in that The product comprises the composition according to claim 1 or 2.

5. The product according to claim 4, characterized in that The product includes at least one of food, medicine, health food, and special medical purpose formula food, wherein the food includes one or more of milk powder, milk tablets, and yogurt.

6. The product according to claim 4 or 5, characterized in that In the product, the mass percentage of the composition according to claim 1 or 2 is 0.03%-0.07%.

7. The product according to any one of claims 4 to 6, characterized in that The product further comprises resistant dextrin and inulin, and in the product, the mass percentage of the resistant dextrin is 0-15%, and the mass percentage of the inulin is 0-15%.

8. The product according to any one of claims 4 to 7, characterized in that The product further comprises one or more of milk mineral salts, lactoferrin, and bifidobacteria, and in the product, the mass percentage of the milk mineral salts is 0-1%, the mass percentage of the lactoferrin is 0-2%, and the mass percentage of the bifidobacteria is 0-4%; And / or, the product further comprises vitamins and minerals.

9. The product according to any one of claims 4 to 8, characterized in that The product comprises, by weight percentage, 16.5% to 30.0% protein, 1.0% to 26.0% fat, 0% to 15.0% dietary fiber, and 30% to 69% carbohydrates.

10. A method for preparing the product according to any one of claims 4 to 9, characterized in that: include: The product is obtained by mixing a raw material system comprising the composition according to claim 1 or 2.

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