Fermented low-GL dietary composition and application of fermented low-GL dietary composition in type 2 diabetes mellitus fortified treatment intervention products

Abstract

The invention belongs to the technical field of functional food, and relates to a fermented low-GL dietary composition and application thereof in an intervention product for fortified treatment of type 2 diabetes mellitus. The low-GL dietary composition is prepared from the following raw materials in parts by weight: 50-60 parts of protein, 10-20 parts of carbohydrate, 0.5-1 part of vegetable oil, 0.1-5 parts of plant extract and 20-30 parts of dietary fiber. By introducing the plant extract prepared by a fermentation process, the absorption of mineral substances and vitamins can be promoted, and additional addition of mineral substances and vitamins is not needed; the dietary fibers are interwoven with carbohydrates such as starch and the like in gastrointestinal tracts and delay absorption of the carbohydrates, so that the effect of reducing postprandial blood sugar can be achieved; meanwhile, all the components cooperate with one another, the effects of reducing blood pressure and regulating lipid can be achieved at the same time, and the effect of relieving blood sugar after strengthening treatment of type 2 diabetes is remarkable.

Description

Technical Field

[0001] The present invention belongs to the technical field of functional foods, and relates to a fermented low-GL dietary composition and its application in products for intensive treatment and intervention of type 2 diabetes mellitus. Background Art

[0002] Type 2 diabetes mellitus (T2DM) is a chronic disease caused by insufficient insulin use or reduced efficiency. Drug treatments include oral hypoglycemic drugs such as sulfonylureas, meglitinides, biguanides, thiazolidinediones, α-glucosidase inhibitors, dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), and sodium-glucose cotransporter-2 (SGLT-2) inhibitors; as well as injection preparations such as insulin and insulin analogs, glucagon-like peptide-1 receptor agonists (GLP-1 receptor agonists), etc. In addition, diet control is a basic measure for the comprehensive treatment of diabetes.

[0003] At present, there are some low-GI foods on the market. When the consumption amount is large, they still have a greater impact on the postprandial blood glucose of patients. The main reason is that the GI value only represents the blood sugar-raising ability of food and has nothing to do with the amount of food intake. The size of the impact of carbohydrates in the actual amount of food consumed per meal on blood glucose is represented by the glycemic load (GL), and the calculation formula is: food GL = food GI × carbohydrate content (grams) in food / 100. Therefore, GL comprehensively reflects the impact of the quality and quantity of carbohydrates in the ingested food on postprandial blood glucose.

[0004] Chinese Patent Application CN117643375A discloses a low-GL dietary formula suitable for maintaining after intensive treatment of T2DM and its preparation method. The low-GL dietary formula includes carbohydrates, dietary fiber, fat, protein, various vitamins (vitamin A, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, pantothenic acid, choline, biotin, and vitamin C), various minerals (sodium, potassium, calcium, phosphorus, magnesium, iron, zinc, copper, manganese, iodine, and selenium), etc. The rich combination of nutritional elements meets the necessary nutritional needs of the human body; the low-GL dietary formula is rich and comprehensive in nutrition, which is helpful for the precise diet control of type 2 diabetes patients throughout the day. However, its composition is relatively complex, and the three meals need to correspond to different formulas and need to be prepared separately, which increases the preparation process and is more troublesome to eat.

[0005] In addition, various complications may also occur in type 2 diabetes, including cardiovascular diseases, neuropathy, kidney diseases, etc. Due to the long-term instability of blood glucose, various tissues and organs will be damaged, leading to the occurrence of complications.

[0006] To optimize the formula of the dietary composition and give full play to the comprehensive effects of each component in the composition in aspects such as blood sugar lowering, lipid regulation, insulin level regulation, liver function improvement, and kidney function improvement after intensive treatment of type 2 diabetes on the basis of ensuring the provision of basic nutritional needs, it is necessary to further improve its formula. Summary of the Invention

[0007] In view of the problems existing in the prior art, the present invention provides a fermented low-GL dietary composition and its application in products for intensive treatment intervention of type 2 diabetes. This dietary composition is rich in nutrition and not only has good blood sugar lowering effect, but also can achieve lipid regulation, liver function improvement, kidney function improvement, etc., and shows outstanding effects in blood sugar, blood pressure, and lipid regulation after the intervention treatment of type 2 diabetes and its complications.

[0008] The technical solution of the present invention is as follows:

[0009] The present invention provides a fermented low-GL dietary composition, which is composed of the following raw materials in parts by weight: 50-60 parts of protein, 10-20 parts of carbohydrate, 0.5-2 parts of vegetable oil, 0.1-5 parts of plant extract, and 20-30 parts of dietary fiber; the plant extract is prepared by microbial fermentation of one or more of peach gum, moringa leaves, or schisandra chinensis.

[0010] Further, the preparation method of the plant extract is specifically as follows:

[0011] (1) Take one or more of the raw materials peach gum, moringa leaves, or schisandra chinensis, add them to water according to a material-liquid ratio of 1 g: 8-15 mL, and adjust the pH to 4.5-5.0 to obtain a raw material liquid;

[0012] (2) Inoculate 3-5 wt% of Saccharomyces cerevisiae into the above raw material liquid and ferment at 35-40 °C for 24-48 h to obtain the plant extract.

[0013] Preferably, the raw materials are peach gum, moringa leaves, and schisandra chinensis.

[0014] More preferably, the mass ratio of peach gum, moringa leaves, and schisandra chinensis is 1: 2-4: 0.05-0.5.

[0015] Peach Resin is the resin secreted from the bark of plants such as Prunus persica or Prunus davidiana in the Rosaceae family. It contains carbohydrates, fats, proteins, and plant collagen, etc. It enters the large intestine and bladder meridians; it has the effects of clearing blood and reducing lipids, relieving stress, and anti-wrinkle and skin beautifying, and is used for chyluria, diabetes, urinary tract infection, dysentery, stone strangury, and hematuria.

[0016] Moringa oleifera Lam., also known as the Drumstick tree, contains rich vitamin A, vitamin C, minerals (iron, potassium, calcium, copper, zinc, magnesium, manganese), as well as different types of active plant components such as protein, quinine, saponins, flavonoids, tannins, sterols, glycosides, and oils. It has pharmacological effects such as anti-asthma, anti-diabetes, liver protection, anti-inflammatory, anti-cancer, anti-microbial, antioxidant, anti-ulcer, anti-allergy, wound healing, analgesic, and antipyretic effects.

[0017] Schisandra chinensis (Turcz.) Baill. is the dried ripe fruit of the Schisandra plant of the Magnoliaceae family. It tastes sour and is warm in nature. It enters the lung meridian, heart meridian, and kidney meridian; it has the functions of astringing and consolidating, replenishing qi and promoting fluid production, and tonifying the kidney and calming the heart. It is used for chronic cough and asthma, spermatorrhea, enuresis and frequent urination, chronic diarrhea, spontaneous sweating, night sweating, thirst due to fluid injury, shortness of breath and weak pulse, internal heat and polydipsia, palpitation and insomnia.

[0018] Furthermore, the protein is selected from one or more of isolated whey protein, casein, soy protein isolate, and rice protein isolate; preferably isolated whey protein and soy protein isolate.

[0019] Furthermore, the carbohydrate is selected from one or more of wheat flour, corn flour, buckwheat flour, sorghum flour, rice flour, brown rice flour, or hulless barley flour; preferably wheat flour, corn flour, and brown rice flour.

[0020] Furthermore, the mass ratio of saturated fatty acid (SFA), monounsaturated fatty acid (MUFA), linoleic acid (LA), and α-linolenic acid (ALA) in the vegetable oil is 1:2 - 4:1 - 2:0.01 - 0.5.

[0021] Still further, the vegetable oil is selected from one or more of olive oil, palm oil, sunflower oil, flaxseed oil, soybean oil, and rapeseed oil.

[0022] The vegetable oil is preferably at least two of olive oil, sunflower oil, palm oil, and rapeseed oil.

[0023] Furthermore, the dietary fiber is selected from one or more of fructooligosaccharide, xylooligosaccharide, galactooligosaccharide, mannan oligosaccharide, isomaltooligosaccharide, or stachyose; preferably fructooligosaccharide, galactooligosaccharide, and isomaltooligosaccharide.

[0024] The present invention also provides the application of the above fermented low-GL dietary composition in products for intensive treatment and intervention of type 2 diabetes and its complications.

[0025] Furthermore, the type 2 diabetes and its complications include any one of diabetic nephropathy, hyperinsulinemia, diabetic ketoacidosis, or cardiovascular disease.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] (1) The low-GL dietary composition of the present invention has a simple composition and a reasonable combination. While ensuring the basic nutrient intake of patients with type 2 diabetes and its complications after intensive treatment, it can effectively control blood sugar, regulate lipid metabolism and liver metabolism; the plant extracts used are prepared by microbial fermentation. The plant raw materials are fully degraded under the action of enzymes produced during the microbial metabolism process, and active substances are released; at the same time, the enzymes produced by microbial metabolism can also promote the absorption of vitamins and minerals by the human body itself, eliminating the need for additional supplementation of vitamins and minerals; in addition, dietary fiber is introduced, which intertwines with carbohydrates such as starch in the gastrointestinal tract and delays the absorption of the latter, playing a role in reducing postprandial blood sugar.

[0028] (2) The present invention also discovers that among the raw materials of the plant extracts, namely peach gum, moringa leaves and schisandra chinensis, there is a significant synergistic effect in reducing blood sugar after intensive treatment of type 2 diabetes within a certain ratio range.

[0029] (3) By further specifying the fat source as vegetable oil, it ensures that the body maintains normal lipid metabolism while avoiding the risk of cardiovascular diseases; at the same time, the ratios of SFA, MUFA and PUFA (including LA and ALA) in the vegetable oil are defined, further improving the lipid metabolism effect.

[0030] (4) Finally, the raw materials of the low-GL dietary composition of the present invention have a wide source, a simple preparation process, and a wide range of applications. Detailed implementation manners

[0031] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention. It is worth noting that the raw materials used in the present invention are all ordinary commercially available products, and no specific limitation is imposed on their sources.

[0032] The source descriptions of the raw materials used in the following examples and comparative examples are as follows:

[0033] Moringa leaves (product number: 46787788) were purchased from Yunnan Dayao Mountain Commerce Co., Ltd.;

[0034] Peach gum (product number: 2-8) was purchased from Hefei Taozhixin Agricultural Development Co., Ltd.;

[0035] Schisandra chinensis (product number: WWZ-001) was purchased from Fuzhentang (Changchun) Ginseng, Antler & Chinese Medicine Co., Ltd.;

[0036] Mulberry leaf powder (product number: QA569) was purchased from Xi'an Allbio Technology Co., Ltd.;

[0037] Saccharomyces cerevisiae (product number: NJJMJ-02) was purchased from Xi'an Allbio Technology Co., Ltd.

[0038] Examples 1 - 3: Investigation on the composition of plant extracts

[0039] Preparation of plant extracts A - C: Except for mulberry leaf powder, the rest of the raw materials were ground and pulverized, passed through an 80 - mesh sieve, and reserved; according to the raw material composition of each of the plant extracts A - C in Table 1, the raw materials were weighed and mixed evenly to obtain a mixed raw material powder; then each mixed raw material powder was added to water at a material - liquid ratio of 1 g:10 mL, and the pH value of the solution was adjusted to 4.5 - 5.0 to obtain a raw material liquid; after sterilizing each raw material liquid, Saccharomyces cerevisiae was inoculated respectively (the inoculation amount was 3% of the total mass of the raw material powder), and fermented at 37 ± 2 °C for 48 h, and the fermented liquid was concentrated until the water content ≤ 3% to obtain plant extracts A - C.

[0040] Table 1 Raw material composition and dosage of plant extracts

[0041]

[0042] Example 4

[0043] A fermented low - GL dietary composition, the specific composition is: 30 parts of isolated whey protein, 20 parts of soy protein isolate, 5 parts of wheat flour, 3 parts of corn flour, 2 parts of brown rice flour, olive oil, sunflower seed oil, 10 parts of fructooligosaccharide, 5 parts of galactooligosaccharide, 5 parts of isomaltooligosaccharide, and 2 parts of plant extract A.

[0044] The preparation method is as follows: Take the above - mentioned raw materials and add them to a three - dimensional motion mixer, set the main shaft speed at 15 rpm, and mix well for 30 min to obtain.

[0045] Example 5

[0046] The difference from Example 4 is only that an equal amount of plant extract B is used instead of plant extract A.

[0047] Example 6

[0048] The difference from Example 4 is only that an equal amount of plant extract C is used instead of plant extract A.

[0049] Test example

[0050] (1) Establishment of type 2 diabetes model rats: Healthy SD rats, male, weighing 180 - 200 g. After being placed in the feeding environment and adaptively fed for 5 days, except for 10 rats in the blank control group fed with ordinary maintenance feed, the other rats began to be fed with a high - sugar and high - fat diet (66.5% ordinary maintenance feed + 10% lard + 20% sucrose + 2.5% cholesterol + 1% sodium cholate). After 10 days, streptozotocin (STZ) was intraperitoneally injected at a dose of 35 mg / kg body weight. Rats with fasting blood glucose > 7.0 mmol / L were considered as successfully modeled rats. The successfully modeled rats were randomly divided into 5 groups, with 10 rats in each group, namely the model group, the positive control group, and experimental groups 1 - 3. Among them, the blank control group and the model group were intragastrically administered with distilled water, the positive control group was intragastrically administered with 500 mg / kg metformin hydrochloride, and experimental groups 1 - 3 were intragastrically administered with the dietary composition prepared in Examples 4 - 6 at a dose of 5 g / kg once a day for 4 consecutive weeks.

[0051] (2) Effects of the fermented low - GL dietary composition of the present invention on fasting blood glucose, glucose tolerance, and glucose metabolism in type 2 diabetes model rats

[0052] Before and 4 weeks after administration, the rats were fasted overnight (12 h), and the tail vein blood glucose value was measured at 9:00 the next day; at the same time, the fasting body weight of the rats was weighed, and 50% glucose was intragastrically administered at a dose of 2 g / kg body weight. The tail vein blood glucose values were measured at 0.5 h, 1 h, 1.5 h, and 2 h, and the area under the curve was calculated through the blood glucose change curve; at the same time, the rats were sacrificed 24 h after the last administration, blood was taken from the abdominal vein, and the serum insulin content was measured. The results are shown in Table 2. The experimental data are expressed as and the data between groups were analyzed by t - test. P < 0.05 was considered statistically significant.

[0053] Table 2 Results of fasting blood glucose, glucose tolerance, and serum insulin in rats

[0054] FPG (mmol / L) 2hPG (mmol / L) Area under the curve Serum insulin Blank control group 4.21±0.32 4.51±0.34 8.54±0.89 14.23±2.05 Model group 5.85±0.45** 7.76±0.54** 15.08±1.35** 30.15±3.37** Positive control group <![CDATA[4.36±0.28 ## > <![CDATA[4.62±0.47 ## > <![CDATA[10.36±1.17 ## > <![CDATA[18.25±2.51 ## > Experimental group 1 <![CDATA[4.66±0.31 # > <![CDATA[5.08±0.37 # > <![CDATA[11.14±0.67 # > <![CDATA[21.36±2.24* ## > Experimental group 2 <![CDATA[5.02±0.40* # > <![CDATA[5.42±0.41* # > <![CDATA[12.08±0.74* # > <![CDATA[23.17±2.82* ## > Experimental group 3 5.66±0.37** 7.01±0.50** 14.69±1.21** 28.94±3.43**

[0055] Note: Compared with the blank group, * P < 0.05, ** P < 0.01; compared with the model group, # P < 0.05, ## P < 0.01.

[0056] As can be seen from the above table, the fasting blood glucose, 2-hour postprandial blood glucose and the area under the glucose tolerance curve of the rats in experimental group 1 and experimental group 2 were significantly lower than those in the model group (P < 0.05), and the serum insulin level was extremely significantly lower than that in the model group (P < 0.01). This indicates that the combination of plant extracts of peach gum, moringa leaves and schisandra chinensis in the dietary composition of the present invention has a better hypoglycemic effect, and at the same time has a better glucose tolerance level, can maintain the postprandial blood glucose at a relatively stable level. In addition, it also has a good insulin resistance state and can improve hyperinsulinemia.

[0057] (3) Effects of the fermented low-GL dietary composition of the present invention on lipid metabolism in type 2 diabetic model rats

[0058] The rats were sacrificed 24 hours after the last administration, and blood was taken from the abdominal vein to detect serum TG, TC, HDL-C, and LDL-C. The results are shown in Table 3. The experimental data are expressed as and the data between groups were analyzed by t-test. P < 0.05 was considered statistically significant.

[0059] Table 3 Results of lipid metabolism determination in rats

[0060] TG (mmol) TC (mmol / L) HDL-C (mmol / L) LDL-C (mmol / L) Blank control group 1.33±0.23 2.36±0.37 1.75±0.31 0.44±0.08 Model group 2.04±0.31** 3.74±0.51** 1.02±0.18** 0.89±0.12** Positive control group <![CDATA[1.32±0.25 ## > <![CDATA[2.45±0.28 ## > <![CDATA[1.82±0.44 ## > <![CDATA[0.62±0.14* # > Experimental group 1 <![CDATA[1.44±0.38 # > <![CDATA[2.50±0.22 ## > <![CDATA[1.65±0.38 ## > <![CDATA[0.66±0.09* # > Experimental group 2 <![CDATA[1.46±0.35 # > <![CDATA[2.54±0.26 ## > <![CDATA[1.62±0.26 ## > <![CDATA[0.65±0.05* # > Experimental group 3 <![CDATA[1.56±0.40* # > <![CDATA[3.01±0.34* # > <![CDATA[1.51±0.27 # > 0.77±0.10*

[0061] Note: Compared with the blank group, * P < 0.05, ** P < 0.01; compared with the model group, # P < 0.05, ## P < 0.01.

[0062] As can be seen from the above table, the serum TG and TC contents of the rats in experimental group 1 and experimental group 2 of the present invention were significantly lower than those in the model group (P < 0.05 and P < 0.01 respectively), the HDL-C content was significantly higher than that in the model group (P < 0.01), and the LDL-C was lower than that in the model group, but there was no significant difference. Generally speaking, the dietary compositions prepared in Examples 4 and 5 of the present invention can improve the lipid metabolism disorder in type 2 diabetic model rats and play a positive role in improving diabetes complicated with cardiovascular and cerebrovascular diseases. The dietary composition prepared in Example 6 has a certain effect on improving the lipid metabolism function of type 2 diabetic model rats, but is not as good as Examples 4 and 5.

[0063] (4) Effects of the fermented low-GL dietary composition of the present invention on liver function in type 2 diabetic model rats

[0064] The rats were sacrificed 24 hours after the last administration, and blood was taken from the abdominal vein to detect serum ALT and AST. The results are shown in Table 4. The experimental data are expressed as and the data between groups were analyzed by t-test. P < 0.05 was considered statistically significant.

[0065] Table 4 Results of liver function determination in rats

[0066]

[0067]

[0068] Note: Compared with the blank group, * P < 0.05, ** P < 0.01; compared with the model group, # P < 0.05, ## P < 0.01.

[0069] As can be seen from the above table, the serum ALT and AST levels of rats in experimental groups 1 and 2 of the present invention were significantly lower than those in the model group, and had an obvious improving effect on the liver function of type 2 diabetic model rats, indicating that the dietary composition of the present invention can reverse the liver function disorder of diabetic rats to a certain extent and has a certain liver protection effect.

[0070] (5) Effect of the fermented low-GL dietary composition of the present invention on the renal function of type 2 diabetic model rats

[0071] Urine was collected 24 hours after the last administration and the contents of urinary microalbumin and urinary creatinine were measured, and the urinary microalbumin creatinine ratio ACR was calculated. The results are shown in Table 5. The experimental data are expressed as and t-tests were used for the data between groups. P < 0.05 was considered statistically significant.

[0072] Table 5 Results of renal function determination in rats

[0073] ACR (mg / g) Blank control group 156.33±5.12 Model group 471.50±33.28** Positive control group <![CDATA[215.74±19.53* ## > Experimental group 1 <![CDATA[189.42±14.25* ## > Experimental group 2 <![CDATA[205.44±13.20* ## > Experimental group 3 <![CDATA[311.18±20.14** # >

[0074] Note: Compared with the blank group, * P < 0.05, ** P < 0.01; compared with the model group, # P < 0.05, ## P < 0.01.

[0075] As can be seen from the above table, the ACR levels of rats in experimental groups 1-3 of the present invention were significantly lower than those in the model group, but experimental group 3 was slightly worse. It can be seen that the dietary composition prepared by the present invention also has a significant effect on the improvement of diabetic nephropathy.

[0076] Examples 7-9: Investigation of the composition of the dietary composition

[0077] Table 6 Formulation of the fermented low-GL dietary composition (parts by weight)

[0078]

[0079]

[0080] The preparation method is the same as that of Example 4.

[0081] The effects of the dietary compositions prepared in Examples 7 - 9 on regulating blood glucose and blood lipids in type 2 diabetic model rats, as well as improving liver and kidney functions, are shown in Table 7.

[0082] Table 7 Detection results of blood glucose and blood lipids in rats, as well as improvement of liver and kidney functions

[0083]

[0084]

[0085] Note: Compared with the blank group, * P < 0.05, ** P < 0.01; compared with the model group, # P < 0.05, ## P < 0.01.

[0086] As can be seen from the above table, compared with Example 4, the dietary composition of Example 7 does not contain plant extracts, but increases compound vitamins and compound minerals, which has a better effect on improving blood glucose in type 2 diabetic model rats, but has a poorer effect on regulating blood lipids and improving liver and kidney functions; the dietary composition of Example 8 does not contain dietary fiber and increases the dosage of plant extracts. Although there is no impact on other aspects, its blood glucose regulation ability is insufficient; the dietary composition of Example 9 does not contain plant extracts and correspondingly increases the dosage of dietary fiber, and the effects in all aspects are poorer; it can be seen that the plant extracts prepared by microbial fermentation in the dietary composition of the present invention play an important role in improving type 2 diabetes and its complications.

[0087] Examples 10 - 11

[0088] Compared with Example 1, the differences in Examples 7 - 11 are only in the composition and dosage of each component in the dietary composition, as specifically shown in Table 8.

[0089] Table 8 Formulation of fermented low - GL dietary composition (parts by weight)

[0090]

[0091]

[0092] The preparation method is the same as that of Example 4

[0093] The effects of the dietary compositions prepared in Examples 10 and 11 on regulating blood glucose and blood lipids in type 2 diabetic model rats, as well as improving liver and kidney functions, are shown in Table 9.

[0094] Table 9 Blood glucose, blood lipids of rats, and test results of improving liver and kidney functions

[0095]

[0096] Remark: Compared with the blank group, * P < 0.05, ** P < 0.01; compared with the model group, # P < 0.05, ## P < 0.01.

[0097] As can be seen from the above table, the specific compositions of each component in Example 10 are different, and the dosages are not much different from those in the example. It also shows significant differences from the model group in regulating blood glucose and blood lipids of type 2 diabetic model rats and improving their liver and kidney functions, and also has significant effects in treating type 2 diabetes and its complications. Compared with Example 4, Example 11 has too much vegetable oil, and its effect in improving blood lipids is poor, and the improvement effect on liver function also decreases significantly.

[0098] Considering that vegetable oil has a certain impact on regulating blood lipids and improving liver function, the type of vegetable oil and the ratios of saturated fatty acid SFA, monounsaturated fatty acid MUFA, linoleic acid LA, and α-linolenic acid ALA in it will be further studied to achieve the improvement of comprehensive effects.

[0099] Examples 12 - 14

[0100] Compared with Example 1, the difference between Examples 12 - 14 lies only in the different compositions of vegetable oil, as shown in Table 10 specifically.

[0101] Table 10 Compositions of vegetable oil in the fermented low-GL dietary compositions of Examples 12 - 14 (parts by weight)

[0102] Olive oil Sunflower oil Rapeseed oil Palm oil SFA:MUFA:LA:ALA Example 4 1.5 0.5 / / 1:3.85:1.65:0.07 Example 12 1.8 0.2 / / 1:4.30:1.13:0.03 Example 13 1 1 / / 1:3.07:2.56:0.15 Example 14 0.5 0.8 0.5 0.2 1:2.60:1.66:0.23 Example 15 0.5 0.5 0.5 0.5 1:2.25:0.89:0.15

[0103] The preparation method is the same as that of Example 4.

[0104] The results of the dietary compositions prepared in Examples 12 - 15 in regulating and improving blood lipids and liver function of type 2 diabetic model rats are shown in Table 11.

[0105] Table 11 Test results of blood lipids and liver function of rats

[0106]

[0107]

[0108] Remark: Compared with the blank group, * P < 0.05, ** P < 0.01; compared with the model group,# P < 0.05, ## P < 0.01.

[0109] As can be seen from the above table, compared with Example 4, the types and ratios of vegetable oils in the dietary composition prepared in Example 14 are quite different. However, the effects on blood lipid regulation and liver function improvement in type 2 diabetic model rats are comparable, and there are significant differences compared with the model group. It is inferred that the main reason may be the different contents of saturated fatty acid SFA, monounsaturated fatty acid MUFA, linoleic acid LA, and α-linolenic acid ALA in the vegetable oil composition. In Examples 12 and 13, the ratio of vegetable oil was changed based on the vegetable oil in Example 4; after changing the ratio of vegetable oil in Example 15 based on Example 4, the effects of the obtained dietary composition on blood lipid regulation and liver function improvement in type 2 diabetic model rats decreased, and there was basically no significant difference from the model group. It can be seen that SFA, MUFA, LA, and ALA in vegetable oil can play a role in regulating blood lipids and improving liver function only within a certain ratio range.

[0110] Human efficacy test

[0111] (1) Test subjects: 60 type 2 diabetic patients were randomly divided into a treatment group and a control group, with 30 people in each group (there were no statistically significant differences in age, disease duration, FPG, 2hPG, GA, HDL, LDL, TG, and TC between the two groups of test subjects).

[0112] Inclusion criteria: (1) Aged 18 - 70 years old, gender not limited; (2) Type 2 diabetic patients diagnosed according to the 1999 World Health Organization (WHO) standard, with a disease duration of at least 3 months or more; (3) Maintaining the original hypoglycemic and lipid-lowering regimens unchanged for more than 1 month; (4) HbA1C at 7 - 9%.

[0113] Exclusion criteria: (1) Pregnant or lactating women; (2) Patients with severe complications such as heart, liver, and kidney, or those with other severe primary diseases or mental illnesses combined.

[0114] (2) Test method: On the basis of the original hypoglycemic and lipid-lowering regimens, the treatment group added the dietary fiber composition of Example 4 of the present invention twice a day, 15 g each time, taken during meals. The control group maintained the original hypoglycemic and lipid-lowering regimens. The course of treatment was 28 days. Follow-up was conducted at 4 weeks after treatment to evaluate the efficacy, observe the changes in the clinical signs of the patients and drug-related adverse reactions, and analyze their severity and whether they were related to the test.

[0115] Effectiveness evaluation indicators: Changes in fasting and 2-hour postprandial venous blood glucose, and glycated serum albumin from the baseline level. Changes in blood lipids [total cholesterol (TG), triglyceride (TC), high-density lipoprotein (HDL-C), and low-density lipoprotein (LDL-C)] from the baseline.

[0116] Safety evaluation indicators: Carefully observe any adverse events that occur to the patients during the observation period. (1) Hypoglycemic events are divided into three situations: hypoglycemic reaction, which refers to only having subjective symptoms; confirmed hypoglycemia, which refers to having a hypoglycemic reaction and a blood glucose level lower than the lower limit of the normal value; severe hypoglycemia, which refers to a blood glucose value lower than 2.8 mmol / L. (2) Other adverse events include gastrointestinal reactions, abnormal clinical manifestations and vital signs, etc. Record their clinical manifestation characteristics, severity, occurrence time, duration, treatment methods and prognosis, and determine their correlation with the test drug. According to the criteria for judging the causality between drugs and adverse events, the correlation between adverse events and the application of the test drug is divided into five levels, namely definitely related, probably related, possibly related, possibly unrelated, and definitely unrelated. And definitely related, probably related, and possibly related are all listed as drug adverse reactions.

[0117] (3) Statistical processing: Statistical analysis is carried out using SPSS 20.0 statistical analysis software. The experimental data are expressed as , and the t-test is used for the data between groups. P < 0.05 indicates that the difference is statistically significant.

[0118] (4) Test results:

[0119] 4.1 The glycometabolism and lipid metabolism indicators of the two groups of test subjects are shown in Table 12 and Table 13 respectively.

[0120] Table 12 Comparison of glycometabolism between the two groups

[0121]

[0122] Note: # Compared with before treatment within the group, P < 0.05; ## Compared with before treatment, P < 0.01; * The difference compared with the control group, P < 0.05; ** Compared with the control group, P < 0.01.

[0123] Compared with before treatment, FPG and GA in the treatment group decreased significantly (P < 0.05), and 2hPG decreased significantly (P < 0.01). In the control group, 2hPG decreased significantly (P < 0.05). Compared with the control group, the degree of decrease in FPG in the treatment group was significantly different (P < 0.05), and the degrees of decrease in 2hPG and GA were significantly different (P < 0.01).

[0124] Table 13 Comparison of lipid metabolism indicators between the two groups

[0125]

[0126]

[0127] Note:# Compared with before treatment within the group, P < 0.05; ** Compared with the control group for the difference value, P < 0.01.

[0128] Compared with before treatment, LDL, TG and TC in the treatment group and the control group decreased significantly (P < 0.05). Compared with the control group, there were significant differences in the degrees of decrease of TG and TC in the treatment group (P < 0.01); Generally speaking, the treatment group was superior to the control group in improving lipid metabolism.

[0129] 4.2 Safety analysis

[0130] No serious adverse reactions or hypoglycemic events were seen in both groups.

[0131] After 2-type diabetic patients in this trial continuously took the dietary composition of the present invention for 4 weeks, there were good improvement effects on blood glucose and blood lipids, especially on the 2-hour postprandial blood glucose and glycosylated serum protein. In terms of lipid metabolism intervention, the treatment group had a more significant improvement effect on TG and TC. In summary, the product of the present invention has a significant effect on reducing blood glucose and regulating lipids after the treatment of type 2 diabetes.

[0132] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than a limitation on the protection scope of the present invention. Any simple modification or equivalent replacement of the technical solution of the present invention by those of ordinary skill in the art does not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A fermented low-GL dietary composition, characterized in that, It consists of the following raw materials in parts by weight: 50 - 60 parts of protein, 10 - 20 parts of carbohydrates, 0.5 - 2 parts of vegetable oil, 0.1 - 5 parts of plant extract, and 20 - 30 parts of dietary fiber; the plant extract is prepared by microbial fermentation from one or more raw materials selected from peach gum, moringa leaves, or schisandra chinensis.

2. The fermented low-GL dietary composition according to claim 1, wherein The specific preparation method of the plant extract is as follows: (1) Take one or more of the raw materials peach gum, moringa leaves, or schisandra chinensis, add them to water at a material - liquid ratio of 1 g: 8 - 15 mL, and adjust the pH to 4.5 - 5.0 to obtain a raw material liquid; (2) Inoculate 3 - 5 wt% of Saccharomyces cerevisiae into the above - mentioned raw material liquid, and ferment at 35 - 40 °C for 24 - 48 h to obtain the plant extract.

3. The fermented low-GL dietary composition according to claim 2, wherein The raw materials are peach gum, moringa leaves, and schisandra chinensis.

4. The fermented low-GL dietary composition according to claim 3, characterized in that The mass ratio of the peach gum, moringa leaves, and schisandra chinensis is 1: 2 - 4: 0.05 - 0.

5.

5. The fermented low-GL dietary composition according to claim 1, wherein The protein is selected from one or more of isolated whey protein, casein, soy protein isolate, and rice protein isolate; preferably isolated whey protein and soy protein isolate; and / or The carbohydrates are selected from one or more of wheat flour, corn flour, buckwheat flour, sorghum flour, rice flour, brown rice flour, or hulless barley flour; preferably wheat flour, corn flour, and brown rice flour.

6. The fermented low-GL dietary composition according to claim 1, wherein The mass ratio of saturated fatty acid, monounsaturated fatty acid, linoleic acid, and α - linolenic acid in the vegetable oil is 1: 2 - 4: 1 - 2: 0.01 - 0.

5.

7. The fermented low-GL dietary composition according to claim 1, wherein The vegetable oil is selected from one or more of olive oil, palm oil, sunflower seed oil, flaxseed oil, soybean oil, and rapeseed oil; preferably at least two of olive oil, sunflower seed oil, palm oil, and rapeseed oil.

8. The fermented low-GL dietary composition according to claim 1, wherein The dietary fiber is selected from one or more of fructooligosaccharide, xylooligosaccharide, galactooligosaccharide, mannan oligosaccharide, isomaltooligosaccharide, or stachyose; preferably fructooligosaccharide, galactooligosaccharide, and isomaltooligosaccharide.

9. Use of the fermented low - GL dietary composition according to any one of claims 1 - 8 in products for intensive treatment and intervention of type 2 diabetes and its complications.

10. The application according to claim 9, characterized in that, The type 2 diabetes and its complications include any one of diabetic nephropathy, hyperinsulinemia, diabetic ketoacidosis, or cardiovascular disease.

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