A combined product with weight loss effect and its application

Abstract

The present invention provides a combination product with a weight loss effect and its application. The combination product with a weight loss effect provided by the present invention includes a breakfast / lunch nutrition meal replacement package, a Chinese medicine drink composition, a blended oil composition for cooking green leafy vegetables, and a Chinese medicine composition for foot bathing before bed. The combination product of the present invention can regulate body metabolism and psychology through multi-level improvements in diet, sleep, and endocrine, and has the characteristics of good weight loss effect, no side effects, and good sleep; in addition, in addition to having a good weight loss effect, the combination product of the present invention has the effect of improving the body's immune function and the body's antioxidant level through the determination of body functions.

Description

Technical Field

[0001] The invention relates to a combined product with weight loss effect and application thereof, belonging to the field of medical health care. Background Art

[0002] There are various weight loss products and methods on the market, including low-calorie meal replacement foods, Chinese medicine weight loss products, high-purity chemical ingredients weight loss foods, and massage, acupuncture and other physical therapy weight loss techniques. However, these methods and technologies have certain defects and shortcomings.

[0003] (I) Low-calorie meal replacements: They achieve the purpose of weight loss by strictly controlling food intake and calorie intake. Common meal replacement powders, nutrition bars, meal replacement shakes, etc. are common. In the market, most meal replacement products are nutritional supplements composed of protein powder or dietary fiber as the main raw materials, supplemented with vitamins or minerals. For example, CN201210193683.8 discloses "a protein-based solid beverage for weight loss meal replacement", in which the disclosed meal replacement solid beverage contains the following ingredients: concentrated whey protein powder, soy protein isolate powder, skim milk powder, water-soluble dietary fiber, maltobionic acid, maltodextrin, oligofructose, soy lecithin, sodium caseinate, and low-fat pectin. Although the patent provides a meal replacement product that increases satiety and reduces calories, the comprehensive and balanced nutrition it emphasizes does not meet the group standard for meal replacement foods (T / CNSS 002-2019) issued by the Chinese Nutrition Society in 2019. For example, the content of vitamin A is 260μg to 580μg, while the content of vitamin A in this product is 650μg, which does not meet the standard. Long-term consumption will pose a safety hazard and is detrimental to the health of consumers. In addition, a clinical study at the University of Oxford proved that although a low-calorie diet brings about metabolic improvements, such as reduced liver fat and reversal of diabetes, the sudden drop in calories will cause fat to be released into the blood from different parts of the body. After being absorbed by the myocardium, a low-calorie diet for just one week will cause a 44% increase in heart fat content, and a significant decrease in heart function (including blood pumping function). The heart fat level and function will not improve until the body has adapted to the period of severe calorie deficiency.

[0004] (II) Traditional Chinese medicine weight loss products: Under the guidance of traditional Chinese medicine theory, Chinese herbal medicine raw materials are selected to achieve weight loss effects. This type of product uses traditional Chinese medicine or medicinal and edible ingredients to make oral decoctions or external ointments, and can be subdivided into products containing laxative ingredients and products without laxative ingredients in terms of ingredients. Products containing laxative ingredients mainly contain anthraquinone traditional Chinese medicines, including rhubarb, senna leaves, aloe, lotus leaves, cassia seeds, Polygonum multiflorum, etc. For example, CN201610218320.3 "A drug composition for weight loss, including its preparation and preparation method" discloses a traditional Chinese medicine composition and its effective ingredients, including Poria, Atractylodes macrocephala, Pinellia, Citrus aurantium, Perilla frutescens, Atractylodes lancea, Magnolia officinalis, Rhubarb, Bupleurum, Cardamomum officinale, Lotus leaf, Wuhe, Cinnamon, Safflower, Angelica sinensis, White Peony Root, Chuanxiong, Sichuan Pepper, Astragalus, Alisma orientalis, Amomum villosum, and capsaicin, providing a method for clearing turbidity and eliminating fullness, improving fat metabolism and treating obesity. This type of weight loss product utilizes the diuretic and laxative effects of rhubarb, but the laxative effect also causes the weight loss patient to lose a large amount of nutrients, resulting in a decrease in human resistance and even collapse. Long-term consumption of anthraquinone ingredients will lead to the destruction of the intestinal mucus secretion mechanism and serious harm to the body. It has also been found in clinical practice that this type of anthraquinone Chinese medicine can cause adverse reactions such as colon melanosis, drug-induced liver injury, and drug-induced kidney injury. Long-term use of this type of Chinese medicine will cause the risk of toxicity to the digestive system, urinary system, reproductive system, immune system, and respiratory system. Another type is a product that does not contain laxative ingredients, which mainly achieves weight loss effects by regulating viscera and gastrointestinal dysfunction. Common products include mulberry leaves, honeysuckle, and fish eye grass. For example, CN201410236212.X "A weight loss tea containing fish eye grass and its preparation method" provides a weight loss tea containing fish eye grass and its ingredients include: green tea, fish eye grass, isatis root, white peony root, silver bupleurum, oriental rhizome, atractylodes, superbus, radish seed, scutellaria baicalensis, and clematis. This type of weight loss product avoids anthraquinone laxative ingredients and uses mild medicinal materials that can be taken for a long time. However, the clinical results in the examples mentioned that 61% of obese subjects lost less than 2.5 kg after three months of administration, which shows that the product is slow to take effect and the oral decoction has a poor taste. In addition, medicinal materials such as Alisma, Bupleurum, and Fish Eye Grass are not among the medicinal materials that are announced by the national health department as medicine and food, and there are safety risks to health when consumed for a long time.

[0005] (III) Weight loss products using high-purity ingredients: In the market, common chemical ingredients added to weight loss products include tea polyphenols, L-carnitine, caffeine, etc., which enter the body for absorption and metabolism to affect various processes such as fat generation, fat decomposition and metabolism, thereby achieving a weight loss effect. For example, tea polyphenols and L-carnitine can promote the entry of fatty acids into mitochondria for oxidative decomposition during fat metabolism, increase the level of high-density lipoprotein in the blood, and help remove cholesterol from the body. This type of product is mostly made into effervescent tablets and capsules, such as CN201310182569.X "L-carnitine tea polyphenol tablets and preparation method thereof", which discloses that the combination of such L-carnitine tea polyphenol tablets is: L-carnitine tartrate, tea extract, tea polyphenols, microcrystalline cellulose, cross-linked polyvinylpyrrolidone, copolyvinylpyrrolidone, silicon dioxide, magnesium stearate, and film coating agent. A weight loss product with a rapid and significant weight loss effect is provided. However, in recent years, the incidence of mental disorders related to L-carnitine in clinical practice has increased year by year. A clinical study on L-carnitine-related mental disorders at the Chongqing Mental Health Center found that L-carnitine can cause auditory hallucinations, persecution delusions, and controlled experiences, as well as emotional disharmony and behavioral disintegration. When the use of diet pills containing L-carnitine is stopped, the symptoms usually disappear quickly, social functions are fully restored, and the condition fluctuates less in the later stage, which also proves the existence of an inevitable connection between L-carnitine and mental disorders. At the same time, a latest study by the National Center for Cardiovascular Diseases published in the Chinese Journal of Molecular Cardiology found that although L-carnitine can protect the cardiovascular system by removing cholesterol from the blood, L-carnitine can also produce trimethylamine and trimethylamine oxide through intestinal microbial dependence, causing atherosclerosis. In addition, another ingredient disclosed in the patent: tea extract, was also found in a pharmacokinetic study by the German Institute of Pharmacology that although it has a lipid-lowering effect, this type of ingredient has obvious individual differences, more than 6 times, and has different effects on different healthy individuals. In addition, chemical ingredients such as caffeine are also reported in the Medical Database Center, which can directly excite the medulla oblongata, cause paroxysmal convulsions and bone tremors, damage important organs such as the liver, stomach, and kidneys, and induce respiratory inflammation, breast cancer in women, and other diseases. Therefore, this type of weight loss technology using chemical ingredients often affects the health of the dieter due to the adverse reactions of the chemical ingredients themselves and the accompanying side effects, and is not suitable for long-term use.

[0006] (IV) Physical therapy weight loss techniques include massage, auricular acupuncture, and acupuncture. The main sites of action are the abdomen, buttocks, and calves, especially the abdomen. From the perspective of traditional Chinese medicine, physical therapy weight loss is to regulate the internal organs through massage, acupuncture, etc., so that the liver, spleen, and kidney functions can be restored to achieve the effect of weight loss. For example, some people are obese because of excessive intake, which leads to impaired gastrointestinal function, and acupuncture can prolong gastric emptying time to suppress appetite. From the perspective of modern medicine, massage, acupuncture, etc. can stimulate the peripheral nerves, open the capillaries of the skin and subcutaneous fat through different forces of lightness, heaviness, speed, and slowness, and the waste of skin tissue is discharged, which promotes the body's metabolism and plays the role of "removing abdominal turbidity". It can be seen that this type of weight loss method can work by regulating metabolic function, and there are currently no reports of side effects. However, this type of method has high technical requirements and requires targeted implementation by professionals. There are also certain restrictions on the place of use. Consumers cannot self-treat, which makes it very inconvenient to use.

[0007] In summary, existing weight loss technologies all have certain shortcomings, such as slow onset, insufficient safety, obvious adverse reactions after long-term use, or inconvenient use and requiring targeted operation by professionals. Therefore, seeking weight loss products with significant weight loss effects, safe effects without side effects, and convenient use will help prevent and treat the current large-scale obesity population. Summary of the invention

[0008] The present invention aims to solve the problems of slow effect, insufficient safety and inconvenient use of existing weight loss products, and provides a combined product with weight loss effect and its application.

[0009] To achieve the purpose, the present invention provides the following technical solutions:

[0010] The present invention provides a combined product with weight loss effect, the combined product comprising a breakfast / lunch nutritional meal replacement package, a Chinese medicine drink composition, a blending oil composition for cooking green leafy vegetables and a Chinese medicine composition for foot bath before bedtime; wherein,

[0011] The breakfast / lunch nutritional meal replacement package is composed of the following components by weight, based on the total weight of a single meal: 21g soy protein isolate, 10g whole milk powder, 6g resistant dextrin, 6g concentrated whey protein, 6g erythritol, 2g conjugated linoleic acid glyceride, 1g spirulina, 4.4g inulin, 4g chia seeds, 2g oatmeal, 1.6g psyllium husk powder, 360μg RE vitamin A, 0.6mg vitamin B1, 0.6mg vitamin B2, 0.6mg vitamin B6, 0.6mg vitamin B 120.8μg, vitamin C 70mg, vitamin D0.7μg, vitamin E 5mg, folic acid 140μg DFE, niacin 6mg, calcium 320mg, magnesium 84mg, iron 7mg, zinc 5.5mg, calories 250kcal;

[0012] The Chinese medicine instant drink composition, based on the total weight of the Chinese medicine instant drink composition required for a single instant drink, is composed of the following components by weight: 3.4g of Poria cocos, 3.4g of Coix seeds, and 1.2g of dried tangerine peel;

[0013] The blended oil composition is composed of the following components in the following weight ratio: 90 parts of linseed oil, 10 parts of olive oil, and 20 to 50 ml of oil for each cooking;

[0014] The Chinese medicine composition for foot bath before bed, based on the total weight of the Chinese medicine composition for foot bath before bed required for a single foot bath, is composed of the following components by weight: 3.6g of mulberry branch, 3.6g of Polygonum multiflorum vine, 2.7g of Prunella vulgaris, and 0.1g of Zanthoxylum bungeanum;

[0015] The particle size of the Chinese medicine instant drink composition and the Chinese medicine foot bath composition is ≤100nm, and these medicinal materials can be crushed to a particle size of ≤100nm by a high-speed air flow mill.

[0016] Among them, the breakfast / lunch nutritional meal replacement pack is used for breakfast and lunch; the Chinese medicine instant drink composition is used for drinking with hot water in the interval between breakfast and lunch; the blended oil composition is used as cooking oil for green leafy vegetables for dinner; and the bedtime foot bath Chinese medicine composition is used for foot bathing before bedtime.

[0017] Furthermore, the weight of the green leafy vegetables for dinner reaches more than 500g, so as to not feel hungry. There is no special restriction on the types of green leafy vegetables, which can be common green leafy vegetables consumed daily, such as lettuce, Chinese cabbage, spinach, bok choy, celery, etc.

[0018] Furthermore, the Chinese medicine composition for foot bath before bedtime is dissolved and dispersed in hot water and then used one hour before bedtime, and the foot bath time is preferably 20-30 minutes.

[0019] The specific method of use of the combination product of the present invention is: use hot water (or warm water) to mix and drink the above-mentioned breakfast / lunch nutritional meal replacement package for breakfast and lunch, mix and drink a package of edible Chinese medicine instant drink composition during the interval between breakfast and lunch, use the blending oil composition to cook 500g or more of green leafy vegetables for dinner, and dissolve and disperse the Chinese medicine composition for foot bath before going to bed with hot water one hour before going to bed, and the foot bath time is 20 to 30 minutes.

[0020] Another aspect of the present invention provides use of the combination product described above in the preparation of a weight-reducing product having a weight-reducing effect.

[0021] The technical solution provided by the present invention has the following beneficial effects:

[0022] The present invention provides a combination product with a weight loss effect. Compared with the prior art, the combination product has the following beneficial effects: 1. The combination product of the present invention can regulate body metabolism and psychology through multi-level improvements in diet and sleep, and has the characteristics of good weight loss effect, no side effects, stable emotions, and good sleep; 2. In addition to having a good weight loss effect, the combination product of the present invention has the effect of improving the body's immune function and the body's antioxidant level through the measurement of body functions. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 This is an electron scanning microscope photo of a Chinese medicine drink composition;

[0024] Figure 2 This is an electron scanning microscope photograph of a Chinese herbal medicine composition powder used for foot bath. DETAILED DESCRIPTION

[0025] The present invention is described below by way of examples. It is necessary to point out that the following specific examples are only used to further illustrate the present invention and do not limit the scope of protection of the present invention to this. Some non-essential modifications and adjustments made by others according to the present invention still belong to the scope of protection of the present invention. Unless otherwise specified, the reagents involved in the embodiments of the present invention are all commercially available materials and can be purchased through commercial channels.

[0026] Example 1

[0027] Preparation of a complete nutritional composition meal replacement pack (i.e., a breakfast / lunch nutritional meal replacement pack): (1) accurately weighing soy protein isolate, whole milk powder, resistant dextrin, whey protein concentrate, erythritol, conjugated linoleic acid glyceride, spirulina, inulin, chia seeds, oatmeal, psyllium husk powder, vitamin A, vitamin B1, vitamin B2, vitamin B6 ... 12 , vitamin C, vitamin D, vitamin E, folic acid, niacin, calcium carbonate, magnesium oxide, ferric pyrophosphate, zinc gluconate; put each component into a three-dimensional mixer, mix for 30 minutes, and then use a powder packaging machine to pack the above mixture; the component contents of each package of the complete nutritional composition meal replacement package are as follows: soy protein isolate 21g, whole milk powder 10g, resistant dextrin 6g, concentrated whey protein 6g, erythritol 6g, conjugated linoleic acid glyceride 2g, spirulina 1g, inulin 4.4g, chia seeds 4g, oatmeal 2g, psyllium husk powder 1.6g, vitamin A 360μg RE, vitamin B1 0.6mg, vitamin B2 0.6mg, vitamin B6 0.6mg, vitamin B 120.8μg, vitamin C 70mg, vitamin D 0.7μg, vitamin E 5mg, folic acid 140μgDFE, niacin 6mg, calcium 320mg, magnesium 84mg, iron 7mg, zinc 5.5mg, calories 250kcal;

[0028] Preparation of a Chinese medicine drinkable composition package: (1) accurately weigh 34 kg of Poria cocos, 34 kg of Coix seeds, and 12 kg of dried orange peel that meet the quality requirements of the Chinese Pharmacopoeia; (2) grind the above medicinal materials with a high-speed airflow ultrafine grinder and pass through an 80-mesh screen; (3) put the sieved materials into a three-dimensional mixer and mix for 30 minutes; (4) use a powder packaging machine to package the above materials into 8 g / package. The particle size of the Chinese medicine drinkable composition was tested using the analytical scanning electron microscope method general rule JY / T 010-1996, and the results were as follows Figure 1 As shown, the powder particle size is ≤100nm.

[0029] Preparation of vegetable blended oil (i.e., blended oil composition) for cooking: (1) accurately weighing 90 kg of physically pressed linseed oil and 10 kg of virgin olive oil that meet quality requirements; (2) pouring the above materials into a mixing tank and mixing for 10 minutes, flushing with nitrogen to isolate the air; (3) packaging the blended oil into 500 ml / bottles using a filling machine.

[0030] Preparation of a package of a Chinese medicine composition for foot bath (i.e., a Chinese medicine composition for foot bath before bed): (1) accurately weigh 36 kg of mulberry branches, 36 kg of Polygonum multiflorum vine, 27 kg of Prunella vulgaris, and 1 kg of Zanthoxylum bungeanum that meet the quality requirements; (2) crush the above medicinal materials using a high-speed airflow ultrafine grinder and pass through an 80-mesh sieve; (3) put the sieved materials into a three-dimensional mixer and mix for 30 minutes; (4) use a powder packaging machine to package the above materials into 10 g / package. The particle size of the Chinese medicine composition for foot bath before bed was tested using the analytical scanning electron microscope method general rule JY / T 010-1996, and the results are as follows Figure 2 As shown, the powder particle size is ≤100nm.

[0031] The method of using the above-mentioned combination product is as follows: use hot water (≥60℃) to prepare 1 packet of the complete nutrition composition meal replacement pack for breakfast and lunch respectively, and consume it instead of the main meals of breakfast and lunch; use warm water (≥40℃) to prepare 1 packet of edible Chinese medicine instant drink composition and drink it between meals of breakfast and lunch; use cooking blending oil (20-50ml) to cook 500g or more of green leafy vegetables (the amount to be consumed is based on not feeling hungry) for dinner, and consume it as dinner; 1 hour before going to bed, use hot water (≥60℃) to dissolve and disperse the external Chinese medicine composition for foot bath before going to bed, and soak the feet for 20-30 minutes after the water temperature cools down.

[0032] Application efficacy verification of combination products

[0033] (1) Experimental groups

[0034] Obese adults aged 25-35 years (30≤BMI≤35) who were interested in losing weight were recruited as research subjects.

[0035] Inclusion criteria for research subjects: The test product contains allergens, and the test subjects must not be allergic to gluten ingredients such as soy and oats. In order to avoid the impact of lifestyle on the study, the test subjects must agree to avoid drinking during the study, maintain a normal diet and work and rest schedule, and do not need to perform physical activities beyond daily needs. In addition, it is necessary to ensure that you are not pregnant or breastfeeding, have not undergone major cardiovascular and visceral surgery in the past year, and have not taken other weight loss health products or appetite-affecting drugs (including antidepressants, steroids, Ritalin) in the past 2 months. Have a physical examination report in the past year (including electrocardiogram, blood lipids, and blood pressure).

[0036] Exclusion criteria: Chronic and uncontrolled health problems (excluding obesity and diabetes). Pacemakers or other internal electronic medical devices. History of schizophrenia, bipolar disorder, or current major depression. Dependence on alcohol or sedative hypnotic drugs (e.g., benzodiazepines). Cognitive impairment severe enough to prevent informed consent. Or taking medications for weight loss or appetite disorders.

[0037] Before the experiment, basic physical condition indicators were measured, including weight, waist circumference, blood pressure, pulse and other data. The body composition (including body fat percentage and water content) was measured using the bioimpedance method. Blood was drawn to measure cholesterol, triglycerides, fasting insulin, superoxide dismutase (SOD), malondialdehyde (MDA), and saliva samples were taken to measure salivary secretory globulin IgA.

[0038] After the experiment, basic physical condition indicators were measured, including weight, waist circumference, blood pressure, pulse and other data. The bioimpedance method was used to measure body composition (including body fat percentage and water content). Blood was drawn to measure cholesterol, triglycerides, fasting insulin, superoxide dismutase (SOD), malondialdehyde (MDA), and saliva samples were taken to measure salivary secretory globulin IgA.

[0039] The subjects were screened by face-to-face screening. Data such as height, weight, waist circumference, blood pressure, and pulse were collected, and body composition was measured using bioimpedance. An eating attitude test (EAT) was performed. Data on general demographics, medical history, weight history, tobacco and alcohol use, exercise, eating habits, and stress sources were collected. Among the 118 obese adults recruited who met the initial eligibility criteria, 96 subjects were finally screened, 63 females and 33 males. All subjects were randomly divided into 8 groups (12 people / group), named Group A, Group B, Group C, Group D, Group E, Comparison Group 1, Comparison Group 2, and Comparison Group 3. After grouping, inter-group difference tests were performed to ensure that there were no significant differences in the physiological indicators of each experimental group.

[0040] A control group 4 was set up, which consisted of 12 adults with normal weight (18.5≤BMI≤24), including 9 females and 3 males, who met the inclusion and exclusion criteria.

[0041] (2) Intervention methods

[0042] Test Group A: One pack of the complete nutritional composition meal replacement pack (hereinafter referred to as Product E) prepared by the method of Example 1 was consumed for breakfast and lunch, one pack of the edible Chinese medicine instant drink composition pack (hereinafter referred to as Product F) prepared by the method of Example 1 was consumed between meals, and dinner was cooked with the cooking vegetable blending oil (hereinafter referred to as Product G) prepared by the method of Example 1 (500g or more of green leafy vegetables, and one or more of the green vegetables selected from lettuce, Chinese cabbage, lettuce, celery, and Shanghai greens, so as not to feel hungry), and the Chinese medicine composition pack for foot bath prepared by the method of Example 1 (hereinafter referred to as Product H) was used for soaking feet for 20-30 minutes before going to bed.

[0043] Test group B: one pack of product E for breakfast and lunch, and a normal diet for dinner;

[0044] Test group C: one pack of product E for breakfast and lunch, one pack of product F between breakfast and lunch, and a normal diet for dinner;

[0045] Test group D: one pack of product E for breakfast and lunch, one pack of product F for breakfast and lunch, and one pack of product G for dinner (500g or more of green leafy vegetables, including one or more of lettuce, Chinese cabbage, lettuce, celery, and Shanghai greens, and 20-50ml of oil);

[0046] Test Group E: Eat a normal breakfast, lunch and dinner, and soak your feet in Product H for 20-30 minutes before going to bed.

[0047] Comparative Group 1: A low-calorie diet was designed by a certified nutritionist based on the Dietary Guidelines for Chinese Residents, with three meals a day consuming a total of 200g of cereals, 50g of green leafy vegetables, 50g of fruit, 1 cup of milk, 50g of lean meat, and 15g of soybean oil (providing a total calorie of approximately 5000kJ, or approximately 1200kcal, including 76g of protein, 32g of fat, and 150g of carbohydrates).

[0048] Comparative group 2: consuming a diet of commercially available low-fat meal replacement foods, with a menu designed by a certified nutritionist based on the Chinese Dietary Guidelines. They consumed 240g of commercially available soy-based low-fat, low-calorie meal replacement powder (Scan-Diet brand product of Nurticia, USA, 48g / bag) to replace three meals a day, and an additional 30g of green leafy vegetables, 60g of fruits, and 5g of soybean oil for dinner (providing a total calorie of approximately 5000kJ, or approximately 1200kcal, including 98g of protein, 20g of fat, and 155g of carbohydrates).

[0049] Comparative group 3: No dietary intervention was made. The subjects followed their normal diet and were supplemented with a nutritional tablet containing multiple vitamins and minerals (each tablet contained 320 mg calcium, 80 mg magnesium, 7.0 mg iron, 6.0 mg zinc, 30 μg selenium, 326 μg vitamin A, 3.0 μg vitamin D, 1.0 mg vitamin B1, 1.0 mg vitamin B2, 1.0 mg vitamin B6, 1.0 mg vitamin B 12 1.4μg, niacinamide 8.0mg, folic acid 250μg, biotin 18μg, vitamin C 70mg, pantothenic acid 3.5mg, vitamin E 8.8mg, one tablet per day).

[0050] Comparative group 4: No dietary intervention was made. The subjects followed the normal diet and were supplemented with a nutritional tablet containing multiple vitamins and minerals (each tablet contained 320 mg calcium, 80 mg magnesium, 7.0 mg iron, 6.0 mg zinc, 30 μg selenium, 326 μg vitamin A, 3.0 μg vitamin D, 1.0 mg vitamin B1, 1.0 mg vitamin B2, 1.0 mg vitamin B6, 1.0 mg vitamin B 12 1.4μg, niacinamide 8.0mg, folic acid 250μg, biotin 18μg, vitamin C 70mg, pantothenic acid 3.5mg, vitamin E 8.8mg, one tablet per day).

[0051] One cycle lasts for two cycles, with one meeting with a nutritionist at the end of each cycle to assess physical condition and provide consultation.

[0052] The following indicators were measured before and after the experiment for each group of subjects:

[0053] 1. Determination of weight loss indicators: blood test for cholesterol, triglycerides, and fasting insulin.

[0054] 2. Determination of antioxidant indexes: blood was drawn to determine the levels of superoxide dismutase (SOD) and malondialdehyde (MDA).

[0055] 3. To measure the immune function indicators, saliva sampling is used to measure the salivary secretion globulin IgA.

[0056] 4. Questionnaires were used to investigate the subjects’ mental state, sleep quality and adverse reactions.

[0057] Data collation and analysis: The data of each group were compared before and after the experiment, and the data of the same indicator after the experiment were compared between groups. The t-test was used for significance analysis, with the test level α=0.05, and p<0.05 represented a significant difference.

[0058] (2) Test results

[0059] During the trial, the subjects were in good mental state and no adverse reactions occurred, indicating that all test samples and protocols were safe. The comparison of the subjects' physiological data before and after the trial is shown in Table 1 and Table 2.

[0060] The changes in the weight, total cholesterol and triglyceride data of each group in Table 1 show that, before and after comparison of each group, Group A, Group B, Group C, Group D, Control Group 1 and Control Group 2 all have significant differences (p < 0.05), indicating that the intervention measures taken have a weight loss effect. There was no significant change in the weight of Group E and Control Group 3, indicating that only foot bath Chinese medicine powder had no weight loss effect, and normal diet plus additional nutrient supplements had no weight loss effect. In terms of weight loss, Group A, Group D, Group B, Group C, compared with Control Group 3, had significant differences (p < 0.05), while the reduction degree of Control Group 1 and Control Group 2 compared with Control Group 3 had a certain trend (p < 0.01) but no statistically significant difference, among which Group A had the largest changes in weight, total cholesterol and triglyceride before and after all groups (all with significant differences, p < 0.05), indicating that Group A had the most obvious weight loss and lipid-lowering effects. This shows that the intervention measures of Group A are better than those of the other groups in terms of weight loss and lipid reduction. Interestingly, according to the feedback from the subjects, the subjects in Groups A and E had a great improvement in sleep quality (sleep duration and brain alertness after waking up), while the other groups did not have such an improvement effect.

[0061] The changes in fasting insulin in each group showed that Group A, Group B, Group C, and Group D all had a significant effect on reducing insulin secretion (P < 0.05), among which the change value of Group A was the largest among all groups, and after the experiment, Group A also had significant differences compared with Group C and Group D (p < 0.05), indicating that Group A had the most obvious effect in improving insulin sensitivity. Group E had a trend of reducing insulin secretion, but it was not significant. There was no significant change in fasting insulin before and after the experiment in Control Group 1, Control Group 2, and Control Group 3. Compared with these three control groups, Group A had significant differences after the experiment (P < 0.05), but there was no significant difference compared with Control Group 4 (normal weight group without dietary intervention), indicating that Group A had the best effect in reducing fasting insulin and the effect could reach a level similar to that of normal weight people, further indicating that the intervention measures of Group A were effective in improving metabolism.

[0062] Compared with control group 1 (low-calorie diet) and control group 2 (commercially available low-fat meal replacement products), group A had a significant difference in weight loss after the test (p < 0.05), and the effect of lowering triglycerides and total cholesterol was also more obvious, indicating that compared with other product solutions currently available on the market, the product of Example 1 has a better weight loss effect, as well as the best effect of improving blood lipids and increasing insulin sensitivity.

[0063] Through the analysis of the results of the subjects' questionnaires, the subjects in Group A, Group B, Group C, Group D, Group E and the control group had no adverse reactions during the experiment. Some subjects in Group 1 and Group 2 reported fatigue, and lack of energy. Some subjects in Group 3 reported constipation, chest tightness, shortness of breath, and lack of energy.

[0064] Table 1 Comparison of weight loss indicators of subjects before and after the experiment

[0065]

[0066] Note: a, p < 0.05 (comparison between before and after the experiment in the same group); b, p < 0.05 (comparison between after the experiment and control example 1); c, p < 0.05 (comparison between after the experiment and control example 2); d, p < 0.05 (comparison between after the experiment and control example 3);

[0067] Table 2 Comparison of antioxidant and immune indicators of subjects before and after the test

[0068]

[0069] Note: a, p < 0.05 (comparison before and after the experiment in the same group); b, p < 0.05 (comparison with control example 1 after the experiment); c, p < 0.05 (comparison with control example 2 after the experiment); d, p < 0.05 (comparison with control example 3 after the experiment); e, p < 0.05 (comparison with control example 4 after the experiment).

[0070] From the results in Table 2, it can be observed that the salivary secretory globulin IgA concentration of group A before and after the experiment increased significantly (p < 0.05), the blood antioxidant index SOD (superoxide dismutase) level increased significantly (p < 0.05), and the MDA (malondialdehyde) level decreased significantly (p < 0.05). The IgA concentration of group B, group C, group D and control group 4 showed an increasing trend after the experiment but was not significant (p > 0.05), and the IgA levels of the other groups before and after were almost unchanged. Further analysis showed that the level of IgA in group A after the experiment was significantly higher than that in the other groups (p < 0.05, not indicated in Table 2), which reflected that the level of immunity of group A subjects after the experiment was significantly higher than that of the other groups, and also meant that the intervention program of group A had a prominent effect in improving immunity compared with the programs of the other groups; at the same time, it also reflected that the conventional calorie control weight loss program (control group 1, control group 2) could not improve immunity, and the effect of only supplementing nutrients in improving immunity of obese people and normal weight people was also limited. In terms of the change of SOD index, the increase value of group A before and after the experiment was the largest and significant (P < 0.05), while the changes in the other groups were not obvious (p > 0.05). It should be emphasized that the level of SOD change in group A after the experiment was significantly different from that in the other groups (p < 0.05, not indicated in Table 2), indicating that the intervention program of group A was superior to the programs of the other groups in improving the level of antioxidant capacity. Further analysis of the changes in MDA levels in each group showed that Group A had a significant decrease before and after the experiment (p < 0.05), while the changes in the other groups were high and low but not significant (p > 0.05). Moreover, after the experiment, the level of Group A was significantly different from that of the other groups (p < 0.05), which further illustrates that the intervention plan of Group A has outstanding advantages in improving the body's antioxidant capacity.

[0071] Based on the above analysis, the intervention scheme adopted by Experimental Group A, i.e., the combination product provided by the present invention, has a comprehensive effect on obese people in reducing body weight, lowering triglyceride and total cholesterol levels, improving insulin sensitivity to reduce fasting insulin levels, which is superior to traditional low-calorie diets or low-calorie meal replacement weight loss methods. Surprisingly, the comprehensive intervention combination product provided by the present invention can also show excellent effects in improving the body's immunity and antioxidant capacity, achieving a multi-pronged effect.

[0072] The above description is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical solutions and concepts of the present invention within the technical scope disclosed by the present invention, and they should be covered by the protection scope of the present invention.

Claims

1. A combined product with weight loss effect, characterized in that: The combined products include breakfast / lunch nutrition meal replacement packs, Chinese medicine drink compositions, blended oil compositions for cooking green leafy vegetables, and Chinese medicine compositions for foot bathing before bedtime; wherein, The breakfast / lunch nutritional meal replacement package is composed of the following components by weight, based on the total weight of a single meal: 21g soy protein isolate, 10g whole milk powder, 6g resistant dextrin, 6g concentrated whey protein, 6g erythritol, 2g conjugated linoleic acid glyceride, 1g spirulina, 4.4g inulin, 4g chia seeds, 2g oatmeal, 1.6g psyllium husk powder, 360μg RE vitamin A, 0.6mg vitamin B1, 0.6mg vitamin B2, 0.6mg vitamin B6, 0.6mg vitamin B 12 0.8μg, vitamin C 70mg, vitamin D 0.7μg, vitamin E 5mg, folic acid 140μg DFE, niacin 6mg, calcium 320mg, magnesium 84mg, iron 7mg, zinc 5.5mg, calories 250kcal; The Chinese medicine instant drink composition, based on the total weight of the Chinese medicine instant drink composition required for a single instant drink, is composed of the following weights of the components: 3.4g of Poria cocos, 3.4g of Coix seeds, and 1.2g of dried orange peel; the blended oil composition is composed of the following weight ratios of the components: 90 parts of linseed oil and 10 parts of olive oil, with the amount of oil used each time being 20 to 50ml; The Chinese medicine composition for foot bath before bedtime, based on the total weight of the Chinese medicine composition for foot bath before bedtime required for a single foot bath, is composed of the following components by weight: 3.6g of mulberry branch, 3.6g of Polygonum multiflorum vine, 2.7g of selfheal, and 0.1g of Zanthoxylum bungeanum.

2. The combined product with weight loss effect according to claim 1, characterized in that: The breakfast / lunch nutritional meal replacement pack is used for breakfast and lunch; the Chinese medicine instant drink composition is used for drinking with hot water between breakfast and lunch; the blended oil composition is used as cooking oil for green leafy vegetables for dinner; and the bedtime foot bath Chinese medicine composition is used for foot bathing before bedtime.

3. The combined product with weight loss effect according to claim 2, characterized in that: The weight of the green leafy vegetables for dinner reaches more than 500g.

4. The combined product with weight loss effect according to claim 2, characterized in that: The Chinese medicine composition for foot bath before bedtime is dissolved and dispersed in hot water and then used one hour before bedtime, and the foot bath time is preferably 20-30 minutes.

5. The combined product with weight loss effect according to any one of claims 1 to 4, characterized in that: The particle sizes of the Chinese medicine instant drink composition and the Chinese medicine composition for foot bath before bedtime are respectively ≤100 nm.

6. Use of the combination product according to any one of claims 1 to 5 in the preparation of a weight loss product having a weight loss effect.

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