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The primary aim of this study is to is to determine if a diet (TCM-FMD) which combine fasting-mimicking diet (FMD) with "dispelling dampness" meal replacement (a meal replacement made up of traditional Chinese medicine) is the effective dietary strategy for treatment of phlegm-dampness type overweight/obese patients. A three months randomized trial will be used to observe weight loss generated by TCM-FMD and FMD. And a group keeping a normal diet will be set as a blank control. Through comparison, we aim at examining the effects of interventions on weight and metabolic disease risk factors (plasma lipids, fasting glucose, blood pressure) The secondary aim of this study is to evaluate the safety of TCM-FMD.
Background:Fasting-mimiking Diet (FMD) is a plant-based diet designed to attain fasting-like effect, firstly proposed on 2015[1]. It requires people to limit calorie intake for 5 continuous days, and then return to their normal diet after completion about 25 days until the next cycle. In a clinical trial[2], three FMD cycles reduced body weight, trunk and body fat, and reduced blood pressure, fasting blood glucose, triglycerides and total cholesterol. On the other hand, in the theory of physique of TCM theory, overweight/obesity is usually considered to be phlegm-dampness type.
Objective: We assume that using medicinal-edible plants which was considered to dispel dampness(such as fuling, shanyao, etc.) as FMD's proprietary formulations can enhance the effect of FMD on improve people's characteristic features of metabolic syndrome.
Methods: A 12-week, single-center, pilot study will be conducted to test the study objectives.A new diet is carried. It is a fasting-mimicking diet combined with a "dispelling dampness" meal replacement. Because the theory of applying traditional Chinese medicine combined with FMD, we call it TCM-FMD, the main ingredient of the "wet diet" meal package is millet. Brown rice, oats, purple sweet potato, alfalfa, yam, hazelnut, etc. For comparison, we also designed FMD to make some cereals (including millet, purple potato, oatmeal, walnut, etc.) without a moisturizing effect into a "grain package" as a control group. Both groups were administered using the FMD diet model. At the same time, a group of normal diets was also designed as a blank control group. The primary outcome measure for the study was weight; secondary outcome measures included: waist circumference, blood pressure, triglycerides, total cholesterol and fasting blood glucose, quality of life (evaluated by physical fitness scale and SF-36); safety indicators included: liver and kidney Features, etc. Both groups were subjected to caloric restriction (5 days, daily calorie about 800kcal) and normal diet (dietitian for healthy diet guidance), and the blank control group was given a normal diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCM-FMD | Experimental | Apply fastening-mimicking diet combined with a "dispelling dampness" meal replacement. For the convenience of implementation, a cycle of 4 weeks. The first 5 days of each cycle is the calorie restriction stage (daily calorie about 800kcal). The traditional Chinese medicine with dampness effect is used as the main source of calories in this stage. The normal diet is carried out under the guidance of a professional dietitian for the next 23 days. Study for 12 weeks. |
|
| FMD | Active Comparator | A "grain package" is used to replace the "dispelling dampness" meal replacement, and the other thing is the same as the proposal in TCM-FMD. |
|
| Normal diet | No Intervention | Carrying out normal diet under the guidance of a dietitian, for 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCM-FMD | Drug | Apply fastening-mimicking diet combined with a "dispelling dampness" meal replacement. For the convenience of implementation, a cycle of 4 weeks. The first 5 days of each cycle is the calorie restriction stage (daily calorie about 800kcal). The traditional Chinese medicine with dampness effect is used as the main source of calories in this stage. The normal diet is carried out under the guidance of a professional dietitian for the next 23 days. Study for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Measuring the fasting weight of the day at the required time point and measured by the same instrument | Change from baseline to day 6/week 4/week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Triglycerides | Measured by GPO-PAP enzymatic method | Change from baseline to week 4/week 12 |
| Fasting glucose | Measured by Hexokinase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuanqi Zhao, MD | Guangdong Provincial Hospital of Traditional Chinese Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| FMD | Other | A "grain package" is used to replace the "dispelling dampness" meal replacement, and the other thing is the same as the proposal in TCM-FMD. |
|
| Change from baseline to week 4/week 12 |
| Blood pressure | Measure by the same sphygmomanometer | Change from baseline to week 4/week 12 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |