Effect and Safety of Fasting-Mimicking Diet Combined With a "Dispelling Dampness" Meal Replacement in Phlegm-Dampness Type Overweight/Obesity Patients: A Randomized Controlled Study(EASTAR)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed as overweight / obesity according to the "China Adult Obesity Prevention and Treatment Expert Consensus"
- •Diagnosis as phlegm-dampness type according to the "Traditional Chinese Medicine Classification and Judgment" scale published by the Chinese Medicine Association
- •18 years old ≤ age ≤ 65 years old
- •Signed the informed consent
排除标准
- •Those who have special food requirements or having a history of food allergies
- •Those who have history of previous diabetes, or body weight loss, BMI ≤ 18
- •Those who have had cardiovascular and cerebrovascular events within half a year, or who have a major history of surgery
- •Pregnant or lactating woman
- •Those who have severe primary diseases such as liver or kidney diseases, as well as abnormalities in the hematopoietic system and mental disorders
- •Those who need to take special drugs (such as hormones)
- •Those who refuse to provide information required for research (such as personal information, blood samples, etc.)
研究组 & 干预措施
TCM-FMD
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.
干预措施: TCM-FMD (Drug)
FMD
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.
干预措施: FMD (Other)
结局指标
主要结局
Body weight
时间窗: Change from baseline to day 6/week 4/week 12
Measuring the fasting weight of the day at the required time point and measured by the same instrument
次要结局
- Triglycerides(Change from baseline to week 4/week 12)
- Fasting glucose(Change from baseline to week 4/week 12)
- Blood pressure(Change from baseline to week 4/week 12)
研究者
Yuanqi Zhao,MD
Clinical Professor
Guangdong Provincial Hospital of Traditional Chinese Medicine