Effect and Safety of TCM-FMD in Phlegm-Dampness Type Overweight/Obesity Patients(EASTAR)
Condition: Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): TCM-FMD; FMD
Intervention type(s): Drug; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Fasting-mimicking diet; Traditional Chinese medicine