Fasting-mimicking Diet Combined With Traditional Chinese Medicine for Phlegm-dampness Type Obesity Patients — FASTAR  

Obesity Clinical Trial

Official title: Fasting-mimicking Diet Combined With Traditional Chinese Medicine for Phlegm-dampness Type Obesity Patients(FASTAR): a Randomized Controlled Study

Status Recruiting

Clinical Trial 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 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 the diversity and abundance of intestinal flora .

Clinical Trial Description

Background: Fasting-mimicking Diet (FMD) is a plant-based diet designed to attain fasting-like effect, firstly proposed on 2015. 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, 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, which one the main ingredient of the "dispelling dampness" meal package is Chinese Herbal Medicine such as shaoyao, yiyiren, and chixiaodou, etc. At the same time, a group of normal diets was also designed as a blank control group.

Outcomes: The primary outcome measure for the study was changes in the diversity and abundance of intestinal flora, the number of Firmicutes, Bacteroides and the ratio of Firmicutes/Bacteroides; secondary outcome measures included: weight, BMI, waist circumference, blood pressure, triglycerides, total cholesterol and fasting blood glucose, 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. ;

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT04261764
• Study type: Interventional
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2021
• Completion date: February 12, 2022