Effect and Safety of TCM-FMD in Phlegm-Dampness Type Overweight/Obesity Patients(EASTAR)

• Status: Completed
• Trial end date: 2021-03-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.)