Status:
COMPLETED
Effect and Safety of TCM-FMD in Phlegm-Dampness Type Overweight/Obesity Patients(EASTAR)
Lead Sponsor:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 traditiona...
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, an...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
June 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04029571
Start Date
June 21 2019
End Date
March 29 2021
Last Update
July 13 2021
Active Locations (1)
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1
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China, 510000