Clinical trial NCT04261764: Fasting-mimicking Diet Combined With Traditional Chinese Medicine for Phlegm-dampness Type Obesity Patients
Official title: Fasting-mimicking Diet Combined With Traditional Chinese Medicine for Phlegm-dampness Type Obesity Patients(FASTAR): a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Fasting-mimicking diet
Chinese medicine
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 .

Detailed 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.

Eligibility 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.)

Primary outcomes:
measure: Gut microbiota Gut microbiota
timeFrame: Change from baseline to week 12
Secondary outcomes:
measure: Body morphology indicators
timeFrame: Change from baseline to week 12
measure: Fasting glucose
timeFrame: Change from baseline to week 12
measure: Blood pressure
timeFrame: Change from baseline to week 12
measure: Blood lipids
timeFrame: Change from baseline to week 12
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Yuanqi physical Zhao
state: Guangdong
city: Guangzhou
country: China
facility: Yuanqi physical Zhao
state: Guangdong
Study officials:
References: