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

NCT04261764 | Unknown

• 1 other identifier: TCM-FMD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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 .

Conditions

Obesity

Keywords

Obesity; Fasting-mimicking diet; Chinese medicine

Outcome Measures

Primary Outcomes (1)

• Gut microbiota Gut microbiota

  Changes in the diversity and abundance of intestinal flora, the number of Firmicutes, Bacteroides and the ratio of Firmicutes/Bacteroides

  Change from baseline to week 12

Secondary Outcomes (4)

• Body morphology indicators

  Change from baseline to week 12

• Fasting glucose

  Change from baseline to week 12

• Blood pressure

  Change from baseline to week 12

• Blood lipids

  Change from baseline to week 12

Study Arms (2)

TCM-FMD

EXPERIMENTAL

Fasting-Mimicking Diet Combined With a "Dispelling Dampness" Meal Replacement 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.

Device: Fastening-mimicking diet combined with a "dispelling dampness" meal replacement

Normal diet

PLACEBO COMPARATOR

Carrying out normal diet under the guidance of a dietitian, for 12 weeks.

Other: Normal diet

Interventions

Fastening-mimicking diet combined with a "dispelling dampness" meal replacement DEVICE

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.

TCM-FMD

Normal diet OTHER

Carrying out normal diet under the guidance of a dietitian.

Normal diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years old ≤ age ≤ 65 years old
• Signed the informed consent

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (2)

Yuanqi physical Zhao

Guangzhou, Guangdong, China

ENROLLING BY INVITATION

Yuanqi physical Zhao

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: July 21, 2021
• Primary Completion: November 12, 2021
• Study Completion: February 12, 2022
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

CN (2)