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

NCT04029571 | Completed Phase 2

• 1 other identifier: tcmfmd
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Obesity

Keywords

Obesity; Fasting-mimicking diet; Traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• Body weight

  Measuring the fasting weight of the day at the required time point and measured by the same instrument

  Change from baseline to day 6/week 4/week 12

Secondary Outcomes (3)

• Triglycerides

  Change from baseline to week 4/week 12

• Fasting glucose

  Change from baseline to week 4/week 12

• Blood pressure

  Change from baseline to week 4/week 12

Study Arms (3)

TCM-FMD

EXPERIMENTAL

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.

Drug: TCM-FMD

FMD

ACTIVE COMPARATOR

A "grain package" is used to replace the "dispelling dampness" meal replacement, and the other thing is the same as the proposal in TCM-FMD.

Other: FMD

Normal diet

NO INTERVENTION

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

Interventions

TCM-FMD DRUG

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

FMD OTHER

A "grain package" is used to replace the "dispelling dampness" meal replacement, and the other thing is the same as the proposal in TCM-FMD.

FMD

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 (1)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510000, China

Location

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 Officials

• Yuanqi Zhao, MD

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 20, 2019
• First Posted: July 23, 2019
• Study Start: June 21, 2019
• Primary Completion: September 30, 2020
• Study Completion: March 29, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Locations

CN (1)