Efficacy of Intermittent Fasting on Metabolic Disease
- Conditions
- Individuals With Metabolic Disease
- Interventions
- Behavioral: time-restricted fasting for 4 weeks
- Registration Number
- NCT04795973
- Lead Sponsor
- Beijing Chao Yang Hospital
- Brief Summary
To elucidate the health effects, and further explore the research on safety. This study was conducted among adults with metabolic disease by using the intermittent fasting for 4 weeks. The aim of this study is to provide scientific basis for the IF used as a new prevention and control technology for metabolic disease.
- Detailed Description
In this trail, participants with metabolic disease were enrolled for 4-week intermittent fasting intervention. The intermittent fasting plains include time-restricted fasting and 5:2 project. For TRF regimen, participants are allowed to eat ad libitum from 7am to 5pm and fast in other time. For 5:2 project, chose two non-consecutive days per week to eat very little and eat ad libitum the other 5 days of the week. Serum samples and feces samples were collected before and after intervention for analysis.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Adults aged between 18 to 75 years old with metabolic disease
- diet therapy before participation
- pregnancy
- severe hepatic diseases
- severe nephropathy
- organic digestive diseases
- autoimmune diseases
- cancer
- infectious diseases, including pulmonary tuberculosis and AIDS
- alcoholism
- continuous antibiotic use for over 3 days within 3 months prior to enrollment
- continuous use of a weight-loss drug for over 1 month
- gastrointestinal surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description time-restricted fasting for 4 weeks time-restricted fasting for 4 weeks -
- Primary Outcome Measures
Name Time Method weight Change from Baseline weight at 4 weeks weight
plasma alanine aminotransferase (ALT) Change from Baseline ALT at 4 weeks plasma alanine aminotransferase (ALT)
aspartate aminotransferase (AST) Change from Baseline AST at 4 weeks aspartate aminotransferase (AST)
plasma triglyceride levels (TG) Change from Baseline TG at 4 weeks plasma triglyceride levels (TG)
gamma-glutamyltransferase (GGT) Change from Baseline GGT at 4 weeks gamma-glutamyltransferase (GGT)
alkaline phosphatase (ALP) Change from Baseline ALP at 4 weeks alkaline phosphatase (ALP)
height Change from Baseline height at 4 weeks height
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Beijing Chao-yang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China