Efficacy of Intermittent Fasting on Metabolic Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Intermittent Fasting on Metabolic Disease

Conditions
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Individuals With Metabolic Disease

Intervention / Treatment
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* Behavioral: time-restricted fasting for 4 weeks
* Behavioral: 5:2 regimen for 4 weeks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged between 18 to 75 years old with metabolic disease Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Adults aged between 18 to 75 years old
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: time-restricted fasting for 4 weeks<br> | Behavioral: time-restricted fasting for 4 weeks<br>* eat ad libitum from 7am to 5pm and fast in other time<br>|
| Experimental: 5:2 regimen for 4 weeks<br> | Behavioral: 5:2 regimen for 4 weeks<br>* chose two non-consecutive days per week to eat very little and eat ad libitum the other 5 days of the week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma alanine aminotransferase (ALT) | plasma alanine aminotransferase (ALT) | Change from Baseline ALT at 4 weeks | 
| aspartate aminotransferase (AST) | aspartate aminotransferase (AST) | Change from Baseline AST at 4 weeks | 
| plasma triglyceride levels (TG) | plasma triglyceride levels (TG) | Change from Baseline TG at 4 weeks | 
| gamma-glutamyltransferase (GGT) | gamma-glutamyltransferase (GGT) | Change from Baseline GGT at 4 weeks | 
| alkaline phosphatase (ALP) | alkaline phosphatase (ALP) | Change from Baseline ALP at 4 weeks | 
| height | height | Change from Baseline height at 4 weeks | 
| weight | weight | Change from Baseline weight at 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intermittent Fasting, metabolic disease