Back to resultsEfficacy of Intermittent Fasting on Metabolic Disease
Primary Purpose
Individuals With Metabolic Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
time-restricted fasting for 4 weeks
5:2 regimen for 4 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Individuals With Metabolic Disease focused on measuring Intermittent Fasting, metabolic disease
Eligibility Criteria
Inclusion Criteria:
- Adults aged between 18 to 75 years old without diabetes. 25<BMI<35 kg/m2
Exclusion Criteria:
- diet therapy before participation. liver function impairment. renal function impairment. cancer. pregnant
Sites / Locations
- Beijing Chao-yang Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
time-restricted fasting for 4 weeks
5:2 regimen for 4 weeks
Arm Description
Outcomes
Primary Outcome Measures
plasma alanine aminotransferase (ALT)
plasma alanine aminotransferase (ALT)
aspartate aminotransferase (AST)
aspartate aminotransferase (AST)
plasma triglyceride levels (TG)
plasma triglyceride levels (TG)
gamma-glutamyltransferase (GGT)
gamma-glutamyltransferase (GGT)
alkaline phosphatase (ALP)
alkaline phosphatase (ALP)
height
height
weight
weight
Secondary Outcome Measures
Full Information
NCT ID
NCT04795973
First Posted
March 10, 2021
Last Updated
May 11, 2023
Sponsor
Beijing Chao Yang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04795973
Brief Title
Efficacy of Intermittent Fasting on Metabolic Disease
Official Title
Efficacy of Intermittent Fasting on Metabolic Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Individuals With Metabolic Disease
Keywords
Intermittent Fasting, metabolic disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Adults aged between 18 to 75 years old
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
time-restricted fasting for 4 weeks
Arm Type
Experimental
Arm Title
5:2 regimen for 4 weeks
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
time-restricted fasting for 4 weeks
Intervention Description
eat ad libitum from 7am to 5pm and fast in other time
Intervention Type
Behavioral
Intervention Name(s)
5:2 regimen for 4 weeks
Intervention Description
chose two non-consecutive days per week to eat very little and eat ad libitum the other 5 days of the week
Primary Outcome Measure Information:
Title
plasma alanine aminotransferase (ALT)
Description
plasma alanine aminotransferase (ALT)
Time Frame
Change from Baseline ALT at 4 weeks
Title
aspartate aminotransferase (AST)
Description
aspartate aminotransferase (AST)
Time Frame
Change from Baseline AST at 4 weeks
Title
plasma triglyceride levels (TG)
Description
plasma triglyceride levels (TG)
Time Frame
Change from Baseline TG at 4 weeks
Title
gamma-glutamyltransferase (GGT)
Description
gamma-glutamyltransferase (GGT)
Time Frame
Change from Baseline GGT at 4 weeks
Title
alkaline phosphatase (ALP)
Description
alkaline phosphatase (ALP)
Time Frame
Change from Baseline ALP at 4 weeks
Title
height
Description
height
Time Frame
Change from Baseline height at 4 weeks
Title
weight
Description
weight
Time Frame
Change from Baseline weight at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Liu
Phone
01085231217
Email
liujia0116@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang Wang
Organizational Affiliation
Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chao-yang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Liu, MD
Phone
010-8523161710
Email
liujia0116@126.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Intermittent Fasting on Metabolic Disease
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