Status:
COMPLETED
Time Restricted Feeding on Nonalcoholic Fatty Liver Disease
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Nonalcoholic Fatty Liver Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that involves eating a daily period of 8 hours or less. This is a randomized controlled trial to evaluate the eff...
Eligibility Criteria
Inclusion
- Man or women aged≥18 years;
- Subjects with NAFLD determined by MRI (intrahepatic triglyceride content ≥5%);
- Body mass index (BMI)of 28.0 to 45.0 kg/m2;
Exclusion
- History of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
- History of HIV, or active pulmonary tuberculosis;
- Diagnosis of type 1 and type 2 diabetes;
- History of malignant tumors;
- Serious liver dysfunction or chronic kidney disease (AST or ALT \> 3 times the upper limit of normal, or eGFR\<30 ml/min/1.73 m2);
- Significant alcohol consumption in the past six months (Consumed more than 20 g/day for women or 30 g/day for men);
- History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
- History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
- History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
- Being a smoker or having been a smoker in the 3 months prior to their screening visit;
- Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
- Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) ;
- Women who are pregnant or plan to become pregnant;
- Patients who cannot be followed for 24 months (due to a health situation or migration);
- Patients who are unwilling or unable to give informed consent.
Key Trial Info
Start Date :
April 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2021
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03786523
Start Date
April 19 2019
End Date
February 10 2021
Last Update
November 15 2023
Active Locations (1)
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1
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515