Time Restricted Feeding on Nonalcoholic Fatty Liver Disease (TREATY-FLD)

Nanfang Hospital, Southern Medical University

Status: Completed

Conditions: Nonalcoholic Fatty Liver Disease

Treatments: Behavioral: Time restricted feeding; Behavioral: Continuous Energy Restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT03786523

NFEC-2018-160

Details and patient eligibility

About

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 effect of time restricted feeding (TRF) on hepatic fat contents and cardiometabolic risk factors in obese adults over 6 months compared to continuous energy restriction (CER).

Enrollment: 88 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Man or women aged≥18 years;
2. Subjects with NAFLD determined by MRI (intrahepatic triglyceride content ≥5%);
3. Body mass index (BMI)of 28.0 to 45.0 kg/m2;

Exclusion criteria

1. History of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
2. History of HIV, or active pulmonary tuberculosis;
3. Diagnosis of type 1 and type 2 diabetes;
4. History of malignant tumors;
5. 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);
6. Significant alcohol consumption in the past six months (Consumed more than 20 g/day for women or 30 g/day for men);
7. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
8. History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
9. History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
10. Being a smoker or having been a smoker in the 3 months prior to their screening visit;
11. 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;
12. Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) ;
13. Women who are pregnant or plan to become pregnant;
14. Patients who cannot be followed for 24 months (due to a health situation or migration);
15. Patients who are unwilling or unable to give informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

TRF

Experimental group

Description:

Time Restricted Feeding

Treatment:

Behavioral: Time restricted feeding

CER

Active Comparator group

Description:

Continuous Energy Restriction

Treatment:

Behavioral: Continuous Energy Restriction