Clinical trial NCT03786523: Time Restricted Feeding on Nonalcoholic Fatty Liver Disease
Official title: Effects of Time-Restricted Feeding on Nonalcoholic Fatty Liver Disease in Obese Adults: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonalcoholic Fatty Liver Disease
Keywords: Nonalcoholic Fatty Liver Disease
Obesity
Time restricted feeding
Calorie restriction
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in intrahepatic fat content
timeFrame: Baseline and months 6
Secondary outcomes:
measure: Change in liver fiber
timeFrame: Baseline and months 6
measure: Change in visceral fat
timeFrame: Baseline and months 6
measure: Change in body fat
timeFrame: Baseline and months 6
measure: Change in waist circumference
timeFrame: Baseline and months 6
measure: Change in body weight
timeFrame: Baseline and months 6
measure: Change in HbA1c level
timeFrame: Baseline and months 6
measure: Change in Systolic blood pressure
timeFrame: Baseline and months 6
measure: Change in LDL-c level
timeFrame: Baseline and months 6
measure: Change in serum ALT level
timeFrame: Baseline and months 6
measure: Change in insulin sensitivity
timeFrame: Baseline and months 6
measure: Change in β cell function
timeFrame: Baseline and months 6
measure: Change in pulse wave velocity (PWV)
timeFrame: Baseline and months 6
measure: Depression measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline and months 6
measure: Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)
timeFrame: Baseline and months 6
measure: Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)
timeFrame: Baseline and months 6
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
name: Huijie Zhang, MD,PhD
role: STUDY_CHAIR
References:
citation: Wei X, Lin B, Huang Y, Yang S, Huang C, Shi L, Liu D, Zhang P, Lin J, Xu B, Guo D, Li C, He H, Liu S, Xue Y, Xu Y, Zhang H. Effects of Time-Restricted Eating on Nonalcoholic Fatty Liver Disease: The TREATY-FLD Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e233513. doi: 10.1001/jamanetworkopen.2023.3513.