Time Restricted Feeding on Nonalcoholic Fatty Liver Disease

Not Applicable

Completed

• Conditions: Nonalcoholic Fatty Liver Disease
• Interventions: Behavioral: Continuous Energy Restriction; Behavioral: Time restricted feeding

• Registration Number: NCT03786523
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-22
• Study First Posted: 2018-12-26
• Study Start: 2019-04-19
• Primary Completion: 2021-01-28
• Study Completion: 2021-02-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-12
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CER	Continuous Energy Restriction	Continuous Energy Restriction
TRF	Time restricted feeding	Time Restricted Feeding

Primary Outcome Measures

Name	Time	Method
Change in intrahepatic fat content	Baseline and months 6	Intrahepatic fat content will be assessed by MR mDixon-Quant

Secondary Outcome Measures

Name	Time	Method
Change in body weight	Baseline and months 6
Change in waist circumference	Baseline and months 6
Change in visceral fat	Baseline and months 6	Visceral fat will be assessed by abdominal CT scan
Change in body fat	Baseline and months 6	Body fat will be assessed by whole-body dual x-ray system
Change in HbA1c level	Baseline and months 6
Change in insulin sensitivity	Baseline and months 6	Insulin sensitivity will be assessed by HOMA-IR
Change in liver fiber	Baseline and months 6	Liver fiber will be assessed by liver Fibrotouch
Change in Systolic blood pressure	Baseline and months 6
Change in LDL-c level	Baseline and months 6
Change in serum ALT level	Baseline and months 6
Change in pulse wave velocity (PWV)	Baseline and months 6
Depression measured by the Patient Health Questionnaire-9 (PHQ-9)	Baseline and months 6	Scores of PHQ-9
Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)	Baseline and months 6	Scores of PSQI
Change in β cell function	Baseline and months 6	β cell function will be assessed by HOMA-β
Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)	Baseline and months 6	Scores of SF-12

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China