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

Effects of Time-Restricted Feeding on Nonalcoholic Fatty Liver Disease in Obese Adults: a Randomized Clinical Trial

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).

Study Overview

• Status: Completed
• Conditions: Nonalcoholic Fatty Liver Disease
• Intervention / Treatment: Behavioral: Time restricted feeding; Behavioral: Continuous Energy Restriction

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRF; Time Restricted Feeding	Behavioral: Time restricted feeding; Participants will receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women during a window of 8 h/d (8 am to 4 pm).
Active Comparator: CER; Continuous Energy Restriction	Behavioral: Continuous Energy Restriction; Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on feeding time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intrahepatic fat content	Intrahepatic fat content will be assessed by MR mDixon-Quant	Baseline and months 6

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Investigators: Study Chair: Huijie Zhang, MD,PhD, Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2019
• Primary Completion (Actual): January 28, 2021
• Study Completion (Actual): February 10, 2021

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 22, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Time restricted feeding; Calorie restriction; Nonalcoholic Fatty Liver Disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: NFEC-2018-160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No