Time Restricted Feeding on Nonalcoholic Fatty Liver Disease ( TREATY-FLD )：a 12-month Follow-up Study

NCT04988230 | Completed

• 1 other identifier: NFEC-2018-160R
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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 6-month follow-up study of TREATY-FLD 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).

Conditions

Nonalcoholic Fatty Liver Disease

Keywords

Nonalcoholic Fatty Liver Disease; Time restricted feeding; Calorie restriction

Outcome Measures

Primary Outcomes (1)

• Change in intrahepatic fat content

  Intrahepatic fat content will be assessed by MR mDixon-Quant

  Baseline,month 6, month 12.

Secondary Outcomes (10)

• Change in liver fiber

  Baseline,month 6, month 12.

• Change in visceral fat

  Baseline,month 6, month 12.

• Change in body fat

  Baseline,month 6, month 12.

• Change in waist circumference

  Baseline,month 6, month 12.

• Change in body weight

  Baseline,month 6, month 12.

Study Arms (2)

Time Restricted Feeding

EXPERIMENTAL

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).

Behavioral: Time restricted feeding

Continuous Energy Restriction

ACTIVE COMPARATOR

Participants will follow receive a diet of 1500-1800kcal/ d for men and 1200-1500kcal/d for women, without restriction on feeding time.

Behavioral: Continuous Energy Restriction

Interventions

Time restricted feeding BEHAVIORAL

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).

Time Restricted Feeding

Continuous Energy Restriction BEHAVIORAL

Participants will follow receive a diet of 1500-1800kcal/ d for men and 1200-1500kcal/d for women, without restriction on feeding time.

Continuous Energy Restriction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (1)

• 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.

  PMID: 36930148 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Intermittent Fasting

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fasting; Feeding Behavior; Behavior

Study Officials

• Huijie Zhang, MD,PhD

  Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of Department of Endocrinology and Metabolism

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: August 3, 2021
• Study Start: July 30, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

CN (1)