Time Restricted Feeding on Nonalcoholic Fatty Liver Disease

NCT ID: NCT03786523

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-19
• Study Completion Date: 2021-02-10

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).

Conditions

Nonalcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TRF

Time Restricted Feeding

Group Type: EXPERIMENTAL

Time restricted feeding

Intervention Type: 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).

CER

Continuous Energy Restriction

Group Type: ACTIVE_COMPARATOR

Continuous Energy Restriction

Intervention Type: BEHAVIORAL

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

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huijie Zhang, MD,PhD

Role: STUDY_CHAIR

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

Locations

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 36930148 (View on PubMed)

Other Identifiers

NFEC-2018-160

Identifier Type: -

Identifier Source: org_study_id