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

Not Applicable

Completed

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

• Registration Number: NCT04988230
• 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 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-30
• Study First Submitted: 2021-07-31
• Study First Submitted QC: 2021-07-31
• Study First Posted: 2021-08-03
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06

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
Continuous Energy Restriction	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.
Time Restricted Feeding	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).

Primary Outcome Measures

Name	Time	Method
Change in intrahepatic fat content	Baseline,month 6, month 12.	Intrahepatic fat content will be assessed by MR mDixon-Quant

Secondary Outcome Measures

Name	Time	Method
Change in body fat	Baseline,month 6, month 12.	Body fat will be assessed by whole-body dual x-ray system
Change in waist circumference	Baseline,month 6, month 12.
Change in HbA1c level	Baseline,month 6, month 12.
Change in serum ALT level	Baseline,month 6, month 12.
Change in liver fiber	Baseline,month 6, month 12.	Liver fiber will be assessed by liver Fibrotouch
Change in visceral fat	Baseline,month 6, month 12.	Visceral fat will be assessed by abdominal CT scan
Change in body weight	Baseline,month 6, month 12.
Change in Systolic blood pressure	Baseline,month 6, month 12.
Change in LDL-c level	Baseline,month 6, month 12.
Change in insulin sensitivity	Baseline,month 6, month 12.	Insulin sensitivity will be assessed by HOMA-IR

Trial Locations

Locations (1)

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