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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03786523
Other study ID # NFEC-2018-160
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 19, 2019
Est. completion date February 10, 2021

Study information

Verified date November 2023
Source Nanfang Hospital, Southern Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date February 10, 2021
Est. primary completion date January 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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).
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.

Locations

Country Name City State
China Nanfang Hospital of Southern Medical University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

References & 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. 20 — View Citation

Outcome

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