Clinical trial NCT04988230: Time Restricted Feeding on Nonalcoholic Fatty Liver Disease ( TREATY-FLD )：a 12-month Follow-up Study
Official title: Effects of Time-Restricted Feeding on Nonalcoholic Fatty Liver Disease in Obese Adults: a 12-month Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonalcoholic Fatty Liver Disease
Keywords: Nonalcoholic Fatty Liver Disease
Time restricted feeding
Calorie restriction
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change in intrahepatic fat content
timeFrame: Baseline,month 6, month 12.
Secondary outcomes:
measure: Change in liver fiber
timeFrame: Baseline,month 6, month 12.
measure: Change in visceral fat
timeFrame: Baseline,month 6, month 12.
measure: Change in body fat
timeFrame: Baseline,month 6, month 12.
measure: Change in waist circumference
timeFrame: Baseline,month 6, month 12.
measure: Change in body weight
timeFrame: Baseline,month 6, month 12.
measure: Change in HbA1c level
timeFrame: Baseline,month 6, month 12.
measure: Change in Systolic blood pressure
timeFrame: Baseline,month 6, month 12.
measure: Change in LDL-c level
timeFrame: Baseline,month 6, month 12.
measure: Change in serum ALT level
timeFrame: Baseline,month 6, month 12.
measure: Change in insulin sensitivity
timeFrame: Baseline,month 6, month 12.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
name: Huijie Zhang, MD,PhD
role: STUDY_CHAIR
References: