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

Study Overview
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Brief Summary
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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).

Official Title
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Effects of Time-Restricted Feeding on Nonalcoholic Fatty Liver Disease in Obese Adults: a 12-month Randomized Clinical Trial

Conditions
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Nonalcoholic Fatty Liver Disease

Intervention / Treatment
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* Behavioral: Time restricted feeding
* Behavioral: Continuous Energy Restriction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time Restricted Feeding<br>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<br>* 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).<br>|
| Active Comparator: Continuous Energy Restriction<br>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<br>* Participants will follow receive a diet of 1500-1800kcal/ d for men and 1200-1500kcal/d for women, without restriction on feeding time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intrahepatic fat content | Intrahepatic fat content will be assessed by MR mDixon-Quant | Baseline,month 6, month 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liver fiber | Liver fiber will be assessed by liver Fibrotouch | Baseline,month 6, month 12. | 
| Change in visceral fat | Visceral fat will be assessed by abdominal CT scan | Baseline,month 6, month 12. | 
| Change in body fat | Body fat will be assessed by whole-body dual x-ray system | Baseline,month 6, month 12. | 
| Change in waist circumference |  | Baseline,month 6, month 12. | 
| Change in body weight |  | Baseline,month 6, month 12. | 
| Change in HbA1c level |  | 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 serum ALT level |  | Baseline,month 6, month 12. | 
| Change in insulin sensitivity | Insulin sensitivity will be assessed by HOMA-IR | Baseline,month 6, month 12. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonalcoholic Fatty Liver Disease, Time restricted feeding, Calorie restriction