Nonalcoholic Fatty Liver Disease
Conditions
Keywords
Nonalcoholic Fatty Liver Disease, Obesity, Time restricted feeding, Calorie restriction
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).
Interventions
BEHAVIORALTime 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).
BEHAVIORALContinuous 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.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in intrahepatic fat content | Baseline and months 6 | Intrahepatic fat content will be assessed by MR mDixon-Quant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in visceral fat | Baseline and months 6 | Visceral fat will be assessed by abdominal CT scan |
| Change in body fat | Baseline and months 6 | Body fat will be assessed by whole-body dual x-ray system |
| Change in waist circumference | Baseline and months 6 | — |
| Change in body weight | Baseline and months 6 | — |
| Change in HbA1c level | Baseline and months 6 | — |
| Change in Systolic blood pressure | Baseline and months 6 | — |
| Change in LDL-c level | Baseline and months 6 | — |
| Change in liver fiber | Baseline and months 6 | Liver fiber will be assessed by liver Fibrotouch |
| Change in insulin sensitivity | Baseline and months 6 | Insulin sensitivity will be assessed by HOMA-IR |
| Change in β cell function | Baseline and months 6 | β cell function will be assessed by HOMA-β |
| Change in pulse wave velocity (PWV) | Baseline and months 6 | — |
| Depression measured by the Patient Health Questionnaire-9 (PHQ-9) | Baseline and months 6 | Scores of PHQ-9 |
| Quality of sleep measured by the Pittsburgh sleep quality index (PSQI) | Baseline and months 6 | Scores of PSQI |
| Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12) | Baseline and months 6 | Scores of SF-12 |
| Change in serum ALT level | Baseline and months 6 | — |
Countries
China
Outcome results
None listed