Obesity, Time Restricted Feeding, Weight Loss, Calorie Restriction
Conditions
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 weight loss and cardiometabolic risk factors in obese adults over 12 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 a restriction of 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. Male of female aged between 18 and 75 years old; 2. Body mass index (BMI)of 28.0 to 45.0 kg/m2;
Exclusion criteria
1. History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis; 2. Diagnosis of type 1 and type 2 diabetes; 3. History of malignant tumors; 4. 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); 5. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months; 6. History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months; 7. History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity; 8. Being a smoker or having been a smoker in the 3 months prior to their screening visit; 9. 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; 10. Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) ; 11. Women who are pregnant or plan to become pregnant; 12. Patients who cannot be followed for 24 months (due to a health situation or migration); 13. Patients who are unwilling or unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight over 12 months | Baseline to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Quality of sleep measured by the Pittsburgh sleep quality index (PSQI) | Baseline to 12 months |
| Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12) | Baseline to 12 months |
| Change in body composition | Baseline to 12 months |
| Change in waist circumference | Baseline to 12 months |
| Change in liver fat | Baseline to 12 months |
| Change in visceral fat | Baseline to 12 months |
| Depression measured by the Patient Health Questionnaire-9 (PHQ-9) | Baseline to 12 months |
| Change in Blood pressure | Baseline to 12 months |
| Change in blood lipids | Baseline to 12 months |
| Change in insulin sensitivity | Baseline to 12 months |
| Change in β cell function | Baseline to 12 months |
| Change in pulse wave velocity (PWV) | Baseline to 12 months |
| Change in HbA1c | Baseline to 12 months |
Countries
China
Outcome results
None listed