Weight regain after weight loss is a major problem in the treatment of obesity. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on weight loss maintenance and cardiometabolic risk factors after a low-calorie diet in obese adults over 12 months compared to usual health care.
Weight regain after weight loss is a major problem in the treatment of persons with obesity. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. Preliminary evidence suggests that both TRE and the 5:2 diet have beneficial effects on weight loss and cardioprotection in humans. Whether TRE or the 5:2 diet is an effective approach for weight-loss maintenance remains unknown. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on weight loss maintenance and cardiometabolic risk factors after a low-calorie diet in obese adults over 12 months compared to usual health care. All participants who have achieved greater than 5% of weight loss after a 8-week low-calorie-diet induced weight loss phase, will be assigned to one of the three study groups (TRE, the 5:2 diet and control groups) in a 1:1:1 ratio. Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm) over 12 months. Participants in the 5:2 diet group will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days. Participants in the control group were instructed to receive usual health care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
270
Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm)
Participants will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days.
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGChange in body weight over 12 months
Time frame: Baseline to months 12
Change in body fat composition meassured by DEXA
Body composition is meassured by dual-energy X-ray absorptiometry scans
Time frame: Baseline to months 12
Change in waist circumference
Time frame: Baseline to months 12
Change in body mass index
Time frame: Baseline to months 12
Change in liver fat
Liver fat is assessed by liver Fibroscan.
Time frame: Baseline to months 12
Change in systolic blood pressure
Time frame: Baseline to months 12
Change in diastolic blood pressure
Time frame: Baseline to months 12
Change in serum triglycerides
Time frame: Baseline to months 12
Change in serum total cholesterol
Time frame: Baseline to months 12
Change in serum LDL-c
Time frame: Baseline to months 12
Change in HbA1c
Time frame: Baseline to months 12
Change in insulin sensitivity
Insulin sensitivity is assessed by HOMA-IR
Time frame: Baseline to months 12
Change in β cell function
β cell function is assessed by HOMA-B
Time frame: Baseline to months 12
Change in arterial stiffness measured by pulse wave velocity
arterial stiffness is measured by pulse wave velocity (PWV)
Time frame: Baseline to months 12
Change in depression score measured by the Patient Health Questionnaire-9
Depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline to months 12
Change in quality of sleep score measured by the Pittsburgh sleep quality index
Quality of sleep is measured by the Pittsburgh sleep quality index (PSQI)
Time frame: Baseline to months 12
Change in quality of life score measured by the 12-item Short-Form Health Survey Questionnaire
Quality of life is measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)
Time frame: Baseline to months 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.