Obesity
Conditions
Keywords
Obesity, Time restricted eating, The 5:2 diet, Weight loss maintenance
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTime-restricted eating
Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm)
BEHAVIORALThe 5:2 diet
Participants will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days.
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 18-75 years; * 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 months 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in waist circumference | Baseline to months 12 | — |
| Change in body mass index | Baseline to months 12 | — |
| Change in liver fat | Baseline to months 12 | Liver fat is assessed by liver Fibroscan. |
| Change in systolic blood pressure | Baseline to months 12 | — |
| Change in diastolic blood pressure | Baseline to months 12 | — |
| Change in serum triglycerides | Baseline to months 12 | — |
| Change in serum total cholesterol | Baseline to months 12 | — |
| Change in body fat composition meassured by DEXA | Baseline to months 12 | Body composition is meassured by dual-energy X-ray absorptiometry scans |
| Change in HbA1c | Baseline to months 12 | — |
| Change in insulin sensitivity | Baseline to months 12 | Insulin sensitivity is assessed by HOMA-IR |
| Change in β cell function | Baseline to months 12 | β cell function is assessed by HOMA-B |
| Change in arterial stiffness measured by pulse wave velocity | Baseline to months 12 | arterial stiffness is measured by pulse wave velocity (PWV) |
| Change in depression score measured by the Patient Health Questionnaire-9 | Baseline to months 12 | Depression is measured by the Patient Health Questionnaire-9 (PHQ-9) |
| Change in quality of sleep score measured by the Pittsburgh sleep quality index | Baseline to months 12 | Quality of sleep is measured by the Pittsburgh sleep quality index (PSQI) |
| Change in quality of life score measured by the 12-item Short-Form Health Survey Questionnaire | Baseline to months 12 | Quality of life is measured by the 12-item Short-Form Health Survey Questionnaire (SF-12) |
| Change in serum LDL-c | Baseline to months 12 | — |
Countries
China
Contacts
Primary ContactHuijie Zhang, MD. PhD.
Outcome results
None listed