Obesity
Conditions
Keywords
Obesity, Time restricted eating, Intermittent Fasting, Modified Intermittent Eating strategy, Calorie restriction, Weight loss
Brief summary
Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained 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 days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months.
Detailed description
Obesity is becoming a major global public health issue. Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained 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 days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months.
Interventions
BEHAVIORALIntermittent fasting plus time-restricted eating
Participants in the mTRE group will be instructed to eat during a window of 8 h (8 am to 4 pm) 5 days and fast (approximately 500-600 kcal per day) 2 days per week.
BEHAVIORALCalorie restriction
Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on eating 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 18-75 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 | Description |
|---|---|---|
| Change in body weight over 12 months | Baseline to months 12 | Change in body weight over 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in waist circumference | Baseline to months 12 | Wrap a tape measure around the waist at the level of the navel. |
| 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 liver fat | Baseline to months 12 | Liver fat is assessed by liver Fibroscan |
| Change in systolic blood pressure | Baseline to months 12 | blood pressure |
| Change in diastolic blood pressure | Baseline to months 12 | blood pressure |
| Change in concentration of serum triglyceride | Baseline to months 12 | the contents of serum triglyceride |
| Change in concentration of serum total cholesterol | Baseline to months 12 | the contents of serum total cholesterol |
| Change in body mass index （BMI） | Baseline to months 12 | body mass index : the weight in kilograms divided by the square of the height in meters.The higher scores mean a worse outcome. |
| Change in concentration of HbA1c | Baseline to months 12 | the contents of Glycated hemoglobin |
| Change in insulin sensitivity | Baseline to months 12 | Insulin sensitivity is assessed by HOMA-IR (Homeostatic Model Assessment for Insulin Resistance). |
| 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). The maximum value is 27, and the minimum value is 0 . The higher scores mean a worse outcome. |
| 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). The maximum value is 21, and the minimum value is 0 . The higher scores mean a worse outcome. |
| 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). The maximum value is 100, and the minimum value is 0 . The higher scores mean a better outcome. |
| Change in concentration of serum LDL-c | Baseline to months 12 | the contents of Low Density Lipoprotein |
Countries
China
Contacts
Primary ContactHuijie Zhang, MD. PhD.
Outcome results
None listed