RECRUITINGINTERVENTIONAL

Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial)

Effects of Modified Intermittent Eating Strategy on Weight Loss and Cardiometabolic Risk Factors in Obese Adults: a Randomized Clinical Trial

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Man or women aged 18-75 years; 2. Body mass index (BMI)of 28.0 to 45.0 kg/m2; Who Should NOT Join This Trial: 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 willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BEHAVIORAL

Intermittent 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.

BEHAVIORAL

Calorie restriction

Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on eating time.

Locations (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China