Clinical trial NCT06302803: Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial)
Official title: Effects of Modified Intermittent Eating Strategy on Weight Loss and Cardiometabolic Risk Factors in Obese Adults: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Obesity
Time restricted eating
Intermittent Fasting
Modified Intermittent Eating strategy
Calorie restriction
Weight loss
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in body weight over 12 months
timeFrame: Baseline to months 12
Secondary outcomes:
measure: Change in body mass index （BMI）
timeFrame: Baseline to months 12
measure: Change in waist circumference
timeFrame: Baseline to months 12
measure: Change in body fat composition meassured by DEXA
timeFrame: Baseline to months 12
measure: Change in liver fat
timeFrame: Baseline to months 12
measure: Change in systolic blood pressure
timeFrame: Baseline to months 12
measure: Change in diastolic blood pressure
timeFrame: Baseline to months 12
measure: Change in concentration of serum triglyceride
timeFrame: Baseline to months 12
measure: Change in concentration of serum total cholesterol
timeFrame: Baseline to months 12
measure: Change in concentration of serum LDL-c
timeFrame: Baseline to months 12
measure: Change in concentration of HbA1c
timeFrame: Baseline to months 12
measure: Change in insulin sensitivity
timeFrame: Baseline to months 12
measure: Change in β cell function
timeFrame: Baseline to months 12
measure: Change in arterial stiffness measured by pulse wave velocity
timeFrame: Baseline to months 12
measure: Change in depression score measured by the Patient Health Questionnaire-9
timeFrame: Baseline to months 12
measure: Change in quality of sleep score measured by the Pittsburgh sleep quality index
timeFrame: Baseline to months 12
measure: Change in quality of life score measured by the 12-item Short-Form Health Survey Questionnaire
timeFrame: Baseline to months 12
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
name: Huijie Zhang, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: