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

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Behavioral: Intermittent fasting plus time-restricted eating; Behavioral: Calorie restriction

• Registration Number: NCT06302803
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-12
• Study Start: 2024-04-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-24
• Primary Completion: 2026-12-31
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The mTRE group	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.
The CR group	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.

Primary Outcome Measures

Name	Time	Method
Change in body weight over 12 months	Baseline to months 12	Change in body weight over 12 months

Secondary Outcome Measures

Name	Time	Method
Change in liver fat	Baseline to months 12	Liver fat is assessed by liver Fibroscan
Change in waist circumference	Baseline to months 12	Wrap a tape measure around the waist at the level of the navel.
Change in systolic blood pressure	Baseline to months 12	blood pressure
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 diastolic blood pressure	Baseline to months 12	blood pressure
Change in concentration of serum LDL-c	Baseline to months 12	the contents of Low Density Lipoprotein
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 concentration of serum total cholesterol	Baseline to months 12	the contents of serum total cholesterol
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 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 triglyceride	Baseline to months 12	the contents of serum triglyceride
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)

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China