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

NCT ID: NCT06302803

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-07
• Study Completion Date: 2027-07-01

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

The mTRE group

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.

Group Type: EXPERIMENTAL

Intermittent fasting plus time-restricted eating

Intervention Type: BEHAVIORAL

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

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

Group Type: EXPERIMENTAL

Calorie restriction

Intervention Type: BEHAVIORAL

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

Control

usual health care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

mTRE; CR

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huijie Zhang, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

Locations

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huijie Zhang, MD. PhD.

Role: CONTACT

huijiezhang2005@126.com

+86-020-61641635

Facility Contacts

Huijie Zhang, MD,PhD

Role: primary

Other Identifiers

NFEC-2024-033

Identifier Type: -

Identifier Source: org_study_id