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

NCT06302803 | Recruiting

• 1 other identifier: NFEC-2024-033
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Time restricted eating; Intermittent Fasting; Modified Intermittent Eating strategy; Calorie restriction; Weight loss

Outcome Measures

Primary Outcomes (1)

• Change in body weight over 12 months

  Change in body weight over 12 months

  Baseline to months 12

Secondary Outcomes (16)

• Change in body mass index （BMI）

  Baseline to months 12

• Change in waist circumference

  Baseline to months 12

• Change in body fat composition meassured by DEXA

  Baseline to months 12

• Change in liver fat

  Baseline to months 12

• Change in systolic blood pressure

  Baseline to months 12

Study Arms (3)

The mTRE group

EXPERIMENTAL

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: Intermittent fasting plus time-restricted eating

The CR group

EXPERIMENTAL

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

Behavioral: Calorie restriction

Control

NO INTERVENTION

usual health care

Interventions

Intermittent fasting plus time-restricted eating 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.

Also known as: mTRE

The mTRE group

Calorie restriction BEHAVIORAL

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

Also known as: CR

The CR group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or women aged 18-75 years;
• Body mass index (BMI)of 28.0 to 45.0 kg/m2;

You may not qualify if:

• History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
• Diagnosis of type 1 and type 2 diabetes;
• History of malignant tumors;
• 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);
• History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
• History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
• History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
• Being a smoker or having been a smoker in the 3 months prior to their screening visit;
• 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;
• Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) ;
• Women who are pregnant or plan to become pregnant;
• Patients who cannot be followed for 24 months (due to a health situation or migration);
• Patients who are unwilling or unable to give informed consent.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Obesity; Intermittent Fasting; Weight Loss

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior; Body Weight Changes

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Huijie Zhang, MD. PhD.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huijie Zhang, MD. PhD.

CONTACT

+86-020-61641635; huijiezhang2005@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: April 7, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)