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

NCT06302803 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2024-06-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Huijie Zhang, MD. PhD. · Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-07
Primary Completion
2026-12-31
Completion
2027-07-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06302803 on ClinicalTrials.gov