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RECRUITING
NCT06500078
NA

Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children

Sponsor: Children's Hospital of Fudan University

View on ClinicalTrials.gov

Summary

This randomized trial aims to evaluate the health-promoting effects of intermittent dietary restrictions, including intermittent low-carbohydrate diet (ILCD) and calorie restriction (ICR), in school-aged children with cardiometabolic risk (CMR) compared with general health education based on dietary and physical activity guidelines for Chinese children.

Official title: Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

7 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

324

Start Date

2024-07-13

Completion Date

2026-12-31

Last Updated

2025-08-26

Healthy Volunteers

No

Interventions

BEHAVIORAL

Intermittent dietary restriction

Intermittent dietary restriction will include the ILCD and ICR, which will be self-administered interventions in daily lives. The ILCD intervention will ask participants to restrict carbohydrate intake to ≤ 50 g/d on two consecutive or discontinuous days per week. The ICR intervention will ask participants to restrict caloric intake to 600 kcal/d for boys and 500 kcal/d for girls on two consecutive or discontinuous days per week. At baseline, participants will receive face-to-face oral dietary instructions (e.g., principle of dietary restriction, sample menus, food list with macronutrients). Participants will receive the intervention booklets containing dietary advice and sample menus for diet according to the requirements of the dietary intervention. Participants will be required to record dietary and physical activity data on a regular basis. The total intervention duration will be 12 months, including a 3-month intervention phase and a 9-month self-maintenance phase.

BEHAVIORAL

General health education

General health education based on dietary and physical activity guidelines for Chinese children and adolescents, will regularly send offline and online promotional materials to participants.

Locations (1)

Children's Hospital of Fudan University

Shanghai, China