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

NCT06500078 | Recruiting

• 1 other identifier: IM_Diet_2.0
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Syndrome, Metabolic

Keywords

Intermittent carbohydrate restriction; Intermittent calorie restriction; Cardiometabolic risk; Children

Outcome Measures

Primary Outcomes (1)

• Number of participants with reversal of at least one cardiometabolic abnormalities

  The primary outcome is a composite outcome that will be measured by combining multiple reverse outcomes of the following cardiometabolic abnormalities: (1) prediabetes; (2) lipid abnormalities; (3) elevated blood pressure. It is defined as occurring if any cardiometabolic abnormality has a reversal outcome at 3rd month of study phrase. Reversal of cardiometabolic abnormalities is defined as: at 3rd month of study phrase, at least one of the following status changed from abnormal at baseline to normal: i. Prediabetes; ii. Lipid abnormalities; iii. Elevated blood pressure.

  At month 3 from baseline

Secondary Outcomes (8)

• Number of participants with reversal of at least one cardiometabolic abnormalities

  At month 12 from baseline

• Change in body fat (%)

  From baseline to month 3

• Change in the total score of the Wechsler Intelligence Scale for Children

  From baseline to month 3

• Change in body weight

  From baseline to month 3

• Change in body weight

  From baseline to month 12

Study Arms (2)

Intermittent dietary restriction group (ILCD or ICR)

EXPERIMENTAL

Intermittent dietary restriction group will receive ILCD or ICR intervention. ILCD will be conducted as a carbohydrate intake restriction of ≤ 50 g/day for two consecutive or discontinuous days per week, and ICR will be conducted as a calorie intake restriction of 500-600 kcal/day for two consecutive or discontinuous days per week.

Behavioral: Intermittent dietary restriction; Behavioral: General health education

Health education group

ACTIVE COMPARATOR

Health education group will receive health education based on Chinese guidelines for school-aged children.

Behavioral: General health education

Interventions

Intermittent dietary restriction BEHAVIORAL

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.

Intermittent dietary restriction group (ILCD or ICR)

General health education BEHAVIORAL

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.

Health education group; Intermittent dietary restriction group (ILCD or ICR)

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 7-18 years at baseline.
• At least one of the following cardio-metabolic abnormalities:
• Prediabetes (Impaired fasting glucose: 5.6 ≤ fasting blood glucose level ≤ 6.9 mmol/L; or Impaired glucose tolerance: 7.8 ≤ blood glucose level after 2 hours postprandial ≤ 11.0 mmol/L).
• Lipid abnormalities (High-density lipoprotein cholesterol ≤ 1.04 mmol/L; or Low-density lipoprotein cholesterol ≥ 3.37 mmol/L; or Triglycerides ≥ 1.70 mmol/L, or Total cholesterol ≥ 5.18 mmol/L).
• Elevated blood pressure (Systolic/diastolic blood pressure consistently higher than the 90th percentile for gender, age, and height; or systolic/diastolic blood pressure ≥ 120/80 mmHg).

You may not qualify if:

• Previously diagnosed with heart failure, severe malnutrition, immune deficiency, liver or kidney disease, cancer, or other diseases deemed unsuitable for participation.
• Had a history of bariatric surgery.
• Used weight loss pills or supplements in the last three months.
• Other situations unsuitable for participation.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Yalan Dou

CONTACT

+86 021 64932921; yldou16@fudan.edu.cn

Weili Yan

CONTACT

+86 021 64931215; yanwl@fudan.edu.cn

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: July 8, 2024
• First Posted: July 15, 2024
• Study Start: July 13, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

CN (1)