Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06500078

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Fudan University

Shanghai, China

Location status: Recruiting

Location contact

Yalan Dou

CONTACT

[email protected]

About this study

Childhood obesity comorbid with one or more CMR factors, including hyperglycemia, dyslipidemia, and hypertension, predicts an increased risk for developing cardiovascular disease in adulthood. Lifestyle interventions, including restricting dietary calorie intake and increasing physical activity, have been proposed as the first-line behavioral weight management approaches for pediatric obesity. Long-term adherence to daily dietary restriction is challenging for young populations because they are in a particular period of physical and psychological growth and lifestyle formation. Low-carbohydrate diet and ICR have shown effectiveness in improving cardiometabolic health in adults, however, the evidence supporting the effects of these diets in pediatric populations remains limited.

Eligible participants will be randomized to receive intermittent dietary restriction, including an ILCD (carbohydrate intake ≤ 50 g/d for two days per week) or an ICR (calorie intake is 500-600 kcal/d for two days per week), or general health education based on dietary and physical activity guidelines for Chinese children in daily life. The total study duration will be 12 months consisting of a 3-month intervention phase and a 9-month self-maintenance phase.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of participants with reversal of at least one cardiometabolic abnormalities

    Time frame: At month 3 from baseline

    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.

Secondary outcomes

  1. Number of participants with reversal of at least one cardiometabolic abnormalities

    Time frame: At month 12 from baseline

    It 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 12th month of study phrase.

    Reversal of cardiometabolic abnormalities is defined as: at 12th 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.

  2. Change in body fat (%)

    Time frame: From baseline to month 3

    Body fat(%) will be directly derived from non-invasive DEX body composition analyser, assessed by professional operator.

  3. Change in the total score of the Wechsler Intelligence Scale for Children

    Time frame: From baseline to month 3

    Professionally trained and certified physicians will assess participants using the Wechsler Intelligence Scale for Children at baseline and at month 3 of the study, respectively, to obtain the total score of the scale (continuous variable outcome).

  4. Change in body weight

    Time frame: From baseline to month 3

    Body weight is measured according to the Physical Fitness and Health Surveillance of Chinese School Students by trained, certified study staff. It is measured to the nearest 0.1 kg.

  5. Change in body weight

    Time frame: From baseline to month 12

    Body weight is measured according to the Physical Fitness and Health Surveillance of Chinese School Students by trained, certified study staff. It is measured to the nearest 0.1 kg.

  6. Change in waist circumference

    Time frame: From baseline to month 3

    Waist circumference is measured to the nearest 0.1 cm using a constant tension tape around the waist at 1 cm below the navel as the subject exhaled. It is calculated as the average value of two measurements.

  7. Change in waist circumference

    Time frame: From baseline to month 12

    Waist circumference is measured to the nearest 0.1 cm using a constant tension tape around the waist at 1 cm below the navel as the subject exhaled. It is calculated as the average value of two measurements.

  8. Change in fibroblast growth factor 21 (FGF-21)

    Time frame: From baseline to month 3

    FGF-21 will be measured by enzyme-linked immunosorbent assays (R&D Systems, Inc. USA), using fasting serum samples at baseline and month 3 after intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.