NCT06500078 Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children
| NCT ID | NCT06500078 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Cardiovascular Syndrome, Metabolic |
| Study Type | INTERVENTIONAL |
| Enrollment | 324 participants |
| Start Date | 2024-07-13 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 324 participants in total. It began in 2024-07-13 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Aged 7-18 years at baseline. * At least one of the following cardio-metabolic abnormalities: 1. 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). 2. 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). 3. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06500078 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 18 Years, studying Cardiovascular Syndrome, Metabolic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06500078 currently recruiting?
Yes, NCT06500078 is actively recruiting participants. Contact the research team at yldou16@fudan.edu.cn for enrollment information.
Where is the NCT06500078 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06500078 clinical trial?
NCT06500078 is sponsored by Children's Hospital of Fudan University. The trial plans to enroll 324 participants.