Status:
RECRUITING
Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children
Lead Sponsor:
Children's Hospital of Fudan University
Conditions:
Cardiovascular Syndrome, Metabolic
Eligibility:
All Genders
7-18 years
Phase:
NA
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-a...
Detailed Description
Childhood obesity comorbid with one or more CMR factors, including hyperglycemia, dyslipidemia, and hypertension, predicts an increased risk for developing cardiovascular disease in adulthood. Lifesty...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT06500078
Start Date
July 13 2024
End Date
December 31 2026
Last Update
August 26 2025
Active Locations (1)
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1
Children's Hospital of Fudan University
Shanghai, China