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Recruiting
NCT06500078
Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children
Conditions: Cardiovascular Syndrome, Metabolic
Sex: All
Ages: 7 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 324
Sponsor: Children's Hospital of Fudan University
Location: Children's Hospital of Fudan University Shanghai
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.
Source: ClinicalTrials.gov (NCT06500078). StuddyBuddy aggregates publicly available trial information.