Effects of intermittent dietary restriction on heart and metabolic health in children
Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children: A Randomized Controlled Trial
This study tests if different types of intermittent diets can help school-aged children with heart and metabolic health issues feel better compared to regular health education.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 7 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06500078 on ClinicalTrials.gov |
What this trial studies
This randomized trial evaluates the health benefits of intermittent dietary restrictions, including low-carbohydrate and calorie restriction diets, in school-aged children with cardiometabolic risk factors. Participants will be assigned to either an intermittent low-carbohydrate diet, an intermittent calorie restriction diet, or a general health education program over a 12-month period. The study aims to determine the effectiveness of these dietary approaches in improving cardiometabolic health compared to standard dietary guidelines. The intervention phase lasts for three months, followed by a nine-month self-maintenance phase.
Who should consider this trial
Good fit: Ideal candidates are children aged 7-18 years with at least one cardiometabolic abnormality such as prediabetes, lipid abnormalities, or elevated blood pressure.
Not a fit: Patients with severe health conditions like heart failure, liver or kidney disease, or those who have undergone bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective dietary strategies to reduce cardiometabolic risks in children, potentially improving their long-term health outcomes.
How similar studies have performed: While intermittent dietary restrictions have shown effectiveness in adults, evidence in pediatric populations is limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Children's Hospital of Fudan University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Yalan Dou
- Email: yldou16@fudan.edu.cn
- Phone: +86 021 64932921
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.