Effects of intermittent dietary restriction on heart and metabolic health in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Children's Hospital of Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Yalan Dou
• Email: yldou16@fudan.edu.cn
• Phone: +86 021 64932921

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.