Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT06365567
Eligibility Criteria:
Inclusion Criteria:
* Children and adolescents of both sexes aged 3-6 years and 12-16 years, as interest groups for the assessment of hepatic steatosis induced by fructose consumption.
* Children with overweight (defined by BMI \> 97 year old percentile for children under 5 years old; and BMI \>85 year old percentile for children over 5 years old) or obesity (defined by BMI \> 99 percentile for children under 5 years of age; and BMI \> 97 percentile for children over 5 years of age)
Exclusion Criteria:
* Children and adolescents not in that age group:
* Children and adolescents with different liver diseases of NAFLD, as it is the interest of the study
* Children and adolescents with genetic obesity or secondary obesity since the interest of the study is obesity caused by excessive calorie intake
* Children and adolescents included in diet-therapy regimen with different dietary styles from the Mediterranean or Western diet (example ketogenic diet, FoadMap (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet, vegan/vegetarian diet) to avoid bias in the interpretation of the microbial signature (the microbial signature of the Western and Mediterranean diet is known in the literature);
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
16 Years
Study:
NCT06365567
Study Brief:
Protocol Section:
NCT06365567