Relationship Between Eating Patterns, Body Composition and the Detection of Fatty Liver in Children and Adolescents With Trisomy 21: LiverTy Project

• Study Design

This is an observational cross-sectional study in which participants with T21, with and without obesity, will be evaluated without direct therapeutic intervention.

• Registration and Evaluation Procedures

2.1 Clinical Assessments

• Liver Elastography: Assessment of liver stiffness using FibroScan. Hepatic elastography is a non-invasive imaging technique used to assess liver stiffness and fat content, which correlates with liver fibrosis. It is particularly useful in pediatric populations for evaluating liver diseases such as non-alcoholic fatty liver disease (NAFLD), viral hepatitis, and other chronic liver conditions. FibroScan measures ultrasound signal attenuation due to liver fat content. Higher values (db/m) indicate more fat deposition.
• Anthropometric Measurements: Weight, height, body mass index (BMI), abdominal circumference.
• Body composition parameters measured by bioimpedance:

Adipose tissue %, muscle mass (kg) and visceral fat index.

2.2. Nutritional Evaluation:

• 24-hour dietary recall. To estimate nutrient consumption, dietary intake from the 24-hour dietary recall will be converted given the use of nutritional composition tables and validated food composition software (DIAL).
• KIDMED questionnaire for adherence to the Mediterranean diet.

The KIDMED (Mediterranean Diet Quality Index) questionnaire is a widely used tool to assess adherence to the Mediterranean diet among children and adolescents. It consists of 16 items that evaluate various dietary habits. Each item is scored as follows:

Positive connotation items (reflecting healthy Mediterranean dietary habits): Each receives a score of +1.

Negative connotation items (indicating departure from Mediterranean dietary principles): Each receives a score of -1.

The total KIDMED score ranges from -4 to 12. Based on the total score, adherence to the Mediterranean diet is categorized into three levels:

High adherence: Scores of ≥8. Medium adherence: Scores between 4 and 7. Low adherence: Scores of ≤3.

• Quality Assurance Plan

Electronic data management system with automatic validations to prevent data entry errors.

• Sample Size Evaluation

It is estimated that a sample of 17 participants with T21 and 17 participants in the control group reaches 80% statistical power in detecting significant differences in the detection of fatty liver.

• Statistical Analysis Plan

• Descriptive statistics will be used to characterize the sample.
• Correlation tests and logistic regression will be performed to assess the relationship between NAFLD and metabolic factors.
• Analysis of variance (ANOVA) will be used to compare parameters among subgroups.
• Ethical and Safety Considerations

• Approval from the Research Ethics Committee.
• Data management in compliance with the General Data Protection Regulation (GDPR).

This protocol will allow us to evaluate the relationship between obesity, dietary patterns, and NAFLD in children with T21, providing key information for future preventive strategies.

Inclusion criteria

• Children (5-10 years), and adolescents (11-19) andyoung adults (20-22 years) of bothSexes
• 5 to 22 years old
• Diagnosis of trisomy 21 or other intellectual disability of genetic origin for the group of the cases.
• BMI: 17-40 Kg/m2
• Signing of the informed consent by the parents or guardians.

Exclusion criteria

• Not meeting the inclusion criteria
• Have previous liver pathology.
• Be under any medical treatment that
• Modify composition parameters Body: GLP-1 analogues and derivatives.