Investigating the impact of fructose on obesity in children
Evaluation of Liver and Osteo-metabolic Complications Related to the Consumption of Fructose in a Cohort of Overweight and Obese Children and Adolescents.
This study looks at how eating fructose affects weight and health in children and teenagers aged 3-6 and 12-16.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 3 Years to 16 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliero Universitaria Maggiore della Carita Academic / other |
| Locations | 1 site (Novara) |
| Trial ID | NCT06365567 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on understanding how dietary fructose contributes to obesity-related diseases in children. It involves assessing the dietary habits of children and adolescents aged 3-6 and 12-16 years through various questionnaires that evaluate fructose intake and adherence to the Mediterranean diet. The study aims to gather detailed information on food consumption patterns and their relationship with obesity and liver health. Participants will be recruited from specific outpatient clinics in Italy, where their dietary habits will be analyzed to identify potential metabolic impacts of fructose.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents aged 3-6 and 12-16 years who are overweight or obese.
Not a fit: Patients with genetic or secondary obesity, or those following non-Mediterranean diets, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary modifications that may help prevent or manage obesity-related diseases in children.
How similar studies have performed: While there have been studies examining dietary impacts on obesity, this specific focus on fructose in pediatric populations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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);
Where this trial is running
Novara
- SCDU Pediatria, AOU Ospedale Maggiore della Carità — Novara, Italy (Recruiting)
Study contacts
- Principal investigator: Flavia Prodam, MD PHD — AOU Maggiore della Carità
- Study coordinator: Flavia Prodam, MD PHD
- Email: flavia.prodam@med.uniupo.it
- Phone: +39-0321-660693
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.