Ultra-processed foods and metabolic health in children and teens
The UFO (Ultra Processed Foods in Obesity) Project
This project will try to see if eating more ultra-processed foods is linked to obesity and metabolic syndrome in children and adolescents aged 6–18.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT05554016 on ClinicalTrials.gov |
What this trial studies
The UFO Project is an observational study that compares ultra-processed food (UPF) intake across three pediatric groups: children with obesity, children with obesity plus metabolic syndrome, and age- and sex-matched healthy controls. Participants are Caucasian boys and girls aged 6–18 recruited at the University of Naples Federico II and will have dietary assessments alongside clinical evaluation of metabolic syndrome components. The study uses cross-sectional analyses to look for associations between UPF consumption patterns and metabolic risk markers without assigning any interventions. Findings will be based on clinical and dietary data collected during clinic visits.
Who should consider this trial
Good fit: Ideal candidates are Caucasian children and adolescents aged 6–18 who either have obesity, have obesity with metabolic syndrome, or are healthy age- and sex-matched controls and meet the study's exclusion criteria.
Not a fit: Children outside the 6–18 age range, non‑Caucasian individuals, or those with chronic diseases, recent antibiotic/probiotic use, recent gastrointestinal illness, or other listed exclusions are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the project could identify dietary patterns tied to higher metabolic risk in children and help shape prevention and public health guidance.
How similar studies have performed: Previous observational studies in adults and children have linked higher UPF intake to obesity and metabolic risk, but causal evidence—especially in pediatric populations—is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Caucasian ethnicity, both sexes, age ≥6 and ≤18 years, diagnosis of obesity (Group 1), diagnosis of obesity and Metabolic Syndrome (Group 2), and age- and sex-matched healthy controls (Group 3). Exclusion Criteria: * Non-Caucasian ethnicity; * Age \<6 or \>18 years; * Concomitant presence of chronic diseases, neoplasms, immunodeficiencies, chronic infections,autoimmune diseases, chronic inflammatory bowel disease, celiac disease, metabolic-genetic diseases, cystic fibrosis and other chronic lung diseases, cardiovascular/respiratory/gastrointestinal malformations, neuropsychiatric disorders, and neurological disorders; * Intake of antibiotics and/or pre/pro/synbiotics; * History of obesity surgery and onset of diarrhea or acute gastrointestinal illness during the 12 weeks prior to enrollment; * Presence of tattoos, scars, moles or special lesions on both forearms.
Where this trial is running
Naples
- Department of Traslational Medical Science - University of Naples Federico II — Naples, Italy (Recruiting)
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.