NCT05554016Completed
The UFO (Ultra Processed Foods in Obesity) Project
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
The childhood obesity prevalence has increased dramatically in the last decades, affecting more than 340 million children worldwide. This condition is the major risk factor for a set of metabolic abnormalities, also known as metabolic syndrome, a condition that reduce life expectancy by 5-20 years. Changes in the global food system, and the increased consumption of ultra-processed foods (UPFs), may have contributed to the increase in the prevalence of childhood obesity and related morbidities. The mechanisms by which UPFs might promote obesity and metabolic syndrome could be multiple and not completely identified. The Ultra-processed Food in Obesity (UFO) Project has been designed to investigate the potential associations between UPFs intake and MetS in pediatric subjects
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 21 Sept 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- Federico II University
- Diseases
- Obesity
- NCT number
- NCT05554016
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 1 Sept 2022 to the primary completion date, 1 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- History of obesity surgery and onset of diarrhea or acute gastrointestinal illness during the 12 weeks prior to enrollment;
Age
- Age \<6 or \>18 years;
Other
- Non-Caucasian ethnicity;
- Intake of antibiotics and/or pre/pro/synbiotics;
- Presence of tattoos, scars, moles or special lesions on both forearms.
Who the study is looking for
- 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).
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Traslational Medical Science - University of Naples Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.