NCT05554016 The UFO (Ultra Processed Foods in Obesity) Project
| NCT ID | NCT05554016 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federico II University |
| Condition | Obesity, Morbid |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-09-01 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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.
Frequently Asked Questions
Who can join the NCT05554016 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Obesity, Morbid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05554016 currently recruiting?
Yes, NCT05554016 is actively recruiting participants. Visit ClinicalTrials.gov or contact Federico II University to inquire about joining.
Where is the NCT05554016 trial being conducted?
This trial is being conducted at Naples, Italy.
Who is sponsoring the NCT05554016 clinical trial?
NCT05554016 is sponsored by Federico II University. The trial plans to enroll 200 participants.
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