The UFO (Ultra Processed Foods in Obesity) Project

Last updated: June 3, 2025
Sponsor: Federico II University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Metabolic Syndrome

Obesity

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT05554016
00019173
  • Ages 6-18
  • All Genders

Study 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

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-matchedhealthy controls (Group 3).

Exclusion

Exclusion Criteria:

  • Non-Caucasian ethnicity;

  • Age <6 or >18 years;

  • Concomitant presence of chronic diseases, neoplasms, immunodeficiencies, chronicinfections,autoimmune diseases, chronic inflammatory bowel disease, celiac disease,metabolic-genetic diseases, cystic fibrosis and other chronic lung diseases,cardiovascular/respiratory/gastrointestinal malformations, neuropsychiatricdisorders, and neurological disorders;

  • Intake of antibiotics and/or pre/pro/synbiotics;

  • History of obesity surgery and onset of diarrhea or acute gastrointestinal illnessduring the 12 weeks prior to enrollment;

  • Presence of tattoos, scars, moles or special lesions on both forearms.

Study Design

Total Participants: 200
Study Start date:
September 01, 2022
Estimated Completion Date:
February 01, 2026

Connect with a study center

  • Department of Traslational Medical Science - University of Naples Federico II

    Naples, 80131
    Italy

    Active - Recruiting

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