UFO Project: The UFO (Ultra Processed Foods in Obesity) Project

Federico II University (Other)
Overall Status
CT.gov ID

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Time Perspective:
    Official Title:
    The UFO (Ultra Processed Foods in Obesity) Project
    Actual Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1

    Pediatric patients with obesity

    Group 2

    Pediatric patients with obesity complicated by Metabolic Syndrome

    Group 3

    Age- and sex-matched healthy controls

    Outcome Measures

    Primary Outcome Measures

    1. Dietary UPF intake [At enrollment]

      The assessment of dietary UPF intake will be carried out through a 7-day food diary.

    Secondary Outcome Measures

    1. Daily intake of energy and nutrients [At enrollment]

      The daily intake of energy (kcal) and nutrients will be carried out through a 7-day food diary.

    2. Daily dietary intake of AGEs [At enrollment]

      The intake of Advanced Glycation Endproducts (mostly present in UPFs).

    3. Skin AGEs levels [At enrollment]

      The skin accumulation of AGEs in the subcutaneous.

    4. RAGE expression in peripheral blood mononuclear cells [At enrollment]

      The expressione of the AGEs receptor in peripheral blood mononuclear cells.

    5. Soluble form of RAGE expression [At enrollment]

      The expressione of the AGEs receptor in the serum.

    6. Mitochondrial metabolism [At enrollment]

      The mitochondrial metabolism through the Seahorse XFp analyzer.

    7. Oxidative stress [At enrollment]

      Oxidative stress biomarkers.

    8. Interleukin-6 [At enrollment]

      Serum levels of Interleukin-6.

    9. MicroRNA-221 expression [At enrollment]

      MicroRNA-221 expression in peripheral blood mononuclear cells.

    10. Leptin [At enrollment]

      Serum levels of leptin.

    11. Ghrelin [At enrollment]

      Serum levels of ghrelin.

    Eligibility Criteria


    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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.

    Contacts and Locations


    Site City State Country Postal Code
    1 Department of Traslational Medical Science - University of Naples Federico II Naples Italy 80131

    Sponsors and Collaborators

    • Federico II University


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Roberto Berni Canani, MD, PhD, Professor of Pediatrics, Federico II University
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • 00019173
    First Posted:
    Sep 26, 2022
    Last Update Posted:
    Jan 25, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 25, 2023