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The UFO (Ultra Processed Foods in Obesity) Project

The UFO (Ultra Processed Foods in Obesity) Project

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05554016
Acronym
UFO Project
Enrollment
200
Registered
2022-09-26
Start date
2022-09-01
Completion date
2026-02-01
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Obesity, Morbid

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

Interventions

None listed

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Dietary UPF intakeAt enrollmentThe assessment of dietary UPF intake will be carried out through a 7-day food diary.

Secondary

MeasureTime frameDescription
Daily intake of energy and nutrientsAt enrollmentThe daily intake of energy (kcal) and nutrients will be carried out through a 7-day food diary.
Daily dietary intake of AGEsAt enrollmentThe intake of Advanced Glycation Endproducts (mostly present in UPFs).
Skin AGEs levelsAt enrollmentThe skin accumulation of AGEs in the subcutaneous.
RAGE expression in peripheral blood mononuclear cellsAt enrollmentThe expressione of the AGEs receptor in peripheral blood mononuclear cells.
Soluble form of RAGE expressionAt enrollmentThe expressione of the AGEs receptor in the serum.
Mitochondrial metabolismAt enrollmentThe mitochondrial metabolism through the Seahorse XFp analyzer.
Oxidative stressAt enrollmentOxidative stress biomarkers.
Interleukin-6At enrollmentSerum levels of Interleukin-6.
MicroRNA-221 expressionAt enrollmentMicroRNA-221 expression in peripheral blood mononuclear cells.
LeptinAt enrollmentSerum levels of leptin.
GhrelinAt enrollmentSerum levels of ghrelin.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026