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

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

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome; Obesity, Morbid

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • Department of Traslational Medical Science - University of Naples Federico II
    • Contact: Roberto Berni Canani, MD, PhD; Phone Number: 0817462680; Email: berni@unina.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric subjects of caucasian ethnicity, of both sexes, aged ≥6 and ≤18 years, with a sure diagnosis of obesity (Group 1), of obesity complicated by Metabolic Syndrome (Group 2), and age- and sex-matched healthy controls (Group 3).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group 1; Pediatric patients with obesity
Group 2; Pediatric patients with obesity complicated by Metabolic Syndrome
Group 3; Age- and sex-matched healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary UPF intake	The assessment of dietary UPF intake will be carried out through a 7-day food diary.	At enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily intake of energy and nutrients	The daily intake of energy (kcal) and nutrients will be carried out through a 7-day food diary.	At enrollment
Daily dietary intake of AGEs	The intake of Advanced Glycation Endproducts (mostly present in UPFs).	At enrollment
Skin AGEs levels	The skin accumulation of AGEs in the subcutaneous.	At enrollment
RAGE expression in peripheral blood mononuclear cells	The expressione of the AGEs receptor in peripheral blood mononuclear cells.	At enrollment
Soluble form of RAGE expression	The expressione of the AGEs receptor in the serum.	At enrollment
Mitochondrial metabolism	The mitochondrial metabolism through the Seahorse XFp analyzer.	At enrollment
Oxidative stress	Oxidative stress biomarkers.	At enrollment
Interleukin-6	Serum levels of Interleukin-6.	At enrollment
MicroRNA-221 expression	MicroRNA-221 expression in peripheral blood mononuclear cells.	At enrollment
Leptin	Serum levels of leptin.	At enrollment
Ghrelin	Serum levels of ghrelin.	At enrollment

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Overweight; Obesity; Metabolic Syndrome; Obesity, Morbid
• Other Study ID Numbers: 00019173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No