The UFO (Ultra Processed Foods in Obesity) Project

NCT05554016 | Recruiting

• 1 other identifier: 00019173
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity, Morbid; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Dietary UPF intake

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

  At enrollment

Secondary Outcomes (11)

• Daily intake of energy and nutrients

  At enrollment

• Daily dietary intake of AGEs

  At enrollment

• Skin AGEs levels

  At enrollment

• RAGE expression in peripheral blood mononuclear cells

  At enrollment

• Soluble form of RAGE expression

  At enrollment

Study Arms (3)

Group 1

Pediatric patients with obesity

Group 2

Pediatric patients with obesity complicated by Metabolic Syndrome

Group 3

Age- and sex-matched healthy controls

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 26, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2025
• Study Completion: February 1, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)