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

Federico II University

Status

Enrolling

Conditions

Metabolic Syndrome

Obesity, Morbid

Study type

Observational

Funder types

Other

Identifiers

NCT05554016

00019173

Details and patient eligibility

About

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

Enrollment

200 estimated patients

Sex

All

Ages

6 to 18 years old

Volunteers

No 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.