The UFO (Ultra Processed Foods in Obesity) Project
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity, Morbid
- Sponsor
- Federico II University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Dietary UPF intake
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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
Investigators
Roberto Berni Canani, MD, PhD
Professor of Pediatrics
Federico II University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Dietary UPF intake
Time Frame: At enrollment
The assessment of dietary UPF intake will be carried out through a 7-day food diary.
Secondary Outcomes
- Skin AGEs levels(At enrollment)
- MicroRNA-221 expression(At enrollment)
- Daily dietary intake of AGEs(At enrollment)
- Mitochondrial metabolism(At enrollment)
- Ghrelin(At enrollment)
- Leptin(At enrollment)
- Soluble form of RAGE expression(At enrollment)
- Oxidative stress(At enrollment)
- Interleukin-6(At enrollment)
- Daily intake of energy and nutrients(At enrollment)
- RAGE expression in peripheral blood mononuclear cells(At enrollment)