The UFO (Ultra Processed Foods in Obesity) Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Obesity, Morbid, Metabolic Syndrome. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Primary outcome measures
- Dietary UPF intake [Time frame: At enrollment]
Secondary outcome measures (11)
- Daily intake of energy and nutrients [Time frame: At enrollment]
- Daily dietary intake of AGEs [Time frame: At enrollment]
- Skin AGEs levels [Time frame: At enrollment]
- RAGE expression in peripheral blood mononuclear cells [Time frame: At enrollment]
- Soluble form of RAGE expression [Time frame: At enrollment]
- Mitochondrial metabolism [Time frame: At enrollment]
- Oxidative stress [Time frame: At enrollment]
- Interleukin-6 [Time frame: At enrollment]
- MicroRNA-221 expression [Time frame: At enrollment]
- Leptin [Time frame: At enrollment]
- Ghrelin [Time frame: At enrollment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Department of Traslational Medical Science - University of Naples Federico II — Naples
Identifiers
NCT: NCT05554016 · 00019173