An observational study in Obesity, Morbid and Metabolic Syndrome, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Federico II University · Observational
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
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 200 is above the median of 78 across 306 observational studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
Pediatric patients with obesity
Pediatric patients with obesity complicated by Metabolic Syndrome
Age- and sex-matched healthy controls
Dietary UPF intake
The assessment of dietary UPF intake will be carried out through a 7-day food diary.
Time frame: At enrollment
Daily intake of energy and nutrients
The daily intake of energy (kcal) and nutrients will be carried out through a 7-day food diary.
Time frame: At enrollment
Daily dietary intake of AGEs
The intake of Advanced Glycation Endproducts (mostly present in UPFs).
Time frame: At enrollment
Skin AGEs levels
The skin accumulation of AGEs in the subcutaneous.
Time frame: At enrollment
RAGE expression in peripheral blood mononuclear cells
The expressione of the AGEs receptor in peripheral blood mononuclear cells.
Time frame: At enrollment
Soluble form of RAGE expression
The expressione of the AGEs receptor in the serum.
Time frame: At enrollment
Mitochondrial metabolism
The mitochondrial metabolism through the Seahorse XFp analyzer.
Time frame: At enrollment
Oxidative stress
Oxidative stress biomarkers.
Time frame: At enrollment
Interleukin-6
Serum levels of Interleukin-6.
Time frame: At enrollment
MicroRNA-221 expression
MicroRNA-221 expression in peripheral blood mononuclear cells.
Time frame: At enrollment
Leptin
Serum levels of leptin.
Time frame: At enrollment
Ghrelin
Serum levels of ghrelin.
Time frame: At enrollment
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Federico II University