Clinical trial NCT05554016: The UFO (Ultra Processed Foods in Obesity) Project
Official title: The UFO (Ultra Processed Foods in Obesity) Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Metabolic Syndrome
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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


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.

Primary outcomes:
measure: Dietary UPF intake
timeFrame: At enrollment
Secondary outcomes:
measure: Daily intake of energy and nutrients
timeFrame: At enrollment
measure: Daily dietary intake of AGEs
timeFrame: At enrollment
measure: Skin AGEs levels
timeFrame: At enrollment
measure: RAGE expression in peripheral blood mononuclear cells
timeFrame: At enrollment
measure: Soluble form of RAGE expression
timeFrame: At enrollment
measure: Mitochondrial metabolism
timeFrame: At enrollment
measure: Oxidative stress
timeFrame: At enrollment
measure: Interleukin-6
timeFrame: At enrollment
measure: MicroRNA-221 expression
timeFrame: At enrollment
measure: Leptin
timeFrame: At enrollment
measure: Ghrelin
timeFrame: At enrollment
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Traslational Medical Science - University of Naples Federico II
Study officials:
References: