The UFO (Ultra Processed Foods in Obesity) Project

Recruiting

• Conditions: Obesity, Morbid; Metabolic Syndrome

• Registration Number: NCT05554016
• Lead Sponsor: Federico II University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-26
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dietary UPF intake	At enrollment	The assessment of dietary UPF intake will be carried out through a 7-day food diary.

Secondary Outcome Measures

Name	Time	Method
Skin AGEs levels	At enrollment	The skin accumulation of AGEs in the subcutaneous.
MicroRNA-221 expression	At enrollment	MicroRNA-221 expression in peripheral blood mononuclear cells.
Daily dietary intake of AGEs	At enrollment	The intake of Advanced Glycation Endproducts (mostly present in UPFs).
Mitochondrial metabolism	At enrollment	The mitochondrial metabolism through the Seahorse XFp analyzer.
Ghrelin	At enrollment	Serum levels of ghrelin.
Leptin	At enrollment	Serum levels of leptin.
Daily intake of energy and nutrients	At enrollment	The daily intake of energy (kcal) and nutrients will be carried out through a 7-day food diary.
RAGE expression in peripheral blood mononuclear cells	At enrollment	The expressione of the AGEs receptor in peripheral blood mononuclear cells.
Soluble form of RAGE expression	At enrollment	The expressione of the AGEs receptor in the serum.
Oxidative stress	At enrollment	Oxidative stress biomarkers.
Interleukin-6	At enrollment	Serum levels of Interleukin-6.

Trial Locations

Locations (1)

Department of Traslational Medical Science - University of Naples Federico II; 🇮🇹 Naples, Italy