The UFO (Ultra Processed Foods in Obesity) Project

Metabolic Syndrome Clinical Trial

— UFO Project  

Official title:

The UFO (Ultra Processed Foods in Obesity) Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05554016
• Other study ID #: 00019173
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: January 2023
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity
• Obesity, Morbid

Locations

Country	Name	City	State
Italy	Department of Traslational Medical Science - University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

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