The UFO (Ultra Processed Foods in Obesity) Project

Federico II University200 enrolled

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

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Obesity, Morbid Metabolic Syndrome

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Dietary UPF intake

The assessment of dietary UPF intake will be carried out through a 7-day food diary.

Time frame: At enrollment

Secondary Outcomes

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

The UFO (Ultra Processed Foods in Obesity) Project

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes