The UFO (Ultra Processed Foods in Obesity) Project

Study Overview
=================
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

Official Title
-----------------
The UFO (Ultra Processed Foods in Obesity) Project

Conditions
-----------------
Obesity, Morbid, Metabolic Syndrome

Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Pediatric patients with obesity | |
| Group 2<br>Pediatric patients with obesity complicated by Metabolic Syndrome | |
| Group 3<br>Age- and sex-matched healthy controls | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary UPF intake | The assessment of dietary UPF intake will be carried out through a 7-day food diary. | At enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Daily dietary intake of AGEs | The intake of Advanced Glycation Endproducts (mostly present in UPFs). | At enrollment | 
| Skin AGEs levels | The skin accumulation of AGEs in the subcutaneous. | At enrollment | 
| RAGE expression in peripheral blood mononuclear cells | The expressione of the AGEs receptor in peripheral blood mononuclear cells. | At enrollment | 
| Soluble form of RAGE expression | The expressione of the AGEs receptor in the serum. | At enrollment | 
| Mitochondrial metabolism | The mitochondrial metabolism through the Seahorse XFp analyzer. | At enrollment | 
| Oxidative stress | Oxidative stress biomarkers. | At enrollment | 
| Interleukin-6 | Serum levels of Interleukin-6. | At enrollment | 
| MicroRNA-221 expression | MicroRNA-221 expression in peripheral blood mononuclear cells. | At enrollment | 
| Leptin | Serum levels of leptin. | At enrollment | 
| Ghrelin | Serum levels of ghrelin. | At enrollment |