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NCT Number: NCT05554016

The UFO (Ultra Processed Foods in Obesity) Project

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

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Key information

Conditions

Obesity, Morbid Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

Location status: Recruiting

Location contact

Roberto Berni Canani, MD, PhD

CONTACT

[email protected]

0817462680

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Dietary UPF intake

    Time frame: At enrollment

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

Secondary outcomes

  1. Daily intake of energy and nutrients

    Time frame: At enrollment

    The daily intake of energy (kcal) and nutrients will be carried out through a 7-day food diary.

  2. Daily dietary intake of AGEs

    Time frame: At enrollment

    The intake of Advanced Glycation Endproducts (mostly present in UPFs).

  3. Skin AGEs levels

    Time frame: At enrollment

    The skin accumulation of AGEs in the subcutaneous.

  4. RAGE expression in peripheral blood mononuclear cells

    Time frame: At enrollment

    The expressione of the AGEs receptor in peripheral blood mononuclear cells.

  5. Soluble form of RAGE expression

    Time frame: At enrollment

    The expressione of the AGEs receptor in the serum.

  6. Mitochondrial metabolism

    Time frame: At enrollment

    The mitochondrial metabolism through the Seahorse XFp analyzer.

  7. Oxidative stress

    Time frame: At enrollment

    Oxidative stress biomarkers.

  8. Interleukin-6

    Time frame: At enrollment

    Serum levels of Interleukin-6.

  9. MicroRNA-221 expression

    Time frame: At enrollment

    MicroRNA-221 expression in peripheral blood mononuclear cells.

  10. Leptin

    Time frame: At enrollment

    Serum levels of leptin.

  11. Ghrelin

    Time frame: At enrollment

    Serum levels of ghrelin.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Acronym: UFO Project

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Sep 26, 2022
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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