The Potential Role of Compounds Derived From Ultra-processed Foods in the Pathogenesis of Atopic Dermatitis in Pediatric Age (UPAD Project)

The Potential Role of Compounds Derived From Ultra-processed Foods in the Pathogenesis: the UPAD Project

Atopic dermatitis (AD) is a common chronic inflammatory skin condition, primarily affecting children in urban and high-income areas. Its prevalence has increased significantly over the past 30 years, with up to 20% of children affected, often within their first year of life. AD is characterized by erythematous, scaly, pruritic lesions, xerosis, and frequent atopy, with distinct clinical features in children compared to adults.

The pathophysiology of AD involves skin barrier dysfunction, immune response alterations, and environmental triggers. Genetic factors, particularly mutations in the filaggrin gene, play a significant role in severe AD, leading to increased water loss and skin dehydration. Immunologically, a Th2-predominant response drives inflammation, and environmental exposures, such as air pollutants and irritants, exacerbate the condition.

Recent studies suggest that dietary habits, particularly a high intake of ultra-processed foods (UPFs), may contribute to AD by activating inflammatory pathways. UPFs, rich in advanced glycation end products (AGEs), induce oxidative stress and inflammation, potentially worsening skin damage. This study aims to explore the potential role of UPF-derived compounds, especially AGEs, in the pathogenesis of pediatric AD.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Evaluation of dietary consumption of UPFs

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • Department of Traslational Medical Science - University of Naples Federico II
    • Contact: Roberto Berni Canani, MD, PhD; Phone Number: 0817462680; Email: berni@unina.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Caucasian subjects of both sexes, aged ≥6 and ≤10 years, with a diagnosis of atopic dermatitis, and healthy controls matched for age and sex without atopic dermatitis, recruited from the Pediatric Outpatient Clinics of the University Hospital "Federico II".

Description

Inclusion Criteria:

• Caucasian subjects, both sexes, age: ≥6 months and ≤10 years, with a confirmed diagnosis of atopic dermatitis, and healthy controls matched for age and sex without atopic dermatitis;
• Written informed consent obtained from the participants and/or their parents/legal guardians.

Exclusion Criteria:

• Non-Caucasian ethnicity; age < 6 or > 10 years
• Presence of other chronic conditions: hypereosinophilic syndrome, fungal or viral infections, connective tissue disorders, autoimmune diseases, vasculitis, bullous dermatoses (e.g., pemphigus), drug hypersensitivity reactions, graft-versus-host disease, monogenic disorders (e.g., Marfan syndrome type 2, Hyper-IgE syndrome)
• Presence of scars, nevi, or unusual skin lesions on both forearms
• Absence of written informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric patients with AD; Pediatric patients with a confirmed diagnosis of atopic dermatitis	Other: Evaluation of dietary consumption of UPFs; Evaluation of dietary consumption of ultraprocessed foods
Healthy controls; healthy controls matched for age and sex without atopic dermatitis	Other: Evaluation of dietary consumption of UPFs; Evaluation of dietary consumption of ultraprocessed foods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparative evaluation of dietary consumption of ultraprocessed foods (UPFs)	Comparative evaluation of dietary consumption of UPFs in patients aged from 6 months to 10 years diagnosed with AD and in healthy controls matched for age and sex	First year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparative evaluation of dietary consumption of dietary advanced glycation end products (AGEs)	Comparative evaluation of dietary consumption of dietary AGEs in patients aged from 6 months to 10 years diagnosed with AD and in healthy controls matched for age and sex	First year
Assessment of skin AGEs accumulation level	Evaluation of subcutaneous AGEs concentrations in patients aged from 6 months to 10 years diagnosed with AD and in healthy controls matched for age and sex	First year
Assessment of the effects of AGEs on the expression of tight junction proteins in human keratinocytes	Assessment of the effects of AGEs on the expression of tight junction proteins in human keratinocytes, both under basal conditions and after in vitro stimulation with AGEs	Second year
Evaluation of transepidermal water loss (TEWL)	TEWL assessment	First year
Effects of AGEs intake on SCORAD/EASI scores	Correlation between AGEs intake and Scoring Atopic Dermatitis (SCORAD Score 0 absent - 130 severe) and Eczema Area and Severity Index (EASI Score 0 absent - 72 severe)	First year

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Actual): January 10, 2025
• Study Completion (Estimated): January 10, 2026

Study Registration Dates

• First Submitted: May 21, 2025
• First Submitted That Met QC Criteria: May 21, 2025
• First Posted (Actual): May 30, 2025

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: 163/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No