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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06996327
Acronym
UPAD Project
Enrollment
100
Registered
2025-05-30
Start date
2024-01-10
Completion date
2026-01-10
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

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.

Interventions

OTHEREvaluation of dietary consumption of UPFs

Evaluation of dietary consumption of ultraprocessed foods

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparative evaluation of dietary consumption of ultraprocessed foods (UPFs)First yearComparative 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

Secondary

MeasureTime frameDescription
Assessment of the effects of AGEs on the expression of tight junction proteins in human keratinocytesSecond yearAssessment 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
Effects of AGEs intake on SCORAD/EASI scoresFirst yearCorrelation 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)
Evaluation of transepidermal water loss (TEWL)First yearTEWL assessment
Comparative evaluation of dietary consumption of dietary advanced glycation end products (AGEs)First yearComparative 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
Assessment of skin AGEs accumulation levelFirst yearEvaluation 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026