The UFIM (Ultraprocessed Foods In Breast Milk) Project

NCT ID: NCT05889520

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-23

Study Completion Date

2026-05-23

Brief Summary

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In last decades, a change in dietary habits has been observed in industrialized countries characterized by a drastic increase in the consumption of ultra-processed foods (UPF, Ultra-Processed Foods). As defined by the NOVA classification, UPFs are industrial formulations of food substances added with colourings, flavourings, emulsifiers, thickeners and other additives. Among the main compounds of UPFs are the advanced glycation end-products (AGEs). Increasing evidence suggests an association between dietary exposure to AGEs and the development of chronic non-communicable diseases, such as obesity and allergies, in the general population, through increased oxidative stress and inflammation. Preliminary evidence suggests that a maternal diet rich in AGEs during pregnancy and lactation could negatively influence the composition of breast milk and have a negative impact on the infants health. However, data regarding the presence of derivatives of UPFs in breast milk are not available. The UFIM (Ultraprocessed Foods In Breast Milk) study aims at evaluate the presence of UPFs-derivatives compounds in breast milk.

Detailed Description

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Conditions

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Child Malnutrition Child Allergy Maternal Exposure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lactacting women who are breastfeeding full-term infants

Caucasian women aged between 18 and 35 who are breastfeeding full-term infants observed at Pediatrics Section of Department of Translational Medical Sciences (University of Naples Federico II)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Caucasian women who are breastfeeding full-term infants

Exclusion Criteria

* Non-Caucasian ethnicity;
* Age \<18 and \>35 years;
* Mothers of preterm children;
* Non-exclusive breastfeeding;
* Mothers suffering from chronic, malignancies, immunodeficiencies, chronic infections, autoimmune, inflammatory bowel disease, celiac disease, genetic-metabolic diseases, cystic fibrosis and other chronic lung diseases, cardiovascular / respiratory / intestinal malformations, neuropsychiatric disorders and pathologies neurological, vegetarian and vegan diet;
* Mothers with tattoos, scars, moles or skin lesions on both forearms.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Roberto Berni Canani, MD, PhD

Medical Doctor, Doctor of Philosophy, Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Traslational Medical Science - University of Naples Federico II

Naples, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Roberto Berni Canani, MD, PhD

Role: primary

0817462680

Other Identifiers

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163/2023

Identifier Type: -

Identifier Source: org_study_id

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