Clinical Trial

The UFIM (Ultraprocessed Foods In Breast Milk) Project

Study acronym: UFIM
Recruiting
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Record status
This record was last updated June 4, 2025 (before its estimated May 23, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-05-26; most recent amendment 2025-06-03.
Trial Details
NCT Number NCT05889520
Lead Sponsor Federico II University
Conditions Child Malnutrition, Child Allergy, Maternal Exposure
Enrollment 300 participants
Start Date 2023-05-23
Primary Completion 2026-05-23 (estimated)
Study Completion 2026-05-23 (estimated)
Updated on ClinicalTrials.gov 2025-06-04