The UFIM (Ultraprocessed Foods In Breast Milk) Project

Recruiting

• Conditions: Maternal Exposure; Child Allergy; Child Malnutrition

• Registration Number: NCT05889520
• Lead Sponsor: Federico II University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-23
• Study First Submitted: 2023-05-26
• Study First Submitted QC: 2023-05-26
• Status Verified: 2023-06
• Study First Posted: 2023-06-05
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-08
• Primary Completion: 2026-05-23
• Study Completion: 2026-05-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the presence of the major UPFs-derived compounds AGEs in breast milk	36 months	Through the liquid chromatography with triple quadrupole mass spectrometric detection techniques (LC-MS/MS) will be assessed the quantity of AGEs in breast milk.

Secondary Outcome Measures

Name	Time	Method
Skin AGEs accumulation levels in lactating women	36 months	The non-invasive device AGEs reader will be used to evaluate the skin AGEs accumulation levels in lactating women.
Dietary intake of AGEs in lactating women	36 months	A 7-day food diary will be used for the evaluation of AGEs dietary intake through a reference database reporting the presence of AGEs in food.
Dietary intake of UPF in lactating women	36 months	A 7-day food diary will be used for the evaluation of UPF dietary intake through the NOVA classification system.

Trial Locations

Locations (1)

Department of Traslational Medical Science - University of Naples Federico II; 🇮🇹 Naples, Italy