The UFIM (Ultraprocessed Foods In Breast Milk) Project (UFIM)

ASSESSMENT OF THE PRESENCE OF DERIVATIVES OF ULTRA-PROCESSED FOODS IN BREAST MILK- The UFIM (Ultraprocessed Foods In Breast Milk) Project

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.

Study Overview

• Status: Recruiting
• Conditions: Child Malnutrition; Maternal Exposure; Child Allergy

• Study Type: Observational
• Enrollment (Estimated): 300

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: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary intake of UPF in lactating women	A 7-day food diary will be used for the evaluation of UPF dietary intake through the NOVA classification system.	36 months
Dietary intake of AGEs in lactating women	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.	36 months
Skin AGEs accumulation levels in lactating women	The non-invasive device AGEs reader will be used to evaluate the skin AGEs accumulation levels in lactating women.	36 months

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Estimated): May 23, 2026
• Study Completion (Estimated): May 23, 2026

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Child Nutrition Disorders
• Other Study ID Numbers: 163/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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