The UFIM (Ultraprocessed Foods In Breast Milk) Project

NCT05889520 | Recruiting

• 1 other identifier: 163/2023
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Malnutrition; Child Allergy; Maternal Exposure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Dietary intake of UPF in lactating women

  36 months

• Dietary intake of AGEs in lactating women

  36 months

• Skin AGEs accumulation levels in lactating women

  36 months

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

• Caucasian women who are breastfeeding full-term infants

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Doctor of Philosophy, Full Professor

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 5, 2023
• Study Start: May 23, 2023
• Primary Completion (Estimated): May 23, 2026
• Study Completion (Estimated): May 23, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)