The UFIM (Ultraprocessed Foods In Breast Milk) Project

Federico II University

Status: Enrolling

Conditions: Child Malnutrition; Child Allergy; Maternal Exposure

Study type: Observational

Funder types: Other

Identifiers

NCT05889520

163/2023

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Lactacting women who are breastfeeding full-term infants

Description:

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)