The UFIM (Ultraprocessed Foods In Breast Milk) Project
Recruiting now
Conditions studied: Child Malnutrition, Child Allergy, Maternal Exposure
In brief
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.
Key facts
- Study ID
- NCT05889520
- Run by
- Federico II University
- People needed
- 300
- Starts
- 2023-05-23
- Expected to finish
- 2026-05-23
- Last updated by the study team
- 2025-06-04
Who can join
Age: 18 and older, up to 35. Sex: female. Healthy volunteers: not accepted.
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.
Where it is running
- Department of Traslational Medical Science - University of Naples Federico II — Naples, Italy (enrolling)
Full record on ClinicalTrials.gov
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