Clinical trial NCT05889520: The UFIM (Ultraprocessed Foods In Breast Milk) Project
Official title: ASSESSMENT OF THE PRESENCE OF DERIVATIVES OF ULTRA-PROCESSED FOODS IN BREAST MILK- The UFIM (Ultraprocessed Foods In Breast Milk) Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Child Malnutrition
Child Allergy
Maternal Exposure
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the presence of the major UPFs-derived compounds AGEs in breast milk
timeFrame: 36 months
Secondary outcomes:
measure: Dietary intake of UPF in lactating women
timeFrame: 36 months
measure: Dietary intake of AGEs in lactating women
timeFrame: 36 months
measure: Skin AGEs accumulation levels in lactating women
timeFrame: 36 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Traslational Medical Science - University of Naples Federico II
Study officials:
References: