The UFIM (Ultraprocessed Foods In Breast Milk) Project

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-35
SponsorFederico II University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Non-Caucasian ethnicity;

Age <18 and >35 years;

Mothers of preterm children;

Non-exclusive breastfeeding;

Trial 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)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: Lactacting women who are breastfeeding full-term infants

Trial outcomes

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.

Time frame
36 months

Secondary outcomes

1

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.

Time frame
36 months
2

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.

Time frame
36 months
3

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.

Time frame
36 months

Other outcomes

Sponsors and contacts

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