The UFIM (Ultraprocessed Foods In Breast Milk) Project

ASSESSMENT OF THE PRESENCE OF DERIVATIVES OF ULTRA-PROCESSED FOODS IN BREAST MILK- The UFIM (Ultraprocessed Foods In Breast Milk) Project

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05889520

Acronym

UFIM

Enrollment

300

Registered

2023-06-05

Start date

2023-05-23

Completion date

2026-05-23

Last updated

2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Allergy, Child Malnutrition, Maternal Exposure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the presence of the major UPFs-derived compounds AGEs in breast milk	36 months	Through the liquid chromatography with triple quadrupole mass spectrometric detection techniques (LC-MS/MS) will be assessed the quantity of AGEs in breast milk.

Secondary

Measure	Time frame	Description
Dietary intake of UPF in lactating women	36 months	A 7-day food diary will be used for the evaluation of UPF dietary intake through the NOVA classification system.
Dietary intake of AGEs in lactating women	36 months	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.
Skin AGEs accumulation levels in lactating women	36 months	The non-invasive device AGEs reader will be used to evaluate the skin AGEs accumulation levels in lactating women.

Countries

Italy

Outcome results