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NCT Number: NCT05889520

The UFIM (Ultraprocessed Foods In Breast Milk) Project

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.

Recruiting

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

Location status: Recruiting

Location contact

Roberto Berni Canani, MD, PhD

CONTACT

[email protected]

0817462680

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. To evaluate the presence of the major UPFs-derived compounds AGEs in breast milk

    Time frame: 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 outcomes

  1. Dietary intake of UPF in lactating women

    Time frame: 36 months

    A 7-day food diary will be used for the evaluation of UPF dietary intake through the NOVA classification system.

  2. Dietary intake of AGEs in lactating women

    Time frame: 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.

  3. Skin AGEs accumulation levels in lactating women

    Time frame: 36 months

    The non-invasive device AGEs reader will be used to evaluate the skin AGEs accumulation levels in lactating women.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: UFIM

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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