Actively Recruiting

Age: 18Years - 35Years
FEMALE
NCT05889520

The UFIM (Ultraprocessed Foods In Breast Milk) Project

Led by Federico II University · Updated on 2025-06-04

300

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The UFIM (Ultraprocessed Foods In Breast Milk) Project

Who Can Participate

Age: 18Years - 35Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Caucasian women who are breastfeeding full-term infants
  • Age between 18 and 35 years
  • Exclusive breastfeeding
Not Eligible

You will not qualify if you...

  • Non-Caucasian ethnicity
  • Age younger than 18 years or older than 35 years
  • Mothers of preterm infants
  • Non-exclusive breastfeeding
  • Mothers with chronic diseases, malignancies, immunodeficiencies, chronic infections, autoimmune diseases, inflammatory bowel disease, celiac disease, genetic-metabolic diseases, cystic fibrosis, chronic lung diseases, cardiovascular, respiratory, or intestinal malformations, neuropsychiatric or neurological disorders
  • Mothers following vegetarian or vegan diets
  • Mothers with tattoos, scars, moles, or skin lesions on both forearms

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Traslational Medical Science - University of Naples Federico II

Naples, Italy, 80131

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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