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Search / Trial NCT05889520

The UFIM (Ultraprocessed Foods In Breast Milk) Project

Launched by FEDERICO II UNIVERSITY · May 26, 2023

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

ClinConnect Summary

The UFIM (Ultraprocessed Foods In Breast Milk) Project is a clinical trial that aims to understand how the consumption of ultra-processed foods by mothers may affect the composition of breast milk. Ultra-processed foods are heavily modified foods that often contain artificial ingredients like colorings and preservatives. Research suggests that these foods can lead to health issues, such as obesity and allergies, especially in children. This study is particularly focused on determining whether certain compounds from these foods, known as advanced glycation end-products (AGEs), are present in breast milk and how they may influence infant health.

To participate in this study, mothers need to meet specific criteria: they must be Caucasian, between the ages of 18 and 35, and exclusively breastfeeding a full-term infant. Unfortunately, mothers who have certain health conditions, are non-Caucasian, or have tattoos and skin lesions on their forearms cannot participate. If eligible, participants can expect to provide breast milk samples for testing, contributing to important research that could help improve the health outcomes of infants. This trial is currently recruiting participants, and findings may lead to better dietary recommendations for pregnant and breastfeeding mothers in the future.

Gender

FEMALE

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.

About Federico Ii University

Federico II University, located in Naples, Italy, is a prestigious academic institution with a strong emphasis on advanced research and clinical innovation. As a clinical trial sponsor, the university is committed to fostering the development of novel therapeutic interventions and enhancing patient care through rigorous scientific inquiry. With a multidisciplinary approach, Federico II University collaborates with healthcare professionals, researchers, and industry partners to conduct high-quality clinical trials that adhere to ethical standards and regulatory requirements. Its dedication to improving health outcomes is reflected in its robust research programs and commitment to translating scientific findings into clinical practice.

Locations

Naples, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported