Investigating the impact of ultra-processed foods on breast milk composition
ASSESSMENT OF THE PRESENCE OF DERIVATIVES OF ULTRA-PROCESSED FOODS IN BREAST MILK- The UFIM (Ultraprocessed Foods In Breast Milk) Project
This study looks at how eating a lot of ultra-processed foods affects the nutrients in breast milk and what that might mean for babies' health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT05889520 on ClinicalTrials.gov |
What this trial studies
This observational project examines the relationship between maternal consumption of ultra-processed foods and the composition of breast milk. It focuses on how dietary exposure to advanced glycation end-products (AGEs) may influence child health outcomes, particularly in relation to malnutrition and allergies. The study aims to gather data on the presence of UPF derivatives in breast milk, which has not been previously documented. By analyzing the dietary habits of breastfeeding Caucasian women, the research seeks to understand the implications of maternal diet on infant health.
Who should consider this trial
Good fit: Ideal candidates for this study are Caucasian women who are exclusively breastfeeding full-term infants.
Not a fit: Patients who may not benefit include non-Caucasian women, those with preterm infants, or mothers with certain chronic health conditions.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary guidelines for pregnant and breastfeeding women, potentially enhancing infant health outcomes.
How similar studies have performed: While there is emerging evidence regarding the effects of maternal diet on infant health, this specific investigation into UPFs and breast milk composition is novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Naples
- Department of Traslational Medical Science - University of Naples Federico II — Naples, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.