The UFIM (Ultraprocessed Foods In Breast Milk) Project

Child Malnutrition Clinical Trial

— UFIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05889520
• Other study ID #: 163/2023
• Status: Recruiting
• Start date: May 23, 2023
• Est. completion date: May 23, 2026

Study information

• Verified date: June 2023
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 23, 2026
• Est. primary completion date: May 23, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Malnutrition
• Child Nutrition Disorders
• Malnutrition
• Maternal Exposure

Locations

Country	Name	City	State
Italy	Department of Traslational Medical Science - University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the presence of the major UPFs-derived compounds AGEs in breast milk	Through the liquid chromatography with triple quadrupole mass spectrometric detection techniques (LC-MS/MS) will be assessed the quantity of AGEs in breast milk.	36 months
Secondary	Dietary intake of UPF in lactating women	A 7-day food diary will be used for the evaluation of UPF dietary intake through the NOVA classification system.	36 months
Secondary	Dietary intake of AGEs in lactating women	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.	36 months
Secondary	Skin AGEs accumulation levels in lactating women	The non-invasive device AGEs reader will be used to evaluate the skin AGEs accumulation levels in lactating women.	36 months