Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT05889520
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2023-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The UFIM (Ultraprocessed Foods In Breast Milk) Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015362', 'term': 'Child Nutrition Disorders'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-05-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2023-05-26', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the presence of the major UPFs-derived compounds AGEs in breast milk', 'timeFrame': '36 months', 'description': 'Through the liquid chromatography with triple quadrupole mass spectrometric detection techniques (LC-MS/MS) will be assessed the quantity of AGEs in breast milk.'}], 'secondaryOutcomes': [{'measure': 'Dietary intake of UPF in lactating women', 'timeFrame': '36 months', 'description': 'A 7-day food diary will be used for the evaluation of UPF dietary intake through the NOVA classification system.'}, {'measure': 'Dietary intake of AGEs in lactating women', 'timeFrame': '36 months', 'description': '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.'}, {'measure': 'Skin AGEs accumulation levels in lactating women', 'timeFrame': '36 months', 'description': 'The non-invasive device AGEs reader will be used to evaluate the skin AGEs accumulation levels in lactating women.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Child Malnutrition', 'Child Allergy', 'Maternal Exposure']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Caucasian women aged between 18 and 35 who are breastfeeding full-term infants observed at Pediatrics Section of Department of Translational Medical Sciences (University of Naples Federico II)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCaucasian women who are breastfeeding full-term infants\n\nExclusion Criteria:\n\n* Non-Caucasian ethnicity;\n* Age \\<18 and \\>35 years;\n* Mothers of preterm children;\n* Non-exclusive breastfeeding;\n* 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;\n* Mothers with tattoos, scars, moles or skin lesions on both forearms.'}, 'identificationModule': {'nctId': 'NCT05889520', 'acronym': 'UFIM', 'briefTitle': 'The UFIM (Ultraprocessed Foods In Breast Milk) Project', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'ASSESSMENT OF THE PRESENCE OF DERIVATIVES OF ULTRA-PROCESSED FOODS IN BREAST MILK- The UFIM (Ultraprocessed Foods In Breast Milk) Project', 'orgStudyIdInfo': {'id': '163/2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lactacting women who are breastfeeding full-term infants', 'description': 'Caucasian women aged between 18 and 35 who are breastfeeding full-term infants observed at Pediatrics Section of Department of Translational Medical Sciences (University of Naples Federico II)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Berni Canani, MD, PhD', 'role': 'CONTACT', 'email': 'berni@unina.it', 'phone': '0817462680'}], 'facility': 'Department of Traslational Medical Science - University of Naples Federico II', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Doctor of Philosophy, Full Professor', 'investigatorFullName': 'Roberto Berni Canani, MD, PhD', 'investigatorAffiliation': 'Federico II University'}}}}