Child MalnutritionUFIMNCT05889520
The UFIM (Ultraprocessed Foods In Breast Milk) Project
An observational study of Child Malnutrition and Child Allergy, run by Federico II University at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Child Malnutrition, Child Allergy, Maternal Exposure
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 23 May 2023to 23 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: 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)
Who may be able to join
- Caucasian women who are breastfeeding full-term infants
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Traslational Medical Science - University of Naples Federico II
Naples, Naples, 80131
About this study
Official title: ASSESSMENT OF THE PRESENCE OF DERIVATIVES OF ULTRA-PROCESSED FOODS IN BREAST MILK- The UFIM (Ultraprocessed Foods In Breast Milk) Project
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
- Child Malnutrition, Child Allergy, Maternal Exposure
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lactacting women who are breastfeeding full-term infants | 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (3)
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.
Measured: 36 months
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.
Measured: 36 months
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start23 May 2023
- Primary completion23 May 2026
- Study completion23 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MalnutritionStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889520
- Sponsor's protocol ID
- 163/2023
- Acronym
- UFIM
- Status last verified
- Jun 2026
- First submitted
- 26 May 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF THE PRESENCE OF DERIVATIVES OF ULTRA-PROCESSED FOODS IN BREAST MILK- The UFIM (Ultraprocessed Foods In Breast Milk) Project
- ClinicalTrials.gov ID
- NCT05889520
- Acronym / sponsor ID
- UFIM / 163/2023
- Conditions
- Child Malnutrition, Child Allergy, Maternal Exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 23 May 2026 (actual)
- Study completion
- 23 May 2026 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactacting women who are breastfeeding full-term infants | – | –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) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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)
Key inclusion criteria (1 listed)
- Caucasian women who are breastfeeding full-term infants
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the presence of the major UPFs-derived compounds AGEs in breast milk
Time frame: 36 months
Through the liquid chromatography with triple quadrupole mass spectrometric detection techniques (LC-MS/MS) will be assessed the quantity of AGEs in breast milk.
3 secondary outcomes
Dietary intake of UPF in lactating women
Time frame: 36 months
Dietary intake of AGEs in lactating women
Time frame: 36 months
Skin AGEs accumulation levels in lactating women
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Malnutrition and Child Allergy, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the presence of the major UPFs-derived compounds AGEs in breast milk (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.