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Could junk food chemicals show up in breast milk?

NCT ID NCT05889520

Knowledge-focused Sponsor: Federico II University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

Researchers are testing whether compounds from ultra-processed foods, like additives and advanced glycation end-products (AGEs), can be found in breast milk. They will measure AGE levels in milk samples from 300 healthy nursing mothers and track their diets with a 7-day food diary. The goal is to see if a diet heavy in processed foods changes breast milk composition, which might affect infant health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
No intervention; observational study measuring advanced glycation end-products (AGEs) in breast milk
What this could lead to
If this study finds AGEs in breast milk, it could open the door to dietary advice for nursing mothers and future research on infant health.
What could go wrong
This is an early observational study, so it cannot prove cause and effect. The results may not apply to all mothers or infants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

300 people

The number who actually took part.

Started

May 2023

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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)

Ages

18 to 35 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Child Nutrition Disorders nutritional deficiency disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Child allergy Child malnutrition Maternal exposure

Contacts and locations

Locations

  • Department of Traslational Medical Science - University of Naples Federico II

    Naples, Naples, 80131, Italy

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