Clinical trial Recruiting at 1 site Interventional Ages 3 Months to 35

Exploring the effects of whole eggs on infant brain development

Official title: Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study

Run by University of North Carolina, Chapel Hill · NCT03838536 · Data updated 2026-11-12

This study is testing whether giving whole egg powder to breastfeeding mothers can help improve their infants' brain development compared to egg white powder.

Quick facts

Study typeInterventional
Ages3 Months to 35 Years
SexAll
Enrollment84 (estimated)
SponsorUniversity of North Carolina, Chapel Hill
Academic / other
Locations1 site (Kannapolis, North Carolina)
StatusRecruiting
StartedFebruary 5, 2019
Main results expectedMarch 2027
Study endsMarch 2027
Registry record updatedApril 20, 2026
Trial IDNCT03838536 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include healthy, lactating mothers aged 18-35 with infants aged 12-15 weeks who are consuming less than the recommended amounts of DHA, choline, and lutein.

Probably not a fit

Patients with infants diagnosed with developmental delays or those with egg allergies will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the impact of whole egg consumption on the cognitive development of infants by supplementing breastfeeding mothers with nutrients that support brain growth. A total of 84 breastfeeding mother-infant pairs will be randomized to receive either whole egg powder or egg white powder. Participants will attend three lab visits over three months, during which various biological samples will be collected, and infants will undergo cognitive assessments. The study will also gather dietary intake data to assess the nutritional status of the mothers and infants.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of how specific nutrients from whole eggs can support optimal brain development in infants.

How similar studies have gone: While the specific approach of using whole eggs for cognitive development is novel, previous studies have shown the importance of nutrients like DHA and choline in infant brain health.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* infant is 12-15 weeks of age at enrollment
* healthy, lactating mother age 18-35
* gave birth at \>38 weeks gestation without remarkable incident
* consuming \<=50% of the recommended amounts of 2 of the 3, DHA, choline, and lutein

Exclusion Criteria:

* infant with diagnosis or documented suspicion of developmental delay
* egg allergy or family history of egg allergy
* gestational diabetes
* any documented seizure activity

Where it's running

  • Nutrition Research Institute
    Kannapolis, North Carolina, United States
    Recruiting

Study contacts

  • Principal investigator: Carol L Cheatham, Ph.D. — Associate Professor, University of North Carolina-Chapel Hill
  • Study coordinator: Carol L Cheatham, PhD
  • Email: carol_cheatham@unc.edu
  • Phone: 704-250-5010

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.