Exploring the effects of whole eggs on infant brain development
Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study
NA · University of North Carolina, Chapel Hill · NCT03838536
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 3 Months to 35 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill (other) |
| Locations | 1 site (Kannapolis, North Carolina) |
| Trial ID | NCT03838536 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with infants diagnosed with developmental delays or those with egg allergies will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kannapolis, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breastfeeding, Exclusive, Breastfeeding, Eggs, Baby