Home › Breastfeeding › NCT03838536
Synergistic Activity of Human Milk Nutrients and Infant Cognition
Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study
Who can join
3 Months – 35 Years · All sexes · Healthy volunteers welcome
Full eligibility 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
About the study
Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. There will be 84 breastfeeding dyads, 3 months postnatal.
Mothers will be randomized to a whole egg or egg white (due to lack of an appropriate control food). Initial diet intake will be screened using the NDSR. Participants will come to the lab 3 times across 3 months (age 3 months, 4.5 months, and 6 months). Milk, saliva, and plasma will be collected from the mother, while saliva and plasma (heel stick) are collected from the infant. Diet data will be collected at each visit. The infant will complete a recognition memory test using electrophysiology at 6 months as well as the Bayley Scales of Infant Development at 4.5 months. The mother will complete a temperament questionnaire at 3 months and 6 months.
What is being tested
- Whole Egg Powder (dietary supplement)
- Egg White Powder (dietary supplement)
Sponsor: University of North Carolina, Chapel Hill · Participants: 84 · Started: Feb 5, 2019
Contact the study team
- Carol L Cheatham, PhD · Phone: 704-250-5010
- Study Coordinator · Phone: 704-250-5018
Official record on ClinicalTrials.gov — NCT03838536
Locations in the U.S.
| North Carolina | Nutrition Research Institute, Kannapolis |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.