Actively Recruiting
Synergistic Activity of Human Milk Nutrients and Infant Cognition
Led by University of North Carolina, Chapel Hill · Updated on 2026-04-20
84
Participants Needed
1
Research Sites
420 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
E
Egg Nutrition Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Synergistic Activity of Human Milk Nutrients and Infant Cognition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant is 12 to 15 weeks old at enrollment
- Healthy lactating mother aged 18 to 35 years
- Mother gave birth after more than 38 weeks of gestation without significant complications
- Mother consumes less than or equal to 50% of the recommended amounts of at least two of these nutrients: DHA, choline, and lutein
You will not qualify if you...
- Infant diagnosed with or suspected of developmental delay
- Egg allergy or family history of egg allergy
- Gestational diabetes
- Any documented seizure activity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nutrition Research Institute
Kannapolis, North Carolina, United States, 28081
Actively Recruiting
Research Team
C
Carol L Cheatham, PhD
CONTACT
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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