Actively Recruiting
Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study
Led by University of North Carolina, Chapel Hill · Updated on 2026-04-20
84
Participants Needed
1
Research Sites
N/A
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
This research aims to evaluate whether supplementing breastfeeding mothers and their infants with whole egg powder, rich in nutrients like choline, lutein, and docosahexaenoic acid, supports optimal brain development. The study involves 84 mother-infant pairs, focusing on infants 3 months postnatal, comparing whole egg powder to egg white powder as a control. The purpose is to understand the combined activity of these nutrients in human milk and their impact on infant cognition. Participants are randomly assigned to receive either whole egg powder or egg white powder, with mothers consuming the equivalent of five servings per week for three months. Visits to the lab occur three times at infant ages 3 months, 4.5 months, and 6 months. During these visits, various samples including milk, saliva, and plasma are collected from mothers, while saliva and plasma are collected from infants. Diet intake is monitored via questionnaires and screening tools throughout the study. Infants undergo a recognition memory test using electrophysiology at 6 months and are assessed with the Bayley Scales of Infant Development at 4.5 months. Mothers complete temperament questionnaires at 3 and 6 months. Researchers track dietary intake, biological samples, and developmental outcomes to measure the effects of the nutrient supplements. The total study duration for each dyad spans three months, with detailed monitoring and assessments at each visit.
CONDITIONS
Brief 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 gestation without notable complications
- Mother consumes 50% or less of recommended amounts of at least two of these nutrients: DHA, choline, lutein
You will not qualify if you...
- Infant has a diagnosis or documented suspicion of developmental delay
- Either mother or infant has egg allergy or family history of egg allergy
- Mother has gestational diabetes
- Any documented seizure activity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Breastfeeding mothers consume either whole egg powder or egg white powder for 3 months to evaluate the impact on infant cognitive development.
Periodic visits during the 3-month intervention
Duration - 1 visit at 6 months of age
Participants' infants undergo cognitive assessment at 6 months of age to measure recognition memory.
1 visit (in-person)
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
S
Study Coordinator
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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