Synergistic Activity of Human Milk Nutrients and Infant Cognition
ConditionBreastfeeding, Exclusive
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-35
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
infant with diagnosis or documented suspicion of developmental delay
egg allergy or family history of egg allergy
gestational diabetes
any documented seizure activity
Trial design
Design model
Parallel
Treatments tested in this trial
Whole Egg Powder
Dietary supplementBreastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months.
Egg White Powder
Dietary supplementBreastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Whole egg powderExperimental treatment 1 intervention
Group B: Egg white powderPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recognition Memory in an Oddball Task
The difference in microvolts between the negative deflection to novel pictures and the negative deflection to familiar pictures at approximately 100-400ms after the pictures come on the screen will be measured in an event-related potentials (ERP) paradigm. The investigators hypothesize that the whole egg group will have better memory for the familiar pictures than the egg white group.
Time frame
13 weeks (at 6 months of age)Other outcomes
1
Bayley Scales of Infant Development (BSID)
BSID administered at 4.5 months
Time frame
6 weeks (at 4.5 months of age)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
Egg Nutrition Center
Collaborator
Source ClinicalTrials.gov