Synergistic Activity of Human Milk Nutrients and Infant Cognition

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

Qualifiers

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

Treatments tested in this trial

  • Whole Egg Powder
  • Egg White Powder

Treatment groups

84 Participants
are divided into 2 treatment groups

Sponsors and collaborators