Synergistic Activity of Human Milk Nutrients and Infant Cognition

Recruiting now · Not applicable

Conditions studied: Breastfeeding, Exclusive

In brief

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.

Key facts

Study ID: NCT03838536
Run by: University of North Carolina, Chapel Hill
People needed: 84
Starts: 2019-02-05
Expected to finish: 2027-03-01
Last updated by the study team: 2026-04-20

Who can join

Age: 0 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

infant with diagnosis or documented suspicion of developmental delay
egg allergy or family history of egg allergy
gestational diabetes
any documented seizure activity

Where it is running

Nutrition Research Institute — Kannapolis, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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