NCT03838536

Synergistic Activity of Human Milk Nutrients and Infant Cognition

Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 3 Months – 35 Years
• Healthy volunteers: Accepted

Summary

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

• Breastfeeding, Exclusive

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Whole Egg Powder	Breastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months.
DIETARY_SUPPLEMENT	Egg White Powder	Breastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months.

Timeline

• Start date: 2019-02-05
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2019-02-12
• Last updated: 2025-03-11

Locations

1 site across 1 country: United States