Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03838536
NA

Synergistic Activity of Human Milk Nutrients and Infant Cognition

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Months - 35 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2019-02-05

Completion Date

2026-03

Last Updated

2025-03-11

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Nutrition Research Institute

Kannapolis, North Carolina, United States