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NCT03838536NARecruitingAccepts Healthy Volunteers

Synergistic Activity of Human Milk Nutrients and Infant Cognition

University of North Carolina, Chapel Hill

Start Date

2/5/2019

Completion Date

3/1/2027

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.

Eligibility Criteria

Age Range: No minimum to 35 years

Inclusion Criteria: * 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 Exclusion Criteria: * infant with diagnosis or documented suspicion of developmental delay * egg allergy or family history of egg allergy * gestational diabetes * any documented seizure activity

Interventions

DIETARY_SUPPLEMENT

Whole Egg Powder

DIETARY_SUPPLEMENT

Egg White Powder

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Conditions

Breastfeeding, Exclusive

Locations

Nutrition Research Institute

Kannapolis, North Carolina 28081

United States