Synergistic Activity of Human Milk Nutrients and Infant Cognition

Overview

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 NCI's ASA24 24h Dietary Assessment Tool. Participants will come to the lab 4 times across 3 months (enrollment, 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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 2024

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.

Arms, Groups and Cohorts

  • Experimental: Whole egg powder
    • Participants are given whole egg powder which contains high levels of the nutrients choline, lutein, and docosahexaenoic acid.
  • Placebo Comparator: Egg white powder
    • The participants are given an egg white powder that does not contain the target nutrients (choline, lutein, and docosahexaenoic acid).

Clinical Trial Outcome Measures

Primary Measures

  • Recognition Memory in an Oddball Task
    • Time Frame: 6 minutes
    • The difference in microvolts between the negative deflection to novel pictures and the negative deflection to familiar pictures at approximately 100-400ms after the pictures come on the screen will be measured in an event-related potentials (ERP) paradigm. The investigators hypothesize that the whole egg group will have better memory for the familiar pictures than the egg white group.

Participating in This Clinical Trial

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 – BMI>29.9 in mother – egg allergy or family history of egg allergy – gestational diabetes – any documented seizure activity

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of North Carolina, Chapel Hill
  • Collaborator
    • Egg Nutrition Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Carol Cheatham, PhD, Associate Professor of Psychology & Neuroscience – University of North Carolina, Chapel Hill
  • Overall Official(s)
    • Carol L Cheatham, Ph.D., Principal Investigator, Associate Professor, University of North Carolina-Chapel Hill

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