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Synergistic Activity of Human Milk Nutrients and Infant Cognition

University of North Carolina, Chapel Hill · with Egg Nutrition Center · NCT03838536

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 4 mo–35 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
84
US sites recruiting
1
Study start
February 5, 2019
Record last updated
April 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Whole Egg Powder; Egg White Powder

Conditions: Breastfeeding, Exclusive

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Nutrition Research Institute

    Kannapolis, NC 28081

    Site contact: Carol L Cheatham, Ph.D.

Study contacts (from the official record)

  • Carol L Cheatham, PhD · 704-250-5010 · carol_cheatham@unc.edu
  • Study Coordinator · 704-250-5018 · feedingbrains@unc.edu
All breastfeeding studies in North Carolina →
Synergistic Activity of Human Milk Nutrients and Infant Cognition (NCT03838536) | Bored Studies