Recruiting

Human Milk Nutrients

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT03838536

Conditions

Breastfeeding, Exclusive

Eligibility Criteria

Sex: All

Age: 0 - 35

Healthy Volunteers: Accepted

Interventions

Whole Egg Powder

Egg White Powder

Study Details

Brief 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

Study ID

NCT03838536

Start date

Feb 5, 2019

Status verified date

Apr, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 35

Healthy Volunteers: Accepted

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

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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).

Interventions

Whole Egg Powder

Breastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months.

Egg White Powder

Breastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months.

Primary outcome measure

  • Recognition Memory in an Oddball Task [ Time Frame: 13 weeks (at 6 months of age) ]

Central Contacts and Locations

Central contacts

Carol L Cheatham, PhD

704-250-5010carol_cheatham@unc.edu

Study Coordinator

704-250-5018feedingbrains@unc.edu

Locations

Nutrition Research Institute

Recruiting

Kannapolis, North Carolina, United States, 28081

Principal Investigator:

Carol L Cheatham, Ph.D.

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

  • Breastfeeding
  • Eggs
  • Baby

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-04-20.