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NCT Number: NCT03838536

Synergistic Activity of Human Milk Nutrients and Infant Cognition

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.

Recruiting

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Key information

Age range

3 month–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location status: Recruiting

Location contact

Carol L Cheatham, Ph.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole egg powder

Dietary Supplement

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

Egg White Powder

Dietary Supplement

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

Primary outcomes

  1. Recognition Memory in an Oddball Task

    Time frame: 13 weeks (at 6 months of age)

    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.

Other outcomes

  1. Bayley Scales of Infant Development (BSID)

    Time frame: 6 weeks (at 4.5 months of age)

    BSID administered at 4.5 months

Study contacts

Contact information is provided by the study sponsor or research team.

Carol L Cheatham, PhD

CONTACT

[email protected]

704-250-5010

Study Coordinator

CONTACT

[email protected]

704-250-5018

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Egg Nutrition Center

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2019
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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