Synergistic Activity of Human Milk Nutrients and Infant Cognition

NCT03838536 | Recruiting

• 1 other identifier: 18-2216
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Keywords

Breastfeeding; Eggs; Baby

Outcome Measures

Primary Outcomes (1)

• Recognition Memory in an Oddball Task

  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.

  13 weeks (at 6 months of age)

Other Outcomes (1)

• Bayley Scales of Infant Development (BSID)

  6 weeks (at 4.5 months of age)

Study Arms (2)

Whole egg powder

EXPERIMENTAL

Participants are given whole egg powder which contains high levels of the nutrients choline, lutein, and docosahexaenoic acid.

Dietary Supplement: Whole Egg Powder

Egg white powder

PLACEBO COMPARATOR

The participants are given an egg white powder that does not contain the target nutrients (choline, lutein, and docosahexaenoic acid).

Dietary Supplement: Egg White Powder

Interventions

Whole Egg Powder DIETARY_SUPPLEMENT

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

Whole egg powder

Egg White Powder DIETARY_SUPPLEMENT

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

Egg white powder

Eligibility Criteria

• Age: 3 Months - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• infant with diagnosis or documented suspicion of developmental delay
• egg allergy or family history of egg allergy
• gestational diabetes
• any documented seizure activity

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Egg Nutrition Center: collaborator

Study Sites (1)

Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Carol L Cheatham, Ph.D.

  Associate Professor, University of North Carolina-Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol L Cheatham, PhD

CONTACT

704-250-5010; carol_cheatham@unc.edu

Study Coordinator

CONTACT

704-250-5018; feedingbrains@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be given a jar of egg powder without labeling and they will not be aware of which they receive (egg white or whole egg).
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to whole egg or egg white powder to consume throughout the study.

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 12, 2019
• Study Start: February 5, 2019
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)