Synergistic Activity of Human Milk Nutrients and Infant Cognition

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breastfeeding, Exclusive
• Intervention / Treatment: Dietary supplement: Whole Egg Powder; Dietary supplement: Egg White Powder

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 704-250-5018; Email: feedingbrains@unc.edu
• Study Contact Backup: Name: Carol L Cheatham, PhD; Phone Number: 704-250-5010; Email: carol_cheatham@unc.edu

Study Locations

• United States
  • North Carolina
    • Kannapolis, North Carolina, United States, 28081
      • Recruiting
      • Nutrition Research Institute
      • Principal Investigator: Carol L Cheatham, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 35 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole egg powder; Participants are given whole egg powder which contains high levels of the nutrients choline, lutein, and docosahexaenoic acid.	Dietary supplement: Whole Egg Powder; Breastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months.
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).	Dietary supplement: Egg White Powder; Breastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bayley Scales of Infant Development (BSID)	BSID administered at 4.5 months	6 weeks (at 4.5 months of age)

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Egg Nutrition Center
• Investigators: Principal Investigator: Carol L Cheatham, Ph.D., Associate Professor, University of North Carolina-Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2019
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Breastfeeding; Eggs; Baby
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding
• Other Study ID Numbers: 18-2216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No