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Synergistic Activity of Human Milk Nutrients and Infant Cognition

NCT03838536 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-04-20

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Whole Egg Powder

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

DIETARY_SUPPLEMENT

Egg White Powder

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

Sponsors & Collaborators

  • Egg Nutrition Center

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Carol L Cheatham, Ph.D. · Associate Professor, University of North Carolina-Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-05
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03838536 on ClinicalTrials.gov