Synergistic Activity of Human Milk Nutrients and Infant Cognition

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Recruiting
CT.gov ID
NCT03838536
Collaborator
Egg Nutrition Center (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Whole Egg Powder
  • Dietary Supplement: Egg White Powder
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomized to whole egg or egg white powder to consume throughout the study.Participants will be randomized to whole egg or egg white powder to consume throughout the study.
Masking:
Single (Participant)
Masking Description:
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).
Primary Purpose:
Basic Science
Official Title:
Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study
Actual Study Start Date :
Feb 5, 2019
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Recognition Memory in an Oddball Task [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 Outcome Measures

  1. Bayley Scales of Infant Development (BSID) [6 weeks (at 4.5 months of age)]

    BSID administered at 4.5 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Months to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nutrition Research Institute Kannapolis North Carolina United States 28081

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill
  • Egg Nutrition Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carol Cheatham, PhD, Associate Professor of Psychology & Neuroscience, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT03838536
Other Study ID Numbers:
  • 18-2216
First Posted:
Feb 12, 2019
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Carol Cheatham, PhD, Associate Professor of Psychology & Neuroscience, University of North Carolina, Chapel Hill

Study Results

No Results Posted as of May 20, 2022