Synergistic Activity of Human Milk Nutrients and Infant Cognition
NCT ID: NCT03838536
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
84 participants
INTERVENTIONAL
2019-02-05
2026-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Whole egg powder
Participants are given whole egg powder which contains high levels of the nutrients choline, lutein, and docosahexaenoic acid.
Whole Egg Powder
Breastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months.
Egg white powder
The participants are given an egg white powder that does not contain the target nutrients (choline, lutein, and docosahexaenoic acid).
Egg White Powder
Breastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months.
Interventions
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Whole Egg Powder
Breastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months.
Egg White Powder
Breastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months.
Eligibility Criteria
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Inclusion Criteria
* 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
* egg allergy or family history of egg allergy
* gestational diabetes
* any documented seizure activity
3 Months
35 Years
ALL
Yes
Sponsors
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Egg Nutrition Center
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Carol L Cheatham, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Associate Professor, University of North Carolina-Chapel Hill
Locations
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Nutrition Research Institute
Kannapolis, North Carolina, United States
Countries
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Central Contacts
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Other Identifiers
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18-2216
Identifier Type: -
Identifier Source: org_study_id
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