Synergistic Activity of Human Milk Nutrients and Infant Cognition

Part of paid clinical trials in Kannapolis, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT03838536
Status
Recruiting
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Conditions

  • Breastfeeding, Exclusive

Eligibility Criteria

Sex
ALL
Age
3 Months - 35 Years
Healthy Volunteers
Accepted

Interventions

  • Whole Egg Powder — DIETARY_SUPPLEMENT
    Breastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months.
  • Egg White Powder — DIETARY_SUPPLEMENT
    Breastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months.

Study Details

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.

Key Dates

Start date
Feb 5, 2019
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

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

Primary Outcome Measure

Recognition Memory in an Oddball Task [ Time Frame: 13 weeks (at 6 months of age) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nutrition Research InstituteKannapolisNorth Carolina28081
Carol L Cheatham, Ph.D. (PRINCIPAL_INVESTIGATOR)

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Nutrition Research Institute· Kannapolis, NC

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