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Purpose

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

Eligibility

Eligible Ages
Between 3 Months and 35 Years
Eligible Sex
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

Study Design

Phase
N/A
Study Type
Interventional
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.
Primary Purpose
Basic Science
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).

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Nutrition Research Institute
Kannapolis, North Carolina 28081

More Details

Status
Recruiting
Sponsor
University of North Carolina, Chapel Hill

Study Contact

Carol L Cheatham, PhD
704-250-5010
carol_cheatham@unc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.