RecruitingNot ApplicableNCT03838536

Synergistic Activity of Human Milk Nutrients and Infant Cognition

Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study


Sponsor

University of North Carolina, Chapel Hill

Enrollment

84 participants

Start Date

Feb 5, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 MonthsMax Age: 35 Years

Inclusion Criteria4

  • 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 Criteria4

  • infant with diagnosis or documented suspicion of developmental delay
  • egg allergy or family history of egg allergy
  • gestational diabetes
  • any documented seizure activity

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Interventions

DIETARY_SUPPLEMENTWhole Egg Powder

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

DIETARY_SUPPLEMENTEgg White Powder

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


Locations(1)

Nutrition Research Institute

Kannapolis, North Carolina, United States

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NCT03838536


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