Synergistic Activity of Human Milk Nutrients and Infant Cognition

Not Applicable

Recruiting

• Conditions: Breastfeeding, Exclusive
• Interventions: Dietary Supplement: Egg White Powder; Dietary Supplement: Whole Egg Powder

• Registration Number: NCT03838536
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-05
• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-02-11
• Study First Posted: 2019-02-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Egg white powder	Egg White Powder	The participants are given an egg white powder that does not contain the target nutrients (choline, lutein, and docosahexaenoic acid).
Whole egg powder	Whole Egg Powder	Participants are given whole egg powder which contains high levels of the nutrients choline, lutein, and docosahexaenoic acid.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nutrition Research Institute; 🇺🇸 Kannapolis, North Carolina, United States