Synergistic Activity of Human Milk Nutrients and Infant Cognition

Breastfeeding, Exclusive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03838536
• Other study ID #: 18-2216
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2019
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Carol L Cheatham, PhD
• Phone: 704-250-5010
• Email: carol_cheatham[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding, Exclusive

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
United States	Nutrition Research Institute	Kannapolis	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Egg Nutrition Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bayley Scales of Infant Development (BSID)	BSID administered at 4.5 months	6 weeks (at 4.5 months of age)
Primary	Recognition Memory in an Oddball Task	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.	13 weeks (at 6 months of age)