Nutrition Research Institute
Kannapolis, North Carolina, 28081, United States
Location status: Recruiting
Location contact
Carol L Cheatham, Ph.D.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT03838536
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.
Interested in participating?
Request Info3 month–35 year
All sexes
Interventional
Not applicable
Kannapolis, North Carolina, 28081, United States
Location status: Recruiting
Carol L Cheatham, Ph.D.
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Breastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months.
Breastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months.
Time frame: 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.
Time frame: 6 weeks (at 4.5 months of age)
BSID administered at 4.5 months
Contact information is provided by the study sponsor or research team.
Carol L Cheatham, PhD
CONTACT
Study Coordinator
CONTACT
University of North Carolina, Chapel Hill
Other
Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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