Synergistic Activity of Human Milk Nutrients and Infant Cognition (ICAN)
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|ClinicalTrials.gov Identifier: NCT03838536|
Recruitment Status : Suspended (Suspended with COVID-9 pandemic; will resume post-pandemic.)
First Posted : February 12, 2019
Last Update Posted : May 4, 2020
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 NCI's ASA24 24h Dietary Assessment Tool. Participants will come to the lab 4 times across 3 months (enrollment, 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 or disease||Intervention/treatment||Phase|
|Breastfeeding, Exclusive||Dietary Supplement: Whole Egg Powder Dietary Supplement: Egg White Powder||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomized to whole egg or egg white powder to consume throughout the study.|
|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).|
|Primary Purpose:||Basic Science|
|Official Title:||Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study|
|Actual Study Start Date :||February 5, 2019|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||February 2025|
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.
- Recognition Memory in an Oddball Task [ Time Frame: 6 minutes ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838536
|United States, North Carolina|
|Nutrition Research Institute|
|Kannapolis, North Carolina, United States, 28081|
|Principal Investigator:||Carol L Cheatham, Ph.D.||Associate Professor, University of North Carolina-Chapel Hill|