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Synergistic Activity of Human Milk Nutrients and Infant Cognition (ICAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Egg Nutrition Center
Information provided by (Responsible Party):
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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to whole egg or egg white powder to consume throughout the study.
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  • BMI>29.9 in mother
  • egg allergy or family history of egg allergy
  • gestational diabetes
  • any documented seizure activity

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Nutrition Research Institute
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Egg Nutrition Center
Investigators
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Principal Investigator: Carol L Cheatham, Ph.D. Associate Professor, University of North Carolina-Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03838536    
Other Study ID Numbers: 18-2216
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Breastfeeding
Eggs
Baby