<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03838536</url>
  </required_header>
  <id_info>
    <org_study_id>18-2216</org_study_id>
    <nct_id>NCT03838536</nct_id>
  </id_info>
  <brief_title>Synergistic Activity of Human Milk Nutrients and Infant Cognition</brief_title>
  <official_title>Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Egg Nutrition Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and&#xD;
      infants with nutrients that support optimal brain development. There will be 84 breastfeeding&#xD;
      dyads, 3 months postnatal.&#xD;
&#xD;
      Mothers will be randomized to a whole egg or egg white (due to lack of an appropriate control&#xD;
      food). Initial diet intake will be screened using the NDSR. Participants will come to the lab&#xD;
      3 times across 3 months (age 3 months, 4.5 months, and 6 months). Milk, saliva, and plasma&#xD;
      will be collected from the mother, while saliva and plasma (heel stick) are collected from&#xD;
      the infant. Diet data will be collected at each visit. The infant will complete a recognition&#xD;
      memory test using electrophysiology at 6 months as well as the Bayley Scales of Infant&#xD;
      Development at 4.5 months. The mother will complete a temperament questionnaire at 3 months&#xD;
      and 6 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 5, 2019</start_date>
  <completion_date type="Anticipated">February 2025</completion_date>
  <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will be randomized to whole egg or egg white powder to consume throughout the study.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
    <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).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Recognition Memory in an Oddball Task</measure>
    <time_frame>13 weeks (at 6 months of age)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Bayley Scales of Infant Development (BSID)</measure>
    <time_frame>6 weeks (at 4.5 months of age)</time_frame>
    <description>BSID administered at 4.5 months</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Breastfeeding, Exclusive</condition>
  <arm_group>
    <arm_group_label>Whole egg powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are given whole egg powder which contains high levels of the nutrients choline, lutein, and docosahexaenoic acid.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Egg white powder</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The participants are given an egg white powder that does not contain the target nutrients (choline, lutein, and docosahexaenoic acid).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whole Egg Powder</intervention_name>
    <description>Breastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months.</description>
    <arm_group_label>Whole egg powder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Egg White Powder</intervention_name>
    <description>Breastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months.</description>
    <arm_group_label>Egg white powder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infant is 12-15 weeks of age at enrollment&#xD;
&#xD;
          -  healthy, lactating mother age 18-35&#xD;
&#xD;
          -  gave birth at &gt;38 weeks gestation without remarkable incident&#xD;
&#xD;
          -  consuming &lt;=50% of the recommended amounts of 2 of the 3, DHA, choline, and lutein&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infant with diagnosis or documented suspicion of developmental delay&#xD;
&#xD;
          -  egg allergy or family history of egg allergy&#xD;
&#xD;
          -  gestational diabetes&#xD;
&#xD;
          -  any documented seizure activity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carol L Cheatham, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor, University of North Carolina-Chapel Hill</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carol L Cheatham, PhD</last_name>
    <phone>704-250-5010</phone>
    <email>carol_cheatham@unc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Study Coordinator</last_name>
    <phone>704-250-5018</phone>
    <email>feedingbrains@unc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nutrition Research Institute</name>
      <address>
        <city>Kannapolis</city>
        <state>North Carolina</state>
        <zip>28081</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Carol L Cheatham, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>March 2, 2023</last_update_submitted>
  <last_update_submitted_qc>March 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breastfeeding</keyword>
  <keyword>Eggs</keyword>
  <keyword>Baby</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03838536
org study id: 18-2216
nct id: NCT03838536
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
primary purpose: Basic Science
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).
measure: Recognition Memory in an Oddball Task
time frame: 13 weeks (at 6 months of age)
description: 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.
measure: Bayley Scales of Infant Development (BSID)
time frame: 6 weeks (at 4.5 months of age)
description: BSID administered at 4.5 months
arm group label: Whole egg powder
arm group type: Experimental
description: Participants are given whole egg powder which contains high levels of the nutrients choline, lutein, and docosahexaenoic acid.
arm group label: Egg white powder
arm group type: Placebo Comparator
description: The participants are given an egg white powder that does not contain the target nutrients (choline, lutein, and docosahexaenoic acid).
intervention type: Dietary Supplement
intervention name: Whole Egg Powder
description: Breastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months.
arm group label: Whole egg powder
intervention type: Dietary Supplement
intervention name: Egg White Powder
description: Breastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months.
arm group label: Egg white powder
criteria: 
gender: All
minimum age: 3 Months
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carol L Cheatham, Ph.D.
role: Principal Investigator
affiliation: Associate Professor, University of North Carolina-Chapel Hill
last name: Carol L Cheatham, PhD
phone: 704-250-5010
email: carol_cheatham@unc.edu
last name: Study Coordinator
phone: 704-250-5018
email: feedingbrains@unc.edu
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Sponsor
sharing ipd: No