<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/NCT02199808</url>
  </required_header>
  <id_info>
    <org_study_id>14-0198</org_study_id>
    <nct_id>NCT02199808</nct_id>
  </id_info>
  <brief_title>Fatty Acids and Executive Function Development in 7-12 Year Olds</brief_title>
  <official_title>Fatty Acids and Executive Functions: Cortical Activation and Behavioral Performance.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sigma Xi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: To examine the effect of the omega-6 to omega-3 fatty acid ratio on age-related&#xD;
      changes in executive functions in children and older adults.&#xD;
&#xD;
      Participants: Eighty-four typically-developing 7-to 12-year-old children.&#xD;
&#xD;
      Procedure (methods): Participants and a caregiver will participate in 4 sessions. Three&#xD;
      sessions will consist of the screening. These sessions will be telephone calls to collect&#xD;
      24-hour diet information that will be used to determine whether they are eligible for the&#xD;
      fourth session. Approximately 120 participants will be screened to find 84 participants who&#xD;
      are eligible for the fourth session, in which participants will complete a series of tests on&#xD;
      the Cambridge Neuropsychological Test Automated Battery (CANTAB) - a touch-screen device that&#xD;
      provides computerized versions of standardized cognitive tests. They will also complete a&#xD;
      maze task in which they figure out a path through the maze by walking on the correct squares.&#xD;
      Brain activity will be recorded using a portable near-infrared spectroscopy (NIRS) system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Error (count) and latency (in milliseconds) measures from executive function tasks</measure>
    <time_frame>One time with children who are 7-12 years old</time_frame>
    <description>For one specific aim, the omega-6 to omega-3 fatty acid ratio will be determined by summing the omega-6 and omega-3 fatty acid levels in plasma and dividing omega-6 fatty acids by omega-3 fatty acids. The calculated ratio will be used to predict error and latency scores on executive function tasks.&#xD;
For a second specific aim, the oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS) measurements will be used to predict the error and latency measures from executive function tasks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS)</measure>
    <time_frame>One time with children who are 7-12 years old.</time_frame>
    <description>Plasma levels of omega-6 and omega-3 fatty acids will be used to predict oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS) measurements in children who are 7-12 years old.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance on the Maze as measured by Noldus Ethovision</measure>
    <time_frame>One time with children who are 7-12 years old</time_frame>
    <description>Performance on the Maze as measured by Noldus Ethovision tracking system will be compared to performance on standardized measures of planning and spatial working memory.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">79</enrollment>
  <condition>Executive Function</condition>
  <arm_group>
    <arm_group_label>7-9 year olds</arm_group_label>
    <description>These are children who are between 7 and 9 years old when they are tested.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10-12 year olds</arm_group_label>
    <description>These are children who are between 10 and 12 years old when they are tested.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All participants will be typically-developing, healthy 7-to-12-year-olds who are fluent in&#xD;
        English. Every effort will be made to recruit roughly equal numbers of boys and girls.&#xD;
        Recruitment will be conducted irrespective of race and ethnicity. An attempt will be made&#xD;
        to match the sample to the race and ethnicity of the region: 80% White, 15%&#xD;
        African-American, and 5% Native American, Asian, and Other descent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Typically-developing children 7-12 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children or parents who do not speak English&#xD;
&#xD;
          -  Any diagnosis of a psychological illness&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  History of tobacco exposure during gestation&#xD;
&#xD;
          -  History of alcohol exposure during gestation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>12 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>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC-Chapel Hill's Nutrition Research Institute</name>
      <address>
        <city>Kannapolis</city>
        <state>North Carolina</state>
        <zip>28081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>December 11, 2020</last_update_submitted>
  <last_update_submitted_qc>December 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of North Carolina, Chapel Hill</investigator_affiliation>
    <investigator_full_name>Carol Cheatham, PhD</investigator_full_name>
    <investigator_title>Associate Professor of Psychology &amp; Neuroscience</investigator_title>
  </responsible_party>
  <!-- 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/NCT02199808
org study id: 14-0198
nct id: NCT02199808
lead sponsor: 
collaborator: 
has dmc: No
Purpose: To examine the effect of the omega-6 to omega-3 fatty acid ratio on age-related
      changes in executive functions in children and older adults.

      Participants: Eighty-four typically-developing 7-to 12-year-old children.

      Procedure (methods): Participants and a caregiver will participate in 4 sessions. Three
      sessions will consist of the screening. These sessions will be telephone calls to collect
      24-hour diet information that will be used to determine whether they are eligible for the
      fourth session. Approximately 120 participants will be screened to find 84 participants who
      are eligible for the fourth session, in which participants will complete a series of tests on
      the Cambridge Neuropsychological Test Automated Battery (CANTAB) - a touch-screen device that
      provides computerized versions of standardized cognitive tests. They will also complete a
      maze task in which they figure out a path through the maze by walking on the correct squares.
      Brain activity will be recorded using a portable near-infrared spectroscopy (NIRS) system.
observational model: Cohort
time perspective: Cross-Sectional
measure: Error (count) and latency (in milliseconds) measures from executive function tasks
time frame: One time with children who are 7-12 years old
description: For one specific aim, the omega-6 to omega-3 fatty acid ratio will be determined by summing the omega-6 and omega-3 fatty acid levels in plasma and dividing omega-6 fatty acids by omega-3 fatty acids. The calculated ratio will be used to predict error and latency scores on executive function tasks.
For a second specific aim, the oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS) measurements will be used to predict the error and latency measures from executive function tasks.
measure: Oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS)
time frame: One time with children who are 7-12 years old.
description: Plasma levels of omega-6 and omega-3 fatty acids will be used to predict oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS) measurements in children who are 7-12 years old.
measure: Performance on the Maze as measured by Noldus Ethovision
time frame: One time with children who are 7-12 years old
description: Performance on the Maze as measured by Noldus Ethovision tracking system will be compared to performance on standardized measures of planning and spatial working memory.
arm group label: 7-9 year olds
description: These are children who are between 7 and 9 years old when they are tested.
arm group label: 10-12 year olds
description: These are children who are between 10 and 12 years old when they are tested.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carol L Cheatham, Ph.D.
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of North Carolina, Chapel Hill
investigator full name: Carol Cheatham, PhD
investigator title: Associate Professor of Psychology & Neuroscience