<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/NCT04427462</url>
  </required_header>
  <id_info>
    <org_study_id>260376</org_study_id>
    <nct_id>NCT04427462</nct_id>
  </id_info>
  <brief_title>Mitochondria (MI) Energy - Linking Bioenergetic Phenotypes in Circulating Cells With Cardiometabolic Health in School-age Children</brief_title>
  <official_title>Linking Bioenergetic Phenotypes in Circulating Cells With Cardiometabolic Health in School-age Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arkansas Children's Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arkansas Children's Hospital Research Institute</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>
      This research study is about how daily activities, behaviors, and fitness affect the health&#xD;
      and function of blood cells and their mitochondria, which are the powerhouses of the cells.&#xD;
      These small mitochondria inside the cells make energy, and are very important for the health&#xD;
      of the body.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Determine the impact of physical activity and obesity status on circulating cells&#xD;
      mitochondrial function (e.g., fat vs. carbohydrates combustion capacity, total oxidative&#xD;
      capacity, mitochondrial number and proton leak).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">March 2024</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Platelet mitochondrial respiration and its association with adiposity and peak aerobic capacity in children 8 to 10 years old.</measure>
    <time_frame>8 days</time_frame>
    <description>Platelet mitochondrial respiration from isolated platelets will be measured using a flux analyzer. Adiposity will be measured with dual X-ray absorptiometry, and peak aerobic capacity with an incremental cycle ergometer test. measure physical activity</description>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Healthy</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, urine, saliva, and stool will be collected.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        8-10 year olds&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Ages 8-10 years Boys and girls All ethnicity All BMI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        severe persistent asthma exercise induced asthma autism spectrum disorder attention deficit&#xD;
        hyperactivity disorder attention deficit disorder&#xD;
&#xD;
          -  Opposition defiant disorder&#xD;
&#xD;
          -  conduct disorder&#xD;
&#xD;
          -  epilepsy&#xD;
&#xD;
          -  chronic kidney disease&#xD;
&#xD;
          -  hormonal disease&#xD;
&#xD;
          -  autoimmune diseases&#xD;
&#xD;
          -  bleeding disorders&#xD;
&#xD;
          -  chronic infections&#xD;
&#xD;
          -  mental health disorder&#xD;
&#xD;
          -  Type 2 and Type 1 diabetes&#xD;
&#xD;
          -  Other pre-existing medical conditions or medications as determined by the&#xD;
             investigators to affect the outcomes of interest&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Tonja C Nolen, MS</last_name>
    <phone>501-364-3309</phone>
    <email>acncstudies@archildrens.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Audrey Martinex, MS, RD, LD</last_name>
    <phone>501-364-3309</phone>
    <email>acncstudies@archildrens.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Arkansas Children's Nutrition Center</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tonja Nolen, MS</last_name>
      <phone>501-364-2853</phone>
      <email>acncstudies@archildrens.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>April 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 26, 2023</last_update_submitted>
  <last_update_submitted_qc>March 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT04427462
org study id: 260376
nct id: NCT04427462
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research study is about how daily activities, behaviors, and fitness affect the health
      and function of blood cells and their mitochondria, which are the powerhouses of the cells.
      These small mitochondria inside the cells make energy, and are very important for the health
      of the body.
Determine the impact of physical activity and obesity status on circulating cells
      mitochondrial function (e.g., fat vs. carbohydrates combustion capacity, total oxidative
      capacity, mitochondrial number and proton leak).
observational model: Cohort
time perspective: Prospective
measure: Platelet mitochondrial respiration and its association with adiposity and peak aerobic capacity in children 8 to 10 years old.
time frame: 8 days
description: Platelet mitochondrial respiration from isolated platelets will be measured using a flux analyzer. Adiposity will be measured with dual X-ray absorptiometry, and peak aerobic capacity with an incremental cycle ergometer test. measure physical activity
Blood, urine, saliva, and stool will be collected.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tonja C Nolen, MS
phone: 501-364-3309
email: acncstudies@archildrens.org
last name: Audrey Martinex, MS, RD, LD
phone: 501-364-3309
email: acncstudies@archildrens.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor