<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/NCT03250234</url>
  </required_header>
  <id_info>
    <org_study_id>17-17H</org_study_id>
    <nct_id>NCT03250234</nct_id>
  </id_info>
  <brief_title>Carbohydrate Availability and microRNA Expression</brief_title>
  <official_title>Influence of Carbohydrate Availability on Skeletal Muscle and Circulating microRNA Expression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United States Army Research Institute of Environmental Medicine</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>United States Army Research Institute of Environmental Medicine</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 investigation will examine the impact of skeletal muscle glycogen stores on skeletal&#xD;
      muscle and circulating microRNA expression and exogenous carbohydrate oxidation.&#xD;
&#xD;
      Primary Objective Determine the influence of carbohydrate availability (e.g., glycogen&#xD;
      depletion and repletion) on skeletal muscle microRNA expression, and if changes in&#xD;
      circulating microRNA are reflective of changes in skeletal muscle microRNA.&#xD;
&#xD;
      Secondary Objective Determine how initiation of exercise with adequate or low glycogen stores&#xD;
      effects exogenous carbohydrate efficiency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twelve, normal weight, healthy, physically active men and women will complete a glycogen&#xD;
      depletion protocol, cycling at various intensities until failure. Participants will then&#xD;
      consume a carbohydrate (CHO: 1 g/kg/hr) or an energy free control (CON) beverage matched for&#xD;
      taste and color during the first 3-hr post glycogen depletion. For the remainder of the day&#xD;
      participants will consume a diet designed to adequately (6.0 g CHO/kg/d) or inadequately (1.2&#xD;
      g CHO/kg/d) replenish glycogen stores. The following day participants will to complete 80-min&#xD;
      of steady-state (~60% VO2peak) cycle ergometry consuming carbohydrate at a rate of 1.8 g/min&#xD;
      enriched with a stable isotope of carbon to determine exogenous carbohydrate efficiency when&#xD;
      glycogen stores are low or adequate at the onset of exercise.&#xD;
&#xD;
      Following a minimum 7-d washout period volunteers will return to the laboratory to complete&#xD;
      the second arm of the investigation. To ensure glycogen stores are similar between volunteers&#xD;
      on testing day, 48-hrs prior to testing all volunteers will complete a glycogen depletion&#xD;
      protocol and then consume a diet providing 6.0 g/kg/d carbohydrate to replenish glycogen&#xD;
      stores.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">May 3, 2018</completion_date>
  <primary_completion_date type="Actual">May 3, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fold Change in microRNA Expression From Baseline</measure>
    <time_frame>24 hours</time_frame>
    <description>Determine the influence of low or adequate glycogen on expression of skeletal muscle and circulating microRNA. Expression of microRNA was determined using real time polymerase chain reaction analysis. microRNA expressions were calculated as a fold change relative to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exogenous Carbohydrate Oxidation</measure>
    <time_frame>80 minutes</time_frame>
    <description>Determine how initiation of exercise with adequate or low glycogen stores effects exogenous carbohydrate efficiency. Exogenous carbohydrate oxidation was measured using an oral 13C-glucose isotope that was consumed in the study carbohydrate drink during steady-state cycling. Breath samples were collected during exercise and analyzed using isotope ratio mass spectrometry to calculate exogenous carbohydrate oxidation rates.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Glycogen Depletion</condition>
  <arm_group>
    <arm_group_label>Adequate Carbohydrate</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Carbohydrate</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Non-nutritive control beverage. Low carbohydrate diet 1.2 g/kg/d</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Adequate Carbohydrate</intervention_name>
    <description>During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion</description>
    <arm_group_label>Adequate Carbohydrate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low Carbohydrate</intervention_name>
    <description>During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free beverage.&#xD;
For the day participants will consume a diet of 1.2 g/kg/d carbohydrate following glycogen depletion</description>
    <arm_group_label>Low Carbohydrate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 18 - 39 years&#xD;
&#xD;
          -  Weight stable (±5 lbs) for at least 2 months prior to the start of the study&#xD;
&#xD;
          -  Body mass index (BMI) between 18.5-30 kg/m2&#xD;
&#xD;
          -  Recreationally active based on assessment of physical activity history 2-4 days per&#xD;
             week aerobic and/or resistance exercise&#xD;
&#xD;
          -  Refrain from taking any NSAIDS (i.e., aspirin, Advil®, Aleve®, Naprosyn®, or any&#xD;
             aspirin-containing product for 10 days before and at least 5 days AFTER each muscle&#xD;
             biopsy. (*Tylenol® or acetaminophen is ok to use if needed for discomfort)&#xD;
&#xD;
          -  Refrain from the use of alcohol and nicotine for the duration of the study&#xD;
&#xD;
          -  Females must be on contraception (e.g., oral birth control, NuvaRing®, Depo Provera®,&#xD;
             etc.)&#xD;
&#xD;
          -  Supervisor approved leave status for federal civilian employees working within the US&#xD;
             Army Natick Soldier Systems Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metabolic or cardiovascular abnormalities, gastrointestinal disorders (i.e., kidney&#xD;
             disease, diabetes, cardiovascular disease, etc.)&#xD;
&#xD;
          -  Disease or medication (i.e., diabetes medications, statins, corticosteroids, etc) that&#xD;
             affects macronutrient utilization and/or the ability to participate in strenuous&#xD;
             exercise&#xD;
&#xD;
          -  Allergies or intolerance to foods (including but not limited to lactose&#xD;
             intolerance/milk allergy), vegetarian practices, or medications (including, but not&#xD;
             limited to, lidocaine or phenylalanine) to be utilized in the study&#xD;
&#xD;
          -  Anemia (HCT &lt; 38) and Sickle Cell Anemia/Trait&#xD;
&#xD;
          -  Abnormal prothrombin time (PT)/ partial thromboplastin time (PTT) test or problems&#xD;
             with blood clotting&#xD;
&#xD;
          -  Present condition of alcoholism, use of nutritional/sports supplements, anabolic&#xD;
             steroids, or other substance abuse issues&#xD;
&#xD;
          -  Musculoskeletal injuries that compromise the ability to exercise&#xD;
&#xD;
          -  Blood donation within 8 weeks of beginning the study&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>USARIEM</name>
      <address>
        <city>Natick</city>
        <state>Massachusetts</state>
        <zip>01760</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <results_first_submitted>October 19, 2020</results_first_submitted>
  <results_first_submitted_qc>August 6, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 2, 2021</results_first_posted>
  <last_update_submitted>August 6, 2021</last_update_submitted>
  <last_update_submitted_qc>August 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>microRNA, carbohydrate oxidation</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT03250234/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This was a cross over design. 12 participants enrolled and completed both study arms.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Adequate Carbohydrate First, Then Low Carbohydrate</title>
          <description>Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d first, then Low carbohydrate diet 1.5 g/kg/d&#xD;
Adequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion&#xD;
7 day washout&#xD;
Low Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion</description>
        </group>
        <group group_id="P2">
          <title>Low Carbohydrate First, Then Adequate Carbohydrate</title>
          <description>Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d first, then adequate carbohydrate diet 6.0 g/kg/d&#xD;
Low Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage.&#xD;
For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion&#xD;
7 day washout&#xD;
Adequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Adequate Carbohydrate First, Then Low Carbohydrate</title>
          <description>Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d&#xD;
Adequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion</description>
        </group>
        <group group_id="B2">
          <title>Low Carbohydrate First, Then Adequate Carbohydrate</title>
          <description>Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d&#xD;
Low Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free beverage.&#xD;
For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>This was a crossover study</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>This was a crossover study</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <population>This was a crossover study</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Fold Change in microRNA Expression From Baseline</title>
        <description>Determine the influence of low or adequate glycogen on expression of skeletal muscle and circulating microRNA. Expression of microRNA was determined using real time polymerase chain reaction analysis. microRNA expressions were calculated as a fold change relative to baseline.</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Adequate Carbohydrate</title>
            <description>Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d&#xD;
Adequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion</description>
          </group>
          <group group_id="O2">
            <title>Low Carbohydrate</title>
            <description>Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d&#xD;
Low Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage.&#xD;
For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion</description>
          </group>
        </group_list>
        <measure>
          <title>Fold Change in microRNA Expression From Baseline</title>
          <description>Determine the influence of low or adequate glycogen on expression of skeletal muscle and circulating microRNA. Expression of microRNA was determined using real time polymerase chain reaction analysis. microRNA expressions were calculated as a fold change relative to baseline.</description>
          <units>fold change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread=".2"/>
                    <measurement group_id="O2" value="1.36" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Exogenous Carbohydrate Oxidation</title>
        <description>Determine how initiation of exercise with adequate or low glycogen stores effects exogenous carbohydrate efficiency. Exogenous carbohydrate oxidation was measured using an oral 13C-glucose isotope that was consumed in the study carbohydrate drink during steady-state cycling. Breath samples were collected during exercise and analyzed using isotope ratio mass spectrometry to calculate exogenous carbohydrate oxidation rates.</description>
        <time_frame>80 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Adequate Carbohydrate</title>
            <description>Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d&#xD;
Adequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion</description>
          </group>
          <group group_id="O2">
            <title>Low Carbohydrate</title>
            <description>Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d&#xD;
Low Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage.&#xD;
For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion</description>
          </group>
        </group_list>
        <measure>
          <title>Exogenous Carbohydrate Oxidation</title>
          <description>Determine how initiation of exercise with adequate or low glycogen stores effects exogenous carbohydrate efficiency. Exogenous carbohydrate oxidation was measured using an oral 13C-glucose isotope that was consumed in the study carbohydrate drink during steady-state cycling. Breath samples were collected during exercise and analyzed using isotope ratio mass spectrometry to calculate exogenous carbohydrate oxidation rates.</description>
          <units>g/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".87" spread=".16"/>
                    <measurement group_id="O2" value=".84" spread=".14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 weeks</time_frame>
      <desc>Hamstring cramping</desc>
      <group_list>
        <group group_id="E1">
          <title>Adequate Carbohydrate</title>
          <description>Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d&#xD;
Adequate Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion</description>
        </group>
        <group group_id="E2">
          <title>Low Carbohydrate</title>
          <description>Non-nutritive control beverage. Low carbohydrate diet 1.5 g/kg/d&#xD;
Low Carbohydrate: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free (0 kcal) beverage.&#xD;
For the day participants will consume a diet of 1.5 g/kg/d carbohydrate following glycogen depletion</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hamstring Cramping</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Lee Margolis</name_or_title>
      <organization>USARIEM</organization>
      <phone>508-206-2335</phone>
      <email>lee.m.margolis.civ@mail.mil</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03250234
org study id: 17-17H
nct id: NCT03250234
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This investigation will examine the impact of skeletal muscle glycogen stores on skeletal
      muscle and circulating microRNA expression and exogenous carbohydrate oxidation.

      Primary Objective Determine the influence of carbohydrate availability (e.g., glycogen
      depletion and repletion) on skeletal muscle microRNA expression, and if changes in
      circulating microRNA are reflective of changes in skeletal muscle microRNA.

      Secondary Objective Determine how initiation of exercise with adequate or low glycogen stores
      effects exogenous carbohydrate efficiency.
Twelve, normal weight, healthy, physically active men and women will complete a glycogen
      depletion protocol, cycling at various intensities until failure. Participants will then
      consume a carbohydrate (CHO: 1 g/kg/hr) or an energy free control (CON) beverage matched for
      taste and color during the first 3-hr post glycogen depletion. For the remainder of the day
      participants will consume a diet designed to adequately (6.0 g CHO/kg/d) or inadequately (1.2
      g CHO/kg/d) replenish glycogen stores. The following day participants will to complete 80-min
      of steady-state (~60% VO2peak) cycle ergometry consuming carbohydrate at a rate of 1.8 g/min
      enriched with a stable isotope of carbon to determine exogenous carbohydrate efficiency when
      glycogen stores are low or adequate at the onset of exercise.

      Following a minimum 7-d washout period volunteers will return to the laboratory to complete
      the second arm of the investigation. To ensure glycogen stores are similar between volunteers
      on testing day, 48-hrs prior to testing all volunteers will complete a glycogen depletion
      protocol and then consume a diet providing 6.0 g/kg/d carbohydrate to replenish glycogen
      stores.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Fold Change in microRNA Expression From Baseline
time frame: 24 hours
description: Determine the influence of low or adequate glycogen on expression of skeletal muscle and circulating microRNA. Expression of microRNA was determined using real time polymerase chain reaction analysis. microRNA expressions were calculated as a fold change relative to baseline.
measure: Exogenous Carbohydrate Oxidation
time frame: 80 minutes
description: Determine how initiation of exercise with adequate or low glycogen stores effects exogenous carbohydrate efficiency. Exogenous carbohydrate oxidation was measured using an oral 13C-glucose isotope that was consumed in the study carbohydrate drink during steady-state cycling. Breath samples were collected during exercise and analyzed using isotope ratio mass spectrometry to calculate exogenous carbohydrate oxidation rates.
arm group label: Adequate Carbohydrate
arm group type: Other
description: Carbohydrate beverage (1 g/kg/hr) Adequate carbohydrate diet 6.0 g/kg/d
arm group label: Low Carbohydrate
arm group type: Other
description: Non-nutritive control beverage. Low carbohydrate diet 1.2 g/kg/d
intervention type: Other
intervention name: Adequate Carbohydrate
description: During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion
arm group label: Adequate Carbohydrate
intervention type: Other
intervention name: Low Carbohydrate
description: During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free beverage.
For the day participants will consume a diet of 1.2 g/kg/d carbohydrate following glycogen depletion
arm group label: Low Carbohydrate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 