<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/NCT03839628</url>
  </required_header>
  <id_info>
    <org_study_id>Leucine study</org_study_id>
    <secondary_id>R21AR073422</secondary_id>
    <nct_id>NCT03839628</nct_id>
  </id_info>
  <brief_title>Translational Control of Anabolic Resistance in Aging Muscle</brief_title>
  <official_title>Translational Control of Anabolic Resistance in Aging Muscle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>Yes</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 is an interventional study enrolling older individuals aged 60-85y to observe changes&#xD;
      during physical inactivity. This study is investigating the relation between short-term&#xD;
      physical inactivity and the impact of muscle health and function. The enrollment goal is 8&#xD;
      participants. The study will occur over the course of a month where participants will undergo&#xD;
      testing before and after a reduction in physically activity levels. There will be a screening&#xD;
      event collecting baseline data, two body composition scans, muscle function and oral glucose&#xD;
      tolerance tests and a metabolic study before and after a 2-week period of inactivity. Each&#xD;
      metabolic study will entail three-muscle biopsies: one before and 2 after the ingestion of&#xD;
      leucine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre-testing- The baseline evaluation will assess muscle function and strength, and an oral&#xD;
      glucose tolerance test. After the baseline visit, participants will be provided with a step&#xD;
      activity monitor to track their level of activity. This will provide a baseline of the&#xD;
      participant's normal level of physical activity so an accurate level of 75% activity&#xD;
      reduction can be determined. A 3-day daily dietary diary will be provided for the participant&#xD;
      to self-report prior to the experiment, as well.&#xD;
&#xD;
      Day 1- After the participant completes their normal activity log and dietary diary, they will&#xD;
      be asked to return to the research center for a body composition scan and a metabolic study.&#xD;
&#xD;
      The metabolic study will involve blood sampling from an arm vein and muscle biopsies from the&#xD;
      thigh before and after a leucine drink.&#xD;
&#xD;
      2-week period of inactivity- After the metabolic study, the participant will return home and&#xD;
      maintain a reduced level of activity (75% reduction) for a two-week period. During this time,&#xD;
      the participant will receive phone calls from research personnel in order to maintain&#xD;
      adherence to the intervention.&#xD;
&#xD;
      Day 14- After the 2-week reduced activity period, the participant will return to the research&#xD;
      center to receive a body composition scan and undergo a metabolic study identical to 'Day 1'.&#xD;
&#xD;
      Post-testing- After Day 14, the participant will be asked to return once again to the&#xD;
      research center for a oral glucose tolerance test and the exercise lab for muscle function&#xD;
      testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2019</start_date>
  <completion_date type="Actual">December 17, 2019</completion_date>
  <primary_completion_date type="Actual">December 17, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Participants will be tested before and 2-weeks after they have reduced their level of physical activity</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lean Mass</measure>
    <time_frame>baseline and 2-weeks</time_frame>
    <description>Change in lean mass</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength</measure>
    <time_frame>baseline and 2-weeks</time_frame>
    <description>Change in muscle strength</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Physical Inactivity</condition>
  <arm_group>
    <arm_group_label>Reduced Physical Activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Reduced Physical Activity</intervention_name>
    <description>Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.</description>
    <arm_group_label>Reduced Physical Activity</arm_group_label>
    <other_name>Muscle Disuse</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 60-85 years&#xD;
&#xD;
          -  Ability to sign informed consent&#xD;
&#xD;
          -  Free-living, prior to admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac abnormalities considered exclusionary by the study physician (e.g., Chronic&#xD;
             heart Failure, right-to-left shunt)&#xD;
&#xD;
          -  Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes)&#xD;
&#xD;
          -  History of kidney disease or failure&#xD;
&#xD;
          -  Vascular disease or risk factors of peripheral atherosclerosis. (e.g., uncontrolled&#xD;
             hypertension, obesity, diabetes, hypercholesterolemia &gt; 250 mg/dl, claudication or&#xD;
             evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal&#xD;
             and pedal arteries)&#xD;
&#xD;
          -  Risk of blood clotting including family history of thrombophilia, pulmonary emboli,&#xD;
             myeloproliferative diseases including polycythemia (Hb&gt;18 g/dL) or thrombocytosis&#xD;
             (platelets&gt;400x103/mL), and connective tissue diseases (positive lupus anticoagulant),&#xD;
             hyperhomocystinemia, deficiencies of factor V Leiden, proteins S and C, and&#xD;
             antithrombine III&#xD;
&#xD;
          -  Use of anticoagulant therapy (e.g., Coumadin, heparin)&#xD;
&#xD;
          -  Elevated systolic pressure &gt;150 or a diastolic blood pressure &gt; 100&#xD;
&#xD;
          -  Cancer or history of successfully treated cancer (less than 1 year) other than basal&#xD;
             cell carcinoma&#xD;
&#xD;
          -  Implanted electronic devices (e.g., pacemakers, electronic infusion pumps,&#xD;
             stimulators)&#xD;
&#xD;
          -  Currently on a weight-loss diet or body mass index &gt; 30 kg/m2&#xD;
&#xD;
          -  Chronic systemic corticosteroid use (≥ 2 weeks) within 4 weeks of enrollment and for&#xD;
             study duration (intra-articular/topical/inhaled therapeutic or physiologic doses of&#xD;
             corticosteroids are permitted). Androgens or growth hormone within 6 months of&#xD;
             enrollment and for study duration (topical physiologic androgen replacement is&#xD;
             permitted)&#xD;
&#xD;
          -  History of stroke with motor disability&#xD;
&#xD;
          -  A recent history (&lt;12 months) of GI bleed&#xD;
&#xD;
          -  History of liver disease&#xD;
&#xD;
          -  History of respiratory disease (acute upper respiratory infection, history of chronic&#xD;
             lung disease)&#xD;
&#xD;
          -  Prior history of Heparin-Induced Thrombocytopenia&#xD;
&#xD;
          -  An HbA1c value at or greater than 6.5%&#xD;
&#xD;
          -  Any other condition or event considered exclusionary by the PI and faculty physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Micah Drummond</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <results_first_submitted>May 3, 2022</results_first_submitted>
  <results_first_submitted_qc>May 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 2, 2022</results_first_posted>
  <last_update_submitted>June 17, 2022</last_update_submitted>
  <last_update_submitted_qc>June 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Micah Drummond</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan has been put into place</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 24, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03839628/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Reduced Physical Activity</title>
          <description>Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity&#xD;
Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Reduced Physical Activity</title>
          <description>Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity&#xD;
Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HbA1c</title>
          <units>% of hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.5" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Lean Mass</title>
        <description>Change in lean mass</description>
        <time_frame>baseline and 2-weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Reduced Physical Activity</title>
            <description>Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity&#xD;
Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.</description>
          </group>
        </group_list>
        <measure>
          <title>Lean Mass</title>
          <description>Change in lean mass</description>
          <units>grams</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="403" spread="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Strength</title>
        <description>Change in muscle strength</description>
        <time_frame>baseline and 2-weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Reduced Physical Activity</title>
            <description>Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity&#xD;
Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.</description>
          </group>
        </group_list>
        <measure>
          <title>Strength</title>
          <description>Change in muscle strength</description>
          <units>percentage of leg strength</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8" spread=".1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Reduced Physical Activity</title>
          <description>Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity&#xD;
Reduced Physical Activity: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.</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="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Micah Drummond</name_or_title>
      <organization>The University of Utah</organization>
      <phone>801-213-2737</phone>
      <email>micah.drummond@hsc.utah.edu</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/NCT03839628
org study id: Leucine study
secondary id: R21AR073422
nct id: NCT03839628
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is an interventional study enrolling older individuals aged 60-85y to observe changes
      during physical inactivity. This study is investigating the relation between short-term
      physical inactivity and the impact of muscle health and function. The enrollment goal is 8
      participants. The study will occur over the course of a month where participants will undergo
      testing before and after a reduction in physically activity levels. There will be a screening
      event collecting baseline data, two body composition scans, muscle function and oral glucose
      tolerance tests and a metabolic study before and after a 2-week period of inactivity. Each
      metabolic study will entail three-muscle biopsies: one before and 2 after the ingestion of
      leucine.
Pre-testing- The baseline evaluation will assess muscle function and strength, and an oral
      glucose tolerance test. After the baseline visit, participants will be provided with a step
      activity monitor to track their level of activity. This will provide a baseline of the
      participant's normal level of physical activity so an accurate level of 75% activity
      reduction can be determined. A 3-day daily dietary diary will be provided for the participant
      to self-report prior to the experiment, as well.

      Day 1- After the participant completes their normal activity log and dietary diary, they will
      be asked to return to the research center for a body composition scan and a metabolic study.

      The metabolic study will involve blood sampling from an arm vein and muscle biopsies from the
      thigh before and after a leucine drink.

      2-week period of inactivity- After the metabolic study, the participant will return home and
      maintain a reduced level of activity (75% reduction) for a two-week period. During this time,
      the participant will receive phone calls from research personnel in order to maintain
      adherence to the intervention.

      Day 14- After the 2-week reduced activity period, the participant will return to the research
      center to receive a body composition scan and undergo a metabolic study identical to 'Day 1'.

      Post-testing- After Day 14, the participant will be asked to return once again to the
      research center for a oral glucose tolerance test and the exercise lab for muscle function
      testing.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Participants will be tested before and 2-weeks after they have reduced their level of physical activity
primary purpose: Basic Science
masking: None (Open Label)
measure: Lean Mass
time frame: baseline and 2-weeks
description: Change in lean mass
measure: Strength
time frame: baseline and 2-weeks
description: Change in muscle strength
arm group label: Reduced Physical Activity
arm group type: Experimental
description: Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity
intervention type: Other
intervention name: Reduced Physical Activity
description: Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.
arm group label: Reduced Physical Activity
other name: Muscle Disuse
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Micah Drummond
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Micah Drummond
investigator title: Associate Professor
sharing ipd: No
ipd description: No plan has been put into place
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 