<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/NCT01669590</url>
  </required_header>
  <id_info>
    <org_study_id>IRB_00050933</org_study_id>
    <nct_id>NCT01669590</nct_id>
  </id_info>
  <brief_title>Nutrient Regulation of Amino Acid Transporters in Aging Human Skeletal Muscle</brief_title>
  <official_title>Nutrient Regulation of Amino Acid Transporters in Aging Human Skeletal Muscle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the research project is to determine how aging and inactivity reduce the muscle&#xD;
      anabolic effect of nutrients and lead to muscle and functional loss. The central hypothesis&#xD;
      is that aging reduces mTORC1 signaling and the expression of skeletal muscle amino acid&#xD;
      transporters in response to anabolic stimulation leading to reduced muscle adaptation to&#xD;
      increased intracellular amino acid requirements. The investigators further hypothesize that&#xD;
      inactivity exacerbates this effect with significant muscle and functional loss, and&#xD;
      rehabilitation restores muscle signaling, metabolism and function to baseline values.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>amino acid transporter</measure>
    <time_frame>before and after (1 and 3h) amino acid ingestion. These samples will be taken before bed rest and 7 days after bed rest.</time_frame>
    <description>Muscle biopsies will be sampled from the vastus laterals before amino acid ingestion and then 1 and 3h after amino acid ingestion. Muscle biopsies will be processed using western blotting and gene expression to assess the expression of specific amino acid transporters. The investigators are interested in the change in expression of amino acid transporters in response to amino acid ingestion from baseline. The response before bed rest will be compared to after bed rest.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>old (60-75yr)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>young (18-35y)</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        young and older healthy humans&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1 . Age between 18-35 and 60-75 yrs 2. Ability to sign informed consent 3. Mini-mental&#xD;
        state exam score &gt;26 4. Free-living, prior to admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cardiac abnormalities considered exclusionary by the study physician (e.g., CHF, CAD,&#xD;
             right-to-left shunt)&#xD;
&#xD;
          2. Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes)&#xD;
&#xD;
          3. GFR &lt;65 mL/min/1.73m2 or evidence of kidney disease or failure&#xD;
&#xD;
          4. 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;
          5. Risk of DVT including family history of thrombophilia, DVT, 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;
             hyperhomocysteinemia, deficiencies of factor V Leiden, proteins S and C, and&#xD;
             antithrombin III&#xD;
&#xD;
          6. Use of anticoagulant therapy. (e.g., Coumadin, heparin)&#xD;
&#xD;
          7. Prior history of Heparin-Induced Thrombocytopenia (HIT)&#xD;
&#xD;
          8. Elevated systolic pressure &gt;150 or a diastolic blood pressure &gt; 100&#xD;
&#xD;
          9. Implanted electronic devices (e.g., pacemakers, electronic infusion pumps,&#xD;
             stimulators)&#xD;
&#xD;
         10. Cancer or history of successfully treated cancer (less than 1 year) other than basal&#xD;
             cell carcinoma&#xD;
&#xD;
         11. Currently on a weight-loss diet or body mass index &gt; 30 kg/m2&#xD;
&#xD;
         12. Inability to abstain from smoking for duration of study&#xD;
&#xD;
         13. A history of &gt; 20 pack per year smoking&#xD;
&#xD;
         14. HIV or hepatitis B or C*&#xD;
&#xD;
         15. Recent anabolic or corticosteroids use (within 3 months)&#xD;
&#xD;
         16. Subjects with hemoglobin or hematocrit lower than accepted lab values&#xD;
&#xD;
         17. Agitation/aggression disorder (by psychiatric history and exam)&#xD;
&#xD;
         18. History of stroke with motor disability&#xD;
&#xD;
         19. A recent history (&lt;12 months) of GI bleed&#xD;
&#xD;
         20. Pregnancy as determined by a pregnancy test&#xD;
&#xD;
         21. Depression [&gt;5 on the 15 items Geriatric Depression Scale (GDS)]&#xD;
&#xD;
         22. Alcohol or drug abuse&#xD;
&#xD;
         23. Exercise training (&gt;1 session of moderate to high intensity aerobic or resistance&#xD;
             exercise/week)&#xD;
&#xD;
         24. Liver disease (AST/ALT 2 times above the normal limit, hyperbilirubinemia)&#xD;
&#xD;
         25. Respiratory disease (acute upper respiratory infection, history of chronic lung&#xD;
             disease with resting oxygen saturation &lt;97% on room air)&#xD;
&#xD;
         26. Any other condition or event considered exclusionary by the PI and faculty physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The 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>November 2016</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>November 15, 2016</last_update_submitted>
  <last_update_submitted_qc>November 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 16, 2016</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>Ph.D.</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/NCT01669590
org study id: IRB_00050933
nct id: NCT01669590
lead sponsor: 
has dmc: Yes
The goal of the research project is to determine how aging and inactivity reduce the muscle
      anabolic effect of nutrients and lead to muscle and functional loss. The central hypothesis
      is that aging reduces mTORC1 signaling and the expression of skeletal muscle amino acid
      transporters in response to anabolic stimulation leading to reduced muscle adaptation to
      increased intracellular amino acid requirements. The investigators further hypothesize that
      inactivity exacerbates this effect with significant muscle and functional loss, and
      rehabilitation restores muscle signaling, metabolism and function to baseline values.
observational model: Cohort
time perspective: Prospective
measure: amino acid transporter
time frame: before and after (1 and 3h) amino acid ingestion. These samples will be taken before bed rest and 7 days after bed rest.
description: Muscle biopsies will be sampled from the vastus laterals before amino acid ingestion and then 1 and 3h after amino acid ingestion. Muscle biopsies will be processed using western blotting and gene expression to assess the expression of specific amino acid transporters. The investigators are interested in the change in expression of amino acid transporters in response to amino acid ingestion from baseline. The response before bed rest will be compared to after bed rest.
arm group label: old (60-75yr)
arm group label: young (18-35y)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Micah Drummond
investigator title: Ph.D.