<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/NCT02246660</url>
  </required_header>
  <id_info>
    <org_study_id>1R21AG047510-01</org_study_id>
    <secondary_id>R21AG047510</secondary_id>
    <nct_id>NCT02246660</nct_id>
  </id_info>
  <brief_title>RESveratrol To Improve Outcomes in oldeR pEople With PAD (the RESTORE Trial)</brief_title>
  <acronym>RESTORE</acronym>
  <official_title>RESveratrol To Improve Outcomes in oldeR pEople With PAD (the RESTORE Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The RESTORE trial will determine whether resveratrol supplementation can improve walking&#xD;
      performance in older people with lower extremity peripheral arterial disease (PAD).&#xD;
      Resveratrol, a polyphenol and natural supplement, specifically targets several impairments&#xD;
      associated with walking difficulty and mobility loss in people with PAD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eight million men and women in the United States have lower extremity peripheral arterial&#xD;
      disease (PAD). PAD is expected to be increasingly common as the population survives longer&#xD;
      with chronic disease. Patients with PAD have greater functional impairment and faster&#xD;
      functional decline compared to those without PAD. However, currently there are only two FDA&#xD;
      approved medications for improving functional performance in patients with PAD. Furthermore,&#xD;
      these FDA approved medications are only modestly beneficial for improving walking performance&#xD;
      in patients with PAD.&#xD;
&#xD;
      Emerging evidence, including our pilot data, demonstrates that calf skeletal muscle&#xD;
      mitochondria dysfunction contributes to functional impairment in people with PAD.&#xD;
      Resveratrol, a polyphenol and natural supplement, has pharmacological properties that target&#xD;
      specific mitochondrial impairments that are associated with functional impairment in older&#xD;
      people with PAD. Animal models and preliminary human evidence show that resveratrol protects&#xD;
      against ischemia-reperfusion injury, reduces inflammation, and improves endothelial&#xD;
      dysfunction. Ischemia-reperfusion injury, inflammation, and endothelial dysfunction are all&#xD;
      present in people with PAD and contribute to adverse outcomes in PAD.&#xD;
&#xD;
      We now propose a pilot study of 66 PAD participants age 65 and older: a double-blind,&#xD;
      randomized controlled pilot clinical trial to provide preliminary data to address our&#xD;
      hypothesis that resveratrol significantly improves lower extremity functioning in people with&#xD;
      PAD by improving calf skeletal muscle oxidative metabolism, increasing calf skeletal muscle&#xD;
      mitochondrial biogenesis, and improving systemic endothelial function in older people with&#xD;
      PAD.&#xD;
&#xD;
      In our primary specific aims, we will determine 1) whether PAD participants randomized to&#xD;
      resveratrol 500 mgs daily achieve greater increases or have less decline in six-minute walk&#xD;
      performance at 6-month follow-up, compared to those randomized to placebo and 2) whether PAD&#xD;
      participants randomized to resveratrol 125 mgs daily achieve greater increases or have less&#xD;
      decline in six-minute walk performance at 6-month follow-up, compared to those randomized to&#xD;
      placebo. In our secondary aims, we will determine whether PAD participants randomized to&#xD;
      resveratrol have improved treadmill walking performance, increased calf muscle&#xD;
      biopsy-measured mitochondrial function, increased calf muscle biopsy-measured mitochondrial&#xD;
      biogenesis, and improved brachial artery flow-mediated dilation at six-month follow-up,&#xD;
      compared to those randomized to control. For each secondary specific aim, participants&#xD;
      randomized to 500 mgs of resveratrol (N=22) will be compared to those randomized to placebo&#xD;
      (N=20) and participants randomized to 125 mgs of resveratrol (N=22) will be compared to those&#xD;
      randomized to placebo (N=22), respectively. In an exploratory specific aim, we will determine&#xD;
      whether participants randomized to resveratrol 125 mgs (N=22) have greater improvement in&#xD;
      each study outcome compared to those randomized to resveratrol 500 mgs (N=22).&#xD;
&#xD;
      If our hypotheses are correct, results will be used to design a large, definitive randomized&#xD;
      controlled trial of resveratrol therapy to improve lower extremity functioning and prevent&#xD;
      mobility loss in the large and growing number of older people who are disabled by PAD. By&#xD;
      studying two doses of resveratrol, our results will also provide guidance on the most optimal&#xD;
      dose of resveratrol to use in a large definitive trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6-Minute Walk Distance, Meters</measure>
    <time_frame>Baseline and 6 month follow-up</time_frame>
    <description>Six month changes in 6-Minute Walk Distance (meters) in response to resveratrol therapy in patients with Peripheral Artery Disease were measured.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Resveratrol - 500 mg/day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resveratrol - 125 mg/day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be taken orally for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Resveratrol</intervention_name>
    <description>The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.&#xD;
OR&#xD;
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.</description>
    <arm_group_label>Resveratrol - 125 mg/day</arm_group_label>
    <arm_group_label>Resveratrol - 500 mg/day</arm_group_label>
    <other_name>Polygonum cuspidatum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be taken orally for 6 months.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>No active study medication</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ankle-brachial index (ABI) &lt; 0.90 at baseline screening (at visit), or, medical&#xD;
             evidence of prior lower extremity revascularization if ABI ≥ 0.90.&#xD;
&#xD;
          -  65 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Above/below-knee amputation, critical limb ischemia, wheelchair-bound, or require the&#xD;
             use of a walker or cane&#xD;
&#xD;
          -  Other symptom(s) limiting walking ability, other than PAD&#xD;
&#xD;
          -  Underwent/experienced lower extremity revascularization, a cardiovascular event, or&#xD;
             coronary artery bypass surgery within 3 months of screening. Underwent major&#xD;
             orthopedic surgery within 6 months of screening. Planning to have revascularization or&#xD;
             major elective surgery within the next 6 months.&#xD;
&#xD;
          -  Major medical illness including renal disease that requires dialysis or lung disease&#xD;
             that requires oxygen&#xD;
&#xD;
          -  Score of &lt; 23 on Mini-Mental Status Examination at screening or major psychiatric&#xD;
             illness&#xD;
&#xD;
          -  Currently participating in a separate clinical trial&#xD;
&#xD;
          -  Significant renal or liver dysfunction at baseline&#xD;
&#xD;
          -  Does not successfully complete the study run-in period&#xD;
&#xD;
          -  Has an extreme baseline 6 minute walk value (&lt; 500 ft or &gt; 1,600 feet )&#xD;
&#xD;
          -  Treated for cancer during the last 2 years (unless prognosis is excellent)&#xD;
&#xD;
          -  Severe hearing impairment or other communication difficulties (e.g. non-English&#xD;
             speaking) or legally blind&#xD;
&#xD;
          -  Diagnosis of Parkinson's disease&#xD;
&#xD;
          -  Unable to return to medical center at required visit frequency&#xD;
&#xD;
          -  Otherwise poorly suited to intervention (at the discretion of the PI)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary M McDermott, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <results_first_submitted>November 29, 2017</results_first_submitted>
  <results_first_submitted_qc>March 28, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">April 30, 2018</results_first_posted>
  <last_update_submitted>March 28, 2018</last_update_submitted>
  <last_update_submitted_qc>March 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Mary McDermott</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Peripheral Artery Disease</keyword>
  <keyword>Peripheral Arterial Disease</keyword>
  <keyword>PAD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Resveratrol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Resveratrol - 500 mg/Day</title>
          <description>The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.&#xD;
Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.&#xD;
OR&#xD;
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.</description>
        </group>
        <group group_id="P2">
          <title>Resveratrol - 125 mg/Day</title>
          <description>The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.&#xD;
Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.&#xD;
OR&#xD;
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Placebo will be taken orally for 6 months.&#xD;
Placebo: Placebo will be taken orally for 6 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" 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="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Resveratrol - 500 mg/Day</title>
          <description>The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.&#xD;
Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.&#xD;
OR&#xD;
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.</description>
        </group>
        <group group_id="B2">
          <title>Resveratrol - 125 mg/Day</title>
          <description>The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.&#xD;
Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.&#xD;
OR&#xD;
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Placebo will be taken orally for 6 months.&#xD;
Placebo: Placebo will be taken orally for 6 months.</description>
        </group>
        <group group_id="B4">
          <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="23"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="22"/>
            <count group_id="B4" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75.6" spread="7.3"/>
                    <measurement group_id="B2" value="73.6" spread="6.6"/>
                    <measurement group_id="B3" value="74.1" spread="6.1"/>
                    <measurement group_id="B4" value="74.4" spread="6.6"/>
                  </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 group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="45"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ankle Brachial Index</title>
          <description>A handheld Doppler probe was used to measure systolic blood pressures in the right brachial, dorsalis pedis, and posterior tibial arteries and left dorsalis pedis, posterior tibial, and brachial arteries. The ABI was calculated by dividing mean pressures in each leg by the mean of the 4 brachial pressures. A normal ABI is between 1.10- 1.30. A value of &lt; 0.90 is about 70% sensitive and highly specific for the presence of peripheral artery disease. Lower ABI values indicate more severe PAD.</description>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.69" spread="0.23"/>
                    <measurement group_id="B2" value="0.68" spread="0.15"/>
                    <measurement group_id="B3" value="0.63" spread="0.13"/>
                    <measurement group_id="B4" value="0.67" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current Smoker</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Former Smoker</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.6" spread="5.5"/>
                    <measurement group_id="B2" value="28.9" spread="5.4"/>
                    <measurement group_id="B3" value="31.2" spread="4.8"/>
                    <measurement group_id="B4" value="29.9" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Myocardial Infarction</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Heart Failure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stroke</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Angina</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pulmonary Disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cancer</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intermittent Claudication</title>
          <description>Intermittent claudication was defined as exertional calf pain that did not begin at rest, caused the participant to stop walking, and resolved within 10 minutes of rest. Participants without intermittent claudication were either asymptomatic (ie, reported no exertional leg symptoms) or had exertional leg symptoms that did not meet criteria for intermittent claudication.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Exertional leg symptoms not consistent with classical intermittent claudication</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Asymptomatic</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>6-Minute Walk Distance</title>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="357" spread="58"/>
                    <measurement group_id="B2" value="370" spread="65"/>
                    <measurement group_id="B3" value="354" spread="70"/>
                    <measurement group_id="B4" value="360" spread="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Treadmill Distance</title>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="529.4" spread="268.6"/>
                    <measurement group_id="B2" value="492.8" spread="261.2"/>
                    <measurement group_id="B3" value="443.3" spread="242.4"/>
                    <measurement group_id="B4" value="488.4" spread="255.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Treadmill distance at onset of leg symptom</title>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="271.1" spread="217.7"/>
                    <measurement group_id="B2" value="226.6" spread="123.4"/>
                    <measurement group_id="B3" value="218.0" spread="147.3"/>
                    <measurement group_id="B4" value="239.1" spread="168.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cilostazol use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pentoxifylline use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Antiplatelet therapy use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Statin use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Reported walking for exercise 3 or more times/week</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>6-Minute Walk Distance, Meters</title>
        <description>Six month changes in 6-Minute Walk Distance (meters) in response to resveratrol therapy in patients with Peripheral Artery Disease were measured.</description>
        <time_frame>Baseline and 6 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Resveratrol - 500 mg/Day</title>
            <description>The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.&#xD;
Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.&#xD;
OR&#xD;
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.</description>
          </group>
          <group group_id="O2">
            <title>Resveratrol - 125 mg/Day</title>
            <description>The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.&#xD;
Resveratrol: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.&#xD;
OR&#xD;
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Placebo will be taken orally for 6 months.&#xD;
Placebo: Placebo will be taken orally for 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>6-Minute Walk Distance, Meters</title>
          <description>Six month changes in 6-Minute Walk Distance (meters) in response to resveratrol therapy in patients with Peripheral Artery Disease were measured.</description>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.8" spread="7.5"/>
                    <measurement group_id="O2" value="4.6" spread="8.1"/>
                    <measurement group_id="O3" value="-12.3" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Resveratrol - 500 mg/Day</title>
          <description>The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.</description>
        </group>
        <group group_id="E2">
          <title>Resveratrol - 125 mg/Day</title>
          <description>The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Placebo will be taken orally for 6 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Coronary stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to lisinopril</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urologic procedure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritic rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Elective plastic surgery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Toe amputation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lower extremity revascularization</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="19" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Black stool</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nausea/vomiting</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Walking difficulty</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Leg pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Foot pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hand cramp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness/headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
              </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>Dr. Mary McDermott</name_or_title>
      <organization>Northwestern University</organization>
      <phone>312-503-6419</phone>
      <email>mdm608@northwestern.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/NCT02246660
org study id: 1R21AG047510-01
secondary id: R21AG047510
nct id: NCT02246660
lead sponsor: 
collaborator: 
has dmc: Yes
The RESTORE trial will determine whether resveratrol supplementation can improve walking
      performance in older people with lower extremity peripheral arterial disease (PAD).
      Resveratrol, a polyphenol and natural supplement, specifically targets several impairments
      associated with walking difficulty and mobility loss in people with PAD.
Eight million men and women in the United States have lower extremity peripheral arterial
      disease (PAD). PAD is expected to be increasingly common as the population survives longer
      with chronic disease. Patients with PAD have greater functional impairment and faster
      functional decline compared to those without PAD. However, currently there are only two FDA
      approved medications for improving functional performance in patients with PAD. Furthermore,
      these FDA approved medications are only modestly beneficial for improving walking performance
      in patients with PAD.

      Emerging evidence, including our pilot data, demonstrates that calf skeletal muscle
      mitochondria dysfunction contributes to functional impairment in people with PAD.
      Resveratrol, a polyphenol and natural supplement, has pharmacological properties that target
      specific mitochondrial impairments that are associated with functional impairment in older
      people with PAD. Animal models and preliminary human evidence show that resveratrol protects
      against ischemia-reperfusion injury, reduces inflammation, and improves endothelial
      dysfunction. Ischemia-reperfusion injury, inflammation, and endothelial dysfunction are all
      present in people with PAD and contribute to adverse outcomes in PAD.

      We now propose a pilot study of 66 PAD participants age 65 and older: a double-blind,
      randomized controlled pilot clinical trial to provide preliminary data to address our
      hypothesis that resveratrol significantly improves lower extremity functioning in people with
      PAD by improving calf skeletal muscle oxidative metabolism, increasing calf skeletal muscle
      mitochondrial biogenesis, and improving systemic endothelial function in older people with
      PAD.

      In our primary specific aims, we will determine 1) whether PAD participants randomized to
      resveratrol 500 mgs daily achieve greater increases or have less decline in six-minute walk
      performance at 6-month follow-up, compared to those randomized to placebo and 2) whether PAD
      participants randomized to resveratrol 125 mgs daily achieve greater increases or have less
      decline in six-minute walk performance at 6-month follow-up, compared to those randomized to
      placebo. In our secondary aims, we will determine whether PAD participants randomized to
      resveratrol have improved treadmill walking performance, increased calf muscle
      biopsy-measured mitochondrial function, increased calf muscle biopsy-measured mitochondrial
      biogenesis, and improved brachial artery flow-mediated dilation at six-month follow-up,
      compared to those randomized to control. For each secondary specific aim, participants
      randomized to 500 mgs of resveratrol (N=22) will be compared to those randomized to placebo
      (N=20) and participants randomized to 125 mgs of resveratrol (N=22) will be compared to those
      randomized to placebo (N=22), respectively. In an exploratory specific aim, we will determine
      whether participants randomized to resveratrol 125 mgs (N=22) have greater improvement in
      each study outcome compared to those randomized to resveratrol 500 mgs (N=22).

      If our hypotheses are correct, results will be used to design a large, definitive randomized
      controlled trial of resveratrol therapy to improve lower extremity functioning and prevent
      mobility loss in the large and growing number of older people who are disabled by PAD. By
      studying two doses of resveratrol, our results will also provide guidance on the most optimal
      dose of resveratrol to use in a large definitive trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: 6-Minute Walk Distance, Meters
time frame: Baseline and 6 month follow-up
description: Six month changes in 6-Minute Walk Distance (meters) in response to resveratrol therapy in patients with Peripheral Artery Disease were measured.
arm group label: Resveratrol - 500 mg/day
arm group type: Active Comparator
description: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
arm group label: Resveratrol - 125 mg/day
arm group type: Active Comparator
description: The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo will be taken orally for 6 months.
intervention type: Drug
intervention name: Resveratrol
description: The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
OR
The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
arm group label: Resveratrol - 125 mg/day
arm group label: Resveratrol - 500 mg/day
other name: Polygonum cuspidatum
intervention type: Drug
intervention name: Placebo
description: Placebo will be taken orally for 6 months.
arm group label: Placebo
other name: No active study medication
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Mary M McDermott, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Mary McDermott
investigator title: Professor of Medicine
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Resveratrol
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 