<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/NCT02256540</url>
  </required_header>
  <id_info>
    <org_study_id>14-0532</org_study_id>
    <secondary_id>UL1TR001082</secondary_id>
    <secondary_id>R56HL114073</secondary_id>
    <nct_id>NCT02256540</nct_id>
  </id_info>
  <brief_title>The Effects of Resveratrol and Acute Exercise on Endothelial Function in Postmenopausal Women</brief_title>
  <official_title>The Effects of Resveratrol and Acute Exercise on Endothelial Function in Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <brief_summary>
    <textblock>
      This pilot study plans to learn more about the aging of blood vessels and arteries in women.&#xD;
      As women age and go through menopause, their risk for cardiovascular disease increases. Also&#xD;
      with aging and menopause, levels of the reproductive hormone estradiol decline. Hormone&#xD;
      replacement therapy to restore estradiol levels does not protect women from cardiovascular&#xD;
      disease, so lifestyle changes, such as regular exercise, are recommended to reduce disease&#xD;
      risk. However, there are differences between men and women in their response to exercise. In&#xD;
      older men, exercise improves the health of their arteries, but in postmenopausal women,&#xD;
      exercise does not provide this benefit. The purpose of this pilot study is to determine&#xD;
      whether low estradiol levels in postmenopausal women are responsible for the poor vascular&#xD;
      response to exercise. In this study the investigators will also test whether treatment with&#xD;
      resveratrol, a plant compound found in red wine, improves postmenopausal women's response to&#xD;
      exercise. The investigators hypothesize that acute treatment with estrogen or resveratrol&#xD;
      will improve vascular responses to an acute bout of exercise.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 25, 2016</completion_date>
  <primary_completion_date type="Actual">March 25, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point</measure>
    <time_frame>Up to 2 hours post-exercise</time_frame>
    <description>Brachial artery flow-mediated dilation represents the percent change in artery diameter (before and after blood pressure cuff inflation-deflation) within each time point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gene and Protein Expression in Peripheral Blood Mononuclear Cells</measure>
    <time_frame>baseline, 1-2 hours post-exercise</time_frame>
    <description>No gene and protein data were analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Nitrate/Nitrite Levels</measure>
    <time_frame>baseline, 1-2 hrs post-exercise</time_frame>
    <description>Measure of nitric oxide</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Endothelial Dysfunction</condition>
  <arm_group>
    <arm_group_label>Placebo patch - placebo tablets</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Postmenopausal women will be given a placebo patch to wear two days prior to exercise visit and a placebo tablet to take the morning of the exercise visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo patch - Resveratrol tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Postmenopausal women will be given a placebo patch to wear for two days prior to the exercise visit and a resveratrol tablet (dosed at 250mg) to take the morning of the exercise visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Climara patch - placebo tablets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Postmenopausal women will be given a transdermal estrogen patch to wear (0.05mg/day) for two days prior to the exercise visit and a placebo tablet to take the morning of the exercise visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Climara</intervention_name>
    <arm_group_label>Climara patch - placebo tablets</arm_group_label>
    <other_name>Estradiol transdermal patch</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo patch</intervention_name>
    <description>Placebo patch designed to match active Climara patches.</description>
    <arm_group_label>Placebo patch - Resveratrol tablets</arm_group_label>
    <arm_group_label>Placebo patch - placebo tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Resveratrol</intervention_name>
    <arm_group_label>Placebo patch - Resveratrol tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablets designed to match active resveratrol tablets.</description>
    <arm_group_label>Climara patch - placebo tablets</arm_group_label>
    <arm_group_label>Placebo patch - placebo tablets</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 50-70 and at least 1 year beyond menopause;&#xD;
&#xD;
          -  resting blood pressure &lt;140/90 mmHg;&#xD;
&#xD;
          -  plasma glucose concentrations &lt;110 mg/dL under fasting conditions;&#xD;
&#xD;
          -  BMI &lt; 35;&#xD;
&#xD;
          -  LDL cholesterol &lt; 160 mg/dL;&#xD;
&#xD;
          -  sedentary or recreationally active (&lt;3 days of vigorous aerobic exercise);&#xD;
&#xD;
          -  no use of OCs, HT, or other medications that might influence cardiovascular function;&#xD;
&#xD;
          -  nonsmokers;&#xD;
&#xD;
          -  no use of vitamin supplements, blood thinners or NSAIDS, or willing to stop use one&#xD;
             month prior to and for the duration of the study;&#xD;
&#xD;
          -  not taking any other medications that would interact with E2 patch or resveratrol to&#xD;
             confound interpretation of results.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of or active E2-dependent neoplasms, acute liver or gallbladder disease,&#xD;
             vaginal bleeding, venous thromboembolism, hypertriglyceridemia (≥ 150 mg/dL), and CVD;&#xD;
&#xD;
          -  known allergy to transdermal patch, or resveratrol;&#xD;
&#xD;
          -  history of stomach ulcer or bleeding;&#xD;
&#xD;
          -  other contraindications to HT or resveratrol.&#xD;
&#xD;
          -  other conditions for which individuals will be excluded from the study include:&#xD;
             diabetes, active infection, history of seizures or disease that affects the nervous&#xD;
             system or an abnormal resting ECG.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kerrie L Moreau, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <results_first_submitted>March 19, 2020</results_first_submitted>
  <results_first_submitted_qc>March 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 20, 2020</results_first_posted>
  <last_update_submitted>March 19, 2020</last_update_submitted>
  <last_update_submitted_qc>March 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Resveratrol</mesh_term>
    <mesh_term>Estradiol</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Healthy women ages 50-70 years, at least 1 year beyond menopause and free of overt cardiovascular or chronic diseases.</recruitment_details>
      <pre_assignment_details>7 participants did not qualify to participate in the study after consent/enrollment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Visit 1 Placebo - Visit 2 Estrogen - Visit 3 Resveratrol</title>
          <description>Visit 1 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.&#xD;
Placebo tablet: Placebo tablets designed to match active resveratrol tablets.&#xD;
Visit 2 Estrogen: Climara patch was worn two days prior to and during the exercise visit.&#xD;
Placebo tablet:Placebo tablets designed to match active resveratrol tablets.&#xD;
Visit 3 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.&#xD;
Resveratrol tablet: Resveratrol tablets were given on the morning of the exercise visit.</description>
        </group>
        <group group_id="P2">
          <title>Visit 1 Resveratrol - Visit 2 Placebo - Visit 3 Estrogen</title>
          <description>Visit 1 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.&#xD;
Resveratrol tablet: Resveratrol tablets were given on the morning of the exercise visit.&#xD;
Visit 2 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.&#xD;
Placebo tablet: Placebo tablets designed to match active resveratrol tablets.&#xD;
Visit 3 Estrogen: Climara patch was worn two days prior to and during the exercise visit.&#xD;
Placebo tablet:Placebo tablets designed to match active resveratrol tablets.</description>
        </group>
        <group group_id="P3">
          <title>Visit 1 Estrogen - Visit 2 Resveratrol - Visit 3 Placebo</title>
          <description>Visit 1 Estrogen: Climara patch was worn two days prior to and during the exercise visit.&#xD;
Placebo tablet:Placebo tablets designed to match active resveratrol tablets.&#xD;
Visit 2 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.&#xD;
Resveratrol tablet: Resveratrol tablets were given on the morning of the exercise visit.&#xD;
Visit 3 Placebo patch: Placebo patch designed to match active Climara patches and was worn two days prior to exercise visit.&#xD;
Placebo tablet: Placebo tablets designed to match active resveratrol tablets.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
              </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="2"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Back pain preventing exercise</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>All Participants</title>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </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="58.1" spread="3.1"/>
                  </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="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point</title>
        <description>Brachial artery flow-mediated dilation represents the percent change in artery diameter (before and after blood pressure cuff inflation-deflation) within each time point.</description>
        <time_frame>Up to 2 hours post-exercise</time_frame>
        <population>Images were considered invalid and removed from analysis if the vascular boundaries were not able to be identified.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Patch - Placebo Tablets</title>
            <description>Postmenopausal women will be given a placebo patch to wear two days prior to exercise visit and a placebo tablet to take the morning of the exercise visit.&#xD;
Placebo patch: Placebo patch designed to match active Climara patches.&#xD;
Placebo: Placebo tablets designed to match active resveratrol tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Patch - Resveratrol Tablets</title>
            <description>Postmenopausal women will be given a placebo patch to wear for two days prior to the exercise visit and a resveratrol tablet (dosed at 250mg) to take the morning of the exercise visit.&#xD;
Placebo patch: Placebo patch designed to match active Climara patches.&#xD;
Resveratrol</description>
          </group>
          <group group_id="O3">
            <title>Climara Patch - Placebo Tablets</title>
            <description>Postmenopausal women will be given a transdermal estrogen patch to wear (0.05mg/day) for two days prior to the exercise visit and a placebo tablet to take the morning of the exercise visit.&#xD;
Climara&#xD;
Placebo: Placebo tablets designed to match active resveratrol tablets.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point</title>
          <description>Brachial artery flow-mediated dilation represents the percent change in artery diameter (before and after blood pressure cuff inflation-deflation) within each time point.</description>
          <population>Images were considered invalid and removed from analysis if the vascular boundaries were not able to be identified.</population>
          <units>Percent Change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.11" spread="0.44"/>
                    <measurement group_id="O2" value="6.93" spread="0.79"/>
                    <measurement group_id="O3" value="5.86" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 min after exercise</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.20" spread="0.45"/>
                    <measurement group_id="O2" value="5.88" spread="0.81"/>
                    <measurement group_id="O3" value="5.41" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 min after exercise</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.23" spread="0.44"/>
                    <measurement group_id="O2" value="7.01" spread="0.79"/>
                    <measurement group_id="O3" value="6.99" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 min after exercise</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.35" spread="0.44"/>
                    <measurement group_id="O2" value="7.57" spread="0.81"/>
                    <measurement group_id="O3" value="8.03" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Gene and Protein Expression in Peripheral Blood Mononuclear Cells</title>
        <description>No gene and protein data were analyzed.</description>
        <time_frame>baseline, 1-2 hours post-exercise</time_frame>
        <population>No data were collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Patch - Placebo Tablets</title>
            <description>Postmenopausal women will be given a placebo patch to wear two days prior to exercise visit and a placebo tablet to take the morning of the exercise visit.&#xD;
Placebo patch: Placebo patch designed to match active Climara patches.&#xD;
Placebo: Placebo tablets designed to match active resveratrol tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Patch - Resveratrol Tablets</title>
            <description>Postmenopausal women will be given a placebo patch to wear for two days prior to the exercise visit and a resveratrol tablet (dosed at 250mg) to take the morning of the exercise visit.&#xD;
Placebo patch: Placebo patch designed to match active Climara patches.&#xD;
Resveratrol</description>
          </group>
          <group group_id="O3">
            <title>Climara Patch - Placebo Tablets</title>
            <description>Postmenopausal women will be given a transdermal estrogen patch to wear (0.05mg/day) for two days prior to the exercise visit and a placebo tablet to take the morning of the exercise visit.&#xD;
Climara&#xD;
Placebo: Placebo tablets designed to match active resveratrol tablets.</description>
          </group>
        </group_list>
        <measure>
          <title>Gene and Protein Expression in Peripheral Blood Mononuclear Cells</title>
          <description>No gene and protein data were analyzed.</description>
          <population>No data were collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Nitrate/Nitrite Levels</title>
        <description>Measure of nitric oxide</description>
        <time_frame>baseline, 1-2 hrs post-exercise</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo Patch - Placebo Tablets</title>
            <description>Postmenopausal women will be given a placebo patch to wear two days prior to exercise visit and a placebo tablet to take the morning of the exercise visit.&#xD;
Placebo patch: Placebo patch designed to match active Climara patches.&#xD;
Placebo: Placebo tablets designed to match active resveratrol tablets.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Patch - Resveratrol Tablets</title>
            <description>Postmenopausal women will be given a placebo patch to wear for two days prior to the exercise visit and a resveratrol tablet (dosed at 250mg) to take the morning of the exercise visit.&#xD;
Placebo patch: Placebo patch designed to match active Climara patches.&#xD;
Resveratrol</description>
          </group>
          <group group_id="O3">
            <title>Climara Patch - Placebo Tablets</title>
            <description>Postmenopausal women will be given a transdermal estrogen patch to wear (0.05mg/day) for two days prior to the exercise visit and a placebo tablet to take the morning of the exercise visit.&#xD;
Climara&#xD;
Placebo: Placebo tablets designed to match active resveratrol tablets.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Nitrate/Nitrite Levels</title>
          <description>Measure of nitric oxide</description>
          <units>micromolar</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121.3" spread="57.6"/>
                    <measurement group_id="O2" value="134.2" spread="65.6"/>
                    <measurement group_id="O3" value="110.9" spread="53.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 min after exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.6" spread="48.5"/>
                    <measurement group_id="O2" value="109.6" spread="59.2"/>
                    <measurement group_id="O3" value="118.2" spread="61.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 min after exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114.7" spread="54.2"/>
                    <measurement group_id="O2" value="118.7" spread="56.0"/>
                    <measurement group_id="O3" value="111.1" spread="60.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Placebo Patch - Placebo Tablets</title>
          <description>Postmenopausal women will be given a placebo patch to wear two days prior to exercise visit and a placebo tablet to take the morning of the exercise visit.&#xD;
Placebo patch: Placebo patch designed to match active Climara patches.&#xD;
Placebo: Placebo tablets designed to match active resveratrol tablets.</description>
        </group>
        <group group_id="E2">
          <title>Placebo Patch - Resveratrol Tablets</title>
          <description>Postmenopausal women will be given a placebo patch to wear for two days prior to the exercise visit and a resveratrol tablet (dosed at 250mg) to take the morning of the exercise visit.&#xD;
Placebo patch: Placebo patch designed to match active Climara patches.&#xD;
Resveratrol</description>
        </group>
        <group group_id="E3">
          <title>Climara Patch - Placebo Tablets</title>
          <description>Postmenopausal women will be given a transdermal estrogen patch to wear (0.05mg/day) for two days prior to the exercise visit and a placebo tablet to take the morning of the exercise visit.&#xD;
Climara&#xD;
Placebo: Placebo tablets designed to match active resveratrol tablets.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
              </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. Kerrie Moreau</name_or_title>
      <organization>University of Colorado Anschutz Medical Campus</organization>
      <phone>303-724-1914</phone>
      <email>kerrie.moreau@cuanschutz.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/NCT02256540
org study id: 14-0532
secondary id: UL1TR001082
secondary id: R56HL114073
nct id: NCT02256540
lead sponsor: 
collaborator: 
This pilot study plans to learn more about the aging of blood vessels and arteries in women.
      As women age and go through menopause, their risk for cardiovascular disease increases. Also
      with aging and menopause, levels of the reproductive hormone estradiol decline. Hormone
      replacement therapy to restore estradiol levels does not protect women from cardiovascular
      disease, so lifestyle changes, such as regular exercise, are recommended to reduce disease
      risk. However, there are differences between men and women in their response to exercise. In
      older men, exercise improves the health of their arteries, but in postmenopausal women,
      exercise does not provide this benefit. The purpose of this pilot study is to determine
      whether low estradiol levels in postmenopausal women are responsible for the poor vascular
      response to exercise. In this study the investigators will also test whether treatment with
      resveratrol, a plant compound found in red wine, improves postmenopausal women's response to
      exercise. The investigators hypothesize that acute treatment with estrogen or resveratrol
      will improve vascular responses to an acute bout of exercise.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point
time frame: Up to 2 hours post-exercise
description: Brachial artery flow-mediated dilation represents the percent change in artery diameter (before and after blood pressure cuff inflation-deflation) within each time point.
measure: Gene and Protein Expression in Peripheral Blood Mononuclear Cells
time frame: baseline, 1-2 hours post-exercise
description: No gene and protein data were analyzed.
measure: Change in Nitrate/Nitrite Levels
time frame: baseline, 1-2 hrs post-exercise
description: Measure of nitric oxide
arm group label: Placebo patch - placebo tablets
arm group type: Placebo Comparator
description: Postmenopausal women will be given a placebo patch to wear two days prior to exercise visit and a placebo tablet to take the morning of the exercise visit.
arm group label: Placebo patch - Resveratrol tablets
arm group type: Experimental
description: Postmenopausal women will be given a placebo patch to wear for two days prior to the exercise visit and a resveratrol tablet (dosed at 250mg) to take the morning of the exercise visit.
arm group label: Climara patch - placebo tablets
arm group type: Active Comparator
description: Postmenopausal women will be given a transdermal estrogen patch to wear (0.05mg/day) for two days prior to the exercise visit and a placebo tablet to take the morning of the exercise visit.
intervention type: Drug
intervention name: Climara
arm group label: Climara patch - placebo tablets
other name: Estradiol transdermal patch
intervention type: Drug
intervention name: Placebo patch
description: Placebo patch designed to match active Climara patches.
arm group label: Placebo patch - Resveratrol tablets
arm group label: Placebo patch - placebo tablets
intervention type: Dietary Supplement
intervention name: Resveratrol
arm group label: Placebo patch - Resveratrol tablets
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo tablets designed to match active resveratrol tablets.
arm group label: Climara patch - placebo tablets
arm group label: Placebo patch - placebo tablets
criteria: 
gender: Female
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kerrie L Moreau, PhD
role: Principal Investigator
affiliation: University of Colorado School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Resveratrol
mesh term: Estradiol
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 