<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/NCT01668836</url>
  </required_header>
  <id_info>
    <org_study_id>788012</org_study_id>
    <secondary_id>2012/01051-5</secondary_id>
    <nct_id>NCT01668836</nct_id>
  </id_info>
  <brief_title>Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years</brief_title>
  <official_title>Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InCor Heart Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InCor Heart Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Women have a natural protection that gives them greater longevity. One hypothesis most&#xD;
      commonly used is the estrogen protection in the premenopausal period. However many studies of&#xD;
      various forms of hormone replacement therapy proved ineffective in promoting additional&#xD;
      protection for women. Thus, it is discussed other ways of protection associated with&#xD;
      longevity in women. Of these, the sirtuin system was found in several animal studies to be&#xD;
      associated with longevity. This system also showed, through the involvement of several&#xD;
      metabolic pathways, an important protection against the process of atherosclerosis. But the&#xD;
      activity of this system in humans is unknown and if it is more active in women than in men.&#xD;
      The study's main objectives are to analyze this system in healthy 24 women and 24 men aged 55&#xD;
      to 65 years, and their influence on the main metabolic pathways related to longevity and the&#xD;
      process of atherosclerosis. The research protocol includes analysis of the influence of&#xD;
      sirtuin (SIRT1) in vascular reactivity, lipid profile, antioxidant capacity, markers of&#xD;
      inflammation and homeostasis, before and after the interventions with caloric restriction or&#xD;
      resveratrol administration. It is expected of this study mechanistic conclusion for longevity&#xD;
      and possible clinical applications in the mechanism of atherosclerosis prevention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After a washout period of 15 days without medication, men and women will be randomized to the&#xD;
      group of calorie restriction or resveratrol so that in 24 individuals (12 women and 12 men)&#xD;
      will be given a hypocaloric diet (1000 calories per day) and the remaining 24 individuals (12&#xD;
      women and 12 men), a daily pill of 500mg of resveratrol. In the two moments, after the&#xD;
      washout period and before the intervention (baseline) and after 30 days of intervention&#xD;
      (final) will evaluate the clinical, laboratory and vascular reactivity of all subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Direct Evaluation of the Sirtuin 1 Gene Expression</measure>
    <time_frame>30 days post-treatment</time_frame>
    <description>The Sirtuin 1 gene expression was measured by real time PCR in peripheric blood. Unit of measure was arbitrary unit. &quot;Arbitrary unit was relative to the control gene expression (control gene = 1)&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sirtuin</measure>
    <time_frame>30 days post-treatment</time_frame>
    <description>Sirtuin plasma levels before and 30 days post-treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.</measure>
    <time_frame>30 days post-treatment</time_frame>
    <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- serum HDL, LDL, lipoprotein(a), C reactive protein, glucose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of the Sirtuin 1 System on Apolipoproteins AI and B.</measure>
    <time_frame>30 days post-treatment</time_frame>
    <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- apolipoproteins AI and B</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of the Sirtuin 1 System on Estradiol</measure>
    <time_frame>30 days post-treatment</time_frame>
    <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- estradiol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of the Sirtuin 1 System on Platelet Aggregation.</measure>
    <time_frame>30 days post-treatment</time_frame>
    <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- platelet aggregation by ADP and norepinephrine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of the Sirtuin 1 System on Biomarkers</measure>
    <time_frame>30 days post-treatment</time_frame>
    <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- non-esterified fatty acids, insulin, luteinizing hormone, follicle stimulating hormone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of the Sirtuin 1 System on Estrone and Norepinephrine.</measure>
    <time_frame>30 days post-treatment</time_frame>
    <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- estrone, norepinephrine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression</measure>
    <time_frame>30 days post-treatment</time_frame>
    <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
RAGE gene expression&#xD;
&quot;Arbitrary unit was relative to the control gene expression (control gene = 1)&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.</measure>
    <time_frame>30 days post-treatment</time_frame>
    <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
-dynamics of clot formation: clot onset time and clot complet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of the Sirtuin 1 System on Thromboelastography.</measure>
    <time_frame>30 days post-treatment</time_frame>
    <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- slope of clot formation dynamics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography.</measure>
    <time_frame>30 days post-treatment</time_frame>
    <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
-max elasticity of clot on thromboelastography</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Differences Between Men and Women.</measure>
    <time_frame>30 days</time_frame>
    <description>We will also compare women vs men baseline and final data.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Vascular System Injuries</condition>
  <condition>Lipid Metabolism Disorders</condition>
  <condition>Endothelial Disfunction</condition>
  <arm_group>
    <arm_group_label>men with resveratrol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 men will receive a pill with 500mg of resveratrol daily for 30 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>women with resveratrol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 women will receive a pill with 500mg of resveratrol daily for 30 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>men with caloric restriction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 men will follow a 1000 calories per day diet for 30 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>women with caloric restriction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 women will follow a 1000 calories per day diet for 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Resveratrol</intervention_name>
    <description>1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
    <arm_group_label>men with resveratrol</arm_group_label>
    <arm_group_label>women with resveratrol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Caloric restriction</intervention_name>
    <description>Diet of 1000kcal per day for 30 days</description>
    <arm_group_label>men with caloric restriction</arm_group_label>
    <arm_group_label>women with caloric restriction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical history, physical examination and electrocardiogram normal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  premenopausal women (less than 1 year of natural amenorrhea)&#xD;
&#xD;
          -  Body mass index ≥ 35 kg/m2&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Severe hypertension (diastolic blood pressure ≥ 110 mmHg)&#xD;
&#xD;
          -  Severe dyslipidemia (triglycerides ≥ 500mg/dL, total cholesterol ≥ 300mg/dL)&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Previous using previous statins or hormone replacement therapy. Other exclusion&#xD;
             criteria are: chronic renal failure (serum creatinine ≥ 2.0 mg / dl), hepatic,&#xD;
             endocrine, hematologic, respiratory or metabolic clinically significant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antônio de Pádua Mansur, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>InCor Heart Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>INCOR - Heart Institute</name>
      <address>
        <city>São Paulo</city>
        <zip>05403-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <results_first_submitted>August 24, 2015</results_first_submitted>
  <results_first_submitted_qc>March 17, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 18, 2016</results_first_posted>
  <last_update_submitted>March 17, 2016</last_update_submitted>
  <last_update_submitted_qc>March 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>InCor Heart Institute</investigator_affiliation>
    <investigator_full_name>ANTONIO DE PADUA MANSUR</investigator_full_name>
    <investigator_title>PHD</investigator_title>
  </responsible_party>
  <keyword>sirtuin</keyword>
  <keyword>atherosclerosis</keyword>
  <keyword>longevity</keyword>
  <keyword>calorie restriction</keyword>
  <keyword>resveratrol</keyword>
  <keyword>vascular reactivity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular System Injuries</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Lipid Metabolism Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Resveratrol</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Men With Resveratrol</title>
          <description>12 men will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
        </group>
        <group group_id="P2">
          <title>Women With Resveratrol</title>
          <description>12 women will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
        </group>
        <group group_id="P3">
          <title>Men With Caloric Restriction</title>
          <description>12 men will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1000kcal per day for 30 days</description>
        </group>
        <group group_id="P4">
          <title>Women With Caloric Restriction</title>
          <description>12 women will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1000kcal per day for 30 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Men With Resveratrol</title>
          <description>12 men will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
        </group>
        <group group_id="B2">
          <title>Women With Resveratrol</title>
          <description>12 women will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
        </group>
        <group group_id="B3">
          <title>Men With Caloric Restriction</title>
          <description>12 men will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
        </group>
        <group group_id="B4">
          <title>Women With Caloric Restriction</title>
          <description>12 women will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
        </group>
        <group group_id="B5">
          <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="12"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="12"/>
            <count group_id="B4" value="12"/>
            <count group_id="B5" value="48"/>
          </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="58.4" spread="3.6"/>
                    <measurement group_id="B2" value="58.5" spread="3.4"/>
                    <measurement group_id="B3" value="57.7" spread="3.5"/>
                    <measurement group_id="B4" value="59.5" spread="3.7"/>
                    <measurement group_id="B5" value="58.5" spread="3.5"/>
                  </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="0"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Brazil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index</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="28.5" spread="4.4"/>
                    <measurement group_id="B2" value="26.5" spread="3.4"/>
                    <measurement group_id="B3" value="26.2" spread="3.5"/>
                    <measurement group_id="B4" value="25.5" spread="3.7"/>
                    <measurement group_id="B5" value="26.7" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>abdominal circumference</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100.9" spread="13.9"/>
                    <measurement group_id="B2" value="92.7" spread="8.7"/>
                    <measurement group_id="B3" value="96.5" spread="7.6"/>
                    <measurement group_id="B4" value="92" spread="7"/>
                    <measurement group_id="B5" value="95.5" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>heart rate</title>
          <units>beats/minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.6" spread="7.9"/>
                    <measurement group_id="B2" value="65.6" spread="9.1"/>
                    <measurement group_id="B3" value="63.9" spread="10.7"/>
                    <measurement group_id="B4" value="60.8" spread="8.3"/>
                    <measurement group_id="B5" value="63.6" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic blood pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="136.9" spread="15.0"/>
                    <measurement group_id="B2" value="126" spread="14.5"/>
                    <measurement group_id="B3" value="133.2" spread="16.6"/>
                    <measurement group_id="B4" value="125.6" spread="14.1"/>
                    <measurement group_id="B5" value="130.6" spread="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diastolic blood pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83.9" spread="12.0"/>
                    <measurement group_id="B2" value="78.5" spread="9.3"/>
                    <measurement group_id="B3" value="84.8" spread="9.9"/>
                    <measurement group_id="B4" value="80.6" spread="12.3"/>
                    <measurement group_id="B5" value="82" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>total cholesterol</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="192.8" spread="28.1"/>
                    <measurement group_id="B2" value="222.7" spread="32.5"/>
                    <measurement group_id="B3" value="197.3" spread="36.2"/>
                    <measurement group_id="B4" value="235.1" spread="44.9"/>
                    <measurement group_id="B5" value="212.0" spread="39.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HDL-cholesterol</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.6" spread="10.2"/>
                    <measurement group_id="B2" value="54.8" spread="15.2"/>
                    <measurement group_id="B3" value="43.5" spread="9.0"/>
                    <measurement group_id="B4" value="67.2" spread="18.2"/>
                    <measurement group_id="B5" value="52.3" spread="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>LDL-cholesterol</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="125.5" spread="29.9"/>
                    <measurement group_id="B2" value="140.8" spread="28.7"/>
                    <measurement group_id="B3" value="127.6" spread="34.0"/>
                    <measurement group_id="B4" value="149.8" spread="37.6"/>
                    <measurement group_id="B5" value="135.5" spread="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Triglycerides</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="126.5" spread="63.0"/>
                    <measurement group_id="B2" value="121.6" spread="72.4"/>
                    <measurement group_id="B3" value="131.0" spread="77.9"/>
                    <measurement group_id="B4" value="91.4" spread="37.4"/>
                    <measurement group_id="B5" value="117.6" spread="64.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>C-reactive protein</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.13" spread="0.67"/>
                    <measurement group_id="B2" value="3.47" spread="2.38"/>
                    <measurement group_id="B3" value="1.63" spread="1.01"/>
                    <measurement group_id="B4" value="2.31" spread="2.44"/>
                    <measurement group_id="B5" value="2.13" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Apolipoprotein A1</title>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.37" spread="0.21"/>
                    <measurement group_id="B2" value="1.53" spread="0.19"/>
                    <measurement group_id="B3" value="1.34" spread="0.11"/>
                    <measurement group_id="B4" value="1.72" spread="0.25"/>
                    <measurement group_id="B5" value="1.49" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Apolipoprotein B</title>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.91" spread="0.18"/>
                    <measurement group_id="B2" value="1.04" spread="0.28"/>
                    <measurement group_id="B3" value="0.97" spread="0.25"/>
                    <measurement group_id="B4" value="1.04" spread="0.27"/>
                    <measurement group_id="B5" value="0.99" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>lipoprotein (a)</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.2" spread="20.1"/>
                    <measurement group_id="B2" value="24.1" spread="29.7"/>
                    <measurement group_id="B3" value="31.8" spread="44.7"/>
                    <measurement group_id="B4" value="23.9" spread="17.4"/>
                    <measurement group_id="B5" value="24.0" spread="29.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>glucose</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95.8" spread="14.1"/>
                    <measurement group_id="B2" value="96.3" spread="13.8"/>
                    <measurement group_id="B3" value="91.8" spread="12.6"/>
                    <measurement group_id="B4" value="95.4" spread="8.5"/>
                    <measurement group_id="B5" value="94.8" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>luteinizing hormone</title>
          <units>microUI/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.34" spread="1.67"/>
                    <measurement group_id="B2" value="20.9" spread="7.53"/>
                    <measurement group_id="B3" value="4.46" spread="1.95"/>
                    <measurement group_id="B4" value="29.9" spread="9.05"/>
                    <measurement group_id="B5" value="14.7" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>follicle stimulating hormone</title>
          <units>microUI/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.12" spread="2.2"/>
                    <measurement group_id="B2" value="60.8" spread="20.4"/>
                    <measurement group_id="B3" value="6.22" spread="3.53"/>
                    <measurement group_id="B4" value="75.8" spread="18.7"/>
                    <measurement group_id="B5" value="36.8" spread="35.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Estradiol</title>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.4" spread="10.5"/>
                    <measurement group_id="B2" value="38.6" spread="16.4"/>
                    <measurement group_id="B3" value="43.4" spread="12.3"/>
                    <measurement group_id="B4" value="25.9" spread="8.3"/>
                    <measurement group_id="B5" value="36.0" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>norepinephrine</title>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="267.8" spread="148.9"/>
                    <measurement group_id="B2" value="270.8" spread="88.6"/>
                    <measurement group_id="B3" value="286.3" spread="126.8"/>
                    <measurement group_id="B4" value="420.9" spread="171.0"/>
                    <measurement group_id="B5" value="306.7" spread="144.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insulin</title>
          <units>microUI/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.7" spread="33.7"/>
                    <measurement group_id="B2" value="77.1" spread="62.2"/>
                    <measurement group_id="B3" value="69.3" spread="57.1"/>
                    <measurement group_id="B4" value="44.3" spread="28.9"/>
                    <measurement group_id="B5" value="61.5" spread="48.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sirtuin</title>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.95" spread="0.46"/>
                    <measurement group_id="B2" value="1.16" spread="0.90"/>
                    <measurement group_id="B3" value="1.65" spread="1.40"/>
                    <measurement group_id="B4" value="1.65" spread="2.21"/>
                    <measurement group_id="B5" value="1.35" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Estrone</title>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.6" spread="18.3"/>
                    <measurement group_id="B2" value="12.4" spread="17.4"/>
                    <measurement group_id="B3" value="3.1" spread="0.0"/>
                    <measurement group_id="B4" value="5.11" spread="6.7"/>
                    <measurement group_id="B5" value="10.0" spread="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sirtuin-1 gene expression by real time polimerase chain reaction &quot;RT-PCR&quot;</title>
          <description>Values obtained from delta CT (cycle threshold) using as normalizer GAPDH gene.</description>
          <units>arbitrary unit</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.4" spread="1.28"/>
                    <measurement group_id="B2" value="11.6" spread="1.38"/>
                    <measurement group_id="B3" value="11.4" spread="1.26"/>
                    <measurement group_id="B4" value="10.6" spread="1.15"/>
                    <measurement group_id="B5" value="11.0" spread="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>RAGE (receptor for advanced glycation end-products) gene expression &quot;RT-PCR&quot;</title>
          <units>arbitrary unit</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.3" spread="1.24"/>
                    <measurement group_id="B2" value="12.7" spread="1.65"/>
                    <measurement group_id="B3" value="10.9" spread="1.68"/>
                    <measurement group_id="B4" value="10.5" spread="1.76"/>
                    <measurement group_id="B5" value="11.3" spread="1.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Platelet aggregation by adenosine diphosphate (ADP)</title>
          <description>percentage of maximum amplitude aggregation by adenosine diphosphate</description>
          <units>%</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86.13" spread="4.06"/>
                    <measurement group_id="B2" value="88.90" spread="5.87"/>
                    <measurement group_id="B3" value="84.20" spread="7.80"/>
                    <measurement group_id="B4" value="88.45" spread="3.65"/>
                    <measurement group_id="B5" value="86.92" spread="5.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Platelet aggregation by epinephrine</title>
          <description>percentage of maximum amplitude aggregation</description>
          <units>%</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84.23" spread="3.90"/>
                    <measurement group_id="B2" value="83.42" spread="10.22"/>
                    <measurement group_id="B3" value="66.88" spread="25.92"/>
                    <measurement group_id="B4" value="81.20" spread="18.27"/>
                    <measurement group_id="B5" value="78.93" spread="17.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nonesterified fatty acid</title>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.73" spread="16.55"/>
                    <measurement group_id="B2" value="18.64" spread="14.12"/>
                    <measurement group_id="B3" value="29.75" spread="49.34"/>
                    <measurement group_id="B4" value="24.17" spread="20.92"/>
                    <measurement group_id="B5" value="24.67" spread="28.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clot onset time</title>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.25" spread="4.16"/>
                    <measurement group_id="B2" value="30.75" spread="9.58"/>
                    <measurement group_id="B3" value="38.25" spread="4.00"/>
                    <measurement group_id="B4" value="91.64" spread="177.95"/>
                    <measurement group_id="B5" value="48.83" spread="86.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clot complete</title>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="103.83" spread="13.67"/>
                    <measurement group_id="B2" value="80.83" spread="12.01"/>
                    <measurement group_id="B3" value="100.17" spread="14.32"/>
                    <measurement group_id="B4" value="152.64" spread="211.01"/>
                    <measurement group_id="B5" value="108.45" spread="102.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Slope</title>
          <description>Slope reflects activity of fibrinogen and platelet function. Denotes the speed at which solid clot was formed. Its value is reduced in presence of low levels of fibrinogen and platelet function. It shows the strength which the clot is formed.</description>
          <units>Pascal/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100.83" spread="38.42"/>
                    <measurement group_id="B2" value="165.42" spread="60.43"/>
                    <measurement group_id="B3" value="108.17" spread="43.98"/>
                    <measurement group_id="B4" value="158.36" spread="37.85"/>
                    <measurement group_id="B5" value="132.66" spread="53.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Max Elasticity</title>
          <units>Pascal</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1598.50" spread="398.18"/>
                    <measurement group_id="B2" value="2202.98" spread="391.50"/>
                    <measurement group_id="B3" value="1639.82" spread="383.97"/>
                    <measurement group_id="B4" value="2164.64" spread="275.91"/>
                    <measurement group_id="B5" value="1895.88" spread="456.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Direct Evaluation of the Sirtuin 1 Gene Expression</title>
        <description>The Sirtuin 1 gene expression was measured by real time PCR in peripheric blood. Unit of measure was arbitrary unit. &quot;Arbitrary unit was relative to the control gene expression (control gene = 1)&quot;.</description>
        <time_frame>30 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Men With Resveratrol</title>
            <description>12 men will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O2">
            <title>Women With Resveratrol</title>
            <description>12 women will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O3">
            <title>Men With Caloric Restriction</title>
            <description>12 men will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1000kcal per day for 30 days</description>
          </group>
          <group group_id="O4">
            <title>Women With Caloric Restriction</title>
            <description>12 women will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1000kcal per day for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Direct Evaluation of the Sirtuin 1 Gene Expression</title>
          <description>The Sirtuin 1 gene expression was measured by real time PCR in peripheric blood. Unit of measure was arbitrary unit. &quot;Arbitrary unit was relative to the control gene expression (control gene = 1)&quot;.</description>
          <units>arbitrary unit relative to control gene</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.04" spread="1.75"/>
                    <measurement group_id="O2" value="11.43" spread="1.42"/>
                    <measurement group_id="O3" value="12.84" spread="1.36"/>
                    <measurement group_id="O4" value="12.05" spread="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.</title>
        <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- serum HDL, LDL, lipoprotein(a), C reactive protein, glucose.</description>
        <time_frame>30 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Men With Resveratrol</title>
            <description>12 men will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O2">
            <title>Women With Resveratrol</title>
            <description>12 women will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O3">
            <title>Men With Caloric Restriction</title>
            <description>12 men will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1000kcal per day for 30 days</description>
          </group>
          <group group_id="O4">
            <title>Women With Caloric Restriction</title>
            <description>12 women will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1000kcal per day for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.</title>
          <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- serum HDL, LDL, lipoprotein(a), C reactive protein, glucose.</description>
          <units>&quot;mg/dL&quot;</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HDL-cholesterol &quot;mg/dL&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.00" spread="10.37"/>
                    <measurement group_id="O2" value="53.33" spread="15.11"/>
                    <measurement group_id="O3" value="41.08" spread="9.10"/>
                    <measurement group_id="O4" value="62.92" spread="15.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL-cholesterol &quot;mg/dL&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125.50" spread="29.93"/>
                    <measurement group_id="O2" value="153.58" spread="45.92"/>
                    <measurement group_id="O3" value="126.33" spread="33.47"/>
                    <measurement group_id="O4" value="134.25" spread="34.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipoprotein(a)&quot;mg/dL&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.03" spread="19.98"/>
                    <measurement group_id="O2" value="24.43" spread="33.57"/>
                    <measurement group_id="O3" value="32.73" spread="41.34"/>
                    <measurement group_id="O4" value="20.86" spread="12.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>total cholesterol &quot;mg/dL&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="196.08" spread="31.67"/>
                    <measurement group_id="O2" value="239.08" spread="47.12"/>
                    <measurement group_id="O3" value="193.83" spread="37.20"/>
                    <measurement group_id="O4" value="211.50" spread="41.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides &quot;mg/dL&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137.75" spread="62.22"/>
                    <measurement group_id="O2" value="159.50" spread="118.13"/>
                    <measurement group_id="O3" value="131.00" spread="77.91"/>
                    <measurement group_id="O4" value="72.25" spread="30.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C-reactive protein &quot;mg/dL&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="0.14"/>
                    <measurement group_id="O2" value="0.28" spread="0.23"/>
                    <measurement group_id="O3" value="0.17" spread="0.14"/>
                    <measurement group_id="O4" value="0.16" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>glucose &quot;mg/dL&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.83" spread="16.29"/>
                    <measurement group_id="O2" value="97.33" spread="12.51"/>
                    <measurement group_id="O3" value="89.92" spread="5.78"/>
                    <measurement group_id="O4" value="91.17" spread="6.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Differences Between Men and Women.</title>
        <description>We will also compare women vs men baseline and final data.</description>
        <time_frame>30 days</time_frame>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sirtuin</title>
        <description>Sirtuin plasma levels before and 30 days post-treatment</description>
        <time_frame>30 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Men With Resveratrol</title>
            <description>12 men will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O2">
            <title>Women With Resveratrol</title>
            <description>12 women will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O3">
            <title>Men With Caloric Restriction</title>
            <description>12 men will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1000kcal per day for 30 days</description>
          </group>
          <group group_id="O4">
            <title>Women With Caloric Restriction</title>
            <description>12 women will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1000kcal per day for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Sirtuin</title>
          <description>Sirtuin plasma levels before and 30 days post-treatment</description>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.84" spread="2.78"/>
                    <measurement group_id="O2" value="6.67" spread="2.99"/>
                    <measurement group_id="O3" value="6.14" spread="1.98"/>
                    <measurement group_id="O4" value="5.46" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Influence of the Sirtuin 1 System on Apolipoproteins AI and B.</title>
        <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- apolipoproteins AI and B</description>
        <time_frame>30 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Men With Resveratrol</title>
            <description>12 men will receive a pill with 500mg of resveratrol</description>
          </group>
          <group group_id="O2">
            <title>Women With Resveratrol</title>
            <description>12 women will receive a pill with 500mg of resveratrol</description>
          </group>
          <group group_id="O3">
            <title>Men With Caloric Restriction</title>
            <description>12 men will follow a 1000Kcal/day of caloric restriction</description>
          </group>
          <group group_id="O4">
            <title>Women With Caloric Restriction</title>
            <description>12 women will follow a 1000Kcal/day of caloric restriction</description>
          </group>
        </group_list>
        <measure>
          <title>Influence of the Sirtuin 1 System on Apolipoproteins AI and B.</title>
          <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- apolipoproteins AI and B</description>
          <units>&quot;g/dL&quot;</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Apolipoprotein A1 &quot;g/dL&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.33" spread="0.20"/>
                    <measurement group_id="O2" value="1.55" spread="0.24"/>
                    <measurement group_id="O3" value="1.29" spread="0.21"/>
                    <measurement group_id="O4" value="1.57" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apolipoprotein B &quot;g/dL&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.95" spread="0.19"/>
                    <measurement group_id="O2" value="1.13" spread="0.31"/>
                    <measurement group_id="O3" value="0.97" spread="0.27"/>
                    <measurement group_id="O4" value="0.93" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Influence of the Sirtuin 1 System on Estradiol</title>
        <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- estradiol</description>
        <time_frame>30 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Men With Resveratrol</title>
            <description>12 men will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O2">
            <title>Women With Resveratrol</title>
            <description>12 women will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O3">
            <title>Men With Caloric Restriction</title>
            <description>12 men will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
          <group group_id="O4">
            <title>Women With Caloric Restriction</title>
            <description>12 women will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Influence of the Sirtuin 1 System on Estradiol</title>
          <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- estradiol</description>
          <units>&quot;pg/mL&quot;</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.92" spread="13.60"/>
                    <measurement group_id="O2" value="34.81" spread="12.73"/>
                    <measurement group_id="O3" value="42.13" spread="14.26"/>
                    <measurement group_id="O4" value="29.05" spread="7.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Influence of the Sirtuin 1 System on Platelet Aggregation.</title>
        <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- platelet aggregation by ADP and norepinephrine.</description>
        <time_frame>30 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Men With Resveratrol</title>
            <description>12 men will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O2">
            <title>Women With Resveratrol</title>
            <description>12 women will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O3">
            <title>Men With Caloric Restriction</title>
            <description>12 men will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
          <group group_id="O4">
            <title>Women With Caloric Restriction</title>
            <description>12 women will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Influence of the Sirtuin 1 System on Platelet Aggregation.</title>
          <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- platelet aggregation by ADP and norepinephrine.</description>
          <units>percentage platelet aggregation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Platelet aggregation by ADP &quot;%&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.03" spread="4.92"/>
                    <measurement group_id="O2" value="88.96" spread="4.15"/>
                    <measurement group_id="O3" value="87.32" spread="4.12"/>
                    <measurement group_id="O4" value="87.24" spread="12.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet aggregation by norepinephrine &quot;%&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.06" spread="10.46"/>
                    <measurement group_id="O2" value="81.77" spread="16.91"/>
                    <measurement group_id="O3" value="74.43" spread="23.83"/>
                    <measurement group_id="O4" value="72.09" spread="27.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Influence of the Sirtuin 1 System on Biomarkers</title>
        <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- non-esterified fatty acids, insulin, luteinizing hormone, follicle stimulating hormone.</description>
        <time_frame>30 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Men With Resveratrol</title>
            <description>12 men will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O2">
            <title>Women With Resveratrol</title>
            <description>12 women will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O3">
            <title>Men With Caloric Restriction</title>
            <description>12 men will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
          <group group_id="O4">
            <title>Women With Caloric Restriction</title>
            <description>12 women will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Influence of the Sirtuin 1 System on Biomarkers</title>
          <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- non-esterified fatty acids, insulin, luteinizing hormone, follicle stimulating hormone.</description>
          <units>&quot;microUI/mL&quot;</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non sterified fatty acid &quot;microUI/mL&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.45" spread="10.32"/>
                    <measurement group_id="O2" value="23.73" spread="12.51"/>
                    <measurement group_id="O3" value="8.83" spread="8.73"/>
                    <measurement group_id="O4" value="24.67" spread="19.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insulin &quot;microUI/mL&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.00" spread="54.55"/>
                    <measurement group_id="O2" value="80.58" spread="64.15"/>
                    <measurement group_id="O3" value="53.25" spread="32.28"/>
                    <measurement group_id="O4" value="67.08" spread="30.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Luteinizing hormone &quot;microUI/mL&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.93" spread="1.66"/>
                    <measurement group_id="O2" value="19.97" spread="7.01"/>
                    <measurement group_id="O3" value="4.50" spread="1.65"/>
                    <measurement group_id="O4" value="28.56" spread="11.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follicle stimulating hormone &quot;microUI/mL&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.40" spread="2.26"/>
                    <measurement group_id="O2" value="57.78" spread="15.35"/>
                    <measurement group_id="O3" value="6.31" spread="3.71"/>
                    <measurement group_id="O4" value="79.79" spread="26.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Influence of the Sirtuin 1 System on Estrone and Norepinephrine.</title>
        <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- estrone, norepinephrine.</description>
        <time_frame>30 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Men With Resveratrol</title>
            <description>12 men will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O2">
            <title>Women With Resveratrol</title>
            <description>12 women will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O3">
            <title>Men With Caloric Restriction</title>
            <description>12 men will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
          <group group_id="O4">
            <title>Women With Caloric Restriction</title>
            <description>12 women will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Influence of the Sirtuin 1 System on Estrone and Norepinephrine.</title>
          <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- estrone, norepinephrine.</description>
          <units>&quot;pg/dL&quot;</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Norepinephrine &quot;pg/dL&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="219.33" spread="99.24"/>
                    <measurement group_id="O2" value="227.83" spread="92.13"/>
                    <measurement group_id="O3" value="190.83" spread="124.82"/>
                    <measurement group_id="O4" value="329.00" spread="194.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Estrone&quot;pg/dL&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.92" spread="18.54"/>
                    <measurement group_id="O2" value="13.23" spread="15.49"/>
                    <measurement group_id="O3" value="7.62" spread="15.68"/>
                    <measurement group_id="O4" value="4.12" spread="3.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression</title>
        <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
RAGE gene expression&#xD;
&quot;Arbitrary unit was relative to the control gene expression (control gene = 1)&quot;</description>
        <time_frame>30 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Men With Resveratrol</title>
            <description>12 men will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O2">
            <title>Women With Resveratrol</title>
            <description>12 women will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O3">
            <title>Men With Caloric Restriction</title>
            <description>12 men will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
          <group group_id="O4">
            <title>Women With Caloric Restriction</title>
            <description>12 women will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression</title>
          <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
RAGE gene expression&#xD;
&quot;Arbitrary unit was relative to the control gene expression (control gene = 1)&quot;</description>
          <units>arbitrary unit relative to control gene</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.88" spread="1.80"/>
                    <measurement group_id="O2" value="12.78" spread="1.38"/>
                    <measurement group_id="O3" value="12.17" spread="1.99"/>
                    <measurement group_id="O4" value="11.75" spread="1.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.</title>
        <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
-dynamics of clot formation: clot onset time and clot complet</description>
        <time_frame>30 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Men With Resveratrol</title>
            <description>12 men will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O2">
            <title>Women With Resveratrol</title>
            <description>12 women will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O3">
            <title>Men With Caloric Restriction</title>
            <description>12 men will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
          <group group_id="O4">
            <title>Women With Caloric Restriction</title>
            <description>12 women will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.</title>
          <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
-dynamics of clot formation: clot onset time and clot complet</description>
          <units>&quot;sec&quot;</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clot onset time &quot;sec&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.00" spread="5.62"/>
                    <measurement group_id="O2" value="35.50" spread="5.50"/>
                    <measurement group_id="O3" value="40.42" spread="7.93"/>
                    <measurement group_id="O4" value="35.67" spread="5.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clot complet &quot;sec&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.83" spread="17.47"/>
                    <measurement group_id="O2" value="89.00" spread="16.59"/>
                    <measurement group_id="O3" value="101.00" spread="23.68"/>
                    <measurement group_id="O4" value="86.83" spread="15.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Influence of the Sirtuin 1 System on Thromboelastography.</title>
        <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- slope of clot formation dynamics</description>
        <time_frame>30 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Men With Resveratrol</title>
            <description>12 men will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O2">
            <title>Women With Resveratrol</title>
            <description>12 women will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O3">
            <title>Men With Caloric Restriction</title>
            <description>12 men will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
          <group group_id="O4">
            <title>Women With Caloric Restriction</title>
            <description>12 women will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Influence of the Sirtuin 1 System on Thromboelastography.</title>
          <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
- slope of clot formation dynamics</description>
          <units>&quot;Pascal/min&quot;</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.83" spread="50.13"/>
                    <measurement group_id="O2" value="158.67" spread="47.13"/>
                    <measurement group_id="O3" value="115.42" spread="67.38"/>
                    <measurement group_id="O4" value="156.75" spread="43.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography.</title>
        <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
-max elasticity of clot on thromboelastography</description>
        <time_frame>30 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Men With Resveratrol</title>
            <description>12 men will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O2">
            <title>Women With Resveratrol</title>
            <description>12 women will receive a pill with 500mg of resveratrol daily for 30 days&#xD;
Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days</description>
          </group>
          <group group_id="O3">
            <title>Men With Caloric Restriction</title>
            <description>12 men will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
          <group group_id="O4">
            <title>Women With Caloric Restriction</title>
            <description>12 women will follow a 1000kcal/day diet for 30 days&#xD;
Caloric restriction: Diet of 1,000kcal per day for 30 days</description>
          </group>
        </group_list>
        <measure>
          <title>Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography.</title>
          <description>For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:&#xD;
-max elasticity of clot on thromboelastography</description>
          <units>&quot;Pascal&quot;</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1690.58" spread="522.54"/>
                    <measurement group_id="O2" value="2059.83" spread="337.48"/>
                    <measurement group_id="O3" value="1691.50" spread="380.49"/>
                    <measurement group_id="O4" value="2041.12" spread="318.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Men With Resveratrol</title>
          <description>12 men will receive a pill with 500mg of resveratrol</description>
        </group>
        <group group_id="E2">
          <title>Women With Resveratrol</title>
          <description>12 women will receive a pill with 500mg of resveratrol</description>
        </group>
        <group group_id="E3">
          <title>Men With Caloric Restriction</title>
          <description>12 men will follow a 1000Kcal/day of caloric restriction</description>
        </group>
        <group group_id="E4">
          <title>Women With Caloric Restriction</title>
          <description>12 women will follow a 1000Kcal/day of caloric restriction</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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </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>Antonio de Padua Mansur - Associate Professor</name_or_title>
      <organization>Heart Institute (InCor), University of São Paulo Medical School</organization>
      <phone>55-11-26615387</phone>
      <email>apmansur@usp.br; apmansur@yahoo.com</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/NCT01668836
org study id: 788012
secondary id: 2012/01051-5
nct id: NCT01668836
lead sponsor: 
has dmc: No
Women have a natural protection that gives them greater longevity. One hypothesis most
      commonly used is the estrogen protection in the premenopausal period. However many studies of
      various forms of hormone replacement therapy proved ineffective in promoting additional
      protection for women. Thus, it is discussed other ways of protection associated with
      longevity in women. Of these, the sirtuin system was found in several animal studies to be
      associated with longevity. This system also showed, through the involvement of several
      metabolic pathways, an important protection against the process of atherosclerosis. But the
      activity of this system in humans is unknown and if it is more active in women than in men.
      The study's main objectives are to analyze this system in healthy 24 women and 24 men aged 55
      to 65 years, and their influence on the main metabolic pathways related to longevity and the
      process of atherosclerosis. The research protocol includes analysis of the influence of
      sirtuin (SIRT1) in vascular reactivity, lipid profile, antioxidant capacity, markers of
      inflammation and homeostasis, before and after the interventions with caloric restriction or
      resveratrol administration. It is expected of this study mechanistic conclusion for longevity
      and possible clinical applications in the mechanism of atherosclerosis prevention.
After a washout period of 15 days without medication, men and women will be randomized to the
      group of calorie restriction or resveratrol so that in 24 individuals (12 women and 12 men)
      will be given a hypocaloric diet (1000 calories per day) and the remaining 24 individuals (12
      women and 12 men), a daily pill of 500mg of resveratrol. In the two moments, after the
      washout period and before the intervention (baseline) and after 30 days of intervention
      (final) will evaluate the clinical, laboratory and vascular reactivity of all subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Direct Evaluation of the Sirtuin 1 Gene Expression
time frame: 30 days post-treatment
description: The Sirtuin 1 gene expression was measured by real time PCR in peripheric blood. Unit of measure was arbitrary unit. "Arbitrary unit was relative to the control gene expression (control gene = 1)".
measure: Sirtuin
time frame: 30 days post-treatment
description: Sirtuin plasma levels before and 30 days post-treatment
measure: Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.
time frame: 30 days post-treatment
description: For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- serum HDL, LDL, lipoprotein(a), C reactive protein, glucose.
measure: Influence of the Sirtuin 1 System on Apolipoproteins AI and B.
time frame: 30 days post-treatment
description: For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- apolipoproteins AI and B
measure: Influence of the Sirtuin 1 System on Estradiol
time frame: 30 days post-treatment
description: For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- estradiol
measure: Influence of the Sirtuin 1 System on Platelet Aggregation.
time frame: 30 days post-treatment
description: For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- platelet aggregation by ADP and norepinephrine.
measure: Influence of the Sirtuin 1 System on Biomarkers
time frame: 30 days post-treatment
description: For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- non-esterified fatty acids, insulin, luteinizing hormone, follicle stimulating hormone.
measure: Influence of the Sirtuin 1 System on Estrone and Norepinephrine.
time frame: 30 days post-treatment
description: For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- estrone, norepinephrine.
measure: Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression
time frame: 30 days post-treatment
description: For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
RAGE gene expression
"Arbitrary unit was relative to the control gene expression (control gene = 1)"
measure: Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.
time frame: 30 days post-treatment
description: For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
-dynamics of clot formation: clot onset time and clot complet
measure: Influence of the Sirtuin 1 System on Thromboelastography.
time frame: 30 days post-treatment
description: For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- slope of clot formation dynamics
measure: Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography.
time frame: 30 days post-treatment
description: For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
-max elasticity of clot on thromboelastography
measure: Differences Between Men and Women.
time frame: 30 days
description: We will also compare women vs men baseline and final data.
arm group label: men with resveratrol
arm group type: Experimental
description: 12 men will receive a pill with 500mg of resveratrol daily for 30 days
arm group label: women with resveratrol
arm group type: Experimental
description: 12 women will receive a pill with 500mg of resveratrol daily for 30 days
arm group label: men with caloric restriction
arm group type: Active Comparator
description: 12 men will follow a 1000 calories per day diet for 30 days
arm group label: women with caloric restriction
arm group type: Active Comparator
description: 12 women will follow a 1000 calories per day diet for 30 days
intervention type: Drug
intervention name: Resveratrol
description: 1 pill daily containing 500 mg/d of resveratrol for 30 days
arm group label: men with resveratrol
arm group label: women with resveratrol
intervention type: Behavioral
intervention name: Caloric restriction
description: Diet of 1000kcal per day for 30 days
arm group label: men with caloric restriction
arm group label: women with caloric restriction
criteria: 
gender: All
minimum age: 55 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Antônio de Pádua Mansur, PHD
role: Principal Investigator
affiliation: InCor Heart Institute
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: InCor Heart Institute
investigator full name: ANTONIO DE PADUA MANSUR
investigator title: PHD
mesh term: Vascular System Injuries
mesh term: Metabolic Diseases
mesh term: Lipid Metabolism Disorders
mesh term: Resveratrol
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 