<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/NCT01729234</url>
  </required_header>
  <id_info>
    <org_study_id>Nitrate for vascular age</org_study_id>
    <nct_id>NCT01729234</nct_id>
  </id_info>
  <brief_title>Effects of Dietary Nitrate on Age-related Vascular Function</brief_title>
  <official_title>Effects of Dietary Nitrate Supplementation on Age-related Vascular Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heinrich-Heine University, Duesseldorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heinrich-Heine University, Duesseldorf</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of the study is to characterize the chronic effect of dietary nitrate on vascular&#xD;
      function in healthy volunteers with particular emphasis on age-related alterations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Endothelial function measured by flow-mediated dilation (FMD)</measure>
    <time_frame>30 days</time_frame>
    <description>The effect of dietary nitrate on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Endothelial Dysfunction</condition>
  <arm_group>
    <arm_group_label>Nitrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>150µmol /Kg bodyweight /day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLacebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>150µmol /Kg bodyweight /day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nitrate</intervention_name>
    <description>Dietary Supplement</description>
    <arm_group_label>Nitrate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Dietary Supplement</description>
    <arm_group_label>PLacebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        &gt;55 Years Healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        known cardiovascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Heinrich-Heine-University</name>
      <address>
        <city>Duesseldorf,</city>
        <state>Nrw,</state>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>December 6, 2013</last_update_submitted>
  <last_update_submitted_qc>December 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>age related Endothelial Dysfunction</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01729234
org study id: Nitrate for vascular age
nct id: NCT01729234
lead sponsor: 
has dmc: No
Purpose of the study is to characterize the chronic effect of dietary nitrate on vascular
      function in healthy volunteers with particular emphasis on age-related alterations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Endothelial function measured by flow-mediated dilation (FMD)
time frame: 30 days
description: The effect of dietary nitrate on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.
arm group label: Nitrate
arm group type: Experimental
description: 150µmol /Kg bodyweight /day
arm group label: PLacebo
arm group type: Placebo Comparator
description: 150µmol /Kg bodyweight /day
intervention type: Dietary Supplement
intervention name: Nitrate
description: Dietary Supplement
arm group label: Nitrate
intervention type: Dietary Supplement
intervention name: Placebo
description: Dietary Supplement
arm group label: PLacebo
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Sponsor