<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/NCT01712386</url>
  </required_header>
  <id_info>
    <org_study_id>12/SW/0327</org_study_id>
    <secondary_id>PC/jse</secondary_id>
    <nct_id>NCT01712386</nct_id>
  </id_info>
  <brief_title>Nitrate, Chronic Obstructive Pulmonary Disease (COPD) and Exercise</brief_title>
  <official_title>The Effects of Dietary Nitrate Supplementation on the Oxygen Cost of Moderate-Intensity Exercise and Functional Capacity in Mild-Moderate COPD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NIHR Exeter Clinical Research Facility</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Torbay and South Devon NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NIHR Exeter Clinical Research Facility</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with moderate chronic obstructive pulmonary disease (COPD) typically have reduced&#xD;
      exercise capacity. This is because their lungs are damaged and because of increased work of&#xD;
      breathing. In some patients, exercise capacity is reduced to such a level that even simple&#xD;
      activities of daily living, such as washing and dressing, may impose a challenge.&#xD;
&#xD;
      Recent findings in healthy young people suggest that increasing the amount of nitrate in our&#xD;
      diet in the form of beetroot juice can improve the ability to exercise. Studies involving&#xD;
      cycling have shown that less oxygen is needed to perform the same level of exercise after&#xD;
      taking more nitrate in the diet. Nitrate (found in abundance in beetroot) is known to be&#xD;
      converted in the body to nitric oxide (NO), a substance which increases blood flow and may&#xD;
      affect the energy-producing mechanisms inside muscle cells. A recent exciting finding is that&#xD;
      such dietary nitrate supplementation appears to reduce the amount of oxygen needed to&#xD;
      complete moderate intensity exercise (walking) in healthy individuals. It is the purpose of&#xD;
      this study to see if such effects could be seen in COPD patients. If this is indeed the case,&#xD;
      then it may suggest that a period of dietary supplementation of a relatively cheap, widely&#xD;
      available, and natural food product may improve the ability of patients to undergo everyday&#xD;
      tasks and ultimately improve their quality of life.&#xD;
&#xD;
      To help investigators understand the effects of dietary nitrate supplementation on the&#xD;
      ability to exercise in COPD patients, the investigators will recruit 15 people with mild to&#xD;
      moderate disease. They will complete a series of undemanding exercise tests on three separate&#xD;
      occasions. On one occasion they will have had a course of nitrate rich beetroot juice leading&#xD;
      up to the tests, and on the other occasion they will have had a course of beetroot juice with&#xD;
      the nitrate removed. The investigators will monitor blood pressure, levels of nitrate and&#xD;
      nitrite in the blood, oxygen uptake and functional capacity during the tests which will allow&#xD;
      us to assess any effects that may have occurred as a result of increased nitrate intake.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 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>Crossover Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>O2 cost of moderate-intensity cycling exercise</measure>
    <time_frame>Twice over a maximum of a 2 month period</time_frame>
    <description>whether nitrate reduces the O2 cost of moderate intensity exercise.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Single-breath lung diffusion capacity</measure>
    <time_frame>Once at screening. i.e. on one day that will last 10 seconds (before should only have been at familiarisation)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Functional capacity measured by 6-Minute Walking Test (6MWT)</measure>
    <time_frame>Twice over a maximum of a 2 month period</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>COPD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Beetroot</intervention_name>
    <arm_group_label>COPD</arm_group_label>
    <other_name>James Whites Drinks beetroot sports shot</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Beetroot placebo</intervention_name>
    <arm_group_label>COPD</arm_group_label>
    <other_name>James Whites Drinks beetroot sports shot</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild-moderate COPD (FEV1 30%-80% predicted values)&#xD;
&#xD;
          -  Between the ages of 40-75&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic BP&gt; 160mmHg, diastolic &gt;100mmHg)&#xD;
&#xD;
          -  Regular therapy with organic nitrates, nicorandil and antibiotics.&#xD;
&#xD;
          -  Current smoker (Have smoked within the last 3 months)&#xD;
&#xD;
          -  Chronic Kidney Disease (stage 4 or worse)&#xD;
&#xD;
          -  Any other serious medical condition which would interfere with data interpretation and&#xD;
             safety or that may make cycling exercise difficult, limited or uncomfortable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nigel Benjamin, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Torbay and South Devon NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>South Devon Healthcare NHS Foundation Trust</name>
      <address>
        <city>Torquay</city>
        <state>Devon</state>
        <zip>TQ2 7AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>October 2, 2014</last_update_submitted>
  <last_update_submitted_qc>October 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01712386
org study id: 12/SW/0327
secondary id: PC/jse
nct id: NCT01712386
lead sponsor: 
collaborator: 
has dmc: No
Patients with moderate chronic obstructive pulmonary disease (COPD) typically have reduced
      exercise capacity. This is because their lungs are damaged and because of increased work of
      breathing. In some patients, exercise capacity is reduced to such a level that even simple
      activities of daily living, such as washing and dressing, may impose a challenge.

      Recent findings in healthy young people suggest that increasing the amount of nitrate in our
      diet in the form of beetroot juice can improve the ability to exercise. Studies involving
      cycling have shown that less oxygen is needed to perform the same level of exercise after
      taking more nitrate in the diet. Nitrate (found in abundance in beetroot) is known to be
      converted in the body to nitric oxide (NO), a substance which increases blood flow and may
      affect the energy-producing mechanisms inside muscle cells. A recent exciting finding is that
      such dietary nitrate supplementation appears to reduce the amount of oxygen needed to
      complete moderate intensity exercise (walking) in healthy individuals. It is the purpose of
      this study to see if such effects could be seen in COPD patients. If this is indeed the case,
      then it may suggest that a period of dietary supplementation of a relatively cheap, widely
      available, and natural food product may improve the ability of patients to undergo everyday
      tasks and ultimately improve their quality of life.

      To help investigators understand the effects of dietary nitrate supplementation on the
      ability to exercise in COPD patients, the investigators will recruit 15 people with mild to
      moderate disease. They will complete a series of undemanding exercise tests on three separate
      occasions. On one occasion they will have had a course of nitrate rich beetroot juice leading
      up to the tests, and on the other occasion they will have had a course of beetroot juice with
      the nitrate removed. The investigators will monitor blood pressure, levels of nitrate and
      nitrite in the blood, oxygen uptake and functional capacity during the tests which will allow
      us to assess any effects that may have occurred as a result of increased nitrate intake.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: O2 cost of moderate-intensity cycling exercise
time frame: Twice over a maximum of a 2 month period
description: whether nitrate reduces the O2 cost of moderate intensity exercise.
measure: Single-breath lung diffusion capacity
time frame: Once at screening. i.e. on one day that will last 10 seconds (before should only have been at familiarisation)
measure: Functional capacity measured by 6-Minute Walking Test (6MWT)
time frame: Twice over a maximum of a 2 month period
arm group label: COPD
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Beetroot
arm group label: COPD
other name: James Whites Drinks beetroot sports shot
intervention type: Dietary Supplement
intervention name: Beetroot placebo
arm group label: COPD
other name: James Whites Drinks beetroot sports shot
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Nigel Benjamin, Professor
role: Principal Investigator
affiliation: Torbay and South Devon NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor