<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/NCT03020862</url>
  </required_header>
  <id_info>
    <org_study_id>D2013A2014</org_study_id>
    <nct_id>NCT03020862</nct_id>
  </id_info>
  <brief_title>Beetroot Juice - Effects on Performance in Chronic Obstructive Pulmonary Disease Patients</brief_title>
  <acronym>COPD</acronym>
  <official_title>Beetroot Juice - Effects on Performance in Chronic Obstructive Pulmonary Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose is to evaluate exercise performance in patients with Chronic Obstructive&#xD;
      Pulmonary Disease (COPD) after supplementing with higher doses of dietary NO3-, compared to&#xD;
      previous studies, as beetroot juice for seven days. The secondary purpose is to evaluate&#xD;
      oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity&#xD;
      level.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose is to evaluate exercise performance in patients with Chronic Obstructive&#xD;
      Pulmonary Disease (COPD) using the 6-minute walk test (6MWT) after supplementing with higher&#xD;
      doses of dietary NO3- compared to previous studies, as beetroot juice for seven days. The&#xD;
      secondary purpose is to evaluate oxygen consumption of submaximal cycling, amendments in&#xD;
      blood pressure, and physical activity level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">April 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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical performance on 6-min walk test (6MWT)</measure>
    <time_frame>6 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>At baseline and 150 minutes after consumption of beverages</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Nitrite concentration</measure>
    <time_frame>Baseline, 150 and 210 minutes after consumption of beverages</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen consumption during submaximal cycling</measure>
    <time_frame>Two trials of 6 minutes duration (10 min break between trials)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity level</measure>
    <time_frame>Six days</time_frame>
    <description>Measured all intervention days except on the day of testing</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease Moderate</condition>
  <arm_group>
    <arm_group_label>Placebo ---&gt; Dietary beetroot</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo was administrated in the first period of the cross-over trial, while the intervention beverage Dietary Beetroot juice was administrated in the second period of the trial.&#xD;
The placebo: was an NO3- negligble drink from James White Drinks England (Beet-it), which was otherwise similar to the dietary beetroot juice in nutrient composition, smell and appearance. Dose: 2x70 mL consumed twice a day for six days.&#xD;
Intervention beverage, Dietary beetroot juice:Consumed as beetroot juice from James White Drinks England (Beet-it) and contained 300 mg dietary nitrate. Dose: 2x70 mL consumed twice a day for six days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dietary beetroot juice --&gt; Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention beverage Dietary beetroot juice was administrated in the first period of the cross-over trial, while placebo was administrated in the second period of the trail Intervention beverage, Dietary beetroot juice:Consumed as beetroot juice from James White Drinks England (Beet-it) and contained 300 mg dietary nitrate. Dose: 2x70 mL consumed twice a day for six days. The placebo: was an NO3- negligble drink from James White Drinks England (Beet-it), which was otherwise similar to the dietary beetroot juice in nutrient composition, smell and appearance. Dose: 2x70 mL consumed twice a day for six days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary beetroot juice</intervention_name>
    <description>Consumed as concentrated beetroot juice from James White Drinks England (Beet-it) and contained 300 mg dietary nitrate. Dose: 2x70 mL consumed twice a day for six days.</description>
    <arm_group_label>Dietary beetroot juice --&gt; Placebo</arm_group_label>
    <arm_group_label>Placebo ---&gt; Dietary beetroot</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate-severe Chronics Obstructive Pulmonary Disease (COPD) (FEV1 &lt;80% of&#xD;
             predicted).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking,&#xD;
&#xD;
          -  failure to complete physical testing,&#xD;
&#xD;
          -  on-going participation in rehabilitation programs,&#xD;
&#xD;
          -  pacemaker or use of nicotine products,&#xD;
&#xD;
          -  oxygen mask,&#xD;
&#xD;
          -  beta blockers,&#xD;
&#xD;
          -  antibacterial mouthwash,&#xD;
&#xD;
          -  chewing gum or stomach-neutralizing medicine during the intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mette Hansen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University, Department for Public Health, Section for Sport Sciene</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sport Science, Department of Public Health, Aarhus University</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dietary nitrate</keyword>
  <keyword>Physical performance</keyword>
  <keyword>Blood pressure</keyword>
  <keyword>Nitrite</keyword>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03020862
org study id: D2013A2014
nct id: NCT03020862
lead sponsor: 
has dmc: Yes
The purpose is to evaluate exercise performance in patients with Chronic Obstructive
      Pulmonary Disease (COPD) after supplementing with higher doses of dietary NO3-, compared to
      previous studies, as beetroot juice for seven days. The secondary purpose is to evaluate
      oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity
      level.
The purpose is to evaluate exercise performance in patients with Chronic Obstructive
      Pulmonary Disease (COPD) using the 6-minute walk test (6MWT) after supplementing with higher
      doses of dietary NO3- compared to previous studies, as beetroot juice for seven days. The
      secondary purpose is to evaluate oxygen consumption of submaximal cycling, amendments in
      blood pressure, and physical activity level.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Physical performance on 6-min walk test (6MWT)
time frame: 6 minutes
measure: Blood Pressure
time frame: At baseline and 150 minutes after consumption of beverages
measure: Plasma Nitrite concentration
time frame: Baseline, 150 and 210 minutes after consumption of beverages
measure: Oxygen consumption during submaximal cycling
time frame: Two trials of 6 minutes duration (10 min break between trials)
measure: Physical activity level
time frame: Six days
description: Measured all intervention days except on the day of testing
arm group label: Placebo ---> Dietary beetroot
arm group type: Experimental
description: Placebo was administrated in the first period of the cross-over trial, while the intervention beverage Dietary Beetroot juice was administrated in the second period of the trial.
The placebo: was an NO3- negligble drink from James White Drinks England (Beet-it), which was otherwise similar to the dietary beetroot juice in nutrient composition, smell and appearance. Dose: 2x70 mL consumed twice a day for six days.
Intervention beverage, Dietary beetroot juice:Consumed as beetroot juice from James White Drinks England (Beet-it) and contained 300 mg dietary nitrate. Dose: 2x70 mL consumed twice a day for six days.
arm group label: Dietary beetroot juice --> Placebo
arm group type: Experimental
description: The intervention beverage Dietary beetroot juice was administrated in the first period of the cross-over trial, while placebo was administrated in the second period of the trail Intervention beverage, Dietary beetroot juice:Consumed as beetroot juice from James White Drinks England (Beet-it) and contained 300 mg dietary nitrate. Dose: 2x70 mL consumed twice a day for six days. The placebo: was an NO3- negligble drink from James White Drinks England (Beet-it), which was otherwise similar to the dietary beetroot juice in nutrient composition, smell and appearance. Dose: 2x70 mL consumed twice a day for six days.
intervention type: Dietary Supplement
intervention name: Dietary beetroot juice
description: Consumed as concentrated beetroot juice from James White Drinks England (Beet-it) and contained 300 mg dietary nitrate. Dose: 2x70 mL consumed twice a day for six days.
arm group label: Dietary beetroot juice --> Placebo
arm group label: Placebo ---> Dietary beetroot
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mette Hansen
role: Principal Investigator
affiliation: Aarhus University, Department for Public Health, Section for Sport Sciene
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No