<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/NCT02223403</url>
  </required_header>
  <id_info>
    <org_study_id>383967-4</org_study_id>
    <nct_id>NCT02223403</nct_id>
  </id_info>
  <brief_title>Effect of Nitrate-rich Beetroot Juice on Exercise Performance in Heart Failure Patients</brief_title>
  <official_title>Single Dose of Nitrate-rich Beetroot Juice Does Not Improve Steady State Oxygen Consumption or Six-minute Walk Distance in Patients With Systolic Heart Failure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brooke Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brooke Army Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nitrate-rich beetroot juice supplementation has demonstrated reduced oxygen consumption and&#xD;
      submaximal exercise performance in healthy adults. Investigation for similar effects in&#xD;
      patients with heart failure has not previously been conducted.&#xD;
&#xD;
      This was a randomized, double-blind, placebo controlled trial. Following ingestion of the&#xD;
      active agent or placebo, subjects with systolic heart failure underwent submaximal steady&#xD;
      state exercise with gas exchange analysis followed thirty minutes later by a six minute walk&#xD;
      test. Second testing sessions were performed ten days.&#xD;
&#xD;
      There were no significant differences in the treatment and placebo arms in average oxygen&#xD;
      consumption or six minute walk distance.&#xD;
&#xD;
      In conclusion, in patients with heart failure who have ingested a single dose of nitrate-rich&#xD;
      beetroot juice concentrate, there is no significant difference with regard to oxygen&#xD;
      consumption during submaximal steady state exercise or six minute walk testing distance.&#xD;
&#xD;
      Further study is warranted to determine the true efficacy of nitrate consumption in this&#xD;
      population with adjustments in acute or chronic dosing, exercise duration, or intensity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>steady state exercise oxygen consumption</measure>
    <time_frame>10 minutes</time_frame>
    <description>Subjects performed steady state treadmill walking at a pre-determine submaximal workload. Oxygen consumption was measured for the last 10 minutes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>six minute walk distance</measure>
    <time_frame>six minutes</time_frame>
    <description>subjects walked at their chosen pace for six minutes on a pre-determined course. Total distance was recorded.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Systolic Heart Failure</condition>
  <arm_group>
    <arm_group_label>submaximal steady state exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>90 minutes after respective beetroot juice ingestion, subjects walked on treadmill at a pre-determined steady state workload for a total of 15 minutes with oxygen consumption recorded for the last 10 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>six minute walk test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects performed six-minute walk at self-determined pace 30 minutes after treadmill exercise was performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>nitrate-rich beetroot juice</intervention_name>
    <description>3 ounces of nitrate-rich beetroot juice ingested orally once 90 minutes before exercise interventions of steady state treadmill exercise followed 30 minutes later by six minute walk</description>
    <arm_group_label>six minute walk test</arm_group_label>
    <arm_group_label>submaximal steady state exercise</arm_group_label>
    <other_name>Beet It Sport Stamina Shot</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>nitrate-deplete beetroot juice</intervention_name>
    <description>3 ounces of nitrate-deplete beetroot juice ingested orally once 90 minutes before exercise interventions of steady state treadmill exercise followed 30 minutes later by six minute walk</description>
    <arm_group_label>six minute walk test</arm_group_label>
    <arm_group_label>submaximal steady state exercise</arm_group_label>
    <other_name>Beet It Sport Stamina Shot</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Local institutional beneficiaries between the ages of 18 and 80&#xD;
&#xD;
          -  Documentation of left ventricular systolic dysfunction with ejection fraction &lt; 40% by&#xD;
             any modality within the past six months&#xD;
&#xD;
          -  Documentation of New York Heart Association class II or III status.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &gt; 80 years of age&#xD;
&#xD;
          -  Unable to adequately or safely perform treadmill exercise&#xD;
&#xD;
          -  Pulmonary disease deemed significant enough to be a limitation to exercise&#xD;
&#xD;
          -  Greater than moderate stenotic or regurgitant valvular heart disease&#xD;
&#xD;
          -  Presence of atrial fibrillation or other uncontrolled arrhythmias&#xD;
&#xD;
          -  Uncompensated heart failure&#xD;
&#xD;
          -  Continuously paced rhythms&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Chronic nitroglycerine use (oral isosorbide di or mono-nitrate, or topical&#xD;
             nitroglycerine)&#xD;
&#xD;
          -  Phosphodiesterase inhibitor (sildenafil or tadalafil) use within a week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth M Leclerc, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brooke Army Medical Center</affiliation>
  </overall_official>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brooke Army Medical Center</investigator_affiliation>
    <investigator_full_name>Kenneth M Leclerc</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Nitrate-rich beetroot juice</keyword>
  <keyword>heart failure</keyword>
  <keyword>exercise performance</keyword>
  <keyword>oxygen consumption</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Heart Failure, Systolic</mesh_term>
    <mesh_term>Systolic Murmurs</mesh_term>
  </condition_browse>
  <!-- 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/NCT02223403
org study id: 383967-4
nct id: NCT02223403
lead sponsor: 
has dmc: Yes
Nitrate-rich beetroot juice supplementation has demonstrated reduced oxygen consumption and
      submaximal exercise performance in healthy adults. Investigation for similar effects in
      patients with heart failure has not previously been conducted.

      This was a randomized, double-blind, placebo controlled trial. Following ingestion of the
      active agent or placebo, subjects with systolic heart failure underwent submaximal steady
      state exercise with gas exchange analysis followed thirty minutes later by a six minute walk
      test. Second testing sessions were performed ten days.

      There were no significant differences in the treatment and placebo arms in average oxygen
      consumption or six minute walk distance.

      In conclusion, in patients with heart failure who have ingested a single dose of nitrate-rich
      beetroot juice concentrate, there is no significant difference with regard to oxygen
      consumption during submaximal steady state exercise or six minute walk testing distance.

      Further study is warranted to determine the true efficacy of nitrate consumption in this
      population with adjustments in acute or chronic dosing, exercise duration, or intensity.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: steady state exercise oxygen consumption
time frame: 10 minutes
description: Subjects performed steady state treadmill walking at a pre-determine submaximal workload. Oxygen consumption was measured for the last 10 minutes.
measure: six minute walk distance
time frame: six minutes
description: subjects walked at their chosen pace for six minutes on a pre-determined course. Total distance was recorded.
arm group label: submaximal steady state exercise
arm group type: Experimental
description: 90 minutes after respective beetroot juice ingestion, subjects walked on treadmill at a pre-determined steady state workload for a total of 15 minutes with oxygen consumption recorded for the last 10 minutes
arm group label: six minute walk test
arm group type: Experimental
description: subjects performed six-minute walk at self-determined pace 30 minutes after treadmill exercise was performed
intervention type: Dietary Supplement
intervention name: nitrate-rich beetroot juice
description: 3 ounces of nitrate-rich beetroot juice ingested orally once 90 minutes before exercise interventions of steady state treadmill exercise followed 30 minutes later by six minute walk
arm group label: six minute walk test
arm group label: submaximal steady state exercise
other name: Beet It Sport Stamina Shot
intervention type: Dietary Supplement
intervention name: nitrate-deplete beetroot juice
description: 3 ounces of nitrate-deplete beetroot juice ingested orally once 90 minutes before exercise interventions of steady state treadmill exercise followed 30 minutes later by six minute walk
arm group label: six minute walk test
arm group label: submaximal steady state exercise
other name: Beet It Sport Stamina Shot
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kenneth M Leclerc, MD
role: Principal Investigator
affiliation: Brooke Army Medical Center
responsible party type: Principal Investigator
investigator affiliation: Brooke Army Medical Center
investigator full name: Kenneth M Leclerc
investigator title: MD
mesh term: Heart Failure
mesh term: Heart Failure, Systolic
mesh term: Systolic Murmurs