<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/NCT01710761</url>
  </required_header>
  <id_info>
    <org_study_id>2012-05-0033</org_study_id>
    <nct_id>NCT01710761</nct_id>
  </id_info>
  <brief_title>Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance</brief_title>
  <official_title>Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Neogenis Laboratories</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas at Austin</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute supplementation of Neo40(TM), a nitrate lozenge, will improve cycling performance&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">May 2013</completion_date>
  <primary_completion_date type="Anticipated">February 2013</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improved Time Trial Performance</measure>
    <time_frame>After 20 min steady-state cycling</time_frame>
    <description>Participants will cycle 20 min at increasing intensity: 8 min at 55% VO2max, 6 min at 65% VO2max, 6 min at 75% VO2max. The 20 km time trial consists of rolling hills.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improved work efficiency</measure>
    <time_frame>During 20 min steady-state cycling</time_frame>
    <description>Expired gases will be collected and compared to expected VO2. Blood will be collected prior to treatment, prior to exercise and during each cycling intensity to analyze lactate accumulation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Nitrate supplement with caffeine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Same form factor and flavor as test lozenge but contains no active ingredients</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nitrate supplement with caffeine</intervention_name>
    <description>Lozenge consisting of beetroot and 75 mg caffeine</description>
    <arm_group_label>Nitrate supplement with caffeine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Regular commuter cyclist or spin class participant&#xD;
&#xD;
          -  Male (VO2max &lt; 50) or Female (VO2max &lt; 45)&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Blood pressure below 140/90&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not cycle 2-3 times/week&#xD;
&#xD;
          -  Regular consumption of performance-enhancing substances&#xD;
&#xD;
          -  Type I or Type II diabetes&#xD;
&#xD;
          -  Renal, hepatic or cardiac disease&#xD;
&#xD;
          -  Current infectious disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lynne Kammer-Kerwick, MSE, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas at Austin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas at Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>January 22, 2013</last_update_submitted>
  <last_update_submitted_qc>January 22, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nitric oxide</keyword>
  <keyword>cycling performance</keyword>
  <keyword>lactate</keyword>
  <keyword>VO2</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caffeine</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>July 5, 2013</submitted>
    <returned>September 17, 2013</returned>
  </pending_results>
  <!-- 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/NCT01710761
org study id: 2012-05-0033
nct id: NCT01710761
lead sponsor: 
collaborator: 
has dmc: Yes
Acute supplementation of Neo40(TM), a nitrate lozenge, will improve cycling performance
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Improved Time Trial Performance
time frame: After 20 min steady-state cycling
description: Participants will cycle 20 min at increasing intensity: 8 min at 55% VO2max, 6 min at 65% VO2max, 6 min at 75% VO2max. The 20 km time trial consists of rolling hills.
measure: Improved work efficiency
time frame: During 20 min steady-state cycling
description: Expired gases will be collected and compared to expected VO2. Blood will be collected prior to treatment, prior to exercise and during each cycling intensity to analyze lactate accumulation.
arm group label: Nitrate supplement with caffeine
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Placebo
description: Same form factor and flavor as test lozenge but contains no active ingredients
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: Nitrate supplement with caffeine
description: Lozenge consisting of beetroot and 75 mg caffeine
arm group label: Nitrate supplement with caffeine
criteria: 
gender: All
minimum age: 21 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lynne Kammer-Kerwick, MSE, MA
role: Principal Investigator
affiliation: The University of Texas at Austin
facility: 
country: United States
responsible party type: Sponsor
mesh term: Caffeine
submitted: July 5, 2013
returned: September 17, 2013