<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/NCT01727479</url>
  </required_header>
  <id_info>
    <org_study_id>2012-048</org_study_id>
    <secondary_id>INAF-2012-048</secondary_id>
    <nct_id>NCT01727479</nct_id>
  </id_info>
  <brief_title>Ribose and Sport Performance</brief_title>
  <official_title>The Effect of Ribose on Performance and Recovery in Athletes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Atrium Innovations</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Laval University</source>
  <brief_summary>
    <textblock>
      Investigate the acute effect of ribose supplementation on performance and recovery in&#xD;
      athletes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in time to complete the third of 3 consecutive 3km time trials on bike</measure>
    <time_frame>baseline and 1 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance on the 3 consecutive 3km time trials on bike</measure>
    <time_frame>baseline and 1 week</time_frame>
    <description>Performance measures: peak power (watts/kg), mean power (watts/kg), time to peak power (sec), total work (kJ) and maximum cadence (RPMmax)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fatigue perception after each of the 3 consecutive 3km time trials on bike</measure>
    <time_frame>baseline and 1 week</time_frame>
    <description>Post-exercise fatigue perception on visual analog scale (VAS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Peak Vo2 consumption during each of the 3km time trials on bike</measure>
    <time_frame>baseline and 1 week</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Sports</condition>
  <arm_group>
    <arm_group_label>Ribose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After each of the 3km time trial (3 in total), consumption of ribose incorporated in a sports drink.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After each of the 3km time trial (3 in total), consumption of placebo incorporated in a sports drink.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ribose</intervention_name>
    <description>After each of the 3km time trial (3 in total), participants will be asked to drink the experimental product (or placebo) incorporated in a sports drink.</description>
    <arm_group_label>Ribose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women&#xD;
&#xD;
          -  Training volume &gt; 7hrs/week&#xD;
&#xD;
          -  VO2 max &gt; 40 and 45 mg/kg/min (for women and men respectively)&#xD;
&#xD;
          -  Otherwise healthy individuals&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Individuals with endocrine disorders, hypercholesterolemia, cardiovascular diseases,&#xD;
             gut diseases, cancer, anemia, hypoglycemia&#xD;
&#xD;
          -  Medication for lipids, diabetes, hypertension, inflammation, autoimmune diseases, mood&#xD;
             disorders&#xD;
&#xD;
          -  Excessive alcohol consumption (more than two drinks by day for men, one for women),&#xD;
             smoking, drug use, supplements or natural products consumption during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benoît Lamarche, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute on nutraceuticals and functional foods</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Université Laval</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1V0A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Peak VO2 consumption</keyword>
  <keyword>3km time trial</keyword>
  <keyword>fatigue perception</keyword>
  <keyword>lactate</keyword>
  <keyword>time to complete</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/NCT01727479
org study id: 2012-048
secondary id: INAF-2012-048
nct id: NCT01727479
lead sponsor: 
collaborator: 
Investigate the acute effect of ribose supplementation on performance and recovery in
      athletes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in time to complete the third of 3 consecutive 3km time trials on bike
time frame: baseline and 1 week
measure: Performance on the 3 consecutive 3km time trials on bike
time frame: baseline and 1 week
description: Performance measures: peak power (watts/kg), mean power (watts/kg), time to peak power (sec), total work (kJ) and maximum cadence (RPMmax)
measure: Fatigue perception after each of the 3 consecutive 3km time trials on bike
time frame: baseline and 1 week
description: Post-exercise fatigue perception on visual analog scale (VAS)
measure: Peak Vo2 consumption during each of the 3km time trials on bike
time frame: baseline and 1 week
arm group label: Ribose
arm group type: Experimental
description: After each of the 3km time trial (3 in total), consumption of ribose incorporated in a sports drink.
arm group label: Placebo
arm group type: Placebo Comparator
description: After each of the 3km time trial (3 in total), consumption of placebo incorporated in a sports drink.
intervention type: Other
intervention name: Ribose
description: After each of the 3km time trial (3 in total), participants will be asked to drink the experimental product (or placebo) incorporated in a sports drink.
arm group label: Ribose
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Benoît Lamarche, PhD
role: Principal Investigator
affiliation: Institute on nutraceuticals and functional foods
facility: 
country: Canada
responsible party type: Sponsor