<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/NCT02985606</url>
  </required_header>
  <id_info>
    <org_study_id>181739/02</org_study_id>
    <nct_id>NCT02985606</nct_id>
  </id_info>
  <brief_title>How Does Altering the Timing of Pre-exercise Low-dose Caffeine Ingestion Affect Endurance Exercise Performance</brief_title>
  <official_title>How Does Altering the Timing of Pre-exercise Low-dose Caffeine Ingestion Affect Endurance Exercise Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Exeter</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Exeter</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigate how manipulating the time between caffeine ingestion and exercise may alter&#xD;
      exercise performance and cognition&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">September 15, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</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>Work done in kilojoules (kJ) during a 15 minute time trial on a cycle ergometer</measure>
    <time_frame>15 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Whole body fuel substrate utilisation measured using indirect calorimetry</measure>
    <time_frame>10 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma caffeine concentration and metabolites</measure>
    <time_frame>2 hours 45 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive function measured using stroop test</measure>
    <time_frame>2 hours 45 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Collection of saliva for genotyping of CYP1A2</measure>
    <time_frame>30 mintes</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Caffeine -60</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Caffeine at 60 minutes prior to time trial</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caffeine -30</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Caffeine at 30 minutes prior to time trial</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caffeine 0</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Caffeine immediately prior to time trial</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo drink at all time points</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Caffeine powder -60</intervention_name>
    <arm_group_label>Caffeine -60</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Caffeine powder -30</intervention_name>
    <arm_group_label>Caffeine -30</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Caffeine powder 0</intervention_name>
    <arm_group_label>Caffeine 0</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo powder -60</intervention_name>
    <arm_group_label>Caffeine -30</arm_group_label>
    <arm_group_label>Caffeine 0</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo powder -30</intervention_name>
    <arm_group_label>Caffeine -60</arm_group_label>
    <arm_group_label>Caffeine 0</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo powder 0</intervention_name>
    <arm_group_label>Caffeine -30</arm_group_label>
    <arm_group_label>Caffeine -60</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  vo2max &gt; 55 ml/kg/min&#xD;
&#xD;
          -  females on contraceptive pill&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  recent skeletal muscle injury&#xD;
&#xD;
          -  cardiovascular injury&#xD;
&#xD;
          -  metabolic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sport and Health Sciences</name>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX1 2LU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>October 11, 2018</last_update_submitted>
  <last_update_submitted_qc>October 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caffeine</mesh_term>
  </intervention_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/NCT02985606
org study id: 181739/02
nct id: NCT02985606
lead sponsor: 
has dmc: No
Investigate how manipulating the time between caffeine ingestion and exercise may alter
      exercise performance and cognition
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Work done in kilojoules (kJ) during a 15 minute time trial on a cycle ergometer
time frame: 15 minutes
measure: Whole body fuel substrate utilisation measured using indirect calorimetry
time frame: 10 minutes
measure: Change in plasma caffeine concentration and metabolites
time frame: 2 hours 45 minutes
measure: Change in cognitive function measured using stroop test
time frame: 2 hours 45 minutes
measure: Collection of saliva for genotyping of CYP1A2
time frame: 30 mintes
arm group label: Caffeine -60
arm group type: Active Comparator
description: Caffeine at 60 minutes prior to time trial
arm group label: Caffeine -30
arm group type: Active Comparator
description: Caffeine at 30 minutes prior to time trial
arm group label: Caffeine 0
arm group type: Active Comparator
description: Caffeine immediately prior to time trial
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo drink at all time points
intervention type: Other
intervention name: Caffeine powder -60
arm group label: Caffeine -60
intervention type: Other
intervention name: Caffeine powder -30
arm group label: Caffeine -30
intervention type: Other
intervention name: Caffeine powder 0
arm group label: Caffeine 0
intervention type: Other
intervention name: Placebo powder -60
arm group label: Caffeine -30
arm group label: Caffeine 0
arm group label: Placebo
intervention type: Other
intervention name: Placebo powder -30
arm group label: Caffeine -60
arm group label: Caffeine 0
arm group label: Placebo
intervention type: Other
intervention name: Placebo powder 0
arm group label: Caffeine -30
arm group label: Caffeine -60
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Caffeine