<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/NCT03304197</url>
  </required_header>
  <id_info>
    <org_study_id>170614/A/01</org_study_id>
    <nct_id>NCT03304197</nct_id>
  </id_info>
  <brief_title>Hydration and Exercise Performance in Cycling</brief_title>
  <official_title>How Does Altering the Composition of Ingested Fluids Affect Hydration Status Whilst Cycling?</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the effects manipulating ingested fluids can have on hydration&#xD;
      status and cycling performance. There will be 4 different conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Being dehydrated can decrease endurance exercise performance. The investigators wish to test&#xD;
      which of three drinks is most effective at re-hydrating cyclists and if this affects&#xD;
      performance. Subjects will undertake 4 tests: once dehydrated, once hydrated with water, once&#xD;
      hydrated with a sports-specific drink, and once with an altered sports drink. Blood samples&#xD;
      will be taken and expired gasses will be sampled at various time points throughout the tests&#xD;
      for later analysis. A small amount of labelled water will be consumed with each drink, a&#xD;
      technique which will allow us to quantify the absorption of each of the drinks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</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>
    <masking_description>Doubly-blinded &amp; randomised using an online randomisation website.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Absorption of fluid through the gut</measure>
    <time_frame>To begin 10 minutes after the completion of the 90 minute steady-state cycle</time_frame>
    <description>Absorption of drinks through the gut will be measured using 2 boluses of deuterated water. This will be consumed alongside 2 of the drinks, and blood samples will be used to quantify enrichment. Total body water calculations are required to provide corrections in equations related to D2O. H218O will be consumed in order to quantify total body water: this will be provided in a single bolus before each trial.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Work done (kJ) during 15 minute cycling time-trial</measure>
    <time_frame>Throughout the 90 minute steady-state cycle &amp; the 15 minute time trial.</time_frame>
    <description>Subjects will perform a cycle ergometer protocol that has been shown to be reproducible in athletes. Subjects will complete the time trial on a Lode Excalibur cycling ergometer. Software linked to this software will record work done and power output.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Substrate utilisation</measure>
    <time_frame>Throughout the 90 minute steady-state cycle</time_frame>
    <description>Substrate utilisation will be calculated from data collected through a metabolic cart and its software. It will be measured during the 90-minute steady-state cycle for 4 periods of 3 minutes. Carbohydrate and lipid oxidation rates will be calculated using equations by Jeukendrup &amp; Wallis (2005).</description>
  </other_outcome>
  <other_outcome>
    <measure>Plasma metabolites</measure>
    <time_frame>Throughout the 90 minute steady-state cycle and time-trial</time_frame>
    <description>A cannula will be used to draw blood from subjects at several time points. Whole blood samples will be analysed immediately for plasma glucose, plasma lactate, haemoglobin content, haematocrit and plasma volume. Remaining whole blood will be centrifuged immediately and its plasma split into aliquots and stored in a -20°C freezer. At the end of the trial, plasma samples will be moved to a -80°C freezer for later analysis for sodium, glycerol, and NEFA.</description>
  </other_outcome>
  <other_outcome>
    <measure>Heart rate</measure>
    <time_frame>Throughout the 90 minute steady-state cycle and time-trial</time_frame>
    <description>Heart rate will be measured throughout with the use of a heart rate monitor.</description>
  </other_outcome>
  <other_outcome>
    <measure>RPE (rating of perceived exertion)</measure>
    <time_frame>Throughout the 90 minute steady-state cycle and time-trial</time_frame>
    <description>RPE will be measured using the Borg Scale.</description>
  </other_outcome>
  <other_outcome>
    <measure>Core body temperature</measure>
    <time_frame>Throughout the 90 minute steady-state cycle and time-trial</time_frame>
    <description>Core temperature will be measured throughout with the use of an ingestible core-body temperature pill (HQ Inc, FL, USA).</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Dehydrated</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>90 minutes cycling, without the ingestion of any fluids, followed by a 15 minute cycling time trial test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypotonic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>90 minutes cycling, with the ingestion of six 250 ml carbohydrate (6g sucrose, 3g glucose) drinks, followed by a 15 minute cycling time trial test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Isotonic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>90 minutes cycling, with the ingestion of six 250 ml carbohydrate (6g glucose, 3g fructose) drinks, followed by a 15 minute cycling time trial test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>90 minutes cycling, with the ingestion of six 250 ml taste-matched water drinks, followed by a 15 minute cycling time trial test</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Hypotonic</intervention_name>
    <description>N/A: see arm description</description>
    <arm_group_label>Hypotonic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Isotonic</intervention_name>
    <description>N/A: see arm description</description>
    <arm_group_label>Isotonic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>N/A: see arm description</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dehydrated</intervention_name>
    <description>N/A: see arm description</description>
    <arm_group_label>Dehydrated</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Highly trained cyclists (vo2max &gt;55 ml/kg/min, PPO (peak power output) &gt; 4 w/kg)&#xD;
&#xD;
          -  Training at least 4 times a week&#xD;
&#xD;
          -  Females must be taking an oral contraceptive, or using the contraceptive implant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent history of musculoskeletal injury&#xD;
&#xD;
          -  Diagnosed cardiovascular disease&#xD;
&#xD;
          -  Regular use of nutritional supplements that may interfere with the protocol&#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>Andrew D Davenport, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Exeter</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Sports 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>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</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 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03304197
org study id: 170614/A/01
nct id: NCT03304197
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the effects manipulating ingested fluids can have on hydration
      status and cycling performance. There will be 4 different conditions.
Being dehydrated can decrease endurance exercise performance. The investigators wish to test
      which of three drinks is most effective at re-hydrating cyclists and if this affects
      performance. Subjects will undertake 4 tests: once dehydrated, once hydrated with water, once
      hydrated with a sports-specific drink, and once with an altered sports drink. Blood samples
      will be taken and expired gasses will be sampled at various time points throughout the tests
      for later analysis. A small amount of labelled water will be consumed with each drink, a
      technique which will allow us to quantify the absorption of each of the drinks.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Doubly-blinded & randomised using an online randomisation website.
measure: Absorption of fluid through the gut
time frame: To begin 10 minutes after the completion of the 90 minute steady-state cycle
description: Absorption of drinks through the gut will be measured using 2 boluses of deuterated water. This will be consumed alongside 2 of the drinks, and blood samples will be used to quantify enrichment. Total body water calculations are required to provide corrections in equations related to D2O. H218O will be consumed in order to quantify total body water: this will be provided in a single bolus before each trial.
measure: Work done (kJ) during 15 minute cycling time-trial
time frame: Throughout the 90 minute steady-state cycle & the 15 minute time trial.
description: Subjects will perform a cycle ergometer protocol that has been shown to be reproducible in athletes. Subjects will complete the time trial on a Lode Excalibur cycling ergometer. Software linked to this software will record work done and power output.
measure: Substrate utilisation
time frame: Throughout the 90 minute steady-state cycle
description: Substrate utilisation will be calculated from data collected through a metabolic cart and its software. It will be measured during the 90-minute steady-state cycle for 4 periods of 3 minutes. Carbohydrate and lipid oxidation rates will be calculated using equations by Jeukendrup & Wallis (2005).
measure: Plasma metabolites
time frame: Throughout the 90 minute steady-state cycle and time-trial
description: A cannula will be used to draw blood from subjects at several time points. Whole blood samples will be analysed immediately for plasma glucose, plasma lactate, haemoglobin content, haematocrit and plasma volume. Remaining whole blood will be centrifuged immediately and its plasma split into aliquots and stored in a -20°C freezer. At the end of the trial, plasma samples will be moved to a -80°C freezer for later analysis for sodium, glycerol, and NEFA.
measure: Heart rate
time frame: Throughout the 90 minute steady-state cycle and time-trial
description: Heart rate will be measured throughout with the use of a heart rate monitor.
measure: RPE (rating of perceived exertion)
time frame: Throughout the 90 minute steady-state cycle and time-trial
description: RPE will be measured using the Borg Scale.
measure: Core body temperature
time frame: Throughout the 90 minute steady-state cycle and time-trial
description: Core temperature will be measured throughout with the use of an ingestible core-body temperature pill (HQ Inc, FL, USA).
arm group label: Dehydrated
arm group type: Experimental
description: 90 minutes cycling, without the ingestion of any fluids, followed by a 15 minute cycling time trial test
arm group label: Hypotonic
arm group type: Experimental
description: 90 minutes cycling, with the ingestion of six 250 ml carbohydrate (6g sucrose, 3g glucose) drinks, followed by a 15 minute cycling time trial test
arm group label: Isotonic
arm group type: Experimental
description: 90 minutes cycling, with the ingestion of six 250 ml carbohydrate (6g glucose, 3g fructose) drinks, followed by a 15 minute cycling time trial test
arm group label: Placebo
arm group type: Experimental
description: 90 minutes cycling, with the ingestion of six 250 ml taste-matched water drinks, followed by a 15 minute cycling time trial test
intervention type: Dietary Supplement
intervention name: Hypotonic
description: N/A: see arm description
arm group label: Hypotonic
intervention type: Dietary Supplement
intervention name: Isotonic
description: N/A: see arm description
arm group label: Isotonic
intervention type: Dietary Supplement
intervention name: Placebo
description: N/A: see arm description
arm group label: Placebo
intervention type: Other
intervention name: Dehydrated
description: N/A: see arm description
arm group label: Dehydrated
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew D Davenport, MSc
role: Principal Investigator
affiliation: The University of Exeter
facility: 
country: United Kingdom
responsible party type: Sponsor