<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/NCT02980939</url>
  </required_header>
  <id_info>
    <org_study_id>16-10-135</org_study_id>
    <nct_id>NCT02980939</nct_id>
  </id_info>
  <brief_title>The Role of Hydration on Exercise Performance - ODIN</brief_title>
  <acronym>ODIN</acronym>
  <official_title>The Role of Hydration on Exercise Performance - ODIN</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas, Fayetteville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arkansas, Fayetteville</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      During exercise in the heat, there is a need to replenish fluids in order to avoid&#xD;
      dehydration and decrease the risk for heat illness. What drives this urge to drink is the&#xD;
      thirst mechanism. Following ingestion of fluids, there is an inhibition of thirst before&#xD;
      there is a replenishing of fluids. However, there is little scientific evidence of where&#xD;
      thirst is inhibited, if this thirst inhibition is augmented by exercise and how thirst itself&#xD;
      influence exercise performance. Further, during rehydration studies, it is very difficult to&#xD;
      successfully blind a subject to their drinking/hydration protocol. Previous studies that have&#xD;
      blinded a subject to their drinking have used various methods such as intravenous fluid&#xD;
      administration and/or nasogastric tubes. Therefore, the purpose of this research is to&#xD;
      examine the mechanistic roles thirst inhibition plays while exercising in the heat while&#xD;
      undergoing intravenous fluid administration. Specific attention will be directed to the&#xD;
      cardiovascular and thermoregulatory function of the individuals. All blood, cardiovascular,&#xD;
      thermoregulatory, and perceptual measures are shown in the diagram below.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">March 18, 2017</completion_date>
  <primary_completion_date type="Actual">March 18, 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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>5km - Cycling Time Trial</measure>
    <time_frame>2hour</time_frame>
    <description>Time to completion 5 km cycling time trial in the heat</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rectal Temperature</measure>
    <time_frame>2hour</time_frame>
    <description>Body core temperature at the end of the 5 km time trial</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Dehydration</condition>
  <arm_group>
    <arm_group_label>Euhydration - no thirst</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dehydration - no Thirst</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>iv fluid infusion</intervention_name>
    <description>Intravenous isotonic saline infusion</description>
    <arm_group_label>Dehydration - no Thirst</arm_group_label>
    <arm_group_label>Euhydration - no thirst</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cycling Racing History category 3 or higher USA cycling certification&#xD;
&#xD;
          -  maximal oxygen uptake &gt;55 ml/kg/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of heat stroke&#xD;
&#xD;
          -  Renal, cardiovascular, metabolic diseases&#xD;
&#xD;
          -  Regular medication&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stavros A Kavouras, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arkansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas - HPER</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>May 27, 2017</last_update_submitted>
  <last_update_submitted_qc>May 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Arkansas, Fayetteville</investigator_affiliation>
    <investigator_full_name>Stavros Kavouras</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dehydration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02980939
org study id: 16-10-135
nct id: NCT02980939
lead sponsor: 
has dmc: No
During exercise in the heat, there is a need to replenish fluids in order to avoid
      dehydration and decrease the risk for heat illness. What drives this urge to drink is the
      thirst mechanism. Following ingestion of fluids, there is an inhibition of thirst before
      there is a replenishing of fluids. However, there is little scientific evidence of where
      thirst is inhibited, if this thirst inhibition is augmented by exercise and how thirst itself
      influence exercise performance. Further, during rehydration studies, it is very difficult to
      successfully blind a subject to their drinking/hydration protocol. Previous studies that have
      blinded a subject to their drinking have used various methods such as intravenous fluid
      administration and/or nasogastric tubes. Therefore, the purpose of this research is to
      examine the mechanistic roles thirst inhibition plays while exercising in the heat while
      undergoing intravenous fluid administration. Specific attention will be directed to the
      cardiovascular and thermoregulatory function of the individuals. All blood, cardiovascular,
      thermoregulatory, and perceptual measures are shown in the diagram below.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: 5km - Cycling Time Trial
time frame: 2hour
description: Time to completion 5 km cycling time trial in the heat
measure: Rectal Temperature
time frame: 2hour
description: Body core temperature at the end of the 5 km time trial
arm group label: Euhydration - no thirst
arm group type: Placebo Comparator
arm group label: Dehydration - no Thirst
arm group type: Experimental
intervention type: Other
intervention name: iv fluid infusion
description: Intravenous isotonic saline infusion
arm group label: Dehydration - no Thirst
arm group label: Euhydration - no thirst
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stavros A Kavouras, PhD
role: Principal Investigator
affiliation: University of Arkansas
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Arkansas, Fayetteville
investigator full name: Stavros Kavouras
investigator title: Associate Professor
mesh term: Dehydration
sharing ipd: No