<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/NCT03258775</url>
  </required_header>
  <id_info>
    <org_study_id>750014-4</org_study_id>
    <nct_id>NCT03258775</nct_id>
  </id_info>
  <brief_title>Water Consumption, Hydration and Resting Energy Expenditure</brief_title>
  <official_title>Water Consumption, Hydration and Resting Energy Expenditure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George Mason University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>George Mason University</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>
      A randomized, cross over study will assess the effects of ingestion of high and low volumes&#xD;
      of water on REE over 90 minutes. The high volume of water 500ml and the low volume of water&#xD;
      250ml. Participants will be computer randomized to determine which volume of water to receive&#xD;
      first. Participants will arrive at the Nutrition Assessment Laboratory between 7:00 and&#xD;
      7:30am following a 9 hour overnight fast. Participants will be instructed not to consume any&#xD;
      food or drink after 10pm the night before the assessment. Participants will also be asked to&#xD;
      abstain from alcohol and caffeine for 3 days before the assessment. After verification of&#xD;
      eligibility, baseline REE will be measured for 30 minutes followed by administration of first&#xD;
      assigned dose of water. REE will be monitored for the next 90 minutes. Blood pressure and&#xD;
      heart rate will also be monitored, simultaneously to REE. After a 7-10 day washout period,&#xD;
      participants will return for their second test day where the second dose of water will be&#xD;
      administered. A 7-10 day washout period was selected to allow participants time to resume&#xD;
      normal diet and hydration between visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2015</start_date>
  <completion_date type="Actual">August 1, 2016</completion_date>
  <primary_completion_date type="Actual">June 1, 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resting Metabolic Rate (RMR)</measure>
    <time_frame>90 minutes</time_frame>
    <description>Resting Metabolic Rate after water intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Substrate oxidation</measure>
    <time_frame>90 minutes</time_frame>
    <description>Change in substrate oxidation after water intake</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>90 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>90 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Hydration and Resting Metabolism</condition>
  <arm_group>
    <arm_group_label>250ml</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>500ml</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>water intake</intervention_name>
    <description>After an overnight fast participants' RMR will be measured by indirect calorimetry for 30 minutes after which either a low (250ml) or high (500ml) dose of water will be consumed followed by an additional 90 minutes of indirect calorimetry. The test day will be repeated after 7-10 days with the second dose of water. The order in which the dose of water will be consumed will be randomized</description>
    <arm_group_label>250ml</arm_group_label>
    <arm_group_label>500ml</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-39 years of age&#xD;
&#xD;
          -  Generally Healthy men and women&#xD;
&#xD;
          -  BMI 18.5-28&#xD;
&#xD;
          -  Willing to abstain from caffeine for 3 days prior to testing&#xD;
&#xD;
          -  Able to provide written consent in English&#xD;
&#xD;
          -  Ability to communicate in English (oral and written&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 or &gt;39 years&#xD;
&#xD;
          -  BMI &lt; 18.5 or &gt;28&#xD;
&#xD;
          -  Pregnant or Nursing&#xD;
&#xD;
          -  Taking prescribed or over the counter medication affecting fluid balance or metabolism&#xD;
&#xD;
          -  Suffers from hepatic, renal, pulmonary, endocrine or hematological disease&#xD;
&#xD;
          -  Performs more than 3 hours a week of strenuous exercise&#xD;
&#xD;
          -  Consumes, on average, more than 2 alcoholic beverages per day&#xD;
&#xD;
          -  More than 5kg of weight change over the past 6 months&#xD;
&#xD;
          -  Claustrophobic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RMR</keyword>
  <keyword>hydration</keyword>
  <keyword>substrate oxidation</keyword>
  <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/NCT03258775
org study id: 750014-4
nct id: NCT03258775
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized, cross over study will assess the effects of ingestion of high and low volumes
      of water on REE over 90 minutes. The high volume of water 500ml and the low volume of water
      250ml. Participants will be computer randomized to determine which volume of water to receive
      first. Participants will arrive at the Nutrition Assessment Laboratory between 7:00 and
      7:30am following a 9 hour overnight fast. Participants will be instructed not to consume any
      food or drink after 10pm the night before the assessment. Participants will also be asked to
      abstain from alcohol and caffeine for 3 days before the assessment. After verification of
      eligibility, baseline REE will be measured for 30 minutes followed by administration of first
      assigned dose of water. REE will be monitored for the next 90 minutes. Blood pressure and
      heart rate will also be monitored, simultaneously to REE. After a 7-10 day washout period,
      participants will return for their second test day where the second dose of water will be
      administered. A 7-10 day washout period was selected to allow participants time to resume
      normal diet and hydration between visits.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Resting Metabolic Rate (RMR)
time frame: 90 minutes
description: Resting Metabolic Rate after water intake
measure: Substrate oxidation
time frame: 90 minutes
description: Change in substrate oxidation after water intake
measure: blood pressure
time frame: 90 minutes
measure: heart rate
time frame: 90 minutes
arm group label: 250ml
arm group type: Active Comparator
arm group label: 500ml
arm group type: Active Comparator
intervention type: Other
intervention name: water intake
description: After an overnight fast participants' RMR will be measured by indirect calorimetry for 30 minutes after which either a low (250ml) or high (500ml) dose of water will be consumed followed by an additional 90 minutes of indirect calorimetry. The test day will be repeated after 7-10 days with the second dose of water. The order in which the dose of water will be consumed will be randomized
arm group label: 250ml
arm group label: 500ml
criteria: 
gender: All
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: No