<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/NCT04502238</url>
  </required_header>
  <id_info>
    <org_study_id>1908002467</org_study_id>
    <nct_id>NCT04502238</nct_id>
  </id_info>
  <brief_title>Dehydration and Population Health</brief_title>
  <official_title>Dehydration and Population Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wayne State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wayne State 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>
      The primary aim of this study is to assess cardiovascular changes (blood pressure, heart&#xD;
      rate, electrocardiogram/ECG) in response to mild fluid-restriction dehydration and subsequent&#xD;
      rehydration in healthy young and old people. Secondary aims are to assess changes in body&#xD;
      composition, mood, and hunger in response to mild dehydration and rehydration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PARTICIPANTS: Forty healthy (no regular prescription medication use) male and females,&#xD;
      between the ages of 18-70 years, will be recruited for this randomized-control cross-over&#xD;
      study. Ideally, the investigators hope to recruit twenty &quot;younger&quot; (18-50) and twenty &quot;older&quot;&#xD;
      (50-70) participants for this pilot study.&#xD;
&#xD;
      All participants will be required to participate in two separate trials (a control and&#xD;
      dehydration-rehydration trial, in randomized order), separated by at least a week. All&#xD;
      menstruating females will be tested during the follicular phase of their menstrual cycle&#xD;
      (i.e. within the first 14 days after the onset of the menstrual period). All participants&#xD;
      will present to the lab in the evening for pre-testing and then in the morning for&#xD;
      mid-testing/post-testing. With both pre-testing and mid-testing/post-testing each taking ~90&#xD;
      minutes each, plus 12-hours of fluid deprivation or regular food/fluid intake overnight, the&#xD;
      total time participating in collective study activities would be approximately 30-hours (~15&#xD;
      hours per trial).&#xD;
&#xD;
      PROCEDURES: For each of the two study trials, participants will come to the lab in the&#xD;
      evening for pre-testing and then the following morning for mid-testing/post-testing (one&#xD;
      trial). Hydration status will be assessed using blood (venipuncture), urine (spot sample),&#xD;
      body weight, and thirst rating (100mm visual analogue scale). Cardiovascular variables will&#xD;
      be assessed via heart rate, ECG, and blood pressure. Body composition will be measured using&#xD;
      a dual energy x-ray absorptiometry (DXA) scan. Mood will be assessed using the Profile of&#xD;
      Mood States (POMS) questionnaire.&#xD;
&#xD;
      Once the participants present to the lab, pre-test blood, urine, body weight and composition,&#xD;
      mood and thirst/sodium/hunger ratings will be obtained. Then, to enhance sweat water losses,&#xD;
      each participant will be asked to walk on a motorized treadmill at a self-selected speed for&#xD;
      60-minutes.&#xD;
&#xD;
      During the Dehydration-Rehydration trial, participants will be asked to refrain from&#xD;
      ingesting any fluid (fluid restriction) for at least 12-hours overnight (i.e. from leaving&#xD;
      the lab that evening until coming into the lab the next morning) to facilitate dehydration.&#xD;
      After mid-testing, the participants will be allowed free access to water for a 60-minute&#xD;
      rehydration period to quench their thirst (&quot;ad libitum&quot; drinking). At the end of this&#xD;
      60-minute rehydration period, post-test measures will be repeated. During the control trial,&#xD;
      the participants can eat and drink as they please during the 12-hour overnight period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 3, 2020</start_date>
  <completion_date type="Anticipated">November 6, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiovascular changes</measure>
    <time_frame>change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)</time_frame>
    <description>Changes in QRS waveforms will be assessed using electrocardiograms (ECG) before and after dehydration (fluid restriction)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in perception of thirst and hunger</measure>
    <time_frame>change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)</time_frame>
    <description>Thirst and hunger will be assessed on a VAS (visual analogue scale) before and after dehydration (fluid restriction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body composition</measure>
    <time_frame>change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)</time_frame>
    <description>Body composition (bone, lean, and fat mass) will be assessed using dual energy x-ray absorptiometry (DXA) scans before and after dehydration (fluid restriction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in mood</measure>
    <time_frame>change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)</time_frame>
    <description>Mood will be assessed using the POMS (profile of mood states) survey before and after dehydration (fluid restriction)</description>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Dehydration (Physiology)</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fluid restriction</intervention_name>
    <description>Study participants will refrain from drinking fluids overnight to facilitate 1-2% fluid loss from baseline</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy (i.e. does not take any regular prescription medications) adults between the ages&#xD;
        of 18-70 years, who can walk comfortably on a treadmill for 1-hour (to enhance fluid loss&#xD;
        before the rehydration period).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy (no regular prescription medication usage)&#xD;
&#xD;
          -  Able to walk continuously on treadmill for 60 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Confirmed or suspected pregnancy&#xD;
&#xD;
          -  Chronic medical condition&#xD;
&#xD;
          -  Regular prescription medication use&#xD;
&#xD;
          -  Inability to walk continuously walk on a treadmill for 60 minutes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Tamara D Hew(-Butler), PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wayne State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>#055 Education Building, Wayne State University</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wayne State University</investigator_affiliation>
    <investigator_full_name>Tamara Hew-Butler DPM, PhD, FACSM</investigator_full_name>
    <investigator_title>Associate Professor, Exercise and Sport Science</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>Undecided</sharing_ipd>
    <ipd_description>All data shared, especially with regards to our University of Chicago collaborators, will be de-identified. Participants will be assigned an unidentified subject number once consent form is signed, and all data collected and imported into a spreadsheet will be de-identified. The &quot;master list&quot; which contains the link between each participant's name and the assigned subject number will be placed in a locked cabinet in Dr Hew-Butler's office, separate from the actual data and signed informed Consent forms. All participant information will remain strictly confidential and will not be identified in any subsequent publications or presentation of the results.</ipd_description>
  </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/NCT04502238
org study id: 1908002467
nct id: NCT04502238
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary aim of this study is to assess cardiovascular changes (blood pressure, heart
      rate, electrocardiogram/ECG) in response to mild fluid-restriction dehydration and subsequent
      rehydration in healthy young and old people. Secondary aims are to assess changes in body
      composition, mood, and hunger in response to mild dehydration and rehydration.
PARTICIPANTS: Forty healthy (no regular prescription medication use) male and females,
      between the ages of 18-70 years, will be recruited for this randomized-control cross-over
      study. Ideally, the investigators hope to recruit twenty "younger" (18-50) and twenty "older"
      (50-70) participants for this pilot study.

      All participants will be required to participate in two separate trials (a control and
      dehydration-rehydration trial, in randomized order), separated by at least a week. All
      menstruating females will be tested during the follicular phase of their menstrual cycle
      (i.e. within the first 14 days after the onset of the menstrual period). All participants
      will present to the lab in the evening for pre-testing and then in the morning for
      mid-testing/post-testing. With both pre-testing and mid-testing/post-testing each taking ~90
      minutes each, plus 12-hours of fluid deprivation or regular food/fluid intake overnight, the
      total time participating in collective study activities would be approximately 30-hours (~15
      hours per trial).

      PROCEDURES: For each of the two study trials, participants will come to the lab in the
      evening for pre-testing and then the following morning for mid-testing/post-testing (one
      trial). Hydration status will be assessed using blood (venipuncture), urine (spot sample),
      body weight, and thirst rating (100mm visual analogue scale). Cardiovascular variables will
      be assessed via heart rate, ECG, and blood pressure. Body composition will be measured using
      a dual energy x-ray absorptiometry (DXA) scan. Mood will be assessed using the Profile of
      Mood States (POMS) questionnaire.

      Once the participants present to the lab, pre-test blood, urine, body weight and composition,
      mood and thirst/sodium/hunger ratings will be obtained. Then, to enhance sweat water losses,
      each participant will be asked to walk on a motorized treadmill at a self-selected speed for
      60-minutes.

      During the Dehydration-Rehydration trial, participants will be asked to refrain from
      ingesting any fluid (fluid restriction) for at least 12-hours overnight (i.e. from leaving
      the lab that evening until coming into the lab the next morning) to facilitate dehydration.
      After mid-testing, the participants will be allowed free access to water for a 60-minute
      rehydration period to quench their thirst ("ad libitum" drinking). At the end of this
      60-minute rehydration period, post-test measures will be repeated. During the control trial,
      the participants can eat and drink as they please during the 12-hour overnight period.
observational model: Case-Crossover
time perspective: Prospective
measure: Cardiovascular changes
time frame: change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
description: Changes in QRS waveforms will be assessed using electrocardiograms (ECG) before and after dehydration (fluid restriction)
measure: Changes in perception of thirst and hunger
time frame: change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
description: Thirst and hunger will be assessed on a VAS (visual analogue scale) before and after dehydration (fluid restriction)
measure: Changes in body composition
time frame: change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
description: Body composition (bone, lean, and fat mass) will be assessed using dual energy x-ray absorptiometry (DXA) scans before and after dehydration (fluid restriction)
measure: Changes in mood
time frame: change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
description: Mood will be assessed using the POMS (profile of mood states) survey before and after dehydration (fluid restriction)
intervention type: Other
intervention name: Fluid restriction
description: Study participants will refrain from drinking fluids overnight to facilitate 1-2% fluid loss from baseline
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
last name: Tamara D Hew(-Butler), PhD
role: Principal Investigator
affiliation: Wayne State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Wayne State University
investigator full name: Tamara Hew-Butler DPM, PhD, FACSM
investigator title: Associate Professor, Exercise and Sport Science
mesh term: Dehydration
sharing ipd: Undecided
ipd description: All data shared, especially with regards to our University of Chicago collaborators, will be de-identified. Participants will be assigned an unidentified subject number once consent form is signed, and all data collected and imported into a spreadsheet will be de-identified. The "master list" which contains the link between each participant's name and the assigned subject number will be placed in a locked cabinet in Dr Hew-Butler's office, separate from the actual data and signed informed Consent forms. All participant information will remain strictly confidential and will not be identified in any subsequent publications or presentation of the results.