<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/NCT03262597</url>
  </required_header>
  <id_info>
    <org_study_id>IRB Application #2667</org_study_id>
    <nct_id>NCT03262597</nct_id>
  </id_info>
  <brief_title>&quot;Beverage Hydration Index&quot; of Commercial Therapeutic Beverages</brief_title>
  <official_title>Beverage Hydration Index of Three Commercial Oral Rehydration Therapy ORT Beverages</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sonoma State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Entrinsic Bioscience Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sonoma 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 &quot;beverage hydration index&quot; (BHI) assesses the hydration potential of any consumable fluid&#xD;
      relative to water. The BHI is a relatively new metric. Our purpose was to assess the BHI of&#xD;
      beverages never previously tested, including an amino acid-based oral rehydration solution&#xD;
      (AA-ORS), a glucose-containing ORS (G-ORS) and a sports drink (SD) compared to water&#xD;
      (control).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The &quot;Beverage Hydration Index&quot; (BHI) was created to assess the degree to which beverages&#xD;
      &quot;hydrate&quot;, by measuring fluid retention after ingesting a 1 liter bolus and comparing it to&#xD;
      water. Drinks with carbohydrates and electrolytes would traditionally be expected to score&#xD;
      higher on the BHI due to glucose-sodium cotransport at the gut and osmolality approaching&#xD;
      isotonicity with blood. One recent study reported that an oral rehydration solution (ORS)&#xD;
      scored better than water, but a &quot;sports drink&quot; did not. No &quot;optimal&quot; BHI beverage composition&#xD;
      has been described, nor has an optimal osmolality. Recently, a hypotonic amino acid-based&#xD;
      rehydration beverage was developed to take advantage of amino acid-sodium cotransport, thus&#xD;
      obviating the need for carbohydrate. However, the BHI of this beverage has not yet been&#xD;
      assessed. The purpose of this investigation was to assess the hydration potential of this&#xD;
      novel beverage in comparison to a commercially available carbohydrate-containing sports drink&#xD;
      and oral rehydration solution.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 17, 2017</start_date>
  <completion_date type="Actual">April 14, 2017</completion_date>
  <primary_completion_date type="Actual">April 14, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Repeated-measures design with generalized latin square arrangement. Each participant will complete 4 separate trials.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Beverage hydration index</measure>
    <time_frame>4 hours</time_frame>
    <description>beverage hydration index</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Beverage Hydration Index of beverages</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will consume 4 different beverages to obtain the beverage hydration index.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>enterade</intervention_name>
    <description>Subjects will consume enterade, which is an amino acid-based oral rehydration solution.</description>
    <arm_group_label>Beverage Hydration Index of beverages</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pedialyte</intervention_name>
    <description>Subjects will consume Pedialyte</description>
    <arm_group_label>Beverage Hydration Index of beverages</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gatorade</intervention_name>
    <description>Subjects will consume Gatorade</description>
    <arm_group_label>Beverage Hydration Index of beverages</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water</intervention_name>
    <description>Subjects will consume water as the control beverage</description>
    <arm_group_label>Beverage Hydration Index of beverages</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female&#xD;
&#xD;
          -  Aged 18-35&#xD;
&#xD;
          -  BMI 18-27 kg/m2&#xD;
&#xD;
          -  No known cardiovascular, renal or metabolic disease&#xD;
&#xD;
          -  Moderately active&#xD;
&#xD;
          -  Moderate alcohol use&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Overweight or obese (BMI &gt;27 kg/m2)&#xD;
&#xD;
               -  Competitive athletes during competition season&#xD;
&#xD;
               -  Current or former cardiovascular, renal or metabolic disease&#xD;
&#xD;
               -  Habitual consumption of alcohol (&gt;21 units/week) or regular (&gt;1/week) high (10&#xD;
                  units) intake*&#xD;
&#xD;
               -  History of psychiatric illness&#xD;
&#xD;
               -  Actively seeking to gain or lose weight&#xD;
&#xD;
               -  Currently taking prescribed medication&#xD;
&#xD;
                    -  Example, a 750 ml bottle of wine at 12% ABV contains 0.750 Liters * 12 = 9&#xD;
                       units&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kurt J Sollanek, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sonoma State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sonoma State Univrsity</name>
      <address>
        <city>Rohnert Park</city>
        <state>California</state>
        <zip>94928</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sonoma State University</investigator_affiliation>
    <investigator_full_name>Kurt Sollanek</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>fluid balance</keyword>
  <keyword>dehydration</keyword>
  <keyword>rehydration</keyword>
  <keyword>electrolytes</keyword>
  <keyword>urine</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/NCT03262597
org study id: IRB Application #2667
nct id: NCT03262597
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The "beverage hydration index" (BHI) assesses the hydration potential of any consumable fluid
      relative to water. The BHI is a relatively new metric. Our purpose was to assess the BHI of
      beverages never previously tested, including an amino acid-based oral rehydration solution
      (AA-ORS), a glucose-containing ORS (G-ORS) and a sports drink (SD) compared to water
      (control).
The "Beverage Hydration Index" (BHI) was created to assess the degree to which beverages
      "hydrate", by measuring fluid retention after ingesting a 1 liter bolus and comparing it to
      water. Drinks with carbohydrates and electrolytes would traditionally be expected to score
      higher on the BHI due to glucose-sodium cotransport at the gut and osmolality approaching
      isotonicity with blood. One recent study reported that an oral rehydration solution (ORS)
      scored better than water, but a "sports drink" did not. No "optimal" BHI beverage composition
      has been described, nor has an optimal osmolality. Recently, a hypotonic amino acid-based
      rehydration beverage was developed to take advantage of amino acid-sodium cotransport, thus
      obviating the need for carbohydrate. However, the BHI of this beverage has not yet been
      assessed. The purpose of this investigation was to assess the hydration potential of this
      novel beverage in comparison to a commercially available carbohydrate-containing sports drink
      and oral rehydration solution.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Repeated-measures design with generalized latin square arrangement. Each participant will complete 4 separate trials.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Beverage hydration index
time frame: 4 hours
description: beverage hydration index
arm group label: Beverage Hydration Index of beverages
arm group type: Experimental
description: Subjects will consume 4 different beverages to obtain the beverage hydration index.
intervention type: Other
intervention name: enterade
description: Subjects will consume enterade, which is an amino acid-based oral rehydration solution.
arm group label: Beverage Hydration Index of beverages
intervention type: Other
intervention name: Pedialyte
description: Subjects will consume Pedialyte
arm group label: Beverage Hydration Index of beverages
intervention type: Other
intervention name: Gatorade
description: Subjects will consume Gatorade
arm group label: Beverage Hydration Index of beverages
intervention type: Other
intervention name: Water
description: Subjects will consume water as the control beverage
arm group label: Beverage Hydration Index of beverages
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kurt J Sollanek, Ph.D.
role: Principal Investigator
affiliation: Sonoma State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Sonoma State University
investigator full name: Kurt Sollanek
investigator title: Assistant Professor
sharing ipd: No