<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/NCT03032445</url>
  </required_header>
  <id_info>
    <org_study_id>Beer Trial</org_study_id>
    <nct_id>NCT03032445</nct_id>
  </id_info>
  <brief_title>Beer for Endurance Exercise Recovery</brief_title>
  <acronym>BEER</acronym>
  <official_title>Potential Impacts of Beer on Post-Race Ultramarathon Athletes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York - Upstate Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York - Upstate Medical 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Athletes who are participating in the Keys100 Ultramarathon event in Key West, FL are&#xD;
      eligible, based on inclusion criteria, to participate in this research study that is seeking&#xD;
      to determine whether supplementation of beer (alcohol) immediately following a long distance&#xD;
      ultramarathon race can positively impact exercise-associated hyponatremia [EAH].&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">May 21, 2017</completion_date>
  <primary_completion_date type="Actual">May 21, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in sodium level pre and post intervention</measure>
    <time_frame>One hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of urine output</measure>
    <time_frame>One hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal laboratory values</measure>
    <time_frame>One hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of cognition</measure>
    <time_frame>Within one month of intervention</time_frame>
    <description>Cognitive level determined by assessment of clock drawing test.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Hyponatremia</condition>
  <arm_group>
    <arm_group_label>Alcoholic beer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At least 6% alcohol content</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non alcoholic beer</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Less than 0.5% alcohol content</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Alcoholic Beer</intervention_name>
    <description>Subject will be asked to consume alcoholic beer within 30 minutes. Subject will be monitored for 60 minutes at commencement of study beverage.</description>
    <arm_group_label>Alcoholic beer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non alcoholic beer</intervention_name>
    <description>Subject will be asked to consume non alcoholic beer within 30 minutes. Subject will be monitored for 60 minutes at commencement of study beverage.</description>
    <arm_group_label>Non alcoholic beer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Completed informed consent&#xD;
&#xD;
          -  Ability to read and speak English language&#xD;
&#xD;
          -  Age 21 years or older&#xD;
&#xD;
          -  Not considered a vulnerable population, such as pregnant (by history) or cognitively&#xD;
             impaired.&#xD;
&#xD;
          -  Able to tolerate needle exposure for blood draw&#xD;
&#xD;
          -  Willing to drink alcoholic or nonalcoholic beer&#xD;
&#xD;
          -  Willing not to eat or drink other than the study fluid during 1 hour study period&#xD;
&#xD;
          -  Participating in 100 mile or 50 mile race&#xD;
&#xD;
          -  To participate in the controlled part of the study the individual must have fully&#xD;
             completed either the 100 mile or the 50 mile race.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under age 21 years&#xD;
&#xD;
          -  Vulnerable population, such as pregnant (by history) or cognitively impaired&#xD;
&#xD;
          -  Subjects who are alcohol-naive (i.e first exposure to alcohol)&#xD;
&#xD;
          -  Subjects with known familial and/or genetic backgrounds at higher risk for the&#xD;
             development of alcohol dependence&#xD;
&#xD;
          -  Subjects should not be seeking treatment for alcohol or drug abuse&#xD;
&#xD;
          -  Subjects who are in general high risk for abuse such as those completing or&#xD;
             participating in alcohol or drug abuse programs&#xD;
&#xD;
          -  Subjects who have had a sustained period of abstinence, with history of heavy drinking&#xD;
             problems, while living in the community&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeremy Joslin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SUNY Upstate Medicial University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>April 25, 2018</last_update_submitted>
  <last_update_submitted_qc>April 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York - Upstate Medical University</investigator_affiliation>
    <investigator_full_name>Jeremy Joslin, MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Body Water/physiology</keyword>
  <keyword>Hyponatremia/etiology</keyword>
  <keyword>Physical Exertion/physiology</keyword>
  <keyword>Running/physiology</keyword>
  <keyword>Sodium/blood</keyword>
  <keyword>Ethanol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyponatremia</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/NCT03032445
org study id: Beer Trial
nct id: NCT03032445
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Athletes who are participating in the Keys100 Ultramarathon event in Key West, FL are
      eligible, based on inclusion criteria, to participate in this research study that is seeking
      to determine whether supplementation of beer (alcohol) immediately following a long distance
      ultramarathon race can positively impact exercise-associated hyponatremia [EAH].
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in sodium level pre and post intervention
time frame: One hour
measure: Measurement of urine output
time frame: One hour
measure: Number of participants with abnormal laboratory values
time frame: One hour
measure: Level of cognition
time frame: Within one month of intervention
description: Cognitive level determined by assessment of clock drawing test.
arm group label: Alcoholic beer
arm group type: Experimental
description: At least 6% alcohol content
arm group label: Non alcoholic beer
arm group type: Placebo Comparator
description: Less than 0.5% alcohol content
intervention type: Other
intervention name: Alcoholic Beer
description: Subject will be asked to consume alcoholic beer within 30 minutes. Subject will be monitored for 60 minutes at commencement of study beverage.
arm group label: Alcoholic beer
intervention type: Other
intervention name: Non alcoholic beer
description: Subject will be asked to consume non alcoholic beer within 30 minutes. Subject will be monitored for 60 minutes at commencement of study beverage.
arm group label: Non alcoholic beer
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jeremy Joslin, MD
role: Principal Investigator
affiliation: SUNY Upstate Medicial University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: State University of New York - Upstate Medical University
investigator full name: Jeremy Joslin, MD
investigator title: Associate Professor
mesh term: Hyponatremia
sharing ipd: No