xml: <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/NCT06042270</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00004218</org_study_id>
      <nct_id>NCT06042270</nct_id>
    </id_info>
    <brief_title>Firefighter Thermoregulatory Responses in Active Fire With Betaine Supplementation</brief_title>
    <acronym>FFBET</acronym>
    <official_title>Thermoregulatory Responses of Betaine Supplementation in Firefighters During Live Burn</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Michael J. Ormsbee</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Florida 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 goal of this clinical trial is to compare betaine supplementation to placebo in&#xD;
        firefighters undergoing live burn training regarding thermoregulation and inflammation. The&#xD;
        main questions it aims to answer are:&#xD;
  &#xD;
          -  Does betaine supplementation mitigate rises in core temperature during firefighter live&#xD;
             burn training?&#xD;
  &#xD;
          -  Does betaine supplementation decrease inflammation from firefighter training?&#xD;
  &#xD;
          -  Does betaine supplementation increase total body water stores?&#xD;
  &#xD;
        Participants will supplement with betaine for 1 month and complete:&#xD;
  &#xD;
          -  Total Body Water measures&#xD;
  &#xD;
          -  Body Composition measures&#xD;
  &#xD;
          -  Live Burn training with Core Temperature Measurements&#xD;
  &#xD;
          -  Provide Salivary samples&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Determine if BET supplementation impacts the thermal response in professional firefighters during live burn training.</measure>
      <time_frame>1 month</time_frame>
      <description>To address Aim 1, we will measure and record changes in core temperature and skin temperature. Temperature will be measured before, during, and after the live burn. Physiological strain index will be calculated based off initial core temperature and heart rate, as well as ending core temperature and heart rate during the live burn. Tegaderm patches will be worn during the live burn to analyze sodium concentration in sweat. Additionally, subjective thermal sensation, rate of perceived exertion, and thirst will be measured before and after the live burn.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Determine if BET supplementation impacts acute physiological stress in professional firefighters during a live burn.</measure>
      <time_frame>1 month</time_frame>
      <description>To address Aim 2, we will collect saliva samples before, immediately after, 10 minutes, and 20 minutes after live burn. These saliva samples will be analyzed for cortisol and testosterone to determine Testosterone Cortisol ratios and markers of inflammation (Interleukin 8 [IL-8] and interleukin-6 [IL-6]). Additionally, heart rate will be measured throughout the live burn. Last, pounds per square inch (PSI) in the firefighter's air tank will be recorded to indicate the amount of air usage.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Determine if BET supplementation decreases chronic physiological stress in professional firefighters.</measure>
      <time_frame>2 months</time_frame>
      <description>To address Aim 3, we will collect saliva samples before and after the 4-week supplementation period to be analyzed for testosterone, cortisol, uric acid, and c-reactive protein. Resting blood pressure, total body water, and heart rate will also be measured.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Body Temperature Changes</condition>
    <condition>Body Water Dehydration</condition>
    <condition>Inflammation</condition>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>10 participants will be given rice-flour as a placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Betaine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>10 participants will be given betaine</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Betaine</intervention_name>
      <description>3 grams per day for ~4 weeks</description>
      <arm_group_label>Betaine</arm_group_label>
      <other_name>Trimethylglycine</other_name>
      <other_name>Betaine Anhydrous</other_name>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>3 grams per day for ~4 weeks</description>
      <arm_group_label>Placebo</arm_group_label>
      <other_name>Rice Flour</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Structural Firefighter&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Participants have a cardiometabolic disease for which they take prescribed&#xD;
               medications&#xD;
  &#xD;
                 -  Participants consume supplements known to impact hydration status or performance&#xD;
                    that they are not willing to stop taking for the study&#xD;
  &#xD;
                 -  Participants are pregnant&#xD;
  &#xD;
                 -  Female participants that have irregular menstrual cycles&#xD;
  &#xD;
                 -  Participants are injured and would not be able to fulfill the live burn scenario&#xD;
  &#xD;
                 -  Participants have sickle cell disease&#xD;
  &#xD;
                 -  Participants have experienced heat stroke within the last 2 years&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Liliana Renteria</last_name>
      <phone>8506451016</phone>
      <email>lir20@fsu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Michael Ormsbee, PhD</last_name>
      <email>mormsbee@fsu.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Florida State University</investigator_affiliation>
      <investigator_full_name>Michael J. Ormsbee</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dehydration</mesh_term>
      <mesh_term>Inflammation</mesh_term>
      <mesh_term>Body Temperature Changes</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Betaine</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042270
  org study id: STUDY00004218
  nct id: NCT06042270
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare betaine supplementation to placebo in
        firefighters undergoing live burn training regarding thermoregulation and inflammation. The
        main questions it aims to answer are:
  
          -  Does betaine supplementation mitigate rises in core temperature during firefighter live
             burn training?
  
          -  Does betaine supplementation decrease inflammation from firefighter training?
  
          -  Does betaine supplementation increase total body water stores?
  
        Participants will supplement with betaine for 1 month and complete:
  
          -  Total Body Water measures
  
          -  Body Composition measures
  
          -  Live Burn training with Core Temperature Measurements
  
          -  Provide Salivary samples
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Determine if BET supplementation impacts the thermal response in professional firefighters during live burn training.
  time frame: 1 month
  description: To address Aim 1, we will measure and record changes in core temperature and skin temperature. Temperature will be measured before, during, and after the live burn. Physiological strain index will be calculated based off initial core temperature and heart rate, as well as ending core temperature and heart rate during the live burn. Tegaderm patches will be worn during the live burn to analyze sodium concentration in sweat. Additionally, subjective thermal sensation, rate of perceived exertion, and thirst will be measured before and after the live burn.
  measure: Determine if BET supplementation impacts acute physiological stress in professional firefighters during a live burn.
  time frame: 1 month
  description: To address Aim 2, we will collect saliva samples before, immediately after, 10 minutes, and 20 minutes after live burn. These saliva samples will be analyzed for cortisol and testosterone to determine Testosterone Cortisol ratios and markers of inflammation (Interleukin 8 [IL-8] and interleukin-6 [IL-6]). Additionally, heart rate will be measured throughout the live burn. Last, pounds per square inch (PSI) in the firefighter's air tank will be recorded to indicate the amount of air usage.
  measure: Determine if BET supplementation decreases chronic physiological stress in professional firefighters.
  time frame: 2 months
  description: To address Aim 3, we will collect saliva samples before and after the 4-week supplementation period to be analyzed for testosterone, cortisol, uric acid, and c-reactive protein. Resting blood pressure, total body water, and heart rate will also be measured.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: 10 participants will be given rice-flour as a placebo
  arm group label: Betaine
  arm group type: Active Comparator
  description: 10 participants will be given betaine
  intervention type: Dietary Supplement
  intervention name: Betaine
  description: 3 grams per day for ~4 weeks
  arm group label: Betaine
  other name: Trimethylglycine
  other name: Betaine Anhydrous
  intervention type: Dietary Supplement
  intervention name: Placebo
  description: 3 grams per day for ~4 weeks
  arm group label: Placebo
  other name: Rice Flour
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Liliana Renteria
  phone: 8506451016
  email: lir20@fsu.edu
  last name: Michael Ormsbee, PhD
  email: mormsbee@fsu.edu
  responsible party type: Sponsor-Investigator
  investigator affiliation: Florida State University
  investigator full name: Michael J. Ormsbee
  investigator title: Director
  mesh term: Dehydration
  mesh term: Inflammation
  mesh term: Body Temperature Changes
  mesh term: Betaine