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/NCT05989607</url>
    </required_header>
    <id_info>
      <org_study_id>23-03-190</org_study_id>
      <nct_id>NCT05989607</nct_id>
    </id_info>
    <brief_title>Kids Rehydration During Exercise</brief_title>
    <official_title>Kids Rehydration During Exercise (ROAR East)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Hartford</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Kraft Heinz Company</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Arizona State University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Hartford</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 present study aims to measure the impact of consuming a lower sugar flavored water&#xD;
        compared to an equal amount of plain water during exercise on selected rehydration markers in&#xD;
        healthy children. Participants will complete two experimental visits designed to examine the&#xD;
        differentiating effects of one of two selected beverages (1) lower sugar flavored water&#xD;
        beverage and 2) plain water) on certain hydration markers and related perceptual variables&#xD;
        during repeated bouts of exercise in a warm environment to induce mild dehydration.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Parents of adolescent children have demonstrated a preference to remove added and larger&#xD;
        boluses of sugar from their child's diet in accordance with accumulating health concerns.&#xD;
        While forms of sugar are often included in oral rehydration solutions, evidence demonstrates&#xD;
        that electrolytes such as sodium are the predominant beverage ingredients contributing to&#xD;
        rehydration. Determining the efficacy and preference when thirsty of a flavored water&#xD;
        beverage (with lower sugar content), compared to plain water could guide future beverage&#xD;
        selection to achieve rehydration in young people.&#xD;
  &#xD;
        Protocol:&#xD;
  &#xD;
        This is a randomized, counter-balanced, cross-over design study. Thirty participants will be&#xD;
        voluntarily enrolled (defined as the completion of assent and successful screening). Upon&#xD;
        enrollment, participants will be familiarized to the study procedures: exercise, dietary&#xD;
        consumption, urine sample collection, body weight measurement, bioelectrical impedance&#xD;
        spectroscopy (BIS) analysis, and perceptual questionnaire completion. Participants will be&#xD;
        scheduled to complete two experimental visits within three weeks of one another. Each&#xD;
        experimental visit is designed to examine the differentiating effects of one of two selected&#xD;
        beverages (1) lower sugar flavored water beverage and 2) plain water) on certain hydration&#xD;
        markers and related perceptual variables during repeated bouts of exercise.&#xD;
  &#xD;
        Day Before study:&#xD;
  &#xD;
        Participants will consume a standardized frozen dinner (provided by the researchers) and&#xD;
        consume at least 250 ml (8oz) of water after dinner. Food and beverages other than water will&#xD;
        be prohibited following dinner.&#xD;
  &#xD;
        Study Day:&#xD;
  &#xD;
        Participants will arrive at each study visit fasted (no food or beverages within the previous&#xD;
        eight hours, except 250 ml of plain water two to three hours prior to the experimental&#xD;
        visit). In the event that the participant did not fast, their visit will be rescheduled. Only&#xD;
        one visit reschedule will be offered throughout the course of their participation. Upon&#xD;
        arrival, participants will then consume a standardized breakfast. Following breakfast&#xD;
        (approximately 15min following completion) they will provide a urine sample, the&#xD;
        investigators will record body weight and measure body fluids by BIS (in a prone position),&#xD;
        and they will complete questionnaires (with appropriate guidance and in visual analogue scale&#xD;
        format) about mouth dryness, taste pleasantness, stomach fullness, and thirst. All body&#xD;
        weight measurements will be taken with as minimal clothing as possible; only the&#xD;
        participant's parent/guardian will be with the participant for this measurement to protect&#xD;
        privacy. Each participant will wear the same amount of clothing for every body weight&#xD;
        measurement during their individual participation.&#xD;
  &#xD;
        Subsequently, the participant will enter a warm room with a controlled/recorded temperature&#xD;
        between 28-30°C (80-85°F). Then the participant will undergo a 3 hour intermittent walk,&#xD;
        cycle, rest protocol. During the 3-h period, each participant will complete the following one&#xD;
        hour test, three sequential times:&#xD;
  &#xD;
          -  10 min walking on the treadmill at 70% of age-predicted max heart rate (~140 bpm)&#xD;
  &#xD;
          -  5 min rest&#xD;
  &#xD;
          -  10 min cycling on the cycle ergometer at 70 of age-predicted max heart rate (~140 bpm)&#xD;
  &#xD;
          -  35 min rest&#xD;
  &#xD;
        During the 3-h period, participants will be provided with the fluid volume equating to 2% of&#xD;
        body mass losses (as determined by ongoing individual body weight difference measurements)&#xD;
        during each one hour test (water or a lower sugar flavored water beverage); anticipated as&#xD;
        ~200ml). During this time body weight, and urine samples, BIS, and perceptual data via&#xD;
        questionnaires will be collected (prior to and following each exercise bout).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</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>
      <intervention_model_description>randomized, counter-balanced, cross-over design</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Net fluid balance (according to body weight change) from baseline to 3 hours post exercise</measure>
      <time_frame>baseline to 3 hours post exercise</time_frame>
      <description>Net fluid balance (according to body weight change) attributable to sweat/body water losses/additions by control of food/beverage intake and urine/fecal output; post 3 hour post exercise body weight (180min) - baseline body weight (0 minutes) = net fluid balance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hydration status change (according to urine concentration) from baseline to 3 hours post exercise</measure>
      <time_frame>baseline to 3 hours post exercise</time_frame>
      <description>Hydration status change according to urine concentration measurement (osmolality, specific gravity, and color); 3 hour post-exercise urine concentration (180min) - baseline urine concentration (0 minutes) = hydration status change.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total and compartmental body water change (according to bioelectrical impedance spectroscopy) from baseline to 3 hours post-exercise</measure>
      <time_frame>baseline to 3 hours post exercise</time_frame>
      <description>Total and compartmental body water change (according to bioelectrical impedance spectroscopy); 3 hour post exercise kilohertz (180 minutes) - baseline kilohertz (0 minutes) = total and compartmental body water change.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hydration-related perceptual variable change (thirst, mouth dryness, taste pleasantness) from baseline to 3 hours post-exercise</measure>
      <time_frame>baseline to 3 hours post exercise</time_frame>
      <description>Hydration-related perceptual variable change (thirst, mouth dryness, taste pleasantness; via visual analog scale, measured in millimeters, where higher millimeters represents greater perception of that variable); 3 hours post-exercise millimeters (180min) - baseline millimeters (0min) = hydration-related perceptual variable change</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Dehydration in Children</condition>
    <condition>Dehydration Following Exertion (Disorder)</condition>
    <arm_group>
      <arm_group_label>Low Sugar Flavored Water</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A commercially available low sugar flavored water (2.88kcal/100ml; 0.57(sugar) +0.03 (stevia)=0.60g/100ml; sodium 7.9mg/100ml).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Plain Water</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Plain water (bottled, spring).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Lower sugar flavored water</intervention_name>
      <description>A commercially available low sugar flavored water (2.88kcal/100ml; 0.57(sugar) +0.03 (stevia)=0.60g/100ml; sodium 7.9mg/100ml).</description>
      <arm_group_label>Low Sugar Flavored Water</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Plain Water</intervention_name>
      <description>Commercially available bottled, spring water.</description>
      <arm_group_label>Plain Water</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Girls and boys age 8 to 10y&#xD;
  &#xD;
            -  Willing and able to walk and cycle at a moderate intensity for sequential brief&#xD;
               exercise periods (separated by a brief rest period) repeatedly (3x) in a warm&#xD;
               environment (80-85°F)&#xD;
  &#xD;
            -  Body weight ≤85th percentile for their age group&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of conditions or current use of medications known to alter body water balance&#xD;
               (diabetes, renal disease, SSRI's, etc.)&#xD;
  &#xD;
            -  Current or recent (past two weeks) illness involving fever, diarrhea, and/or GI&#xD;
               discomfort&#xD;
  &#xD;
            -  Physical or mental disabilities and injuries that would prevent participation in&#xD;
               moderate-intensity treadmill walking/jogging and cycling&#xD;
  &#xD;
            -  Previous diagnosis of heat stroke&#xD;
  &#xD;
            -  Body weight ≥86th percentile for their age group&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Colleen Munoz, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Hartford</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Colleen Munoz, PhD</last_name>
      <phone>860-768-4368</phone>
      <email>cmunoz@hartford.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Chris Standish, x</last_name>
      <phone>860-768-5938</phone>
      <email>standish@hartford.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Hartford</name>
        <address>
          <city>West Hartford</city>
          <state>Connecticut</state>
          <zip>06117</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Colleen Munoz, PhD</last_name>
        <phone>860-768-4368</phone>
        <email>cmunoz@hartford.edu</email>
      </contact>
      <contact_backup>
        <last_name>Chris Standish</last_name>
        <phone>860-768-5938</phone>
        <email>standish@hartford.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Hartford</investigator_affiliation>
      <investigator_full_name>Colleen Munoz</investigator_full_name>
      <investigator_title>PhD, Associate Professor, Hydration Health Center Director</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>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05989607
  org study id: 23-03-190
  nct id: NCT05989607
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The present study aims to measure the impact of consuming a lower sugar flavored water
        compared to an equal amount of plain water during exercise on selected rehydration markers in
        healthy children. Participants will complete two experimental visits designed to examine the
        differentiating effects of one of two selected beverages (1) lower sugar flavored water
        beverage and 2) plain water) on certain hydration markers and related perceptual variables
        during repeated bouts of exercise in a warm environment to induce mild dehydration.
  Parents of adolescent children have demonstrated a preference to remove added and larger
        boluses of sugar from their child's diet in accordance with accumulating health concerns.
        While forms of sugar are often included in oral rehydration solutions, evidence demonstrates
        that electrolytes such as sodium are the predominant beverage ingredients contributing to
        rehydration. Determining the efficacy and preference when thirsty of a flavored water
        beverage (with lower sugar content), compared to plain water could guide future beverage
        selection to achieve rehydration in young people.
  
        Protocol:
  
        This is a randomized, counter-balanced, cross-over design study. Thirty participants will be
        voluntarily enrolled (defined as the completion of assent and successful screening). Upon
        enrollment, participants will be familiarized to the study procedures: exercise, dietary
        consumption, urine sample collection, body weight measurement, bioelectrical impedance
        spectroscopy (BIS) analysis, and perceptual questionnaire completion. Participants will be
        scheduled to complete two experimental visits within three weeks of one another. Each
        experimental visit is designed to examine the differentiating effects of one of two selected
        beverages (1) lower sugar flavored water beverage and 2) plain water) on certain hydration
        markers and related perceptual variables during repeated bouts of exercise.
  
        Day Before study:
  
        Participants will consume a standardized frozen dinner (provided by the researchers) and
        consume at least 250 ml (8oz) of water after dinner. Food and beverages other than water will
        be prohibited following dinner.
  
        Study Day:
  
        Participants will arrive at each study visit fasted (no food or beverages within the previous
        eight hours, except 250 ml of plain water two to three hours prior to the experimental
        visit). In the event that the participant did not fast, their visit will be rescheduled. Only
        one visit reschedule will be offered throughout the course of their participation. Upon
        arrival, participants will then consume a standardized breakfast. Following breakfast
        (approximately 15min following completion) they will provide a urine sample, the
        investigators will record body weight and measure body fluids by BIS (in a prone position),
        and they will complete questionnaires (with appropriate guidance and in visual analogue scale
        format) about mouth dryness, taste pleasantness, stomach fullness, and thirst. All body
        weight measurements will be taken with as minimal clothing as possible; only the
        participant's parent/guardian will be with the participant for this measurement to protect
        privacy. Each participant will wear the same amount of clothing for every body weight
        measurement during their individual participation.
  
        Subsequently, the participant will enter a warm room with a controlled/recorded temperature
        between 28-30°C (80-85°F). Then the participant will undergo a 3 hour intermittent walk,
        cycle, rest protocol. During the 3-h period, each participant will complete the following one
        hour test, three sequential times:
  
          -  10 min walking on the treadmill at 70% of age-predicted max heart rate (~140 bpm)
  
          -  5 min rest
  
          -  10 min cycling on the cycle ergometer at 70 of age-predicted max heart rate (~140 bpm)
  
          -  35 min rest
  
        During the 3-h period, participants will be provided with the fluid volume equating to 2% of
        body mass losses (as determined by ongoing individual body weight difference measurements)
        during each one hour test (water or a lower sugar flavored water beverage); anticipated as
        ~200ml). During this time body weight, and urine samples, BIS, and perceptual data via
        questionnaires will be collected (prior to and following each exercise bout).
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: randomized, counter-balanced, cross-over design
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Net fluid balance (according to body weight change) from baseline to 3 hours post exercise
  time frame: baseline to 3 hours post exercise
  description: Net fluid balance (according to body weight change) attributable to sweat/body water losses/additions by control of food/beverage intake and urine/fecal output; post 3 hour post exercise body weight (180min) - baseline body weight (0 minutes) = net fluid balance.
  measure: Hydration status change (according to urine concentration) from baseline to 3 hours post exercise
  time frame: baseline to 3 hours post exercise
  description: Hydration status change according to urine concentration measurement (osmolality, specific gravity, and color); 3 hour post-exercise urine concentration (180min) - baseline urine concentration (0 minutes) = hydration status change.
  measure: Total and compartmental body water change (according to bioelectrical impedance spectroscopy) from baseline to 3 hours post-exercise
  time frame: baseline to 3 hours post exercise
  description: Total and compartmental body water change (according to bioelectrical impedance spectroscopy); 3 hour post exercise kilohertz (180 minutes) - baseline kilohertz (0 minutes) = total and compartmental body water change.
  measure: Hydration-related perceptual variable change (thirst, mouth dryness, taste pleasantness) from baseline to 3 hours post-exercise
  time frame: baseline to 3 hours post exercise
  description: Hydration-related perceptual variable change (thirst, mouth dryness, taste pleasantness; via visual analog scale, measured in millimeters, where higher millimeters represents greater perception of that variable); 3 hours post-exercise millimeters (180min) - baseline millimeters (0min) = hydration-related perceptual variable change
  arm group label: Low Sugar Flavored Water
  arm group type: Experimental
  description: A commercially available low sugar flavored water (2.88kcal/100ml; 0.57(sugar) +0.03 (stevia)=0.60g/100ml; sodium 7.9mg/100ml).
  arm group label: Plain Water
  arm group type: Active Comparator
  description: Plain water (bottled, spring).
  intervention type: Other
  intervention name: Lower sugar flavored water
  description: A commercially available low sugar flavored water (2.88kcal/100ml; 0.57(sugar) +0.03 (stevia)=0.60g/100ml; sodium 7.9mg/100ml).
  arm group label: Low Sugar Flavored Water
  intervention type: Other
  intervention name: Plain Water
  description: Commercially available bottled, spring water.
  arm group label: Plain Water
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 10 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Colleen Munoz, PhD
  role: Principal Investigator
  affiliation: University of Hartford
  last name: Colleen Munoz, PhD
  phone: 860-768-4368
  email: cmunoz@hartford.edu
  last name: Chris Standish, x
  phone: 860-768-5938
  email: standish@hartford.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Hartford
  investigator full name: Colleen Munoz
  investigator title: PhD, Associate Professor, Hydration Health Center Director
  mesh term: Dehydration
  sharing ipd: No