<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/NCT04422158</url>
  </required_header>
  <id_info>
    <org_study_id>PRO-FY2020-327</org_study_id>
    <nct_id>NCT04422158</nct_id>
  </id_info>
  <brief_title>Impact of Nuun Electrolyte Tablets on Hydration Status in Active Men and Women</brief_title>
  <official_title>Impact of Nuun Electrolyte Tablets on Hydration Status in Active Men and Women: Single-blinded Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Memphis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nuun &amp; Company, Inc (Nuun)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Memphis</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 purpose of this study is to determine the impact of Nuun electrolyte tablets on hydration&#xD;
      status in young and active men and women. We will follow a similar approach as used by&#xD;
      Maughan and colleagues (2016) to measure the beverage hydration index (the relative amount of&#xD;
      urine passed after consumption of a drink compared to water). It is hypothesized that Nuun&#xD;
      electrolyte tablets will result in a greater hydration status as compared to water only. Due&#xD;
      to the fact that athletes use Nuun tablets at varying dosages, we will evaluate Nuun at both&#xD;
      a single dosage and a double dosage. We maintain a non-directional hypothesis regarding the&#xD;
      potential differences between the two different dosages tested.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maintaining adequate hydration is essential to optimal health and athletic performance. When&#xD;
      individuals exercise (in particular in a warm environment), they can lose excessive amounts&#xD;
      of fluids through sweating, along with necessary electrolytes (e.g., sodium, potassium,&#xD;
      chloride). With dehydration, individuals may feel sluggish and can experience impaired&#xD;
      physical performance.&#xD;
&#xD;
      Many attempts have been made to improve and measure the hydration status of active&#xD;
      individuals. This typically involves the ingestion of fluids leading up to activity&#xD;
      (typically plain water), as well as the ingestion of fluids during the activity itself&#xD;
      (water, along with a diluted carbohydrate/electrolyte beverage). This approach seems to work&#xD;
      well; however, some debate remains over what the best fluid is to consume, in particular&#xD;
      related to the macronutrient type and the specific electrolyte mix.&#xD;
&#xD;
      Related to the above, it is well-accepted that electrolyte replenishment is of importance,&#xD;
      both during and following exercise-to aid in rehydration for subsequent bouts. The use of&#xD;
      electrolytes (sodium in particular) has been used for decades to aid athlete hydration and&#xD;
      has led to the development of various sport drinks-which also include small amounts of&#xD;
      carbohydrate. However, one problem with carbohydrate ingestion is that some individuals&#xD;
      experience gastrointestinal (GI) upset following carbohydrate ingestion before and during an&#xD;
      event, despite very good physical performance outcomes. Due to this GI upset, some&#xD;
      individuals (in particular recreationally active individuals who are not competing at high&#xD;
      levels) rely solely on water and seek a method to ingest the lost electrolytes. In addition,&#xD;
      some individuals prefer to have both plain water and an electrolyte beverage during their&#xD;
      training/competition sessions and in some activities (e.g., running, cycling), carrying&#xD;
      multiple bottles of fluid is difficult.&#xD;
&#xD;
      The solution to the above issues for many athletes is the use of electrolyte tablets. These&#xD;
      can be dropped into plain water and will dissolve into a flavored electrolyte-rich beverage.&#xD;
      They are easy to transport and provide the needed electrolytes to replace those that are lost&#xD;
      through intense and/or long duration exercise.&#xD;
&#xD;
      Nuun electrolyte tablets provide only 2 grams of carbohydrate and a combination of&#xD;
      electrolytes, provided at a relatively low percentage of the Daily Value (DV). The DV tells&#xD;
      us how much a particular nutrient in a serving of a food product contributes to a daily diet,&#xD;
      based on a standard 2000 calorie diet. Nuun tablets contain: calcium (13mg, 1%DV), sodium&#xD;
      (300mg, 13%DV), potassium (150mg, 3%DV), magnesium (25mg, 6%DV), and chloride (40mg, 2%DV).&#xD;
      These tablets contain a small percentage of the needed total electrolytes but adequate&#xD;
      amounts to replace lost electrolytes as a result of physical activity.&#xD;
&#xD;
      While Nuun tablets are commercially available and have received positive reviews from end&#xD;
      users, there have been no studies to date to evaluate the impact of these tablets on&#xD;
      hydration status. Therefore, the purpose of this study is to determine the impact of Nuun&#xD;
      electrolyte tablets on hydration status in young and active men and women. We will follow a&#xD;
      similar approach as used by Maughan and colleagues to measure the beverage hydration index&#xD;
      (the relative amount of urine passed after consumption of a drink compared to water). It is&#xD;
      hypothesized that Nuun electrolyte tablets will result in a greater hydration status as&#xD;
      compared to water only. Due to the fact that athletes use Nuun tablets at varying dosages, we&#xD;
      will evaluate Nuun at both a single dosage and a double dosage. We maintain a non-directional&#xD;
      hypothesis regarding the potential differences between the two different dosages tested.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 3, 2020</start_date>
  <completion_date type="Actual">August 18, 2020</completion_date>
  <primary_completion_date type="Actual">August 18, 2020</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, single-blind, placebo-controlled, cross-over with non-directional hypothesis regarding the potential differences between the two different dosages tested.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Drinks will be prepared without subjects aware of which drink they are receiving.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Body weight</measure>
    <time_frame>baseline</time_frame>
    <description>Body weight will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body weight</measure>
    <time_frame>4 hours after drink consumption</time_frame>
    <description>Body weight will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine volume</measure>
    <time_frame>Immediately after completing intervention</time_frame>
    <description>Volume of urine output will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine volume</measure>
    <time_frame>1 hour after intervention</time_frame>
    <description>Volume of urine output will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine volume</measure>
    <time_frame>2 hours after intervention</time_frame>
    <description>Volume of urine output will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine volume</measure>
    <time_frame>3 hours after intervention</time_frame>
    <description>Volume of urine output will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine volume</measure>
    <time_frame>4 hours after intervention</time_frame>
    <description>Volume of urine output will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine mass</measure>
    <time_frame>Immediately after completing intervention</time_frame>
    <description>Urine output will be measured using a scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine mass</measure>
    <time_frame>1 hour after intervention</time_frame>
    <description>Urine output will be measured using a scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine mass</measure>
    <time_frame>2 hours after intervention</time_frame>
    <description>Urine output will be measured using a scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine mass</measure>
    <time_frame>3 hours after intervention</time_frame>
    <description>Urine output will be measured using a scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine mass</measure>
    <time_frame>4 hours after intervention</time_frame>
    <description>Urine output will be measured using a scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>at baseline</time_frame>
    <description>Blood pressure will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>1 hour after intervention</time_frame>
    <description>Blood pressure will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>2 hours after intervention</time_frame>
    <description>Blood pressure will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>3 hours after intervention</time_frame>
    <description>Blood pressure will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>4 hours after intervention</time_frame>
    <description>Blood pressure will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>baseline</time_frame>
    <description>Heart Rate will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>1 hour after intervention</time_frame>
    <description>Heart Rate will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>2 hours after intervention</time_frame>
    <description>Heart Rate will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>3 hours after intervention</time_frame>
    <description>Heart Rate will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>4 hours after intervention</time_frame>
    <description>Heart Rate will be measured</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hydration</condition>
  <arm_group>
    <arm_group_label>Nuun Single strength</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 Nuun electrolyte tablets will be dissolved in 1.4 liters of water. Subjects will drink one liter of the prepared solution over 30 min (250 mL every 7.5 min)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nuun Double strength</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 Nuun electrolyte tablets will be dissolved in 1.4 liters of water. Subjects will drink one liter of the prepared solution over 30 min (250 mL every 7.5 min)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will drink one liter of water over 30 min (250 mL every 7.5 min)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nuun electrolyte tablet</intervention_name>
    <description>Each table contains 2 grams of carbohydrate and a combination of electrolytes. calcium (13mg, 1%DV), sodium (300mg, 13%DV), potassium (150mg, 3%DV), magnesium (25mg, 6%DV), and chloride (40mg, 2%DV).</description>
    <arm_group_label>Nuun Double strength</arm_group_label>
    <arm_group_label>Nuun Single strength</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>water</intervention_name>
    <description>water</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Nuun Double strength</arm_group_label>
    <arm_group_label>Nuun Single strength</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI between 18.5 and 29.9 kg/m2 (not obese)&#xD;
&#xD;
          -  Consumes 2 liters of water daily&#xD;
&#xD;
          -  Exercised 3 hours/week over the past 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Obese&#xD;
&#xD;
          -  Pregnant or trying to become pregnant&#xD;
&#xD;
          -  Tobacco user&#xD;
&#xD;
          -  Cardiac Disease&#xD;
&#xD;
          -  Consumed alcohol within 48 hours of testing visit&#xD;
&#xD;
          -  Consumed caffeine within 48 hours of testing visit&#xD;
&#xD;
          -  Strenuous excercise 24 hours prior to testing visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Bloomer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Memphis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Nutraceutical and Dietary Supplement Research</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38152</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Memphis</investigator_affiliation>
    <investigator_full_name>Richard Bloomer</investigator_full_name>
    <investigator_title>Dean of School of Health Studies</investigator_title>
  </responsible_party>
  <keyword>electrolyte</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/NCT04422158
org study id: PRO-FY2020-327
nct id: NCT04422158
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the impact of Nuun electrolyte tablets on hydration
      status in young and active men and women. We will follow a similar approach as used by
      Maughan and colleagues (2016) to measure the beverage hydration index (the relative amount of
      urine passed after consumption of a drink compared to water). It is hypothesized that Nuun
      electrolyte tablets will result in a greater hydration status as compared to water only. Due
      to the fact that athletes use Nuun tablets at varying dosages, we will evaluate Nuun at both
      a single dosage and a double dosage. We maintain a non-directional hypothesis regarding the
      potential differences between the two different dosages tested.
Maintaining adequate hydration is essential to optimal health and athletic performance. When
      individuals exercise (in particular in a warm environment), they can lose excessive amounts
      of fluids through sweating, along with necessary electrolytes (e.g., sodium, potassium,
      chloride). With dehydration, individuals may feel sluggish and can experience impaired
      physical performance.

      Many attempts have been made to improve and measure the hydration status of active
      individuals. This typically involves the ingestion of fluids leading up to activity
      (typically plain water), as well as the ingestion of fluids during the activity itself
      (water, along with a diluted carbohydrate/electrolyte beverage). This approach seems to work
      well; however, some debate remains over what the best fluid is to consume, in particular
      related to the macronutrient type and the specific electrolyte mix.

      Related to the above, it is well-accepted that electrolyte replenishment is of importance,
      both during and following exercise-to aid in rehydration for subsequent bouts. The use of
      electrolytes (sodium in particular) has been used for decades to aid athlete hydration and
      has led to the development of various sport drinks-which also include small amounts of
      carbohydrate. However, one problem with carbohydrate ingestion is that some individuals
      experience gastrointestinal (GI) upset following carbohydrate ingestion before and during an
      event, despite very good physical performance outcomes. Due to this GI upset, some
      individuals (in particular recreationally active individuals who are not competing at high
      levels) rely solely on water and seek a method to ingest the lost electrolytes. In addition,
      some individuals prefer to have both plain water and an electrolyte beverage during their
      training/competition sessions and in some activities (e.g., running, cycling), carrying
      multiple bottles of fluid is difficult.

      The solution to the above issues for many athletes is the use of electrolyte tablets. These
      can be dropped into plain water and will dissolve into a flavored electrolyte-rich beverage.
      They are easy to transport and provide the needed electrolytes to replace those that are lost
      through intense and/or long duration exercise.

      Nuun electrolyte tablets provide only 2 grams of carbohydrate and a combination of
      electrolytes, provided at a relatively low percentage of the Daily Value (DV). The DV tells
      us how much a particular nutrient in a serving of a food product contributes to a daily diet,
      based on a standard 2000 calorie diet. Nuun tablets contain: calcium (13mg, 1%DV), sodium
      (300mg, 13%DV), potassium (150mg, 3%DV), magnesium (25mg, 6%DV), and chloride (40mg, 2%DV).
      These tablets contain a small percentage of the needed total electrolytes but adequate
      amounts to replace lost electrolytes as a result of physical activity.

      While Nuun tablets are commercially available and have received positive reviews from end
      users, there have been no studies to date to evaluate the impact of these tablets on
      hydration status. Therefore, the purpose of this study is to determine the impact of Nuun
      electrolyte tablets on hydration status in young and active men and women. We will follow a
      similar approach as used by Maughan and colleagues to measure the beverage hydration index
      (the relative amount of urine passed after consumption of a drink compared to water). It is
      hypothesized that Nuun electrolyte tablets will result in a greater hydration status as
      compared to water only. Due to the fact that athletes use Nuun tablets at varying dosages, we
      will evaluate Nuun at both a single dosage and a double dosage. We maintain a non-directional
      hypothesis regarding the potential differences between the two different dosages tested.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized, single-blind, placebo-controlled, cross-over with non-directional hypothesis regarding the potential differences between the two different dosages tested.
primary purpose: Basic Science
masking: Single (Participant)
masking description: Drinks will be prepared without subjects aware of which drink they are receiving.
measure: Body weight
time frame: baseline
description: Body weight will be measured
measure: Body weight
time frame: 4 hours after drink consumption
description: Body weight will be measured
measure: Urine volume
time frame: Immediately after completing intervention
description: Volume of urine output will be measured
measure: Urine volume
time frame: 1 hour after intervention
description: Volume of urine output will be measured
measure: Urine volume
time frame: 2 hours after intervention
description: Volume of urine output will be measured
measure: Urine volume
time frame: 3 hours after intervention
description: Volume of urine output will be measured
measure: Urine volume
time frame: 4 hours after intervention
description: Volume of urine output will be measured
measure: Urine mass
time frame: Immediately after completing intervention
description: Urine output will be measured using a scale
measure: Urine mass
time frame: 1 hour after intervention
description: Urine output will be measured using a scale
measure: Urine mass
time frame: 2 hours after intervention
description: Urine output will be measured using a scale
measure: Urine mass
time frame: 3 hours after intervention
description: Urine output will be measured using a scale
measure: Urine mass
time frame: 4 hours after intervention
description: Urine output will be measured using a scale
measure: Blood Pressure
time frame: at baseline
description: Blood pressure will be measured.
measure: Blood Pressure
time frame: 1 hour after intervention
description: Blood pressure will be measured.
measure: Blood Pressure
time frame: 2 hours after intervention
description: Blood pressure will be measured.
measure: Blood Pressure
time frame: 3 hours after intervention
description: Blood pressure will be measured.
measure: Blood Pressure
time frame: 4 hours after intervention
description: Blood pressure will be measured.
measure: Heart Rate
time frame: baseline
description: Heart Rate will be measured
measure: Heart Rate
time frame: 1 hour after intervention
description: Heart Rate will be measured
measure: Heart Rate
time frame: 2 hours after intervention
description: Heart Rate will be measured
measure: Heart Rate
time frame: 3 hours after intervention
description: Heart Rate will be measured
measure: Heart Rate
time frame: 4 hours after intervention
description: Heart Rate will be measured
arm group label: Nuun Single strength
arm group type: Experimental
description: 3 Nuun electrolyte tablets will be dissolved in 1.4 liters of water. Subjects will drink one liter of the prepared solution over 30 min (250 mL every 7.5 min)
arm group label: Nuun Double strength
arm group type: Experimental
description: 6 Nuun electrolyte tablets will be dissolved in 1.4 liters of water. Subjects will drink one liter of the prepared solution over 30 min (250 mL every 7.5 min)
arm group label: Control
arm group type: Placebo Comparator
description: Subjects will drink one liter of water over 30 min (250 mL every 7.5 min)
intervention type: Dietary Supplement
intervention name: Nuun electrolyte tablet
description: Each table contains 2 grams of carbohydrate and a combination of electrolytes. calcium (13mg, 1%DV), sodium (300mg, 13%DV), potassium (150mg, 3%DV), magnesium (25mg, 6%DV), and chloride (40mg, 2%DV).
arm group label: Nuun Double strength
arm group label: Nuun Single strength
intervention type: Other
intervention name: water
description: water
arm group label: Control
arm group label: Nuun Double strength
arm group label: Nuun Single strength
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Bloomer, PhD
role: Principal Investigator
affiliation: University of Memphis
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Memphis
investigator full name: Richard Bloomer
investigator title: Dean of School of Health Studies
sharing ipd: No