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Impact of Nuun Electrolyte Tablets on Hydration Status in Active Men and Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04422158
Recruitment Status : Completed
First Posted : June 9, 2020
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
Nuun & Company, Inc (Nuun)
Information provided by (Responsible Party):
Richard Bloomer, University of Memphis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hydration Dietary Supplement: Nuun electrolyte tablet Other: water Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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.
Masking: Single (Participant)
Masking Description: Drinks will be prepared without subjects aware of which drink they are receiving.
Primary Purpose: Basic Science
Official Title: Impact of Nuun Electrolyte Tablets on Hydration Status in Active Men and Women: Single-blinded Study
Actual Study Start Date : June 3, 2020
Actual Primary Completion Date : August 18, 2020
Actual Study Completion Date : August 18, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nuun Single strength
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)
Dietary Supplement: Nuun electrolyte tablet
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).

Other: water
water

Experimental: Nuun Double strength
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)
Dietary Supplement: Nuun electrolyte tablet
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).

Other: water
water

Placebo Comparator: Control
Subjects will drink one liter of water over 30 min (250 mL every 7.5 min)
Other: water
water




Primary Outcome Measures :
  1. Body weight [ Time Frame: baseline ]
    Body weight will be measured

  2. Body weight [ Time Frame: 4 hours after drink consumption ]
    Body weight will be measured

  3. Urine volume [ Time Frame: Immediately after completing intervention ]
    Volume of urine output will be measured

  4. Urine volume [ Time Frame: 1 hour after intervention ]
    Volume of urine output will be measured

  5. Urine volume [ Time Frame: 2 hours after intervention ]
    Volume of urine output will be measured

  6. Urine volume [ Time Frame: 3 hours after intervention ]
    Volume of urine output will be measured

  7. Urine volume [ Time Frame: 4 hours after intervention ]
    Volume of urine output will be measured

  8. Urine mass [ Time Frame: Immediately after completing intervention ]
    Urine output will be measured using a scale

  9. Urine mass [ Time Frame: 1 hour after intervention ]
    Urine output will be measured using a scale

  10. Urine mass [ Time Frame: 2 hours after intervention ]
    Urine output will be measured using a scale

  11. Urine mass [ Time Frame: 3 hours after intervention ]
    Urine output will be measured using a scale

  12. Urine mass [ Time Frame: 4 hours after intervention ]
    Urine output will be measured using a scale

  13. Blood Pressure [ Time Frame: at baseline ]
    Blood pressure will be measured.

  14. Blood Pressure [ Time Frame: 1 hour after intervention ]
    Blood pressure will be measured.

  15. Blood Pressure [ Time Frame: 2 hours after intervention ]
    Blood pressure will be measured.

  16. Blood Pressure [ Time Frame: 3 hours after intervention ]
    Blood pressure will be measured.

  17. Blood Pressure [ Time Frame: 4 hours after intervention ]
    Blood pressure will be measured.

  18. Heart Rate [ Time Frame: baseline ]
    Heart Rate will be measured

  19. Heart Rate [ Time Frame: 1 hour after intervention ]
    Heart Rate will be measured

  20. Heart Rate [ Time Frame: 2 hours after intervention ]
    Heart Rate will be measured

  21. Heart Rate [ Time Frame: 3 hours after intervention ]
    Heart Rate will be measured

  22. Heart Rate [ Time Frame: 4 hours after intervention ]
    Heart Rate will be measured



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI between 18.5 and 29.9 kg/m2 (not obese)
  • Consumes 2 liters of water daily
  • Exercised 3 hours/week over the past 6 months

Exclusion Criteria:

  • Obese
  • Pregnant or trying to become pregnant
  • Tobacco user
  • Cardiac Disease
  • Consumed alcohol within 48 hours of testing visit
  • Consumed caffeine within 48 hours of testing visit
  • Strenuous excercise 24 hours prior to testing visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422158


Locations
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United States, Tennessee
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, United States, 38152
Sponsors and Collaborators
University of Memphis
Nuun & Company, Inc (Nuun)
Investigators
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Principal Investigator: Richard Bloomer, PhD University of Memphis
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Responsible Party: Richard Bloomer, Dean of School of Health Studies, University of Memphis
ClinicalTrials.gov Identifier: NCT04422158    
Other Study ID Numbers: PRO-FY2020-327
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Bloomer, University of Memphis:
electrolyte