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Completed

NCT Number: NCT04422158

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

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.

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Key information

Conditions

Hydration

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nuun electrolyte tablet

Dietary Supplement

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).

Water

Other

water

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Collaborators

  • Nuun & Company, Inc (Nuun)

Registry information

Official study title

Impact of Nuun Electrolyte Tablets on Hydration Status in Active Men and Women: Single-blinded Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 9, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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