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Completed

NCT Number: NCT05510791

Impact of Nuun SPORT on Subjective Exercise Performance in Male and Female Runners

The study will examine the impact of the Nuun Sport tablets, as compared to water only, on heart rate, perceived exertion, and related outcomes in male and female runners, during and following the performance of a 60-minute treadmill run.

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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

As discussed in our prior applications (protocol FY2020-327 and FY2021-96), maintaining adequate hydration is essential to optimal health (Perrier, 2017), as well as athletic performance (Nuccio et al., 2017). 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. (Kenefick, 2018)

Many attempts have been made to improve and measure the hydration status of active individuals (Love et al., 2018). 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).

During aerobic exercise, the shift in fluid (intake versus losses) can affect electrolyte balance, with dehydration and potential adverse effects on performance and health (Perrier et al., 2021; Armstrong et al. 2021). A better understanding of rehydration methods and resultant efficacy would permit selection by an athlete of the optimal method for preventing dehydration to optimize physical performance and reduce potential deleterious effects.

It is well-accepted that electrolyte replenishment is of importance, both during and following exercise-to aid in rehydration for subsequent bouts. Electrolytes (sodium in particular) have been used for decades to aid athlete hydration and this has led to the development of various sport drinks-which also include small amounts of carbohydrate (e.g., Gatorade, Powerade).

The present study will examine the impact of the Nuun Sport tablets, as compared to water only, on heart rate, perceived exertion, and related outcomes: changes in body mass, changes in plasma volume, post-exercise urine volume, and changes in urine specific gravity in male and female runners, during and/or following the performance of a 60-minute treadmill run.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • body mass index (BMI) between 18-29.9 kg/m2 (not obese)
  • be able to fast overnight (>8 hrs)
  • consuming a minimum of two liters of water per day, on a regular basis
  • distance runners: run ≥ 15 miles/week, ≥ 3 runs/week, for at least the past 6 months
  • have completed a run of 60 minutes or more at least once per month for the past 6 months
  • normal resting blood pressure (systolic < 140 mmHg, diastolic < 90 mmHg) and heart rate (40-80bpm)
  • a negative verbal pre-study drug screen (alcohol abuse, amphetamines, benzodiazepines, cocaine, opioids, phencyclidine, barbiturates, cotinine) and no history of use of illicit drugs or other substances of abuse within 12 months of the screening visit

Exclusion criteria

  • tobacco user
  • if female, pregnant
  • history of known cardiovascular disease
  • more than 400mg caffeine intake per day
  • self-reported active infection or illness of any kind
  • consumption of alcohol-containing beverages within 48 hours of testing
  • consumption of caffeine-containing beverages within 48 hours of testing
  • strenuous exercise within 48 hours of testing

Treatment and study plan

Nuun Sport Drink

Dietary Supplement

Subjects will consume a total of 24 ounces water and 1.5 tablets of Nuun SPORT. Specifically, subjects will drink 12 ounces of Nuun drink 15 minutes prior to the 60 min run and 4 ounces of Nuun drink at 15 min, 30 min, and 45 min during the run.

Control

Dietary Supplement

Subjects will consume a total of 24 ounces water. Specifically, subjects will drink 12 ounces of water 15 minutes prior to the 60 min run and 4 ounces of water at 15 min, 30 min, and 45 min during the run.

Primary outcomes

  1. Heart rate

    Time frame: baseline

    Heart rate will be measured before and every 10 minutes during the run using a chest strap

  2. Heart rate

    Time frame: 10 minutes into run

    Heart rate will be measured before and every 10 minutes during the run using a chest strap

  3. Heart rate

    Time frame: 20 minutes into run

    Heart rate will be measured before and every 10 minutes during the run using a chest strap

  4. Heart rate

    Time frame: 30 minutes into run

    Heart rate will be measured before and every 10 minutes during the run using a chest strap

  5. Heart rate

    Time frame: 40 minutes into run

    Heart rate will be measured before and every 10 minutes during the run using a chest strap

  6. Heart rate

    Time frame: 50 minutes into run

    Heart rate will be measured before and every 10 minutes during the run using a chest strap

  7. Heart rate

    Time frame: 60 minutes into run

    Heart rate will be measured before and every 10 minutes during the run using a chest strap

  8. Perceived exertion

    Time frame: baseline

    Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)

  9. Perceived exertion

    Time frame: 10 minutes into run

    Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)

  10. Perceived exertion

    Time frame: 20 minutes into run

    Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)

  11. Perceived exertion

    Time frame: 30 minutes into run

    Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)

  12. Perceived exertion

    Time frame: 40 minutes into run

    Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)

  13. Perceived exertion

    Time frame: 50 minutes into run

    Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)

  14. Perceived exertion

    Time frame: 60 minutes into run

    Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)

  15. Specific gravity of urine

    Time frame: baseline

    Specific gravity will be determined from a urine sample

  16. Specific gravity of urine

    Time frame: 15 minutes after run

    Specific gravity will be determined from a urine sample

  17. Plasma Volume

    Time frame: baseline

    Plasma Volume will be determine via blood sampling and determination of hematocrit and hemoglobin

  18. Plasma Volume

    Time frame: 5 minutes after run

    Plasma Volume will be determine via blood sampling and determination of hematocrit and hemoglobin

  19. Body Mass

    Time frame: baseline

    Body Mass will be measured

  20. Body Mass

    Time frame: 5 minutes after run

    Body Mass will be measured

  21. Body Mass

    Time frame: 15 minutes post-run after urine collection

    Body Mass will be measured

  22. Urine output (mass)

    Time frame: 15 minutes post-run

    Urine mass will be determine following collection

  23. Urine output (volume)

    Time frame: 15 minutes post-run

    Urine volume will be determine following collection

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Collaborators

  • Nuun & Company

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 22, 2022
Registry last updated
Aug 22, 2022

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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