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

Sponsor
University of Memphis (Other)
Overall Status
Completed
CT.gov ID
NCT05510791
Collaborator
Nuun & Company (Other)
20
1
2
3.6
5.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Nuun Sport Drink
  • Dietary Supplement: Control
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
randomized, cross-over trial with water control.randomized, cross-over trial with water control.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Impact of Nuun SPORT on Subjective Exercise Performance in Male and Female Runners
Actual Study Start Date :
Jan 19, 2022
Actual Primary Completion Date :
May 10, 2022
Actual Study Completion Date :
May 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nuun Sport

Citric Acid, Dextrose, Sodium Carbonate, Potassium Bicarbonate, Sodium Bicarbonate, Natural Flavors, Potassium Chloride, Magnesium Oxide, Calcium Carbonate, Stevia Leaf Extract, Avocado Oil, Riboflavin (for color).

Dietary Supplement: Nuun Sport Drink
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.

Sham Comparator: Control

Water

Dietary Supplement: Control
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.

Outcome Measures

Primary Outcome Measures

  1. Heart rate [baseline]

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

  2. Heart rate [10 minutes into run]

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

  3. Heart rate [20 minutes into run]

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

  4. Heart rate [30 minutes into run]

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

  5. Heart rate [40 minutes into run]

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

  6. Heart rate [50 minutes into run]

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

  7. Heart rate [60 minutes into run]

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

  8. Perceived exertion [baseline]

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

  9. Perceived exertion [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 [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 [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 [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 [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 [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 [baseline]

    Specific gravity will be determined from a urine sample

  16. Specific gravity of urine [15 minutes after run]

    Specific gravity will be determined from a urine sample

  17. Plasma Volume [baseline]

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

  18. Plasma Volume [5 minutes after run]

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

  19. Body Mass [baseline]

    Body Mass will be measured

  20. Body Mass [5 minutes after run]

    Body Mass will be measured

  21. Body Mass [15 minutes post-run after urine collection]

    Body Mass will be measured

  22. Urine output (mass) [15 minutes post-run]

    Urine mass will be determine following collection

  23. Urine output (volume) [15 minutes post-run]

    Urine volume will be determine following collection

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Nutraceutical and Dietary Supplement Research Memphis Tennessee United States 38152

Sponsors and Collaborators

  • University of Memphis
  • Nuun & Company

Investigators

  • Principal Investigator: Richard Bloomer, PhD, University of Memphis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Richard Bloomer, Dean of the College of Health Sciences, University of Memphis
ClinicalTrials.gov Identifier:
NCT05510791
Other Study ID Numbers:
  • PRO-FY2021-417
First Posted:
Aug 22, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Richard Bloomer, Dean of the College of Health Sciences, University of Memphis

Study Results

No Results Posted as of Aug 22, 2022