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.

Study Overview

• Status: Completed
• Conditions: Hydration
• Intervention / Treatment: Dietary supplement: Nuun Sport Drink; Dietary supplement: Control

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38152
      • Center for Nutraceutical and Dietary Supplement Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate will be measured before and every 10 minutes during the run using a chest strap	baseline
Heart rate	Heart rate will be measured before and every 10 minutes during the run using a chest strap	10 minutes into run
Heart rate	Heart rate will be measured before and every 10 minutes during the run using a chest strap	20 minutes into run
Heart rate	Heart rate will be measured before and every 10 minutes during the run using a chest strap	30 minutes into run
Heart rate	Heart rate will be measured before and every 10 minutes during the run using a chest strap	40 minutes into run
Heart rate	Heart rate will be measured before and every 10 minutes during the run using a chest strap	50 minutes into run
Heart rate	Heart rate will be measured before and every 10 minutes during the run using a chest strap	60 minutes into run
Perceived exertion	Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)	baseline
Perceived exertion	Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)	10 minutes into run
Perceived exertion	Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)	20 minutes into run
Perceived exertion	Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)	30 minutes into run
Perceived exertion	Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)	40 minutes into run
Perceived exertion	Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)	50 minutes into run
Perceived exertion	Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)	60 minutes into run
Specific gravity of urine	Specific gravity will be determined from a urine sample	baseline
Specific gravity of urine	Specific gravity will be determined from a urine sample	15 minutes after run
Plasma Volume	Plasma Volume will be determine via blood sampling and determination of hematocrit and hemoglobin	baseline
Plasma Volume	Plasma Volume will be determine via blood sampling and determination of hematocrit and hemoglobin	5 minutes after run
Body Mass	Body Mass will be measured	baseline
Body Mass	Body Mass will be measured	5 minutes after run
Body Mass	Body Mass will be measured	15 minutes post-run after urine collection
Urine output (mass)	Urine mass will be determine following collection	15 minutes post-run
Urine output (volume)	Urine volume will be determine following collection	15 minutes post-run

Collaborators and Investigators

• Sponsor: University of Memphis
• Collaborators: Nuun & Company

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Actual): May 10, 2022
• Study Completion (Actual): May 10, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Running; Electrolyte; Nuun
• Other Study ID Numbers: PRO-FY2021-417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No