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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hydration

Intervention / Treatment
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* Dietary Supplement: Nuun Sport Drink
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: randomized, cross-over trial with water control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nuun Sport<br>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<br>* 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.<br>|
| Sham Comparator: Control<br>Water | Dietary Supplement: Control<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrolyte, Running, Nuun