HydrationNCT05510791
Impact of Nuun SPORT on Subjective Exercise Performance in Male and Female Runners
A study testing Nuun Sport Drink in people with Hydration, run by University of Memphis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration
- What is being tested?
- Nuun Sport Drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2022to 10 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38152
About this study
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.
Read the 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.
- Conditions
- Hydration
- Being tested
- Nuun Sport Drink, Control
- Keywords
- Electrolyte, Running, Nuun
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuun Sport DrinkDietary 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.
ControlDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Nuun Sport | Experimental | 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). Receives: Dietary Supplement: Nuun Sport Drink |
| Control | Sham comparator | Water Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate will be measured before and every 10 minutes during the run using a chest strap
Measured: baseline
Heart rate
Heart rate will be measured before and every 10 minutes during the run using a chest strap
Measured: 10 minutes into run
Heart rate
Heart rate will be measured before and every 10 minutes during the run using a chest strap
Measured: 20 minutes into run
Heart rate
Heart rate will be measured before and every 10 minutes during the run using a chest strap
Measured: 30 minutes into run
Heart rate
Heart rate will be measured before and every 10 minutes during the run using a chest strap
Measured: 40 minutes into run
Heart rate
Heart rate will be measured before and every 10 minutes during the run using a chest strap
Measured: 50 minutes into run
Heart rate
Heart rate will be measured before and every 10 minutes during the run using a chest strap
Measured: 60 minutes into run
Perceived exertion
Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)
Measured: baseline
Perceived exertion
Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)
Measured: 10 minutes into run
Perceived exertion
Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)
Measured: 20 minutes into run
Perceived exertion
Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)
Measured: 30 minutes into run
Perceived exertion
Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)
Measured: 40 minutes into run
Perceived exertion
Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)
Measured: 50 minutes into run
Perceived exertion
Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)
Measured: 60 minutes into run
Specific gravity of urine
Specific gravity will be determined from a urine sample
Measured: baseline
Specific gravity of urine
Specific gravity will be determined from a urine sample
Measured: 15 minutes after run
Plasma Volume
Plasma Volume will be determine via blood sampling and determination of hematocrit and hemoglobin
Measured: baseline
Plasma Volume
Plasma Volume will be determine via blood sampling and determination of hematocrit and hemoglobin
Measured: 5 minutes after run
Body Mass
Body Mass will be measured
Measured: baseline
Body Mass
Body Mass will be measured
Measured: 5 minutes after run
Body Mass
Body Mass will be measured
Measured: 15 minutes post-run after urine collection
Urine output (mass)
Urine mass will be determine following collection
Measured: 15 minutes post-run
Urine output (volume)
Urine volume will be determine following collection
Measured: 15 minutes post-run
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start19 Jan 2022
- Primary completion10 May 2022
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, cross-over trial with water control.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- Nuun & Company
- Responsible party
- Principal investigator, Richard Bloomer, University of Memphis
- Investigators
- Richard Bloomer, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510791
- Sponsor's protocol ID
- PRO-FY2021-417
- Status last verified
- Aug 2022
- First submitted
- 8 Dec 2021
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nuun SPORT on Subjective Exercise Performance in Male and Female Runners
- ClinicalTrials.gov ID
- NCT05510791
- Acronym / sponsor ID
- PRO-FY2021-417
- Conditions
- Hydration
- Keywords
- Electrolyte, Running, Nuun
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- Nuun & Company
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, cross-over trial with water control.
| Arm | Type | Receives |
|---|---|---|
| Nuun Sport | Experimental | Dietary Supplement: Nuun Sport DrinkCitric Acid, Dextrose, Sodium Carbonate, Potassium Bicarbonate, Sodium Bicarbonate, Natural Flavors, Potassium Chloride, Magnesium Oxide, Calcium Carbonate, Stevia Leaf Extract, Avocado Oil, Riboflavin (for color). |
| Control | Sham comparator | Dietary Supplement: ControlWater |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuun Sport DrinkSubjects 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. | Dietary supplement | Nuun Sport |
| ControlSubjects 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. | Dietary supplement | Control |
Primary outcome
Heart rate
Time frame: baseline
Heart rate will be measured before and every 10 minutes during the run using a chest strap
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
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
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
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
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
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
Perceived exertion
Time frame: baseline
Subjects will self-report perceived exertion using a scale from 0 (no exertion) to 10 (the most exertion)
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)
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)
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)
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)
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)
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)
Specific gravity of urine
Time frame: baseline
Specific gravity will be determined from a urine sample
Specific gravity of urine
Time frame: 15 minutes after run
Specific gravity will be determined from a urine sample
Plasma Volume
Time frame: baseline
Plasma Volume will be determine via blood sampling and determination of hematocrit and hemoglobin
Plasma Volume
Time frame: 5 minutes after run
Plasma Volume will be determine via blood sampling and determination of hematocrit and hemoglobin
Body Mass
Time frame: baseline
Body Mass will be measured
Body Mass
Time frame: 5 minutes after run
Body Mass will be measured
Body Mass
Time frame: 15 minutes post-run after urine collection
Body Mass will be measured
Urine output (mass)
Time frame: 15 minutes post-run
Urine mass will be determine following collection
Urine output (volume)
Time frame: 15 minutes post-run
Urine volume will be determine following collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Bloomer, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nuun Sport Drink in people with Hydration, run by University of Memphis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: baseline). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.