HydrationNCT04422158
Impact of Nuun Electrolyte Tablets on Hydration Status in Active Men and Women
A study testing Nuun electrolyte tablet and water in people with Hydration, run by University of Memphis at 1 site in United States.
Trial summary
The purpose of this study is to determine the impact of Nuun electrolyte tablets on hydration status in young and active men and women. We will follow a similar approach as used by Maughan and colleagues (2016) to measure the beverage hydration index (the relative amount of urine passed after consumption of a drink… 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 electrolyte tablet and water
- 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
- 3 Jun 2020to 18 Aug 2020
- 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
- BMI between 18.5 and 29.9 kg/m2 (not obese)
- Consumes 2 liters of water daily
- Exercised 3 hours/week over the past 6 months
Who cannot join
- Obese
- Pregnant or trying to become pregnant
- Tobacco user
- Cardiac Disease
- Consumed alcohol within 48 hours of testing visit
- Consumed caffeine within 48 hours of testing visit
- Strenuous excercise 24 hours prior to testing visit
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
Official title: Impact of Nuun Electrolyte Tablets on Hydration Status in Active Men and Women: Single-blinded Study
The purpose of this study is to determine the impact of Nuun electrolyte tablets on hydration status in young and active men and women. We will follow a similar approach as used by Maughan and colleagues (2016) to measure the beverage hydration index (the relative amount of urine passed after consumption of a drink compared to water). It is hypothesized that Nuun electrolyte tablets will result in a greater hydration status as compared to water only. Due to the fact that athletes use Nuun tablets at varying dosages, we will evaluate Nuun at both a single dosage and a double dosage. We maintain a non-directional hypothesis regarding the potential differences between the two different dosages tested.
Read the detailed description
Maintaining adequate hydration is essential to optimal health and athletic performance. 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.
Many attempts have been made to improve and measure the hydration status of active individuals. 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). This approach seems to work well; however, some debate remains over what the best fluid is to consume, in particular related to the macronutrient type and the specific electrolyte mix.
Related to the above, it is well-accepted that electrolyte replenishment is of importance, both during and following exercise-to aid in rehydration for subsequent bouts. The use of electrolytes (sodium in particular) has been used for decades to aid athlete hydration and has led to the development of various sport drinks-which also include small amounts of carbohydrate. However, one problem with carbohydrate ingestion is that some individuals experience gastrointestinal (GI) upset following carbohydrate ingestion before and during an event, despite very good physical performance outcomes. Due to this GI upset, some individuals (in particular recreationally active individuals who are not competing at high levels) rely solely on water and seek a method to ingest the lost electrolytes. In addition, some individuals prefer to have both plain water and an electrolyte beverage during their training/competition sessions and in some activities (e.g., running, cycling), carrying multiple bottles of fluid is difficult.
The solution to the above issues for many athletes is the use of electrolyte tablets. These can be dropped into plain water and will dissolve into a flavored electrolyte-rich beverage. They are easy to transport and provide the needed electrolytes to replace those that are lost through intense and/or long duration exercise.
Nuun electrolyte tablets provide only 2 grams of carbohydrate and a combination of electrolytes, provided at a relatively low percentage of the Daily Value (DV). The DV tells us how much a particular nutrient in a serving of a food product contributes to a daily diet, based on a standard 2000 calorie diet. Nuun tablets contain: calcium (13mg, 1%DV), sodium (300mg, 13%DV), potassium (150mg, 3%DV), magnesium (25mg, 6%DV), and chloride (40mg, 2%DV). These tablets contain a small percentage of the needed total electrolytes but adequate amounts to replace lost electrolytes as a result of physical activity.
While Nuun tablets are commercially available and have received positive reviews from end users, there have been no studies to date to evaluate the impact of these tablets on hydration status. Therefore, the purpose of this study is to determine the impact of Nuun electrolyte tablets on hydration status in young and active men and women. We will follow a similar approach as used by Maughan and colleagues to measure the beverage hydration index (the relative amount of urine passed after consumption of a drink compared to water). It is hypothesized that Nuun electrolyte tablets will result in a greater hydration status as compared to water only. Due to the fact that athletes use Nuun tablets at varying dosages, we will evaluate Nuun at both a single dosage and a double dosage. We maintain a non-directional hypothesis regarding the potential differences between the two different dosages tested.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuun electrolyte tabletDietary supplement
Each table contains 2 grams of carbohydrate and a combination of electrolytes. calcium (13mg, 1%DV), sodium (300mg, 13%DV), potassium (150mg, 3%DV), magnesium (25mg, 6%DV), and chloride (40mg, 2%DV).
waterOther
water
| Study group | Role | What they receive |
|---|---|---|
| Nuun Single strength | Experimental | 3 Nuun electrolyte tablets will be dissolved in 1.4 liters of water. Subjects will drink one liter of the prepared solution over 30 min (250 mL every 7.5 min) Receives: Dietary Supplement: Nuun electrolyte tablet; Other: water |
| Nuun Double strength | Experimental | 6 Nuun electrolyte tablets will be dissolved in 1.4 liters of water. Subjects will drink one liter of the prepared solution over 30 min (250 mL every 7.5 min) Receives: Dietary Supplement: Nuun electrolyte tablet; Other: water |
| Control | Placebo comparator | Subjects will drink one liter of water over 30 min (250 mL every 7.5 min) Receives: Other: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight will be measured
Measured: baseline
Body weight
Body weight will be measured
Measured: 4 hours after drink consumption
Urine volume
Volume of urine output will be measured
Measured: Immediately after completing intervention
Urine volume
Volume of urine output will be measured
Measured: 1 hour after intervention
Urine volume
Volume of urine output will be measured
Measured: 2 hours after intervention
Urine volume
Volume of urine output will be measured
Measured: 3 hours after intervention
Urine volume
Volume of urine output will be measured
Measured: 4 hours after intervention
Urine mass
Urine output will be measured using a scale
Measured: Immediately after completing intervention
Urine mass
Urine output will be measured using a scale
Measured: 1 hour after intervention
Urine mass
Urine output will be measured using a scale
Measured: 2 hours after intervention
Urine mass
Urine output will be measured using a scale
Measured: 3 hours after intervention
Urine mass
Urine output will be measured using a scale
Measured: 4 hours after intervention
Blood Pressure
Blood pressure will be measured.
Measured: at baseline
Blood Pressure
Blood pressure will be measured.
Measured: 1 hour after intervention
Blood Pressure
Blood pressure will be measured.
Measured: 2 hours after intervention
Blood Pressure
Blood pressure will be measured.
Measured: 3 hours after intervention
Blood Pressure
Blood pressure will be measured.
Measured: 4 hours after intervention
Heart Rate
Heart Rate will be measured
Measured: baseline
Heart Rate
Heart Rate will be measured
Measured: 1 hour after intervention
Heart Rate
Heart Rate will be measured
Measured: 2 hours after intervention
Heart Rate
Heart Rate will be measured
Measured: 3 hours after intervention
Heart Rate
Heart Rate will be measured
Measured: 4 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start3 Jun 2020
- Primary completion18 Aug 2020
- Study completion18 Aug 2020
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, single-blind, placebo-controlled, cross-over with non-directional hypothesis regarding the potential differences between the two different dosages tested.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- Nuun & Company, Inc (Nuun)
- 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
- NCT04422158
- Sponsor's protocol ID
- PRO-FY2020-327
- Status last verified
- Apr 2021
- First submitted
- 4 Jun 2020
- Last updated
- 28 Apr 2021
- 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 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nuun Electrolyte Tablets on Hydration Status in Active Men and Women: Single-blinded Study
- ClinicalTrials.gov ID
- NCT04422158
- Acronym / sponsor ID
- PRO-FY2020-327
- Conditions
- Hydration
- Keywords
- electrolyte
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- Nuun & Company, Inc (Nuun)
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 9 Jun 2020 (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 purpose of this study is to determine the impact of Nuun electrolyte tablets on hydration status in young and active men and women. We will follow a similar approach as used by Maughan and colleagues (2016) to measure the beverage hydration index (the relative amount of urine passed after consumption of a drink compared to water). It is hypothesized that Nuun electrolyte tablets will result in a greater hydration status as compared to water only. Due to the fact that athletes use Nuun tablets at varying dosages, we will evaluate Nuun at both a single dosage and a double dosage. We maintain a non-directional hypothesis regarding the potential differences between the two different dosages tested.
Detailed description
Maintaining adequate hydration is essential to optimal health and athletic performance. 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.
Many attempts have been made to improve and measure the hydration status of active individuals. 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). This approach seems to work well; however, some debate remains over what the best fluid is to consume, in particular related to the macronutrient type and the specific electrolyte mix.
Related to the above, it is well-accepted that electrolyte replenishment is of importance, both during and following exercise-to aid in rehydration for subsequent bouts. The use of electrolytes (sodium in particular) has been used for decades to aid athlete hydration and has led to the development of various sport drinks-which also include small amounts of carbohydrate. However, one problem with carbohydrate ingestion is that some individuals experience gastrointestinal (GI) upset following carbohydrate ingestion before and during an event, despite very good physical performance outcomes. Due to this GI upset, some individuals (in particular recreationally active individuals who are not competing at high levels) rely solely on water and seek a method to ingest the lost electrolytes. In addition, some individuals prefer to have both plain water and an electrolyte beverage during their training/competition sessions and in some activities (e.g., running, cycling), carrying multiple bottles of fluid is difficult.
The solution to the above issues for many athletes is the use of electrolyte tablets. These can be dropped into plain water and will dissolve into a flavored electrolyte-rich beverage. They are easy to transport and provide the needed electrolytes to replace those that are lost through intense and/or long duration exercise.
Nuun electrolyte tablets provide only 2 grams of carbohydrate and a combination of electrolytes, provided at a relatively low percentage of the Daily Value (DV). The DV tells us how much a particular nutrient in a serving of a food product contributes to a daily diet, based on a standard 2000 calorie diet. Nuun tablets contain: calcium (13mg, 1%DV), sodium (300mg, 13%DV), potassium (150mg, 3%DV), magnesium (25mg, 6%DV), and chloride (40mg, 2%DV). These tablets contain a small percentage of the needed total electrolytes but adequate amounts to replace lost electrolytes as a result of physical activity.
While Nuun tablets are commercially available and have received positive reviews from end users, there have been no studies to date to evaluate the impact of these tablets on hydration status. Therefore, the purpose of this study is to determine the impact of Nuun electrolyte tablets on hydration status in young and active men and women. We will follow a similar approach as used by Maughan and colleagues to measure the beverage hydration index (the relative amount of urine passed after consumption of a drink compared to water). It is hypothesized that Nuun electrolyte tablets will result in a greater hydration status as compared to water only. Due to the fact that athletes use Nuun tablets at varying dosages, we will evaluate Nuun at both a single dosage and a double dosage. We maintain a non-directional hypothesis regarding the potential differences between the two different dosages tested.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized, single-blind, placebo-controlled, cross-over with non-directional hypothesis regarding the potential differences between the two different dosages tested.
| Arm | Type | Receives |
|---|---|---|
| Nuun Single strength | Experimental | Dietary Supplement: Nuun electrolyte tablet, Other: water3 Nuun electrolyte tablets will be dissolved in 1.4 liters of water. Subjects will drink one liter of the prepared solution over 30 min (250 mL every 7.5 min) |
| Nuun Double strength | Experimental | Dietary Supplement: Nuun electrolyte tablet, Other: water6 Nuun electrolyte tablets will be dissolved in 1.4 liters of water. Subjects will drink one liter of the prepared solution over 30 min (250 mL every 7.5 min) |
| Control | Placebo comparator | Other: waterSubjects will drink one liter of water over 30 min (250 mL every 7.5 min) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI between 18.5 and 29.9 kg/m2 (not obese)
- Consumes 2 liters of water daily
- Exercised 3 hours/week over the past 6 months
Key exclusion criteria (7 listed)
- Obese
- Pregnant or trying to become pregnant
- Tobacco user
- Cardiac Disease
- Consumed alcohol within 48 hours of testing visit
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 electrolyte tabletEach table contains 2 grams of carbohydrate and a combination of electrolytes. calcium (13mg, 1%DV), sodium (300mg, 13%DV), potassium (150mg, 3%DV), magnesium (25mg, 6%DV), and chloride (40mg, 2%DV). | Dietary supplement | Nuun Double strength, Nuun Single strength |
| waterwater | Other | Control, Nuun Double strength, Nuun Single strength |
Primary outcome
Body weight
Time frame: baseline
Body weight will be measured
Body weight
Time frame: 4 hours after drink consumption
Body weight will be measured
Urine volume
Time frame: Immediately after completing intervention
Volume of urine output will be measured
Urine volume
Time frame: 1 hour after intervention
Volume of urine output will be measured
Urine volume
Time frame: 2 hours after intervention
Volume of urine output will be measured
Urine volume
Time frame: 3 hours after intervention
Volume of urine output will be measured
Urine volume
Time frame: 4 hours after intervention
Volume of urine output will be measured
Urine mass
Time frame: Immediately after completing intervention
Urine output will be measured using a scale
Urine mass
Time frame: 1 hour after intervention
Urine output will be measured using a scale
Urine mass
Time frame: 2 hours after intervention
Urine output will be measured using a scale
Urine mass
Time frame: 3 hours after intervention
Urine output will be measured using a scale
Urine mass
Time frame: 4 hours after intervention
Urine output will be measured using a scale
Blood Pressure
Time frame: at baseline
Blood pressure will be measured.
Blood Pressure
Time frame: 1 hour after intervention
Blood pressure will be measured.
Blood Pressure
Time frame: 2 hours after intervention
Blood pressure will be measured.
Blood Pressure
Time frame: 3 hours after intervention
Blood pressure will be measured.
Blood Pressure
Time frame: 4 hours after intervention
Blood pressure will be measured.
Heart Rate
Time frame: baseline
Heart Rate will be measured
Heart Rate
Time frame: 1 hour after intervention
Heart Rate will be measured
Heart Rate
Time frame: 2 hours after intervention
Heart Rate will be measured
Heart Rate
Time frame: 3 hours after intervention
Heart Rate will be measured
Heart Rate
Time frame: 4 hours after intervention
Heart Rate will be measured
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 28 Apr 2021.
- 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 electrolyte tablet and water 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 3 inclusion and 7 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 28 Apr 2021. 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?
Body weight (time frame: baseline). The study lists 22 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 28 Apr 2021.