DehydrationREHYDR8NCT06415409
Rehydration Efficiency With Different Sports Drinks
A study testing Water, Gatorade and BodyArmor in people with Dehydration, run by Arizona State University at 1 site in United States.
Trial summary
It is well established that post-exercise rehydration with a carbohydrate-electrolyte solution is better when compared to plain water. However, most of the commercially available drinks today are high in carbohydrates and sodium with low potassium without other active ingredients. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Water, Gatorade and BodyArmor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 12 Jan 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Training > 2x per week
- Age 18-55 y
- stable weight for the last 2 months (<5 lbs. fluctuation)
Who cannot join
- night shifting work
- thyroid medication
- bariatric surgery
- cardiovascular disease
- renal disease
- hepatic disease
- Participating in another study at the same time
- Bodyweight <110 lbs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Interdisciplinary Science and Technology Building 8
Phoenix, Arizona, 85004
About this study
Official title: Rehydration After Exercise With High-electrolyte Sport Drink
It is well established that post-exercise rehydration with a carbohydrate-electrolyte solution is better when compared to plain water. However, most of the commercially available drinks today are high in carbohydrates and sodium with low potassium without other active ingredients. The aim of the present study is to examine the impact of a higher electrolyte sports drink compared with traditional sports drinks and water on the time course and extent of rehydration after exercise-induced dehydration
Read the detailed description
Dehydration:
Based on our previous work, dehydration will be accomplished on the morning of testing via mild exercise and heat exposure to elicit a body weight loss of -2%. The subjects will perform four bouts of 25-min low-intensity exercise and 5 min rest (alternating cycling \& walking) or till they reach -2% of body weight dehydration.
Rehydration:
Following a 20 min rest in thermo-comfortable environment a dehydrated baseline blood sample will be taken, and subject will start the rehydration protocol.
The volunteers will consume one of the four drinks below in a cross over balance mode. During the first hour four equal doses will be consumed in15-min intervals at a total volume of 150% of their body weight loss.
Trials/Drinks (block randomization will be used to assign individual participants to each specific trial/drink using their ID number):
- Water
- GoodSport®
- Gatorade®
- BodyArmor®
Measurements:
All measurements will be performed at one of the test rooms at our lab facility that boarders the room where participants can relax and wait out the end of the study day. When certain measurements need to be performed they simply move from one room to the next. Duration of taking blood and urine samples will take not more than 30-90 seconds each, bioelectrical impedance will take a bit more time to ensure the body is in a stable rested state as a result measurement will be taken in 10 minutes, finally perceptual data will take 30-60 seconds to be reported. To allow to perform all measurements study days will take up to 7 hours. Therefore, there will be a separate space available that allows for self-study or watching TV that includes a chair and table to work on and a couch to relax.
Blood samples (8 per trial, maximal 12 minutes):
A total of eight 10 mL blood samples will be collected on the euhydrated baseline, dehydrated baseline and at 30, 60, 90, 120, 180, and 240 min of the rehydration period.
All samples will be analyzed for glucose, osmolality, total plasma protein, hematocrit, hemoglobin (for plasma volume changes), sodium, potassium, and chloride.
Urine samples (6 per trial, maximal 9 minutes):
Urine samples will be collected using ~900 mL cups at euhydrated baseline, dehydrated baseline and cumulative totals will be collected at 60, 120, 180, and 240 min of the rehydration period. All samples will be analyzed for urine osmolality, specific gravity, volume, sodium, and potassium.
Perceptual Data (6 per trial, maximal 9 minutes):
Thirst, stomach fullness, and taste, assessed via a visual analog scale
- Conditions
- Dehydration
- Being tested
- Water, Gatorade, BodyArmor, GoodSport
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
Plain water
GatoradeOther
Sport Drink Gatorade
BodyArmorOther
Sport Drink BodyArmor
GoodSportOther
Sport Drink GoodSport
| Study group | Role | What they receive |
|---|---|---|
| Water | Placebo comparator | rehydration with Plain water Receives: Other: Water |
| Gatorade | Active comparator | rehydration with Gatorade drink Receives: Other: Gatorade |
| BodyArmor | Active comparator | Rehydration with Body Armor Drink Receives: Other: BodyArmor |
| GoodSport | Experimental | Rehydration with Good Sport drink Receives: Other: GoodSport |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Fluid Balance
Net fluid balance based on body weight changes during the 4 h of the rehydration period
Measured: 3 hours of rehydration
Net Fluid Balance
Net fluid balance based on body weight changes during the 4 h of the rehydration period
Measured: 4 hours of rehydration
Urine volume
cumulative Urine output during the rehydration period
Measured: 3 hours of rehydration
Urine osmotic excretion
Urine osmotic excretion during rehydration
Measured: 3 hours of rehydration
Urine osmotic excretion
Urine osmotic excretion during rehydration
Measured: 4 hours of rehydration
Secondary outcomes (4)
Stomach fullness
Assessed via a Visual Analog scale during rehydration
Measured: 3 hours of rehydration
Stomach fullness
Assessed via a Visual Analog scale during rehydration. Scale is from 0-125mm with higher number indicating greater perception
Measured: 4 hours of rehydration
Thirst
Assessed via a Visual Analog scale during rehydration. Scale is from 0-125mm with higher number indicating greater perception
Measured: 3 hours of rehydration
Thirst
Assessed via a Visual Analog scale during rehydration. Scale is from 0-125mm with higher number indicating greater perception
Measured: 4 hours of rehydration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 May 2023
- Primary completion5 Jan 2024
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized Cross over design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415409
- Sponsor's protocol ID
- FP00034719
- Acronym
- REHYDR8
- Status last verified
- May 2024
- First submitted
- 23 Aug 2023
- Last updated
- 16 May 2024
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehydration After Exercise With High-electrolyte Sport Drink
- ClinicalTrials.gov ID
- NCT06415409
- Acronym / sponsor ID
- REHYDR8 / FP00034719
- Conditions
- Dehydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 16 May 2024 (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.
It is well established that post-exercise rehydration with a carbohydrate-electrolyte solution is better when compared to plain water. However, most of the commercially available drinks today are high in carbohydrates and sodium with low potassium without other active ingredients. The aim of the present study is to examine the impact of a higher electrolyte sports drink compared with traditional sports drinks and water on the time course and extent of rehydration after exercise-induced dehydration
Detailed description
Dehydration:
Based on our previous work, dehydration will be accomplished on the morning of testing via mild exercise and heat exposure to elicit a body weight loss of -2%. The subjects will perform four bouts of 25-min low-intensity exercise and 5 min rest (alternating cycling \& walking) or till they reach -2% of body weight dehydration.
Rehydration:
Following a 20 min rest in thermo-comfortable environment a dehydrated baseline blood sample will be taken, and subject will start the rehydration protocol.
The volunteers will consume one of the four drinks below in a cross over balance mode. During the first hour four equal doses will be consumed in15-min intervals at a total volume of 150% of their body weight loss.
Trials/Drinks (block randomization will be used to assign individual participants to each specific trial/drink using their ID number):
- Water
- GoodSport®
- Gatorade®
- BodyArmor®
Measurements:
All measurements will be performed at one of the test rooms at our lab facility that boarders the room where participants can relax and wait out the end of the study day. When certain measurements need to be performed they simply move from one room to the next. Duration of taking blood and urine samples will take not more than 30-90 seconds each, bioelectrical impedance will take a bit more time to ensure the body is in a stable rested state as a result measurement will be taken in 10 minutes, finally perceptual data will take 30-60 seconds to be reported. To allow to perform all measurements study days will take up to 7 hours. Therefore, there will be a separate space available that allows for self-study or watching TV that includes a chair and table to work on and a couch to relax.
Blood samples (8 per trial, maximal 12 minutes):
A total of eight 10 mL blood samples will be collected on the euhydrated baseline, dehydrated baseline and at 30, 60, 90, 120, 180, and 240 min of the rehydration period.
All samples will be analyzed for glucose, osmolality, total plasma protein, hematocrit, hemoglobin (for plasma volume changes), sodium, potassium, and chloride.
Urine samples (6 per trial, maximal 9 minutes):
Urine samples will be collected using ~900 mL cups at euhydrated baseline, dehydrated baseline and cumulative totals will be collected at 60, 120, 180, and 240 min of the rehydration period. All samples will be analyzed for urine osmolality, specific gravity, volume, sodium, and potassium.
Perceptual Data (6 per trial, maximal 9 minutes):
Thirst, stomach fullness, and taste, assessed via a visual analog scale
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Randomized Cross over design.
| Arm | Type | Receives |
|---|---|---|
| Water | Placebo comparator | Other: Waterrehydration with Plain water |
| Gatorade | Active comparator | Other: Gatoraderehydration with Gatorade drink |
| BodyArmor | Active comparator | Other: BodyArmorRehydration with Body Armor Drink |
| GoodSport | Experimental | Other: GoodSportRehydration with Good Sport drink |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Training > 2x per week
- Age 18-55 y
- stable weight for the last 2 months (<5 lbs. fluctuation)
Key exclusion criteria (8 listed)
- night shifting work
- thyroid medication
- bariatric surgery
- cardiovascular disease
- renal disease
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 |
|---|---|---|
| WaterPlain water | Other | Water |
| GatoradeSport Drink Gatorade | Other | Gatorade |
| BodyArmorSport Drink BodyArmor | Other | BodyArmor |
| GoodSportSport Drink GoodSport | Other | GoodSport |
Primary outcome
Net Fluid Balance
Time frame: 3 hours of rehydration
Net fluid balance based on body weight changes during the 4 h of the rehydration period
Net Fluid Balance
Time frame: 4 hours of rehydration
Net fluid balance based on body weight changes during the 4 h of the rehydration period
Urine volume
Time frame: 3 hours of rehydration
cumulative Urine output during the rehydration period
Urine osmotic excretion
Time frame: 3 hours of rehydration
Urine osmotic excretion during rehydration
Urine osmotic excretion
Time frame: 4 hours of rehydration
Urine osmotic excretion during rehydration
4 secondary outcomes
Stomach fullness
Time frame: 3 hours of rehydration
Stomach fullness
Time frame: 4 hours of rehydration
Thirst
Time frame: 3 hours of rehydration
Thirst
Time frame: 4 hours of rehydration
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 16 May 2024.
- Individual participant dataSharing planned: No
Related trials for Dehydration
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Not yet recruitingPhase 2
Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
Cholera (Disorder)
Recruiting
Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
Obesity & Overweight, Type 2 Diabetes
Recruiting
Hydration & Female Life Stages
Dehydration, Menstruation
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water, Gatorade and BodyArmor in people with Dehydration, run by Arizona State University 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 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 16 May 2024. 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?
Net Fluid Balance (time frame: 3 hours of rehydration). The study lists 5 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 16 May 2024.