Dehydration (Physiology)NCT04613856
Water Bolus Volumes During Continuous Exercise in Heat
A study testing Hydration protocol - 237 mL water bolus and Hydration protocol - 500 mL water bolus in people with Dehydration (Physiology) and Hyperthermia, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
Hydration is important to all individuals including occupational workers who complete physical activity in the heat. Current best practice guidelines suggest drinking a cup of water every 15-20 minutes during activity in a hot environment, but research shows this may not be ideal for best maintaining hydration. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dehydration (Physiology), Hyperthermia
- What is being tested?
- Hydration protocol - 237 mL water bolus and Hydration protocol - 500 mL water bolus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2019to 12 Mar 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 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 18-39 y old
- Self-reported to be healthy
Who cannot join
- Female
- Not within defined age range
- History of any cardiovascular, neurologic, or metabolic disease
- Current tobacco use or regular use within the last 2 years.
- Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
- Inability to follow the rules of the protocols or understand the consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Research and Exercise in Special Environments
Buffalo, New York, 14214
About this study
Hydration is important to all individuals including occupational workers who complete physical activity in the heat. Current best practice guidelines suggest drinking a cup of water every 15-20 minutes during activity in a hot environment, but research shows this may not be ideal for best maintaining hydration. The goal of this study is to determine if larger, more frequent water boluses better maintain hydration than smaller, less frequent water boluses during moderate intensity physical activity in the heat.
- Conditions
- Dehydration (Physiology), Hyperthermia
- Being tested
- Hydration protocol - 237 mL water bolus, Hydration protocol - 500 mL water bolus
- Medical subject headings
- Dehydration, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydration protocol - 237 mL water bolusOther
Subjects consume 237 mL of water every 20 minutes during 2 hours of high intensity work in the heat.
Hydration protocol - 500 mL water bolusOther
Subjects consume 500 mL of water every 40 minutes during 2 hours of high intensity work in the heat.
| Study group | Role | What they receive |
|---|---|---|
| Current Best Practice - 237 mL water bolus | Active comparator | Not described Receives: Other: Hydration protocol - 237 mL water bolus |
| New Intervention - 500 mL water bolus | Experimental | Not described Receives: Other: Hydration protocol - 500 mL water bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent body mass loss
Percent body mass loss after water intake
Measured: 2 hours
Core temperature
Core temperature after water intake
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start17 Apr 2019
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dehydration (Physiology)Studies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, counterbalanced, crossover study
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riana Pryor, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613856
- Sponsor's protocol ID
- STUDY00003387
- Status last verified
- Oct 2020
- First submitted
- 30 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data can be provided upon written request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water Bolus Volumes During Continuous Exercise in Heat
- ClinicalTrials.gov ID
- NCT04613856
- Acronym / sponsor ID
- STUDY00003387
- Conditions
- Dehydration (Physiology), Hyperthermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 3 Nov 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.
Hydration is important to all individuals including occupational workers who complete physical activity in the heat. Current best practice guidelines suggest drinking a cup of water every 15-20 minutes during activity in a hot environment, but research shows this may not be ideal for best maintaining hydration. The goal of this study is to determine if larger, more frequent water boluses better maintain hydration than smaller, less frequent water boluses during moderate intensity physical activity in the heat.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, counterbalanced, crossover study
| Arm | Type | Receives |
|---|---|---|
| Current Best Practice - 237 mL water bolus | Active comparator | Other: Hydration protocol - 237 mL water bolus |
| New Intervention - 500 mL water bolus | Experimental | Other: Hydration protocol - 500 mL water bolus |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- 18-39 y old
- Self-reported to be healthy
Key exclusion criteria (6 listed)
- Female
- Not within defined age range
- History of any cardiovascular, neurologic, or metabolic disease
- Current tobacco use or regular use within the last 2 years.
- Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
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 |
|---|---|---|
| Hydration protocol - 237 mL water bolusSubjects consume 237 mL of water every 20 minutes during 2 hours of high intensity work in the heat. | Other | Current Best Practice - 237 mL water bolus |
| Hydration protocol - 500 mL water bolusSubjects consume 500 mL of water every 40 minutes during 2 hours of high intensity work in the heat. | Other | New Intervention - 500 mL water bolus |
Primary outcome
Percent body mass loss
Time frame: 2 hours
Percent body mass loss after water intake
Core temperature
Time frame: 2 hours
Core temperature after water intake
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 3 Nov 2020.
- Individual participant dataSharing planned: No. IPD data can be provided upon written request.
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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.
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 Hydration protocol - 237 mL water bolus and Hydration protocol - 500 mL water bolus in people with Dehydration (Physiology) and Hyperthermia, run by State University of New York at Buffalo 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 6 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 3 Nov 2020. 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. 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?
Percent body mass loss (time frame: 2 hours). The study lists 2 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 3 Nov 2020.