DehydrationNCT05916183
Dehydration Cognition
A study testing Fluid loss and consumption in people with Dehydration, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The investigators want to understand the impact of the body losing and gaining water on brain function. Participants will restrict fluids consumed and exercise to lose 5% of body mass. Participants will then be provided fluid equal to the volume lost to consume over 2 hours (recovery). Read more about this study
- Who is it for?
- Ages 18 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Fluid loss and consumption
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2023to 22 Dec 2023
- 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 26 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Recreationally active
- 18-26 years old
Who cannot join
- History of cardiovascular, metabolic, respiratory, neural, or renal disease
- Hypertensive (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg) or tachycardic (resting heart rate ≥ 100 bpm) during the screening visit
- Taking medication or supplements with a known side effect of affecting physiological responses to exercise (e.g., aspirin, acetaminophen, beta blockers, statins, stimulants, depressants, SSRIs)
- Tobacco or nicotine use in the past six months
- Current or past musculoskeletal injury impacting physical activity
- Study physician discretion based on any other medical condition or medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Dehydration and Rapid Rehydration on Cognitive Function
The investigators want to understand the impact of the body losing and gaining water on brain function. Participants will restrict fluids consumed and exercise to lose 5% of body mass. Participants will then be provided fluid equal to the volume lost to consume over 2 hours (recovery). A series of brain function tests will be performed at baseline, following weight loss, and following recovery.
Read the detailed description
A baseline series of brain function tests will be performed. Following this, participants will complete a 24 hour fluid and water rich food restriction on the day proceeding testing. Participants will then complete moderate to high intensity exercise in a hot/humid room to achieve 5% body mass loss. Once baseline core body temperature returns to baseline levels, the series of brain function tests will be performed. Participants will then consume a sports drink equal to the volume of sweat lost over the course of a 2 hour recover period. Following this, he series of brain function tests will be performed.
- Conditions
- Dehydration
- Being tested
- Fluid loss and consumption
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid loss and consumptionBehavioural
Upon 5% body mass loss, rehydration of fluid lost to sweating throughout a 2 hour recovery period
| Study group | Role | What they receive |
|---|---|---|
| Dehydration and Rehydration Arm | Experimental | Participants will complete exercise until 5% body mass loss, followed by ad libitum rehydration throughout 2 hours of recovery. Receives: Behavioral: Fluid loss and consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multitasking test
Accuracy score of a multitasking test (0-100%) with greater scores indicating a better outcome
Measured: Upon completion of 5% body mass loss protocol, approximately 2 hours into the trial
Multitasking test
Accuracy score of a multitasking test (0-100%) with greater scores indicating a better outcome
Measured: 2 hours following the dehydration cognitive function test, approximately 4.5 hours into the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start5 Jul 2023
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- Investigators
- Riana R Pryor, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916183
- Sponsor's protocol ID
- STUDY00007342
- Status last verified
- Sep 2024
- First submitted
- 5 Jun 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded data or the methodology will be shared with researchers upon reasonable written request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dehydration and Rapid Rehydration on Cognitive Function
- ClinicalTrials.gov ID
- NCT05916183
- Acronym / sponsor ID
- STUDY00007342
- Conditions
- Dehydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 23 Jun 2023 (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 investigators want to understand the impact of the body losing and gaining water on brain function. Participants will restrict fluids consumed and exercise to lose 5% of body mass. Participants will then be provided fluid equal to the volume lost to consume over 2 hours (recovery). A series of brain function tests will be performed at baseline, following weight loss, and following recovery.
Detailed description
A baseline series of brain function tests will be performed. Following this, participants will complete a 24 hour fluid and water rich food restriction on the day proceeding testing. Participants will then complete moderate to high intensity exercise in a hot/humid room to achieve 5% body mass loss. Once baseline core body temperature returns to baseline levels, the series of brain function tests will be performed. Participants will then consume a sports drink equal to the volume of sweat lost over the course of a 2 hour recover period. Following this, he series of brain function tests will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dehydration and Rehydration Arm | Experimental | Behavioral: Fluid loss and consumptionParticipants will complete exercise until 5% body mass loss, followed by ad libitum rehydration throughout 2 hours of recovery. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Recreationally active
- 18-26 years old
Key exclusion criteria (6 listed)
- History of cardiovascular, metabolic, respiratory, neural, or renal disease
- Hypertensive (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg) or tachycardic (resting heart rate ≥ 100 bpm) during the screening visit
- Taking medication or supplements with a known side effect of affecting physiological responses to exercise (e.g., aspirin, acetaminophen, beta blockers, statins, stimulants, depressants, SSRIs)
- Tobacco or nicotine use in the past six months
- Current or past musculoskeletal injury impacting physical activity
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 |
|---|---|---|
| Fluid loss and consumptionUpon 5% body mass loss, rehydration of fluid lost to sweating throughout a 2 hour recovery period | Behavioural | Dehydration and Rehydration Arm |
Primary outcome
Multitasking test
Time frame: Upon completion of 5% body mass loss protocol, approximately 2 hours into the trial
Accuracy score of a multitasking test (0-100%) with greater scores indicating a better outcome
Multitasking test
Time frame: 2 hours following the dehydration cognitive function test, approximately 4.5 hours into the trial
Accuracy score of a multitasking test (0-100%) with greater scores indicating a better outcome
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 19 Sep 2024.
- Individual participant dataSharing planned: Yes. Coded data or the methodology will be shared with researchers upon reasonable written request.
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Hypernatremia Fluid Therapy in Childhood Diarrhoea
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Hydration & Female Life Stages
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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.
Riana R Pryor, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid loss and consumption in people with Dehydration, 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 19 Sep 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. 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?
Multitasking test (time frame: Upon completion of 5% body mass loss protocol, approximately 2 hours into the trial). 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 19 Sep 2024.