- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05916183
Dehydration Cognition
September 11, 2024 updated by: Riana Pryor, State University of New York at Buffalo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14214
- University at Buffalo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy
- Recreationally active
- 18-26 years old
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dehydration and Rehydration Arm
Participants will complete exercise until 5% body mass loss, followed by ad libitum rehydration throughout 2 hours of recovery.
|
Upon 5% body mass loss, rehydration of fluid lost to sweating throughout a 2 hour recovery period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Upon completion of 5% body mass loss protocol, approximately 2 hours into the trial
|
|
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
|
2 hours following the dehydration cognitive function test, approximately 4.5 hours into the trial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Riana R Pryor, PhD, University at Buffalo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2023
Primary Completion (Actual)
December 22, 2023
Study Completion (Actual)
December 22, 2023
Study Registration Dates
First Submitted
June 5, 2023
First Submitted That Met QC Criteria
June 14, 2023
First Posted (Actual)
June 23, 2023
Study Record Updates
Last Update Posted (Actual)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 11, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00007342
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Coded data or the methodology will be shared with researchers upon reasonable written request.
IPD Sharing Time Frame
Data can be shared for as long as the data is retained, at least 7 years.
IPD Sharing Access Criteria
Data will be shared upon reasonable written request.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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