Back to resultsDehydration Cognition
Primary Purpose
Dehydration
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluid loss and consumption
Sponsored by
About this trial
This is an interventional treatment trial for Dehydration
Eligibility Criteria
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
Sites / Locations
- University at BuffaloRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dehydration and Rehydration Arm
Arm Description
Participants will complete exercise until 5% body mass loss, followed by ad libitum rehydration throughout 2 hours of recovery.
Outcomes
Primary Outcome Measures
Multitasking test
Accuracy score of a multitasking test (0-100%) with greater scores indicating a better outcome
Multitasking test
Accuracy score of a multitasking test (0-100%) with greater scores indicating a better outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT05916183
First Posted
June 5, 2023
Last Updated
August 15, 2023
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT05916183
Brief Title
Dehydration Cognition
Official Title
Impact of Dehydration and Rapid Rehydration on Cognitive Function
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dehydration and Rehydration Arm
Arm Type
Experimental
Arm Description
Participants will complete exercise until 5% body mass loss, followed by ad libitum rehydration throughout 2 hours of recovery.
Intervention Type
Behavioral
Intervention Name(s)
Fluid loss and consumption
Intervention Description
Upon 5% body mass loss, rehydration of fluid lost to sweating throughout a 2 hour recovery period
Primary Outcome Measure Information:
Title
Multitasking test
Description
Accuracy score of a multitasking test (0-100%) with greater scores indicating a better outcome
Time Frame
Upon completion of 5% body mass loss protocol, approximately 2 hours into the trial
Title
Multitasking test
Description
Accuracy score of a multitasking test (0-100%) with greater scores indicating a better outcome
Time Frame
2 hours following the dehydration cognitive function test, approximately 4.5 hours into the trial
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Riana R Pryor, PhD
Phone
7163489306
Email
rpryor@buffalo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyn Stooks, MPH
Email
jstooks@buffalo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riana R Pryor, PhD
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riana R Pryor, PhD
Phone
716-348-9306
Email
rpryor@buffalo.edu
First Name & Middle Initial & Last Name & Degree
Jocelyn Stooks, MPH
Email
jstooks@buffalo.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Dehydration Cognition
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