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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05916183
Other study ID # STUDY00007342
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 5, 2023
Est. completion date December 22, 2023

Study information

Verified date March 2024
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). A series of brain function tests will be performed at baseline, following weight loss, and following recovery.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 22, 2023
Est. primary completion date December 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 26 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Fluid loss and consumption
Upon 5% body mass loss, rehydration of fluid lost to sweating throughout a 2 hour recovery period

Locations

Country Name City State
United States University at Buffalo Buffalo New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Multitasking test 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
Primary Multitasking test 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
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