Back to resultsWater Bolus Volumes During Continuous Exercise in Heat
Primary Purpose
Dehydration (Physiology), Hyperthermia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hydration protocol - 237 mL water bolus
Hydration protocol - 500 mL water bolus
Sponsored by
About this trial
This is an interventional prevention trial for Dehydration (Physiology)
Eligibility Criteria
Inclusion Criteria:
- Male
- 18-39 y old
- Self-reported to be healthy
Exclusion Criteria:
- 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
Sites / Locations
- Center for Research and Exercise in Special Environments
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Current Best Practice - 237 mL water bolus
New Intervention - 500 mL water bolus
Arm Description
Outcomes
Primary Outcome Measures
Percent body mass loss
Percent body mass loss after water intake
Core temperature
Core temperature after water intake
Secondary Outcome Measures
Full Information
NCT ID
NCT04613856
First Posted
October 30, 2020
Last Updated
November 2, 2020
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT04613856
Brief Title
Water Bolus Volumes During Continuous Exercise in Heat
Official Title
Water Bolus Volumes During Continuous Exercise in Heat
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration (Physiology), Hyperthermia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, counterbalanced, crossover study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Current Best Practice - 237 mL water bolus
Arm Type
Active Comparator
Arm Title
New Intervention - 500 mL water bolus
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Hydration protocol - 237 mL water bolus
Intervention Description
Subjects consume 237 mL of water every 20 minutes during 2 hours of high intensity work in the heat.
Intervention Type
Other
Intervention Name(s)
Hydration protocol - 500 mL water bolus
Intervention Description
Subjects consume 500 mL of water every 40 minutes during 2 hours of high intensity work in the heat.
Primary Outcome Measure Information:
Title
Percent body mass loss
Description
Percent body mass loss after water intake
Time Frame
2 hours
Title
Core temperature
Description
Core temperature after water intake
Time Frame
2 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male
18-39 y old
Self-reported to be healthy
Exclusion Criteria:
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
Facility Information:
Facility Name
Center for Research and Exercise in Special Environments
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD data can be provided upon written request.
Learn more about this trial
Water Bolus Volumes During Continuous Exercise in Heat
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