- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06415409
Rehydration Efficiency With Different Sports Drinks (REHYDR8)
Rehydration After Exercise With High-electrolyte Sport Drink
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dehydration:
Based on our previous work, dehydration will be accomplished on the morning of testing via mild exercise and heat exposure to elicit a body weight loss of -2%. The subjects will perform four bouts of 25-min low-intensity exercise and 5 min rest (alternating cycling & walking) or till they reach -2% of body weight dehydration.
Rehydration:
Following a 20 min rest in thermo-comfortable environment a dehydrated baseline blood sample will be taken, and subject will start the rehydration protocol.
The volunteers will consume one of the four drinks below in a cross over balance mode. During the first hour four equal doses will be consumed in15-min intervals at a total volume of 150% of their body weight loss.
Trials/Drinks (block randomization will be used to assign individual participants to each specific trial/drink using their ID number):
- Water
- GoodSport®
- Gatorade®
- BodyArmor®
Measurements:
All measurements will be performed at one of the test rooms at our lab facility that boarders the room where participants can relax and wait out the end of the study day. When certain measurements need to be performed they simply move from one room to the next. Duration of taking blood and urine samples will take not more than 30-90 seconds each, bioelectrical impedance will take a bit more time to ensure the body is in a stable rested state as a result measurement will be taken in 10 minutes, finally perceptual data will take 30-60 seconds to be reported. To allow to perform all measurements study days will take up to 7 hours. Therefore, there will be a separate space available that allows for self-study or watching TV that includes a chair and table to work on and a couch to relax.
Blood samples (8 per trial, maximal 12 minutes):
A total of eight 10 mL blood samples will be collected on the euhydrated baseline, dehydrated baseline and at 30, 60, 90, 120, 180, and 240 min of the rehydration period.
All samples will be analyzed for glucose, osmolality, total plasma protein, hematocrit, hemoglobin (for plasma volume changes), sodium, potassium, and chloride.
Urine samples (6 per trial, maximal 9 minutes):
Urine samples will be collected using ~900 mL cups at euhydrated baseline, dehydrated baseline and cumulative totals will be collected at 60, 120, 180, and 240 min of the rehydration period. All samples will be analyzed for urine osmolality, specific gravity, volume, sodium, and potassium.
Perceptual Data (6 per trial, maximal 9 minutes):
Thirst, stomach fullness, and taste, assessed via a visual analog scale
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Interdisciplinary Science and Technology Building 8
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Training > 2x per week
- Age 18-55 y
- stable weight for the last 2 months (<5 lbs. fluctuation)
Exclusion Criteria:
- night shifting work
- thyroid medication
- bariatric surgery
- cardiovascular disease
- renal disease
- hepatic disease
- Participating in another study at the same time
- Bodyweight <110 lbs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Water
rehydration with Plain water
|
Plain water
|
|
Active Comparator: Gatorade
rehydration with Gatorade drink
|
Sport Drink Gatorade
|
|
Active Comparator: BodyArmor
Rehydration with Body Armor Drink
|
Sport Drink BodyArmor
|
|
Experimental: GoodSport
Rehydration with Good Sport drink
|
Sport Drink GoodSport
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Net Fluid Balance
Time Frame: 3 hours of rehydration
|
Net fluid balance based on body weight changes during the 4 h of the rehydration period
|
3 hours of rehydration
|
|
Net Fluid Balance
Time Frame: 4 hours of rehydration
|
Net fluid balance based on body weight changes during the 4 h of the rehydration period
|
4 hours of rehydration
|
|
Urine volume
Time Frame: 3 hours of rehydration
|
cumulative Urine output during the rehydration period
|
3 hours of rehydration
|
|
Urine osmotic excretion
Time Frame: 3 hours of rehydration
|
Urine osmotic excretion during rehydration
|
3 hours of rehydration
|
|
Urine osmotic excretion
Time Frame: 4 hours of rehydration
|
Urine osmotic excretion during rehydration
|
4 hours of rehydration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stomach fullness
Time Frame: 3 hours of rehydration
|
Assessed via a Visual Analog scale during rehydration
|
3 hours of rehydration
|
|
Stomach fullness
Time Frame: 4 hours of rehydration
|
Assessed via a Visual Analog scale during rehydration.
Scale is from 0-125mm with higher number indicating greater perception
|
4 hours of rehydration
|
|
Thirst
Time Frame: 3 hours of rehydration
|
Assessed via a Visual Analog scale during rehydration.
Scale is from 0-125mm with higher number indicating greater perception
|
3 hours of rehydration
|
|
Thirst
Time Frame: 4 hours of rehydration
|
Assessed via a Visual Analog scale during rehydration.
Scale is from 0-125mm with higher number indicating greater perception
|
4 hours of rehydration
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FP00034719
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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