Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06415409 |
Other study ID # |
FP00034719 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 1, 2023 |
Est. completion date |
January 12, 2024 |
Study information
Verified date |
May 2024 |
Source |
Arizona State University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
It is well established that post-exercise rehydration with a carbohydrate-electrolyte
solution is better when compared to plain water. However, most of the commercially available
drinks today are high in carbohydrates and sodium with low potassium without other active
ingredients. The aim of the present study is to examine the impact of a higher electrolyte
sports drink compared with traditional sports drinks and water on the time course and extent
of rehydration after exercise-induced dehydration
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