- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01974986
Rehydration Following Exercise-Induced Dehydration
May 31, 2016 updated by: Craig A. Horswill, University of Illinois at Chicago
Rehydration Following Exercise-Induced Dehydration: Beverage Formula Effects in Team Sport Athletes
Athletes participating in multiple training sessions a day can be at increased risk of suboptimal hydration and heat illness during their second training session, especially when the environment is hot and humid.
With the exception of the absolute volume of water delivered by a rehydration beverage, characteristics of the beverage consumed play a role in the recovery and completeness of rehydration.
The amount of sodium in the beverage has been shown to be a primary factor in rehydration.
Recently, an effect of the carbohydrate concentration of the beverage was been reported, with its effects mediated by the renal system in response to elevated serum insulin.
The purpose of this study is to compare sodium and carbohydrate effects on rehydration and recovery.
Study Overview
Status
Completed
Conditions
Detailed Description
The effectiveness of beverage composition will be evaluated by modifying the sodium content and carbohydrate content of the beverage.
Hypothesis: Completeness of rehydration will be greater in the beverage with higher sodium concentration.
It is also hypothesized that electrolyte-carbohydrate beverages will promote rehydration that exceeds that of consuming placebo (water).
Using a randomized balanced-treatment crossover design, physically trained males (18-35 yrs) will participate in intermittent exercise for 85 to 100 minutes in three experimental trials of variable intensity training in the heat (30 +/-3 C) followed by a rehydration-recovery period.
Exercise will be done at varying intensities (intermittent intervals) ranging from 50% to nearly 100% of maximum oxygen uptake (max VO2) determined prior to the experimental trials.
During the 85 to 100 min of exercise, no fluids will be given during the trial to elicit an acute reduction in body mass of approximately 2.5 to 3% (standardized for each subject).
Following exercise, 100% of the volume of fluid lost will be replaced with one of the beverages.
Beverages will be ingested in six aliquots over a 1-hr period given at the end of the trial.
Retention of fluid will be calculated by measuring volume of urine lost at 30, 60, 135, and 210 min following ingestion of the rehydration beverage.
The primary outcome variable is the percentage of fluid retained, i.e., the difference between volume ingested and cumulative urine produced in 3.5 h as a percentage of volume ingested.
Body mass, urine specific gravity, total body water, and ratings of vigor and affect will be assessed prior to exercise, after exercise in a state of dehydration, and at 210 min post-exercise following rehydration.
A one-way ANOVA will be used to test the hypothesis for rehydration, the primary outcome variable.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60608
- University of Illinois
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male, age 18-35 y, physically fit, and regularly undergoing exercise training particularly but not exclusively in team sports.
Exclusion Criteria:
- "Yes" on PAR-Q survey, symptoms or signs of exercise intolerance, VO2 max <50 mL/kg/min, smoker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Water with flavoring and non-nutritive sweetener.
|
A volume of fluid (water) was given after exercise to return each subject's body mass (to euhydration).
|
Experimental: High-Na low-CHO beverage
Beverage containing sodium concentration of 40 to 50 mEq/L and carbohydrate concentration between 310 and 350 mmol/L.
|
A volume of fluid (high-Na, low-CHO) was given after exercise to return each subject's body mass (to euhydration).
|
Experimental: Low-Na high-CHO beverage
Beverage containing sodium concentration of 15 to 25 mEq/L and carbohydrate concentration between 120 and 160 mmol/L.
|
A volume of fluid (low-Na, high-CHO) was given after exercise to return each subject's body mass (to euhydration).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rehydration
Time Frame: 8 hours
|
Fluid retained to rehydrate the body as a percentage of volume of beverage ingested.
|
8 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body weight
Time Frame: 8 hours
|
Change in body mass from the start of data collection.
|
8 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total body water
Time Frame: 8 hours
|
Change in estimated total body water from the start of data collection.
|
8 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Craig Horswill, PhD, UIC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
October 28, 2013
First Submitted That Met QC Criteria
November 1, 2013
First Posted (Estimate)
November 3, 2013
Study Record Updates
Last Update Posted (Estimate)
June 2, 2016
Last Update Submitted That Met QC Criteria
May 31, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AN-US-1307
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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