Rehydration Following Exercise-Induced Dehydration
Primary Purpose
Dehydration Related to Exercise
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water with flavoring and non-nutritive sweetener.
High-Na low-CHO beverage
Low-Na high-CHO beverage
Sponsored by
About this trial
This is an interventional treatment trial for Dehydration Related to Exercise focused on measuring dehydration, exercise, rehydration, sodium, water, carbohydrate
Eligibility Criteria
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
Sites / Locations
- University of Illinois
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
High-Na low-CHO beverage
Low-Na high-CHO beverage
Arm Description
Water with flavoring and non-nutritive sweetener.
Beverage containing sodium concentration of 40 to 50 mEq/L and carbohydrate concentration between 310 and 350 mmol/L.
Beverage containing sodium concentration of 15 to 25 mEq/L and carbohydrate concentration between 120 and 160 mmol/L.
Outcomes
Primary Outcome Measures
Rehydration
Fluid retained to rehydrate the body as a percentage of volume of beverage ingested.
Secondary Outcome Measures
Body weight
Change in body mass from the start of data collection.
Full Information
NCT ID
NCT01974986
First Posted
October 28, 2013
Last Updated
May 31, 2016
Sponsor
University of Illinois at Chicago
Collaborators
Abbott Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT01974986
Brief Title
Rehydration Following Exercise-Induced Dehydration
Official Title
Rehydration Following Exercise-Induced Dehydration: Beverage Formula Effects in Team Sport Athletes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Abbott Nutrition
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration Related to Exercise
Keywords
dehydration, exercise, rehydration, sodium, water, carbohydrate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Water with flavoring and non-nutritive sweetener.
Arm Title
High-Na low-CHO beverage
Arm Type
Experimental
Arm Description
Beverage containing sodium concentration of 40 to 50 mEq/L and carbohydrate concentration between 310 and 350 mmol/L.
Arm Title
Low-Na high-CHO beverage
Arm Type
Experimental
Arm Description
Beverage containing sodium concentration of 15 to 25 mEq/L and carbohydrate concentration between 120 and 160 mmol/L.
Intervention Type
Other
Intervention Name(s)
Water with flavoring and non-nutritive sweetener.
Intervention Description
A volume of fluid (water) was given after exercise to return each subject's body mass (to euhydration).
Intervention Type
Other
Intervention Name(s)
High-Na low-CHO beverage
Intervention Description
A volume of fluid (high-Na, low-CHO) was given after exercise to return each subject's body mass (to euhydration).
Intervention Type
Other
Intervention Name(s)
Low-Na high-CHO beverage
Intervention Description
A volume of fluid (low-Na, high-CHO) was given after exercise to return each subject's body mass (to euhydration).
Primary Outcome Measure Information:
Title
Rehydration
Description
Fluid retained to rehydrate the body as a percentage of volume of beverage ingested.
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Body weight
Description
Change in body mass from the start of data collection.
Time Frame
8 hours
Other Pre-specified Outcome Measures:
Title
Total body water
Description
Change in estimated total body water from the start of data collection.
Time Frame
8 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Horswill, PhD
Organizational Affiliation
UIC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
12. IPD Sharing Statement
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Rehydration Following Exercise-Induced Dehydration
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