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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01974986
Other study ID # AN-US-1307
Secondary ID
Status Completed
Phase N/A
First received October 28, 2013
Last updated May 31, 2016
Start date July 2013
Est. completion date May 2016

Study information

Verified date May 2016
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date May 2016
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
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).
High-Na low-CHO beverage
A volume of fluid (high-Na, low-CHO) was given after exercise to return each subject's body mass (to euhydration).
Low-Na high-CHO beverage
A volume of fluid (low-Na, high-CHO) was given after exercise to return each subject's body mass (to euhydration).

Locations

Country Name City State
United States University of Illinois Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Chicago Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Total body water Change in estimated total body water from the start of data collection. 8 hours No
Primary Rehydration Fluid retained to rehydrate the body as a percentage of volume of beverage ingested. 8 hours No
Secondary Body weight Change in body mass from the start of data collection. 8 hours No