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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Water with flavoring and non-nutritive sweetener.
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).
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.
Other: 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).
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.
Other: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abbott Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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