Dehydration Related to ExerciseNCT01974986
Rehydration Following Exercise-Induced Dehydration
A study testing Water with flavoring and non-nutritive sweetener., High-Na low-CHO beverage and Low-Na high-CHO beverage in people with Dehydration Related to Exercise, run by University of Illinois Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dehydration Related to Exercise
- What is being tested?
- Water with flavoring and non-nutritive sweetener., High-Na low-CHO beverage and Low-Na high-CHO beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, age 18-35 y, physically fit, and regularly undergoing exercise training particularly but not exclusively in team sports.
Who cannot join
- "Yes" on PAR-Q survey, symptoms or signs of exercise intolerance, VO2 max <50 mL/kg/min, smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dehydration Related to Exercise
- Being tested
- Water with flavoring and non-nutritive sweetener., High-Na low-CHO beverage, Low-Na high-CHO beverage
- Keywords
- dehydration, exercise, rehydration, sodium, water, carbohydrate
- Medical subject headings
- Dehydration, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water with flavoring and non-nutritive sweetener.Other
A volume of fluid (water) was given after exercise to return each subject's body mass (to euhydration).
High-Na low-CHO beverageOther
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 beverageOther
A volume of fluid (low-Na, high-CHO) was given after exercise to return each subject's body mass (to euhydration).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Water with flavoring and non-nutritive sweetener. Receives: Other: Water with flavoring and non-nutritive sweetener. |
| High-Na low-CHO beverage | Experimental | Beverage containing sodium concentration of 40 to 50 mEq/L and carbohydrate concentration between 310 and 350 mmol/L. Receives: Other: High-Na low-CHO beverage |
| Low-Na high-CHO beverage | Experimental | Beverage containing sodium concentration of 15 to 25 mEq/L and carbohydrate concentration between 120 and 160 mmol/L. Receives: Other: Low-Na high-CHO beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehydration
Fluid retained to rehydrate the body as a percentage of volume of beverage ingested.
Measured: 8 hours
Secondary outcomes (1)
Body weight
Change in body mass from the start of data collection.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dehydration Related to ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Nutrition
- Responsible party
- Principal investigator, Craig A. Horswill, University of Illinois Chicago
- Investigators
- Craig Horswill, PhD, Principal investigator, UIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974986
- Sponsor's protocol ID
- AN-US-1307
- Status last verified
- May 2016
- First submitted
- 28 Oct 2013
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehydration Following Exercise-Induced Dehydration: Beverage Formula Effects in Team Sport Athletes
- ClinicalTrials.gov ID
- NCT01974986
- Acronym / sponsor ID
- AN-US-1307
- Conditions
- Dehydration Related to Exercise
- Keywords
- dehydration, exercise, rehydration, sodium, water, carbohydrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Abbott Nutrition
- Study start
- Jul 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Water with flavoring and non-nutritive sweetener.Water with flavoring and non-nutritive sweetener. |
| High-Na low-CHO beverage | Experimental | Other: High-Na low-CHO beverageBeverage containing sodium concentration of 40 to 50 mEq/L and carbohydrate concentration between 310 and 350 mmol/L. |
| Low-Na high-CHO beverage | Experimental | Other: Low-Na high-CHO beverageBeverage containing sodium concentration of 15 to 25 mEq/L and carbohydrate concentration between 120 and 160 mmol/L. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male, age 18-35 y, physically fit, and regularly undergoing exercise training particularly but not exclusively in team sports.
Key exclusion criteria (1 listed)
- "Yes" on PAR-Q survey, symptoms or signs of exercise intolerance, VO2 max <50 mL/kg/min, smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Placebo |
| High-Na low-CHO beverageA volume of fluid (high-Na, low-CHO) was given after exercise to return each subject's body mass (to euhydration). | Other | High-Na low-CHO beverage |
| Low-Na high-CHO beverageA volume of fluid (low-Na, high-CHO) was given after exercise to return each subject's body mass (to euhydration). | Other | Low-Na high-CHO beverage |
Primary outcome
Rehydration
Time frame: 8 hours
Fluid retained to rehydrate the body as a percentage of volume of beverage ingested.
1 secondary outcome
Body weight
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Horswill, PhD principal investigator
UIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water with flavoring and non-nutritive sweetener., High-Na low-CHO beverage and Low-Na high-CHO beverage in people with Dehydration Related to Exercise, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehydration (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2016.