Post-exercise Rehydration: A Randomised Cross-over Trial Comparing a 100% Fruit Beverage, a Glucose-based Sports Drink, and Water
Comparing The Rehydration Properties Of Two Sports / Hydration Drinks And Water, Following Exercise In The Heat
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nottingham, United Kingdom, NG11 8NS
- Nottingham Trent University, Clifton Campus
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Training/performing > 1 hrs a week
Exclusion Criteria:
- Smoker.
- Pregnant, attempting to become pregnant, or breastfeeding.
- Diabetic.
- You have adverse events/reactions in response to fingertip capillary blood sampling which includes, but is not limited to; fainting and/or serious bruising.
- History of heat-related illness.
- History of heart failure, pulmonary hypertension, embolism, or other pulmonary heart disease.
- Previously diagnosed with COPD, emphysema, bronchitis or similar respiratory illness.
- Have a history of severe allergic reactions.
- History of kidney issues.
- Regular use of non-steroidal anti-inflammatory medications.
- Any other medical conditions / medications that may interfere with an individuals ability to safely perform exercise in the heat and experience dehydration.
- Allergies/intolerances to any of the following ingredients: Glucose Syrup, Acid (Citric Acid), Acidity Regulator (Sodium Citrate), Extract of Black Carrot, Watermelon, pomegranate, lime, Preservatives (Potassium Sorbate, Dimethyl Dicarbonate), Stabilisers (Acacia Gum), Sweeteners (Aspartame, Acesulfame K), Antioxidant (Ascorbic Acid), Flavourings, Niacin (Vitamin B3).
- Elite athlete subject to doping tests
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Water
Consumption of a water volume (from water) equal to 150% of body mass loses from exercise-induced hypohydration
|
Consumption of a water volume (from water) equal to 150% of body mass loses from exercise-induced hypohydration
|
|
Experimental: Glucose-based sports drink
Consumption of a water volume (from a glucose-based sports drink) equal to 150% of body mass loses from exercise-induced hypohydration
|
Consumption of a water volume (from a glucose-based sports drink) equal to 150% of body mass loses from exercise-induced hypohydration
|
|
Experimental: Fruit beverage
Consumption of a water volume (from a fruit beverage) equal to 150% of body mass loses from exercise-induced hypohydration
|
Consumption of a water volume (from a fruit beverage) equal to 150% of body mass loses from exercise-induced hypohydration
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Net water Balance
Time Frame: Baseline (pre-exercise), post-exercise, and 0, 1, 2, 3, and 4 h post-rehydration
|
([post-exercise body mass (kg) - Pre-exercise body mass (kg)] x 1000) + water volume consumed (g) - cumulative urine output during rehydration period (g)
|
Baseline (pre-exercise), post-exercise, and 0, 1, 2, 3, and 4 h post-rehydration
|
|
Cumulative urine volume
Time Frame: 0, 1, 2, 3, and 4 h post-rehydration
|
0, 1, 2, 3, and 4 h post-rehydration
|
|
|
Total urine volume
Time Frame: Sum of urine produced at 0, 1, 2, 3, and 4 h post-rehydration
|
Total urine volume produced during the rehydration period
|
Sum of urine produced at 0, 1, 2, 3, and 4 h post-rehydration
|
|
Water retention
Time Frame: 4 h post-rehydration
|
([water volume consumed (g) - total urine volume produced during the rehydration period (g)] / water volume consumed (g)) x 100
|
4 h post-rehydration
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood glucose concentration
Time Frame: Baseline (pre-exercise), post-exercise, and 0, 0.25, 0.5, 0.75, 1, 1.5, and 2 h post-rehydration
|
Baseline (pre-exercise), post-exercise, and 0, 0.25, 0.5, 0.75, 1, 1.5, and 2 h post-rehydration
|
|
|
Blood glucose area under the curve
Time Frame: The 2h period following rehydration
|
The 2h period following rehydration
|
|
|
Hyperglycaemia incidence
Time Frame: The 2 h period following rehydration
|
Number of participants that experience blood glucose > 7.8 mmol/L
|
The 2 h period following rehydration
|
|
Hypoglycaemia incidence
Time Frame: The 2 h period following rehydration
|
The number of participants that experience blood glucose < 3.9 mmol/L
|
The 2 h period following rehydration
|
|
Urine osmolality
Time Frame: Baseline (pre-exercise), post-exercise, and 0, 1, 2, 3, and 4 h post-rehydration
|
A measure of urine concentration.
|
Baseline (pre-exercise), post-exercise, and 0, 1, 2, 3, and 4 h post-rehydration
|
|
Body mass
Time Frame: Baseline (pre-exercise) and post-exercise (approximately 2 h post-baseline, depending on sweat losses during cycling in the heat)
|
Body mass in kilograms at baseline compared across trials.
Body mass loss (both in grams and as a percentage) from pre-exercise to post-exercise compared across trials.
|
Baseline (pre-exercise) and post-exercise (approximately 2 h post-baseline, depending on sweat losses during cycling in the heat)
|
|
Thirst
Time Frame: Baseline (pre-exercise), towards the end of each 10 minute block of exercise (cycling in the heat), post-exercise, and 0, 1, 2, 3, and 4 h post-rehydration
|
Participants asked to rate their thirst on a scale of 0-10 (0 = no symptom, 10 = maximum symptom)
|
Baseline (pre-exercise), towards the end of each 10 minute block of exercise (cycling in the heat), post-exercise, and 0, 1, 2, 3, and 4 h post-rehydration
|
|
Gastrointestinal comfort
Time Frame: Baseline (pre-exercise), post-exercise, and 0, 1, 2, 3, and 4 h post-rehydration
|
Participants asked to rate their gastrointestinal comfort on a scale of 0-10 (0 = no symptom, 10 = maximum symptom)
|
Baseline (pre-exercise), post-exercise, and 0, 1, 2, 3, and 4 h post-rehydration
|
|
Rating of perceived exertion (RPE)
Time Frame: Measured towards the end of each 10 minute block of exercise (cycling in the heat). Up to 8 blocks lasting a total of 120 minutes (10 minutes of cycling, followed by 5 minutes of rest), depending on body mass loss.
|
Participants asked to rate their RPE on a scale of 6-20.
This is a measure of exercise intensity.
Average taken for dehydration period.
Average compared across trials.
|
Measured towards the end of each 10 minute block of exercise (cycling in the heat). Up to 8 blocks lasting a total of 120 minutes (10 minutes of cycling, followed by 5 minutes of rest), depending on body mass loss.
|
|
Thermal sensation
Time Frame: Measured towards the end of each 10 minute block of exercise (cycling in the heat). Up to 8 blocks lasting a total of 120 minutes (10 minutes of cycling, followed by 5 minutes of rest), depending on body mass loss.
|
Participants asked to rate their thermal sensation on a scale of -10 (unbearably cold) to 10 (unbearably hot).
Average taken for dehydration period.
Average compared across trials.
|
Measured towards the end of each 10 minute block of exercise (cycling in the heat). Up to 8 blocks lasting a total of 120 minutes (10 minutes of cycling, followed by 5 minutes of rest), depending on body mass loss.
|
|
Time in environmental chamber
Time Frame: Up to 120 minutes, depending on body mass losses during cycling in the heat
|
The time in minutes that the participant spent in the environmental chamber at 35 degrees Celsius, doing repeated blocks of 10 minutes of cycling followed by 5 minutes of rest, until they reached approximately 1.5% body mass loss.
Time compared across trials.
|
Up to 120 minutes, depending on body mass losses during cycling in the heat
|
|
Laboratory temperature
Time Frame: Baseline (pre-exercise), post-exercise, and 0, 1, 2, 3, and 4 h post-rehydration
|
Temperature (degrees Celsius) of the laboratory measured across the day and averaged.
Averages compared across trials.
|
Baseline (pre-exercise), post-exercise, and 0, 1, 2, 3, and 4 h post-rehydration
|
|
Environmental chamber temperature
Time Frame: Measured towards the end of each 10 minute block of exercise (cycling in the heat). Up to 8 blocks lasting a total of 120 minutes (10 minutes of cycling, followed by 5 minutes of rest), depending on body mass loss.
|
Environmental chamber temperature (degrees Celsius) measured and averaged for the cycling in the heat period of each participant.
Averages compared across trials.
|
Measured towards the end of each 10 minute block of exercise (cycling in the heat). Up to 8 blocks lasting a total of 120 minutes (10 minutes of cycling, followed by 5 minutes of rest), depending on body mass loss.
|
|
Laboratory humidity
Time Frame: Baseline (pre-exercise), post-exercise, and 0, 1, 2, 3, and 4 h post-rehydration
|
Humidity (relative humidity) of the laboratory measured across the day and averaged.
Averages compared across trials.
|
Baseline (pre-exercise), post-exercise, and 0, 1, 2, 3, and 4 h post-rehydration
|
|
Environmental chamber humidity
Time Frame: Measured towards the end of each 10 minute block of exercise (cycling in the heat). Up to 8 blocks lasting a total of 120 minutes (10 minutes of cycling, followed by 5 minutes of rest), depending on body mass loss.
|
Environmental chamber humidity (relative humidity) measured and averaged for the cycling in the heat period of each participant.
Averages compared across trials.
|
Measured towards the end of each 10 minute block of exercise (cycling in the heat). Up to 8 blocks lasting a total of 120 minutes (10 minutes of cycling, followed by 5 minutes of rest), depending on body mass loss.
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 1911625
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.