The Effect of Manipulating Hydration Status During Cycling in the Heat on Acute Kidney Injury Biomarkers
Primary Purpose
Hypohydrated, Euhydrated
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Water intake
Sponsored by
About this trial
This is an interventional prevention trial for Hypohydrated
Eligibility Criteria
Inclusion Criteria:
- Healthy
- recreationally active
Exclusion Criteria:
- Smoker/vaper
- regular use of anti-inflammatory medications (e.g. ibuprofen)
- history of kidney disease or diabetes
Sites / Locations
- Loughborough University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hypohydrated
Euhydrated
Arm Description
Participants will be required to restrict their water intake during cycling in the heat (90-120 minutes at 35°C), in order to achieve a body mass loss of approximately 3%.
Participants will be provided with water intake that matches their sweat losses during cycling in the heat (90-120 minutes at 35°C)
Outcomes
Primary Outcome Measures
Changes in urinary Kidney Injury Molecule 1 (uKIM-1) (uncorrected/raw values and urine osmolality-corrected values)
A novel protein biomarker for acute kidney injury
Changes in urinary neutrophil gelatinase-associated lipocalin (uNGAL) (uncorrected/raw values and urine osmolality-corrected values)
A novel protein biomarker for acute kidney injury
Changes in urine osmolality
A measure of urine concentration.
Changes in serum creatinine
Serum creatinine is a marker of kidney function
Incidence of Acute Kidney Injury (as determined by changes in serum creatinine)
A rise in serum creatinine of 1.5 fold or more from baseline will be defined as acute kidney injury
Secondary Outcome Measures
Plasma volume changes
Changes in serum osmolality
The gold standard marker of hydration status
Body mass changes
Changes in creatine kinase
A marker of muscle damage
Changes in lactate dehydrogenase
A marker of muscle damage
Ad libitum energy (Kj), carbohydrate (g), sugar (g), protein (g), fat (g), saturated fat (g), sodium (g) and water intake (g).
Participants will complete a weighed food and fluid diary, using a set of food scales and a diary, to record all food and fluid that they ingest. This data will then be analysed using dietary analysis software (e.g. Nutritics)
Changes in headache scores
Participants will be asked to rate their headache on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in nausea scores
Participants will be asked to rate their nausea on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in dizziness scores
Participants will be asked to rate their dizziness on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in thirst scores
Participants will be asked to rate their thirst on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in thermal comfort scores
Participants will be asked to rate their thermal comfort on a scale of -10 to 10, with -10 being cold impossible to bear and 10 being heat impossible to bear
Changes in gastrointestinal comfort scores
Participants will be asked to rate their gastrointestinal comfort on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in stomach fullness scores
Participants will be asked to rate their stomach fullness on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in stomach bloatedness scores
Participants will be asked to rate their stomach bloatedness on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in urge to vomit scores
Participants will be asked to rate their urge to vomit on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in urinary creatinine
Changes in heart rate
Provides insight into exercise intensity
changes in rating of perceived exertion
Provides insight into exercise intensity
Changes in aural temperature
in-ear temperature
Full Information
NCT ID
NCT04140045
First Posted
October 21, 2019
Last Updated
July 31, 2020
Sponsor
Loughborough University
1. Study Identification
Unique Protocol Identification Number
NCT04140045
Brief Title
The Effect of Manipulating Hydration Status During Cycling in the Heat on Acute Kidney Injury Biomarkers
Official Title
The Effect of Hypohydration During Cycling in the Heat on Acute Kidney Injury Biomarkers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 28, 2019 (Actual)
Primary Completion Date
March 17, 2020 (Actual)
Study Completion Date
March 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loughborough University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Acute Kidney Injury (AKI) is common in prolonged endurance events. Risk factors for exercise-associated AKI include: the exercise itself, heat, hypohydration, muscle breakdown and non-steroidal anti-inflammatory drug (NSAID) use. Prior research from our laboratory showed the hypohydration during high-intensity running increased a biomarker of AKI (urine osmolality-corrected kidney injury molecule 1). Therefore, the current study will now investigate the effect of manipulating hydration status during cycling on biomarkers of AKI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypohydrated, Euhydrated
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypohydrated
Arm Type
Experimental
Arm Description
Participants will be required to restrict their water intake during cycling in the heat (90-120 minutes at 35°C), in order to achieve a body mass loss of approximately 3%.
Arm Title
Euhydrated
Arm Type
Experimental
Arm Description
Participants will be provided with water intake that matches their sweat losses during cycling in the heat (90-120 minutes at 35°C)
Intervention Type
Other
Intervention Name(s)
Water intake
Intervention Description
Water intake will be manipulated in both arms to create a hypohydrated state and a euhydrated state, post-exercise
Primary Outcome Measure Information:
Title
Changes in urinary Kidney Injury Molecule 1 (uKIM-1) (uncorrected/raw values and urine osmolality-corrected values)
Description
A novel protein biomarker for acute kidney injury
Time Frame
Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Title
Changes in urinary neutrophil gelatinase-associated lipocalin (uNGAL) (uncorrected/raw values and urine osmolality-corrected values)
Description
A novel protein biomarker for acute kidney injury
Time Frame
Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Title
Changes in urine osmolality
Description
A measure of urine concentration.
Time Frame
Pre-exercise (baseline) and post-exercise (immediately after the intervention), as well as all urine produced from post-exercise until 24 hours post-baseline
Title
Changes in serum creatinine
Description
Serum creatinine is a marker of kidney function
Time Frame
Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baseline
Title
Incidence of Acute Kidney Injury (as determined by changes in serum creatinine)
Description
A rise in serum creatinine of 1.5 fold or more from baseline will be defined as acute kidney injury
Time Frame
Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baseline
Secondary Outcome Measure Information:
Title
Plasma volume changes
Time Frame
Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Title
Changes in serum osmolality
Description
The gold standard marker of hydration status
Time Frame
Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Title
Body mass changes
Time Frame
pre-exercise (baseline), throughout exercise, post-exercise (immediately after the intervention), 24 hours post-baseline
Title
Changes in creatine kinase
Description
A marker of muscle damage
Time Frame
Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Title
Changes in lactate dehydrogenase
Description
A marker of muscle damage
Time Frame
Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Title
Ad libitum energy (Kj), carbohydrate (g), sugar (g), protein (g), fat (g), saturated fat (g), sodium (g) and water intake (g).
Description
Participants will complete a weighed food and fluid diary, using a set of food scales and a diary, to record all food and fluid that they ingest. This data will then be analysed using dietary analysis software (e.g. Nutritics)
Time Frame
from post-exercise (immediately after the intervention) until 24 hours post-baseline
Title
Changes in headache scores
Description
Participants will be asked to rate their headache on a scale of 0-10, with higher scores meaning a worse outcome .
Time Frame
pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
Title
Changes in nausea scores
Description
Participants will be asked to rate their nausea on a scale of 0-10, with higher scores meaning a worse outcome .
Time Frame
pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
Title
Changes in dizziness scores
Description
Participants will be asked to rate their dizziness on a scale of 0-10, with higher scores meaning a worse outcome .
Time Frame
pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
Title
Changes in thirst scores
Description
Participants will be asked to rate their thirst on a scale of 0-10, with higher scores meaning a worse outcome .
Time Frame
pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
Title
Changes in thermal comfort scores
Description
Participants will be asked to rate their thermal comfort on a scale of -10 to 10, with -10 being cold impossible to bear and 10 being heat impossible to bear
Time Frame
pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
Title
Changes in gastrointestinal comfort scores
Description
Participants will be asked to rate their gastrointestinal comfort on a scale of 0-10, with higher scores meaning a worse outcome .
Time Frame
pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
Title
Changes in stomach fullness scores
Description
Participants will be asked to rate their stomach fullness on a scale of 0-10, with higher scores meaning a worse outcome .
Time Frame
pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
Title
Changes in stomach bloatedness scores
Description
Participants will be asked to rate their stomach bloatedness on a scale of 0-10, with higher scores meaning a worse outcome .
Time Frame
pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
Title
Changes in urge to vomit scores
Description
Participants will be asked to rate their urge to vomit on a scale of 0-10, with higher scores meaning a worse outcome .
Time Frame
pre-exercise (baseline), every 30 minutes during exercise (30, 60,90 and 120 minutes), post-exercise (immediately after the intervention) and 24 hours post-baseline
Title
Changes in urinary creatinine
Time Frame
pre-exercise (baseline), post-exercise (immediately after the intervention) and 24 hours post-baseline
Title
Changes in heart rate
Description
Provides insight into exercise intensity
Time Frame
Will be monitored throughout the exercise intervention, at 15 minute intervals (15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes and 120 minutes)
Title
changes in rating of perceived exertion
Description
Provides insight into exercise intensity
Time Frame
Will be monitored throughout the exercise intervention, at 30 minute intervals (30 minutes, 60 minutes, 90 minutes and 120 minutes)
Title
Changes in aural temperature
Description
in-ear temperature
Time Frame
Will be determined immediately prior to the exercise intervention (at rest) and then throughout the exercise intervention at 15 minute intervals (15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes and 120 minutes)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy
recreationally active
Exclusion Criteria:
Smoker/vaper
regular use of anti-inflammatory medications (e.g. ibuprofen)
history of kidney disease or diabetes
Facility Information:
Facility Name
Loughborough University
City
Loughborough
ZIP/Postal Code
LE11 3TU
Country
United Kingdom
12. IPD Sharing Statement
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The Effect of Manipulating Hydration Status During Cycling in the Heat on Acute Kidney Injury Biomarkers
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