The Effect of Manipulating Hydration Status During Cycling in the Heat on Acute Kidney Injury Biomarkers
- Conditions
- HypohydratedEuhydrated
- Interventions
- Other: Water intake
- Registration Number
- NCT04140045
- Lead Sponsor
- Loughborough University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 14
- Healthy
- recreationally active
- Smoker/vaper
- regular use of anti-inflammatory medications (e.g. ibuprofen)
- history of kidney disease or diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Euhydrated Water intake Participants will be provided with water intake that matches their sweat losses during cycling in the heat (90-120 minutes at 35°C) Hypohydrated Water intake 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%.
- Primary Outcome Measures
Name Time Method Changes in urinary neutrophil gelatinase-associated lipocalin (uNGAL) (uncorrected/raw values and urine osmolality-corrected values) Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline A novel protein biomarker for acute kidney injury
Changes in serum creatinine Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baseline Serum creatinine is a marker of kidney function
Changes in urinary Kidney Injury Molecule 1 (uKIM-1) (uncorrected/raw values and urine osmolality-corrected values) Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline A novel protein biomarker for acute kidney injury
Changes in urine osmolality Pre-exercise (baseline) and post-exercise (immediately after the intervention), as well as all urine produced from post-exercise until 24 hours post-baseline A measure of urine concentration.
Incidence of Acute Kidney Injury (as determined by changes in serum creatinine) Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baseline A rise in serum creatinine of 1.5 fold or more from baseline will be defined as acute kidney injury
- Secondary Outcome Measures
Name Time Method Changes in creatine kinase Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline A marker of muscle damage
Changes in nausea scores 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 Participants will be asked to rate their nausea on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in stomach fullness scores 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 Participants will be asked to rate their stomach fullness on a scale of 0-10, with higher scores meaning a worse outcome .
Plasma volume changes Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline Body mass changes pre-exercise (baseline), throughout exercise, post-exercise (immediately after the intervention), 24 hours post-baseline Changes in thirst scores 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 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 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 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 stomach bloatedness scores 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 Participants will be asked to rate their stomach bloatedness on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in serum osmolality Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline The gold standard marker of hydration status
Changes in lactate dehydrogenase Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline 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). from post-exercise (immediately after the intervention) until 24 hours post-baseline 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 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 Participants will be asked to rate their headache on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in dizziness scores 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 Participants will be asked to rate their dizziness on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in gastrointestinal comfort scores 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 Participants will be asked to rate their gastrointestinal comfort on a scale of 0-10, with higher scores meaning a worse outcome .
Changes in urge to vomit scores 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 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 pre-exercise (baseline), post-exercise (immediately after the intervention) and 24 hours post-baseline Changes in heart rate 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) Provides insight into exercise intensity
changes in rating of perceived exertion Will be monitored throughout the exercise intervention, at 30 minute intervals (30 minutes, 60 minutes, 90 minutes and 120 minutes) Provides insight into exercise intensity
Changes in aural temperature 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) in-ear temperature
Trial Locations
- Locations (1)
Loughborough University
🇬🇧Loughborough, United Kingdom