HypohydratedNCT04140045
The Effect of Manipulating Hydration Status During Cycling in the Heat on Acute Kidney Injury Biomarkers
A study testing Water intake in people with Hypohydrated and Euhydrated, run by Loughborough University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypohydrated, Euhydrated
- What is being tested?
- Water intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2019to 17 Mar 2020
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- recreationally active
Who cannot join
- Smoker/vaper
- regular use of anti-inflammatory medications (e.g. ibuprofen)
- history of kidney disease or diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hypohydration During Cycling in the Heat on Acute Kidney Injury Biomarkers
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.
- Conditions
- Hypohydrated, Euhydrated
- Being tested
- Water intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water intakeOther
Water intake will be manipulated in both arms to create a hypohydrated state and a euhydrated state, post-exercise
| Study group | Role | What they receive |
|---|---|---|
| Hypohydrated | Experimental | 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%. Receives: Other: Water intake |
| Euhydrated | Experimental | Participants will be provided with water intake that matches their sweat losses during cycling in the heat (90-120 minutes at 35°C) Receives: Other: Water intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Changes in urinary neutrophil gelatinase-associated lipocalin (uNGAL) (uncorrected/raw values and urine osmolality-corrected values)
A novel protein biomarker for acute kidney injury
Measured: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Changes in urine osmolality
A measure of urine concentration.
Measured: Pre-exercise (baseline) and post-exercise (immediately after the intervention), as well as all urine produced from post-exercise until 24 hours post-baseline
Changes in serum creatinine
Serum creatinine is a marker of kidney function
Measured: Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baseline
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
Measured: Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baseline
Secondary outcomes (19)
Plasma volume changes
Measured: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Changes in serum osmolality
The gold standard marker of hydration status
Measured: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Body mass changes
Measured: pre-exercise (baseline), throughout exercise, post-exercise (immediately after the intervention), 24 hours post-baseline
Changes in creatine kinase
A marker of muscle damage
Measured: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Changes in lactate dehydrogenase
A marker of muscle damage
Measured: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
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)
Measured: from post-exercise (immediately after the intervention) until 24 hours post-baseline
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 .
Measured: 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
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 .
Measured: 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
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 .
Measured: 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
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 .
Measured: 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
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
Measured: 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
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 .
Measured: 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
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 .
Measured: 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
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 .
Measured: 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
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 .
Measured: 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
Changes in urinary creatinine
Measured: pre-exercise (baseline), post-exercise (immediately after the intervention) and 24 hours post-baseline
Changes in heart rate
Provides insight into exercise intensity
Measured: 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)
changes in rating of perceived exertion
Provides insight into exercise intensity
Measured: Will be monitored throughout the exercise intervention, at 30 minute intervals (30 minutes, 60 minutes, 90 minutes and 120 minutes)
Changes in aural temperature
in-ear temperature
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start28 Oct 2019
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypohydratedStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loris Juett, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140045
- Sponsor's protocol ID
- R19-P130
- Status last verified
- Jul 2020
- First submitted
- 21 Oct 2019
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hypohydration During Cycling in the Heat on Acute Kidney Injury Biomarkers
- ClinicalTrials.gov ID
- NCT04140045
- Acronym / sponsor ID
- R19-P130
- Conditions
- Hypohydrated, Euhydrated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 25 Oct 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypohydrated | Experimental | Other: Water intakeParticipants 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%. |
| Euhydrated | Experimental | Other: Water intakeParticipants will be provided with water intake that matches their sweat losses during cycling in the heat (90-120 minutes at 35°C) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- recreationally active
Key exclusion criteria (3 listed)
- Smoker/vaper
- regular use of anti-inflammatory medications (e.g. ibuprofen)
- history of kidney disease or diabetes
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 intakeWater intake will be manipulated in both arms to create a hypohydrated state and a euhydrated state, post-exercise | Other | Euhydrated, Hypohydrated |
Primary outcome
Changes in urinary Kidney Injury Molecule 1 (uKIM-1) (uncorrected/raw values and urine osmolality-corrected values)
Time frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
A novel protein biomarker for acute kidney injury
Changes in urinary neutrophil gelatinase-associated lipocalin (uNGAL) (uncorrected/raw values and urine osmolality-corrected values)
Time frame: 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
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
A measure of urine concentration.
Changes in serum creatinine
Time frame: Pre-exercise (baseline), post-exercise (immediately post-exercise), 24 hours post-baseline
Serum creatinine is a marker of kidney function
Incidence of Acute Kidney Injury (as determined by changes in serum creatinine)
Time frame: 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
19 secondary outcomes
Plasma volume changes
Time frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Changes in serum osmolality
Time frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Body mass changes
Time frame: pre-exercise (baseline), throughout exercise, post-exercise (immediately after the intervention), 24 hours post-baseline
Changes in creatine kinase
Time frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Changes in lactate dehydrogenase
Time frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline
Ad libitum energy (Kj), carbohydrate (g), sugar (g), protein (g), fat (g), saturated fat (g), sodium (g) and water intake (g).
Time frame: from post-exercise (immediately after the intervention) until 24 hours post-baseline
Changes in headache scores
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
Changes in nausea scores
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
Changes in dizziness scores
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
Changes in thirst scores
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
Changes in thermal comfort scores
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
Changes in gastrointestinal comfort scores
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
Changes in stomach fullness scores
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
Changes in stomach bloatedness scores
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
Changes in urge to vomit scores
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
Changes in urinary creatinine
Time frame: pre-exercise (baseline), post-exercise (immediately after the intervention) and 24 hours post-baseline
Changes in heart rate
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)
changes in rating of perceived exertion
Time frame: Will be monitored throughout the exercise intervention, at 30 minute intervals (30 minutes, 60 minutes, 90 minutes and 120 minutes)
Changes in aural 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)
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 3 Aug 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 intake in people with Hypohydrated and Euhydrated, run by Loughborough University at 1 site in United Kingdom.
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 2 inclusion and 3 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 3 Aug 2020. 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 Kingdom. 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. 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?
Changes in urinary Kidney Injury Molecule 1 (uKIM-1) (uncorrected/raw values and urine osmolality-corrected values) (time frame: Pre-exercise (baseline), post-exercise (immediately after the intervention), 24 hours post-baseline). The study lists 5 primary outcomes in all. 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 3 Aug 2020.