HydrationNCT03525470
Autonomic Adaptations to Hydration and Brain Functioning
A study testing Water and No drink in people with Hydration, run by Swansea University.
Trial summary
The influence of relatively small decreases in hydration status have been little studied. On two occasions subjects will be allowed to lose about 0,5% of their body weight and one occasion 300ml of water will be consumed. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hydration
- What is being tested?
- Water and No drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Apr 2018
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self declared as healthy and not taking any medication
Who cannot join
None listed.
About this study
Official title: Autonomic Adaptation to Hydration and Brain Functioning
The influence of relatively small decreases in hydration status have been little studied. On two occasions subjects will be allowed to lose about 0,5% of their body weight and one occasion 300ml of water will be consumed. Functional MRI will be used to monitor brain functioning when performing a mental arithmetic task. Heart rate variability will be monitored and related to differences in brain functioning when water has and has not been drunk
Read the detailed description
On two mornings twelve male participants will be exposed to a temperature of 30oC for four hours and either drink or not drink two 150ml glasses of water during that time. The subjects the participate in an fMRI protocol during which they complete a modified version of the Paced Auditory Serial Addition Test (PASAT): a challenging arithmetic task designed to elicit autonomic arousal.
Throughout the morning subjects will their heart rate variability (HRV) monitored. At periodic intervals subjects will rate their thirst and mood by visual analogue scales and at the end of the PASAT task they rate its difficulty. Changes in body temperature and fluid loss (perspiration and urine) and urine osmolality will be monitored.
- Conditions
- Hydration
- Being tested
- Water, No drink
- Keywords
- Hydration, Brain functioning, Heart-rate variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterBiological
150 mil of water was drunk on two occasions
No drinkOther
Although body weight lost no drink consumed
| Study group | Role | What they receive |
|---|---|---|
| Water | Experimental | Subjects consumed water Receives: Biological: Water |
| No water | Experimental | Subjects did not consume water Receives: Other: No drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD signal
Participants will be presented with an arithmetic task, modified for use in the scanner, similar to the Paced Auditory Serial Addition Task: a 'stressful' task that measures calculation ability and is known to elicit an autonomic response 35. Pairs of two digit numbers appeared on a screen in red and participants will be required to mentally add or subtract the numbers. After 2 seconds the screens will be removed and a second screen appeared containing a correct and an incorrect answer. Participants will be required to press either a left or right button to indicate which answer was correct ). The speed of presentation is designed to be just at the level that it is possible to perform the task although it required mental effort and was 'stressful'.This allows investigation of areas of the brain associated with working memory but also those associated with emotional arousal.
Measured: One hour in scanner (1300-1400 hours)
Heart-rate variability
Differences in inter-beat intervals derived from RS800 Polar heart rate monitor with a sampling rate of 1000Hz. Profile to be analysed using the Kubios software
Measured: Differences on two testing occasions (0900 and 1300 hours) will be related to BOLD
Secondary outcomes (3)
Ratings of ,mood and perceived effort
Using visual analogue scales mood and perceived effort will be rated.
Measured: Rated baseline (0830 hours), 30 mins later, 280 minutes later
Change in body weight
Scales, sensitive to 5 grams, will be used to monitor changes in body weight
Measured: Measured at baseline (0830 hours), after 290 minutes (before urinating) and 300 mintues (after urinating)
Osmolality
Using an Osmomat 300 freezing point osmometer the osmolality of urine will be measured at the beginning and end of testing sessions
Measured: Baseline (0830 hours) and after 300 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start1 Jan 2016
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross-over design where on one occasion subjects lost 0.5% body weight,and drank 300ml water and on another occasion nothing was consumed
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Benton, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525470
- Sponsor's protocol ID
- DB-0123-Hydration
- Status last verified
- May 2018
- First submitted
- 13 Apr 2018
- Last updated
- 15 May 2018
- 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 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Adaptation to Hydration and Brain Functioning
- ClinicalTrials.gov ID
- NCT03525470
- Acronym / sponsor ID
- DB-0123-Hydration
- Conditions
- Hydration
- Keywords
- Hydration, Brain functioning, Heart-rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 15 May 2018 (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.
The influence of relatively small decreases in hydration status have been little studied. On two occasions subjects will be allowed to lose about 0,5% of their body weight and one occasion 300ml of water will be consumed. Functional MRI will be used to monitor brain functioning when performing a mental arithmetic task. Heart rate variability will be monitored and related to differences in brain functioning when water has and has not been drunk
Detailed description
On two mornings twelve male participants will be exposed to a temperature of 30oC for four hours and either drink or not drink two 150ml glasses of water during that time. The subjects the participate in an fMRI protocol during which they complete a modified version of the Paced Auditory Serial Addition Test (PASAT): a challenging arithmetic task designed to elicit autonomic arousal.
Throughout the morning subjects will their heart rate variability (HRV) monitored. At periodic intervals subjects will rate their thirst and mood by visual analogue scales and at the end of the PASAT task they rate its difficulty. Changes in body temperature and fluid loss (perspiration and urine) and urine osmolality will be monitored.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-over design where on one occasion subjects lost 0.5% body weight,and drank 300ml water and on another occasion nothing was consumed
| Arm | Type | Receives |
|---|---|---|
| Water | Experimental | Biological: WaterSubjects consumed water |
| No water | Experimental | Other: No drinkSubjects did not consume water |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Self declared as healthy and not taking any medication
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Water150 mil of water was drunk on two occasions | Biological | Water |
| No drinkAlthough body weight lost no drink consumed | Other | No water |
Primary outcome
BOLD signal
Time frame: One hour in scanner (1300-1400 hours)
Participants will be presented with an arithmetic task, modified for use in the scanner, similar to the Paced Auditory Serial Addition Task: a 'stressful' task that measures calculation ability and is known to elicit an autonomic response 35. Pairs of two digit numbers appeared on a screen in red and participants will be required to mentally add or subtract the numbers. After 2 seconds the screens will be removed and a second screen appeared containing a correct and an incorrect answer. Participants will be required to press either a left or right button to indicate which answer was correct ). The speed of presentation is designed to be just at the level that it is possible to perform the task although it required mental effort and was 'stressful'.This allows investigation of areas of the brain associated with working memory but also those associated with emotional arousal.
Heart-rate variability
Time frame: Differences on two testing occasions (0900 and 1300 hours) will be related to BOLD
Differences in inter-beat intervals derived from RS800 Polar heart rate monitor with a sampling rate of 1000Hz. Profile to be analysed using the Kubios software
3 secondary outcomes
Ratings of ,mood and perceived effort
Time frame: Rated baseline (0830 hours), 30 mins later, 280 minutes later
Change in body weight
Time frame: Measured at baseline (0830 hours), after 290 minutes (before urinating) and 300 mintues (after urinating)
Osmolality
Time frame: Baseline (0830 hours) and after 300 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 15 May 2018.
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Hydration Status
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.
Questions about this trial
What is this clinical trial studying?
A study testing Water and No drink in people with Hydration, run by Swansea University.
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 0 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 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
BOLD signal (time frame: One hour in scanner (1300-1400 hours)). The study lists 2 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 15 May 2018.