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Orthostatic HypotensionNCT05621460

The Effect of Water Carbonation on Orthostatic Tolerance

A study testing 500mL carbonated water, 500mL still water and 50mL still water in people with Orthostatic Hypotension and Syncope, run by Simon Fraser University at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The primary purpose of this investigation is to determine whether water carbonation can improve orthostatic tolerance in healthy control volunteers. Orthostatic tolerance refers to the ability to maintain an adequate blood pressure when standing. Read more about this study

Who is it for?
Ages 19 to 50 yearsHealthy volunteers can take part
What is being tested?
500mL carbonated water, 500mL still water and 50mL still water
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteCanada
Study dates
1 Sep 2023to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 19 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • healthy, English-speaking

Who cannot join

  • pregnancy or suspected pregnancy, history of cardiovascular disease, history of neurological disease, history of recurrent fainting (≥ 2 episodes of fainting with loss of consciousness in the prior 6 months)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Victoria E Claydon, PhD contact

7787828513

victoria_claydon@sfu.ca

Vera-Ellen M Lucci, PhD contact

7787828560

vlucci@sfu.ca

Canada1 site, 1 recruiting
  • Simon Fraser University

    Burnaby, British Columbia, V5A 1S6

    Vera-Ellen M Lucci, PhD, 7787828560, vlucci@sfu.ca

    Victoria E Claydon, PhD

    Recruiting

Other trials in Canada

About this study

The primary purpose of this investigation is to determine whether water carbonation can improve orthostatic tolerance in healthy control volunteers. Orthostatic tolerance refers to the ability to maintain an adequate blood pressure when standing. In some individuals blood pressure can fall when standing, predisposing to dizzy spells or fainting episodes. Drinking water can boost blood pressure and making fainting episodes less likely. However, it is not clear whether the carbonation of the water has any further impact on the blood pressure response. This is important because it may be that carbonated water expands the stomach (gastric distension), provoking an increase in sympathetic activity. The increase in sympathetic nervous system activity boosts blood pressure. Resolving this question would have important implications for patients with syncope. This study will test whether carbonated water will have any further impact on blood pressure than the already known effect of non-carbonated water.

Read the detailed description

The primary purpose of this investigation is to determine whether water carbonation can improve orthostatic tolerance in healthy control volunteers. Orthostatic tolerance refers to the ability to maintain an adequate blood pressure when standing [1]. In some individuals blood pressure can fall when standing, predisposing to dizzy spells or fainting episodes [1]. Drinking water can boost blood pressure and making fainting episodes less likely [2-8]. However, it is not clear whether the carbonation of the water has any further impact on the blood pressure response [9,10]. This is important because it may be that carbonated water expands the stomach (gastric distension), provoking an increase in sympathetic activity. The increase in sympathetic nervous system activity boosts blood pressure. Resolving this question would have important implications for patients with syncope. This study will test whether carbonated water will have any further impact on blood pressure than the already known effect of non-carbonated water.

Volunteers (n=25) will be asked to undergo a "tilt test" to assess cardiovascular reflex control and orthostatic tolerance (measured as time to presyncope, or near fainting, in minutes). It has been previously shown that this technique to be reproducible, reliable, and to have high sensitivity and specificity for differentiating persons with differing orthostatic tolerance, or for examining the effects of interventions aimed at improving orthostatic tolerance [4,6,11-18].

Volunteers will undergo this test on three separate days. On each day participants will be asked to drink a glass of water: either a 50ml drink of room temperature water (control condition), a 500ml drink of flat (non-carbonated) room temperature water, or a 500ml drink of carbonated room temperature water. The study will be conducted in a randomised, single-blind fashion. The investigator responsible for terminating the test will be blinded as to the water condition on each test day, rendering the study single blind. It will not be possible to blind participants as to the carbonation of the water, however, participants will not be informed as to the hypothesised impact of the water conditions.

Being tested
500mL carbonated water, 500mL still water, 50mL still water
Keywords
Tilt table, Osmopressor reflex, Gastropressor reflex
Medical subject headings
Hypotension, Orthostatic, Syncope, Syncope, Vasovagal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 500mL carbonated waterOther

    Drink 500mL carbonated water immediately prior to head-up tilt test

  • 500mL still waterOther

    Drink 500mL still water immediately prior to head-up tilt test

  • 50mL still waterOther

    Drink 50mL still water immediately prior to head-up tilt test

Study groups in NCT05621460
Study groupRoleWhat they receive
500mL carbonated water first, then 500mL of still water, then 50mL of still waterExperimentalParticipants will undergo this test on three separate days. On each day participants will be asked to drink a glass of water: either a 50mL drink of still water (control condition), a 500mL drink of still (non-carbonated) water, or a 500mL drink of carbonated water. In this arm of the study, participants will receive 500mL carbonated water on the first test day, 500mL still water on the second test day, then 50mL still water on the third day.
Receives: Other: 500mL carbonated water; Other: 500mL still water; Other: 50mL still water
500mL still water first, then 500 mL carbonated water, then 50mL still waterExperimentalParticipants will undergo this test on three separate days. On each day participants will be asked to drink a glass of water: either a 50mL drink of still water (control condition), a 500mL drink of still (non-carbonated) water, or a 500mL drink of carbonated water. In this arm of the study, participants will receive 500mL still water on the first test day, 500mL carbonated water on the second test day, then 50mL still water on the third day.
Receives: Other: 500mL carbonated water; Other: 500mL still water; Other: 50mL still water
500mL carbonated water first, then 50mL of still water, then 500mL of still waterExperimentalParticipants will undergo this test on three separate days. On each day participants will be asked to drink a glass of water: either a 50mL drink of still water (control condition), a 500mL drink of still (non-carbonated) water, or a 500mL drink of carbonated water. In this arm of the study, participants will receive 500mL carbonated water on the first test day, 50mL still water on the second test day, then 500mL still water on the third day.
Receives: Other: 500mL carbonated water; Other: 500mL still water; Other: 50mL still water
500mL still water first, then 50mL still water, then 500 mL carbonated waterExperimentalParticipants will undergo this test on three separate days. On each day participants will be asked to drink a glass of water: either a 50mL drink of still water (control condition), a 500mL drink of still (non-carbonated) water, or a 500mL drink of carbonated water. In this arm of the study, participants will receive 500mL still water on the first test day, 50mL still water on the second test day, then 500mL carbonated water on the third day.
Receives: Other: 500mL carbonated water; Other: 500mL still water; Other: 50mL still water
50mL still water first, then 500mL still water, then 500 mL carbonated waterExperimentalParticipants will undergo this test on three separate days. On each day participants will be asked to drink a glass of water: either a 50mL drink of still water (control condition), a 500mL drink of still (non-carbonated) water, or a 500mL drink of carbonated water. In this arm of the study, participants will receive 50mL still water on the first test day, 500mL carbonated water on the second test day, then 500mL carbonated water on the third day.
Receives: Other: 500mL carbonated water; Other: 500mL still water; Other: 50mL still water
50mL still water first, then 500mL carbonated water, then 500 mL still waterExperimentalParticipants will undergo this test on three separate days. On each day participants will be asked to drink a glass of water: either a 50mL drink of still water (control condition), a 500mL drink of still (non-carbonated) water, or a 500mL drink of carbonated water. In this arm of the study, participants will receive 50mL still water on the first test day, 500mL still water on the second test day, then 500mL still water on the third day.
Receives: Other: 500mL carbonated water; Other: 500mL still water; Other: 50mL still water

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Orthostatic tolerance

    The time, in minutes, to presyncope (near-fainting) after the initiation of head-up tilt

    Measured: 0-50 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2022
  2. Study start1 Sep 2023
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Each participant will complete the test for every condition (3 tests per participant, order of treatment randomized).
Masking
Single blind
Who is masked
Investigator
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05621460
Sponsor's protocol ID
30000955
Status last verified
Apr 2026
First submitted
10 Nov 2022
Last updated
23 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be presented in aggregate form and no identifiers will be included.

Publications

  • Hainsworth R, Claydon V E. Syncope and fainting: classification and physiological basis. In: Bannister R, Mathias CJ, eds. Autonomic failure: a textbook of clinical disorders of the autonomic nervous system. Oxford: Oxford University Press, 2006

  • Mathias CJ. A 21st century water cure. Lancet. 2000 Sep 23;356(9235):1046-8. doi: 10.1016/S0140-6736(00)02723-9.

    PubMed 11009136
  • Mathias CJ, Young TM. Water drinking in the management of orthostatic intolerance due to orthostatic hypotension, vasovagal syncope and the postural tachycardia syndrome. Eur J Neurol. 2004 Sep;11(9):613-9. doi: 10.1111/j.1468-1331.2004.00840.x.

    PubMed 15379740
  • Schroeder C, Bush VE, Norcliffe LJ, Luft FC, Tank J, Jordan J, Hainsworth R. Water drinking acutely improves orthostatic tolerance in healthy subjects. Circulation. 2002 Nov 26;106(22):2806-11. doi: 10.1161/01.cir.0000038921.64575.d0.

    PubMed 12451007
  • Brown CM, Barberini L, Dulloo AG, Montani JP. Cardiovascular responses to water drinking: does osmolality play a role? Am J Physiol Regul Integr Comp Physiol. 2005 Dec;289(6):R1687-92. doi: 10.1152/ajpregu.00205.2005. Epub 2005 Jul 21.

    PubMed 16037127
  • Claydon VE, Schroeder C, Norcliffe LJ, Jordan J, Hainsworth R. Water drinking improves orthostatic tolerance in patients with posturally related syncope. Clin Sci (Lond). 2006 Mar;110(3):343-52. doi: 10.1042/CS20050279.

    PubMed 16321141
  • Lu CC, Diedrich A, Tung CS, Paranjape SY, Harris PA, Byrne DW, Jordan J, Robertson D. Water ingestion as prophylaxis against syncope. Circulation. 2003 Nov 25;108(21):2660-5. doi: 10.1161/01.CIR.0000101966.24899.CB. Epub 2003 Nov 17.

    PubMed 14623807
  • Boschmann M, Steiniger J, Hille U, Tank J, Adams F, Sharma AM, Klaus S, Luft FC, Jordan J. Water-induced thermogenesis. J Clin Endocrinol Metab. 2003 Dec;88(12):6015-9. doi: 10.1210/jc.2003-030780.

    PubMed 14671205
  • May M, Jordan J. The osmopressor response to water drinking. Am J Physiol Regul Integr Comp Physiol. 2011 Jan;300(1):R40-6. doi: 10.1152/ajpregu.00544.2010. Epub 2010 Nov 3.

    PubMed 21048076
  • Jordan J, Shannon JR, Black BK, Ali Y, Farley M, Costa F, Diedrich A, Robertson RM, Biaggioni I, Robertson D; New Collective Author. The pressor response to water drinking in humans : a sympathetic reflex? Circulation. 2000 Feb 8;101(5):504-9. doi: 10.1161/01.cir.101.5.504.

    PubMed 10662747
  • Al Shamma YMA, Hainsworth R. A quantitative comparison of the circulatory responses in humans to graded upright tilting and graded lower body negative pressure. Cardiogenic Reflexes (1987):431-432.

  • Brown CM, Hainsworth R. Forearm vascular responses during orthostatic stress in control subjects and patients with posturally related syncope. Clin Auton Res. 2000 Apr;10(2):57-61. doi: 10.1007/BF02279892.

    PubMed 10823336
  • Bush VE, Wight VL, Brown CM, Hainsworth R. Vascular responses to orthostatic stress in patients with postural tachycardia syndrome (POTS), in patients with low orthostatic tolerance, and in asymptomatic controls. Clin Auton Res. 2000 Oct;10(5):279-84. doi: 10.1007/BF02281110.

    PubMed 11198483
  • Claydon VE, Hainsworth R. Salt supplementation improves orthostatic cerebral and peripheral vascular control in patients with syncope. Hypertension. 2004 Apr;43(4):809-13. doi: 10.1161/01.HYP.0000122269.05049.e7. Epub 2004 Feb 23.

    PubMed 14981050
  • Claydon VE, Hainsworth R. Cerebral autoregulation during orthostatic stress in healthy controls and in patients with posturally related syncope. Clin Auton Res. 2003 Oct;13(5):321-9. doi: 10.1007/s10286-003-0120-8.

    PubMed 14564654

Questions about this trial

What is this clinical trial studying?

A study testing 500mL carbonated water, 500mL still water and 50mL still water in people with Orthostatic Hypotension and Syncope, run by Simon Fraser University at 1 site in Canada.

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 1 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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 Canada. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Victoria E Claydon, PhD (7787828513, victoria_claydon@sfu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Orthostatic tolerance (time frame: 0-50 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05621460, which also lists 18 linked publications.

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 23 Apr 2026.

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