ClinicalTrials.gg
RecruitingNCT05621460Updated Apr 23, 2026

The Effect of Water Carbonation on Orthostatic Tolerance

An interventional study of 500mL carbonated water and 500mL still water in Orthostatic Hypotension, Syncope and Vasovagal Syncope, sponsored by Simon Fraser University. Recruiting at 1 site in Canada. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Simon Fraser University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Orthostatic Hypotension
  • Syncope
  • Vasovagal Syncope

Keywords

  • Tilt table
  • Osmopressor reflex
  • Gastropressor reflex
03

In context

Hypotension, Orthostatic

159 studies on the registry are indexed under Hypotension, Orthostatic; 35 are open to participants now.

This study's planned enrollment of 25 is below the median of 28 across 113 interventional studies indexed under Hypotension, Orthostatic.

Browse Hypotension, Orthostatic studies →

Lead sponsor

Simon Fraser University is the lead sponsor of 29 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy, English-speaking

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    500mL carbonated water first, then 500mL of still water, then 50mL of still water

    Participants 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.

    Other: 500mL carbonated water · Other: 500mL still water · Other: 50mL still water

  • Experimental
    500mL still water first, then 500 mL carbonated water, then 50mL still water

    Participants 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.

    Other: 500mL carbonated water · Other: 500mL still water · Other: 50mL still water

  • Experimental
    500mL carbonated water first, then 50mL of still water, then 500mL of still water

    Participants 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.

    Other: 500mL carbonated water · Other: 500mL still water · Other: 50mL still water

  • Experimental
    500mL still water first, then 50mL still water, then 500 mL carbonated water

    Participants 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.

    Other: 500mL carbonated water · Other: 500mL still water · Other: 50mL still water

  • Experimental
    50mL still water first, then 500mL still water, then 500 mL carbonated water

    Participants 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.

    Other: 500mL carbonated water · Other: 500mL still water · Other: 50mL still water

  • Experimental
    50mL still water first, then 500mL carbonated water, then 500 mL still water

    Participants 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.

    Other: 500mL carbonated water · Other: 500mL still water · Other: 50mL still water

Interventions

  • Other500mL carbonated water

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

  • Other500mL still water

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

  • Other50mL still water

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

06

What researchers measure

Primary outcomes

  1. Orthostatic tolerance

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

    Time frame: 0-50 minutes

07

Study locations

1 of 1 sites recruiting
  • Simon Fraser University
    Burnaby, British Columbia V5A 1S6, Canada
    Recruiting
    • Vera-Ellen M Lucci, PhD · Contactvlucci@sfu.ca · 7787828560
    • Victoria E Claydon, PhD · Principal investigator
    • Vera-Ellen M Lucci, PhD · Sub investigator
08

References and documents

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 ↗
  • el-Bedawi KM, Hainsworth R. Combined head-up tilt and lower body suction: a test of orthostatic tolerance. Clin Auton Res. 1994 Apr;4(1-2):41-7. doi: 10.1007/BF01828837. PubMed 8054836 ↗
  • Cooper VL, Hainsworth R. Carotid baroreceptor reflexes in humans during orthostatic stress. Exp Physiol. 2001 Sep;86(5):677-81. doi: 10.1113/eph8602213. PubMed 11571497 ↗
  • Cooper VL, Hainsworth R. Effects of dietary salt on orthostatic tolerance, blood pressure and baroreceptor sensitivity in patients with syncope. Clin Auton Res. 2002 Aug;12(4):236-41. doi: 10.1007/s10286-002-0018-x. PubMed 12357276 ↗

Individual participant data

Plan to share: No — Data will be presented in aggregate form and no identifiers will be included.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Apr 2027, 43 months after the start.

Of 34 interventional studies with no phase under Hypotension, Orthostatic, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 70. This study's planned 43 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 10, 2022
First posted
Nov 18, 2022
StartActual
Sep 1, 2023
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
Apr 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05621460
Lead sponsor
Simon Fraser University
Responsible party
Dr. Victoria Claydon (Professor, Simon Fraser University) — Principal investigator
First posted
Nov 18, 2022
Start date
Sep 1, 2023
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Apr 23, 2026

Study contacts

Victoria E Claydon, PhD
Contact
victoria_claydon@sfu.ca
7787828513
Vera-Ellen M Lucci, PhD
Contact
vlucci@sfu.ca
7787828560
Victoria E Claydon, PhD
principal investigator · Professor, Biomedical Physiology and Kinesiology

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion