The Effect of Water Carbonation on Orthostatic Tolerance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Orthostatic Hypotension Syncope Vasovagal Syncope

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each participant will complete the test for every condition (3 tests per participant, order of treatment randomized).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The investigator determining the end of the test (the time to presyncope) will be blinded to the condition.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

500mL carbonated water

Intervention Type OTHER

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

500mL still water

Intervention Type OTHER

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

50mL still water

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

500mL carbonated water

Intervention Type OTHER

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

500mL still water

Intervention Type OTHER

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

50mL still water

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

500mL carbonated water

Intervention Type OTHER

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

500mL still water

Intervention Type OTHER

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

50mL still water

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

500mL carbonated water

Intervention Type OTHER

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

500mL still water

Intervention Type OTHER

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

50mL still water

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

500mL carbonated water

Intervention Type OTHER

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

500mL still water

Intervention Type OTHER

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

50mL still water

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

500mL carbonated water

Intervention Type OTHER

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

500mL still water

Intervention Type OTHER

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

50mL still water

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

500mL carbonated water

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

Intervention Type OTHER

500mL still water

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

Intervention Type OTHER

50mL still water

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* healthy, English-speaking

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)

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Victoria Claydon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Victoria E Claydon, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor, Biomedical Physiology and Kinesiology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Simon Fraser University

Burnaby, British Columbia, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Victoria E Claydon, PhD

Role: CONTACT

[email protected]

7787828513

Vera-Ellen M Lucci, PhD

Role: CONTACT

[email protected]

7787828560

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Vera-Ellen M Lucci, PhD

Role: primary

[email protected]

7787828560

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

PMID: 11009136 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 15379740 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12451007 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16037127 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16321141 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 14623807 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 14671205 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 21048076 (View on PubMed)

Jordan J, Shannon JR, Black BK, Ali Y, Farley M, Costa F, Diedrich A, Robertson RM, Biaggioni I, Robertson D. 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.

Reference Type BACKGROUND

PMID: 10662747 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

PMID: 10823336 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11198483 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 14981050 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 14564654 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 8054836 (View on PubMed)

Cooper VL, Hainsworth R. Carotid baroreceptor reflexes in humans during orthostatic stress. Exp Physiol. 2001 Sep;86(5):677-81. doi: 10.1113/eph8602213.

Reference Type BACKGROUND

PMID: 11571497 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12357276 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

30000955

Identifier Type: -

Identifier Source: org_study_id

The Effect of Water Carbonation on Orthostatic Tolerance

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

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

500mL carbonated water

500mL still water

50mL still water

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

500mL carbonated water

500mL still water

50mL still water

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

500mL carbonated water

500mL still water

50mL still water

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

500mL carbonated water

500mL still water

50mL still water

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

500mL carbonated water

500mL still water

50mL still water

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

500mL carbonated water

500mL still water

50mL still water

Interventions

500mL carbonated water

500mL still water

50mL still water

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Simon Fraser University

Responsible Party

Dr. Victoria Claydon

Principal Investigators

Victoria E Claydon, PhD

Locations

Simon Fraser University

Countries

Central Contacts

Victoria E Claydon, PhD

Vera-Ellen M Lucci, PhD

Facility Contacts

Vera-Ellen M Lucci, PhD

References

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.

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.

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.

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.

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.

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.

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.

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.

Jordan J, Shannon JR, Black BK, Ali Y, Farley M, Costa F, Diedrich A, Robertson RM, Biaggioni I, Robertson D. 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.

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.

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.

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.

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.

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.

Cooper VL, Hainsworth R. Carotid baroreceptor reflexes in humans during orthostatic stress. Exp Physiol. 2001 Sep;86(5):677-81. doi: 10.1113/eph8602213.

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.

Other Identifiers

30000955