The Effect of Water Carbonation on Orthostatic Tolerance

NCT05621460 | Recruiting

• 1 other identifier: 30000955
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthostatic Hypotension; Syncope; Vasovagal Syncope

Keywords

Tilt table; Osmopressor reflex; Gastropressor reflex

Outcome Measures

Primary Outcomes (1)

• Orthostatic tolerance

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

  0-50 minutes

Study Arms (6)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

500mL carbonated water OTHER

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

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

500mL still water OTHER

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

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

50mL still water OTHER

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

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

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy, English-speaking

You may not qualify if:

• 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)

Sponsors & Collaborators

• Simon Fraser University: lead

Study Sites (1)

Simon Fraser University

Burnaby, British Columbia, V5A 1S6, Canada

RECRUITING

Related Publications (18)

• 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

  BACKGROUND

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

  PMID: 11009136 BACKGROUND

• 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.

  PMID: 15379740 BACKGROUND

• 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.

  PMID: 12451007 BACKGROUND

• 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.

  PMID: 16037127 BACKGROUND

• 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.

  PMID: 16321141 BACKGROUND

• 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.

  PMID: 14623807 BACKGROUND

• 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.

  PMID: 14671205 BACKGROUND

• 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.

  PMID: 21048076 BACKGROUND

• 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.

  PMID: 10662747 BACKGROUND

• 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.

  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.

  PMID: 10823336 BACKGROUND

• 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.

  PMID: 11198483 BACKGROUND

• 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.

  PMID: 14981050 BACKGROUND

• 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.

  PMID: 14564654 BACKGROUND

• 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.

  PMID: 8054836 BACKGROUND

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

  PMID: 11571497 BACKGROUND

• 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.

  PMID: 12357276 BACKGROUND

MeSH Terms

Conditions

Hypotension, Orthostatic; Syncope; Syncope, Vasovagal

Interventions

Carbonated Water

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mineral Waters; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Carbonated Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Drinking Water; Food and Beverages

Study Officials

• Victoria E Claydon, PhD

  Professor, Biomedical Physiology and Kinesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria E Claydon, PhD

CONTACT

7787828513; victoria_claydon@sfu.ca

Vera-Ellen M Lucci, PhD

CONTACT

7787828560; vlucci@sfu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator determining the end of the test (the time to presyncope) will be blinded to the condition.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 18, 2022
• Study Start: September 1, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)