search
Back to results

The Effect of Water Carbonation on Orthostatic Tolerance

Primary Purpose

Orthostatic Hypotension, Syncope, Vasovagal Syncope

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
500mL carbonated water
500mL still water
50mL still water
Sponsored by
Simon Fraser University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthostatic Hypotension focused on measuring Tilt table, Osmopressor reflex, Gastropressor reflex

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Simon Fraser UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

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

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

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

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

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

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 10, 2022
Last Updated
April 17, 2023
Sponsor
Simon Fraser University
search

1. Study Identification

Unique Protocol Identification Number
NCT05621460
Brief Title
The Effect of Water Carbonation on Orthostatic Tolerance
Official Title
The Effect of Water Carbonation on Orthostatic Tolerance
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Simon Fraser University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension, Syncope, Vasovagal Syncope
Keywords
Tilt table, Osmopressor reflex, Gastropressor reflex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each participant will complete the test for every condition (3 tests per participant, order of treatment randomized).
Masking
Investigator
Masking Description
The investigator determining the end of the test (the time to presyncope) will be blinded to the condition.
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
500mL carbonated water first, then 500mL of still water, then 50mL of still water
Arm Type
Experimental
Arm Description
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.
Arm Title
500mL still water first, then 500 mL carbonated water, then 50mL still water
Arm Type
Experimental
Arm Description
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.
Arm Title
500mL carbonated water first, then 50mL of still water, then 500mL of still water
Arm Type
Experimental
Arm Description
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.
Arm Title
500mL still water first, then 50mL still water, then 500 mL carbonated water
Arm Type
Experimental
Arm Description
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.
Arm Title
50mL still water first, then 500mL still water, then 500 mL carbonated water
Arm Type
Experimental
Arm Description
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.
Arm Title
50mL still water first, then 500mL carbonated water, then 500 mL still water
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
500mL carbonated water
Intervention Description
Drink 500mL carbonated water immediately prior to head-up tilt test
Intervention Type
Other
Intervention Name(s)
500mL still water
Intervention Description
Drink 500mL still water immediately prior to head-up tilt test
Intervention Type
Other
Intervention Name(s)
50mL still water
Intervention Description
Drink 50mL still water immediately prior to head-up tilt test
Primary Outcome Measure Information:
Title
Orthostatic tolerance
Description
The time, in minutes, to presyncope (near-fainting) after the initiation of head-up tilt
Time Frame
0-50 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria E Claydon, PhD
Phone
7787828513
Email
victoria_claydon@sfu.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Vera-Ellen M Lucci, PhD
Phone
7787828560
Email
vlucci@sfu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria E Claydon, PhD
Organizational Affiliation
Professor, Biomedical Physiology and Kinesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simon Fraser University
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5A 1S6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vera-Ellen M Lucci, PhD
Phone
7787828560
Email
vlucci@sfu.ca
First Name & Middle Initial & Last Name & Degree
Victoria E Claydon, PhD
First Name & Middle Initial & Last Name & Degree
Vera-Ellen M Lucci, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be presented in aggregate form and no identifiers will be included.
Citations:
Citation
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
Results Reference
background
PubMed Identifier
11009136
Citation
Mathias CJ. A 21st century water cure. Lancet. 2000 Sep 23;356(9235):1046-8. doi: 10.1016/S0140-6736(00)02723-9.
Results Reference
background
PubMed Identifier
15379740
Citation
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.
Results Reference
background
PubMed Identifier
12451007
Citation
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.
Results Reference
background
PubMed Identifier
16037127
Citation
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.
Results Reference
background
PubMed Identifier
16321141
Citation
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.
Results Reference
background
PubMed Identifier
14623807
Citation
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. Erratum In: Circulation. 2005 Apr 5;111(13):1717.
Results Reference
background
PubMed Identifier
14671205
Citation
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.
Results Reference
background
PubMed Identifier
21048076
Citation
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.
Results Reference
background
PubMed Identifier
10662747
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
10823336
Citation
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.
Results Reference
background
PubMed Identifier
11198483
Citation
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.
Results Reference
background
PubMed Identifier
14981050
Citation
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.
Results Reference
background
PubMed Identifier
14564654
Citation
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.
Results Reference
background
PubMed Identifier
8054836
Citation
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.
Results Reference
background
PubMed Identifier
11571497
Citation
Cooper VL, Hainsworth R. Carotid baroreceptor reflexes in humans during orthostatic stress. Exp Physiol. 2001 Sep;86(5):677-81. doi: 10.1113/eph8602213.
Results Reference
background
PubMed Identifier
12357276
Citation
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.
Results Reference
background

Learn more about this trial

The Effect of Water Carbonation on Orthostatic Tolerance

We'll reach out to this number within 24 hrs