Simon Fraser University
Burnaby, British Columbia, V5A 1S6, Canada
Location status: Recruiting
Location contact
Vera-Ellen M Lucci, PhD
CONTACT
Vera-Ellen M Lucci, PhD
SUB_INVESTIGATOR
Victoria E Claydon, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05621460
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.
Interested in participating?
Request Info19 year–50 year
All sexes
Interventional
Not applicable
Burnaby, British Columbia, V5A 1S6, Canada
Location status: Recruiting
Vera-Ellen M Lucci, PhD
CONTACT
Vera-Ellen M Lucci, PhD
SUB_INVESTIGATOR
Victoria E Claydon, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drink 500mL carbonated water immediately prior to head-up tilt test
Drink 500mL still water immediately prior to head-up tilt test
Drink 50mL still water immediately prior to head-up tilt test
Time frame: 0-50 minutes
The time, in minutes, to presyncope (near-fainting) after the initiation of head-up tilt
Contact information is provided by the study sponsor or research team.
Vera-Ellen M Lucci, PhD
CONTACT
Victoria E Claydon, PhD
CONTACT
Simon Fraser University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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