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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06217159
Other study ID # MEKC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 19, 2024
Est. completion date August 31, 2024

Study information

Verified date January 2024
Source McMaster University
Contact Jeremy J Walsh, PhD
Phone 9055259140
Email walshj18@mcmaster.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Oral supplements containing exogenous ketones have recently become available and represent a novel tool for increasing plasma ketone bodies without the need for dietary restriction. Early evidence suggests that oral ketone supplements may enhance cerebral blood flow (CBF). However, a higher dose of a ketone monoester has been shown to slightly lower blood pH and reduce end-tidal CO2 (PetCO2) due to compensatory hyperventilation, which is accompanied by parallel reductions in CBF. Whether reductions in PetCO2 causes reductions in CBF is currently unknown. The purpose of this study is to investigate the effect of manipulating PetCO2 at normocapnia (PetCO2 maintained at baseline) or poikilocapnia (no PetCO2 targeting; breathing room air), following the ingestion of a dose of a ketone monoester on CBF and cerebrovascular reactivity to CO2 in young adults.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 31, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Having a normal blood pressure (=125/=85 mmHg) - Between the ages of 18 and 35 Exclusion Criteria: - Individuals who are obese (body mass index > 30 kg/m^2) - Individuals who smoke - Individuals with respiratory illnesses - A history of type 2 diabetes, hypoglycemia, or cardiovascular diseases (i.e. heart attack, stroke) - Individuals currently following a ketogenic diet or taking ketone supplements - Individuals with a history of concussion(s) with persistent symptoms - Individuals participating in elite-level physical training (i.e. varsity athletics)

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Poikilocapnia
Following ingestion of 0.6 g ß-OHB/kg body weight ketone monoester, participants will wear a specialized face mask and breathe room air for 60 min. The face mask will be attached to an automated gas-blender system; however, only room air will be delivered.
Normocapnia
Following ingestion of 0.6 g ß-OHB/kg body weight ketone monoester, participants will be outfitted with a specialized face mask and breathe air with a slightly higher concentration of CO2 to maintain PetCO2 to resting baseline values for 60 min. Gas will be continuously delivered by an automated gas-blender system.

Locations

Country Name City State
Canada McMaster University Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resting cerebral blood flow (CBF) Measured via duplex ultrasound of the internal carotid artery and vertebral artery 90-minutes
Secondary Plasma beta-hydroxybutyrate area under the curve Venous blood samples will be obtained via intravenous catheter 90-minutes
Secondary Blood pH Venous blood samples will be obtained via intravenous catheter 90-minutes
Secondary End-tidal CO2 Breath-by-breath analysis performed via RespirAct (RespirAct, Thornhill Research, Toronto, ON, Canada). 90-minutes
Secondary Mean arterial pressure (MAP) Automated blood pressure cuff measurements of brachial artery pressure in mmHg 90-minutes
Secondary Cerebrovascular Reactivity of the Internal Carotid and Middle Cerebral Artery as assessed by Duplex Ultrasound and Transcranial Doppler Ultrasound, respectively. Automated gas-blender used to apply sequential gas delivery using an algorithm to target end-tidal CO2 at +3mmHg, +6mmHg, and +9mmHg above baseline, using five-minute step-wise stages. Simultaneously, changes in cerebral blood flow in the internal carotid artery and the middle cerebral artery will be assessed using duplex ultrasound and transcranial Doppler ultrasound, respectively. The final minute of each stage will be analyzed to characterize the slope of cerebrovascular reactivity to CO2 in the internal carotid artery and the middle cerebral artery. 90-minutes
Secondary Middle Cerebral Artery Blood Velocity Measured via transcranial Doppler Ultrasound using a 2MHz probe 90-minutes
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