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Clinical Trials/NCT06217159
NCT06217159CompletedNot Applicable

The Mechanistic Effect of Ketones on Cerebral Blood Flow and Cerebrovascular Function

McMaster University1 site in 1 country23 target enrollmentStarted: January 19, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
23
Locations
1
Primary Endpoint
Resting cerebral blood flow (CBF)

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

Poikilocapnia

Sham Comparator

Room air-breathing

Intervention: Poikilocapnia (Dietary Supplement)

Normocapnia

Experimental

Breathing air mixture with slightly elevated CO2 to maintain PetCO2 to resting baseline levels

Intervention: Normocapnia (Dietary Supplement)

Outcomes

Primary Outcomes

Resting cerebral blood flow (CBF)

Time Frame: 90-minutes

Measured via duplex ultrasound of the internal carotid artery and vertebral artery

Secondary Outcomes

  • Plasma beta-hydroxybutyrate area under the curve(90-minutes)
  • Middle Cerebral Artery Blood Velocity(90-minutes)
  • Cerebrovascular Reactivity of the Internal Carotid and Middle Cerebral Artery as assessed by Duplex Ultrasound and Transcranial Doppler Ultrasound, respectively.(90-minutes)
  • Blood pH(90-minutes)
  • End-tidal CO2(90-minutes)
  • Mean arterial pressure (MAP)(90-minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeremy Walsh

Assistant Professor

McMaster University

Study Sites (1)

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