Ketone Dose and Cerebral Blood Flow Study (kCBF)

McMaster University

Status: Enrolling

Conditions: Cerebrovascular Function; Cognition

Treatments: Dietary Supplement: High Dose β-OHB; Dietary Supplement: Low Dose β-OHB; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06032156

kCBF

Details and patient eligibility

About

Ketone bodies are produced by the liver during periods of food scarcity or severe carbohydrate restriction. Blood ketones are an alternative fuel source used by the brain, heart, and skeletal muscle during periods of fasting. Further, ketones bodies act as a signalling molecule that have pleiotropic effects that upregulate cellular stress-resistance pathways throughout the body.

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 and improve cognition. However, the dose-dependent effects of a single ketone supplement on cerebral blood flow and cognition in young adults is currently unknown.

The purpose of this study is to characterize the effects of ingesting a high versus low dose of an oral ketone monoester on cerebral blood flow, circulating blood markers, and cognition in young adults.

As an exploratory aim, this study will investigate how oxygen uptake kinetics during submaximal exercise are impacted 2 hours after ingestion of a ketone supplement. Recent findings indicate that ketone supplementation may impair exercise performance due to the physiological stress (i.e., pH disturbances) imposed by an acute ketone dose. Delaying exercise onset by 2 hours after ingestion of a ketone supplement may enhance oxygen kinetics in a dose-dependent manner.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Between the ages of 18 and 35

Exclusion criteria

• Presence of obesity (body mass index > 30 kg/m^2)
• Presence of known cardiovascular disease
• Presence of type 2 diabetes
• History of cardiovascular events requiring hospitalization (i.e., heart attack)
• History of concussion(s) with persistent symptoms
• Currently following a ketogenic diet and/or taking ketone body supplements

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Single dose of a taste-matched calorie-free placebo

Treatment:

Other: Placebo

High Dose β-OHB

Experimental group

Description:

Single dose of a ketone monoester (\[R\]-3-hydroxybutyl \[R\]-3-hydroxybutyrate; 0.6 g β-OHB/kg body weight)

Treatment:

Dietary Supplement: High Dose β-OHB

Low Dose β-OHB

Experimental group

Description:

Single dose of a ketone monoester (\[R\]-3-hydroxybutyl \[R\]-3-hydroxybutyrate; 0.3 g β-OHB/kg body weight)

Treatment:

Dietary Supplement: Low Dose β-OHB