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Oral Ketone Monoester Supplementation and Resting-state Brain Connectivity

NCT ID: NCT05992571

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-25

Study Completion Date

2024-08-31

Brief Summary

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People who report subjective memory complaints have a greater risk of developing dementia. Memory issues may be an early warning sign of dysfunctional cerebral glucose metabolism and cerebral blood flow. Interventions that can restore cerebral metabolism and enhance cerebral blood flow may protect against conversion to dementia. Exogenous ketone supplements have been shown rapidly improves brain network function in young adults. Further, infusion studies demonstrate that ketone bodies enhance cerebral blood flow in cognitively normal adults. Whether acute ketone monoester supplementation can improve brain function in adults with subjective memory complaints is currently unknown.

This study will investigate the effects of a single ketone monoester dose on resting-state functional connectivity in the default mode network and resting cerebral blood flow in adults with subjective memory complaints.

Detailed Description

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Conditions

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Cerebrovascular Function Cognition

Keywords

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Beta-hydroxybutyrate (β-OHB) cerebral blood flow cognition brain connectivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A randomized double-blind placebo-controlled crossover design will be used to test two conditions. Participants will consume 60 mL of: 1) a drink containing a ketone monoester supplement (\[R\]-3-hydroxybutyl \[R\]-3-hydroxybutyrate; 0.3 g β-OHB/kg body weight); and 2) a taste-matched calorie-free inert placebo drink.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Single dose of a taste-matched calorie-free placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Ingestion of a taste-matched calorie-free placebo drink followed by 90 minutes of rest.

β-OHB

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

Group Type EXPERIMENTAL

β-OHB

Intervention Type DIETARY_SUPPLEMENT

Ingestion of a high dose \[R\]-3-hydroxybutyl \[R\]-3-hydroxybutyrate (0.6 g β-OHB/kg body weight) followed by 90 minutes of rest.

Interventions

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Placebo

Ingestion of a taste-matched calorie-free placebo drink followed by 90 minutes of rest.

Intervention Type OTHER

β-OHB

Ingestion of a high dose \[R\]-3-hydroxybutyl \[R\]-3-hydroxybutyrate (0.6 g β-OHB/kg body weight) followed by 90 minutes of rest.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* between the ages of 55 and 70
* presence of subjective memory complaints as determined by the Prospective- Retrospective Memory Questionnaire
* cognitively normal, e.g. score ≥26 on the Montreal Cognitive Assessment

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 in the past 3 years (e.g., heart attack, stroke)
* History of concussion(s) with persistent symptoms
* Currently following a ketogenic diet and/or taking ketone body supplements
* Diagnosis of any form of Alzheimer's disease or dementia
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alzheimer's Society of Brant, Haldimand Norfolk, Hamilton Halton

UNKNOWN

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Walsh

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeremy Walsh, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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McMaster University

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jeremy Walsh, PhD

Role: CONTACT

Phone: 905-525-9140

Email: [email protected]

Facility Contacts

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Jeremy Walsh, PhD

Role: primary

Other Identifiers

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rs-KME

Identifier Type: -

Identifier Source: org_study_id