Clinical trial NCT05992571: Oral Ketone Monoester Supplementation and Resting-state Brain Connectivity
Official title: The Impact of Acute Oral Ketone Monoester Supplementation on Resting-state Brain Connectivity in Adults With Memory Complaints
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebrovascular Function
Cognition
Keywords: Beta-hydroxybutyrate (β-OHB)
cerebral blood flow
cognition
brain connectivity
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Alzheimer's Society of Brant, Haldimand Norfolk, Hamilton Halton
First posted: 2023-08-15
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Brain network connectivity
timeFrame: 90 minutes
measure: Cerebral blood flow
timeFrame: 90 minutes
Secondary outcomes:
measure: Working memory
timeFrame: 90 minutes
measure: Executive function
timeFrame: 90 minutes
measure: Attention and working memory
timeFrame: 90 minutes
Other outcomes:
measure: Mean arterial pressure
timeFrame: 90 minutes
measure: Plasma beta-hydroxybutyrate
timeFrame: 90 minutes
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Jeremy Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
References: