An interventional study of Placebo and β-OHB in Cerebrovascular Function and Cognition, sponsored by McMaster University. Recruiting at 1 site in Canada. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by McMaster University · Not applicable, Interventional, and Basic science
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.
McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single dose of a taste-matched calorie-free placebo
Other: Placebo
Single dose of a ketone monoester (\[R\]-3-hydroxybutyl \[R\]-3-hydroxybutyrate; 0.6 g β-OHB/kg body weight)
Dietary Supplement: β-OHB
Ingestion of a taste-matched calorie-free placebo drink followed by 90 minutes of rest.
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.
Brain network connectivity
Functional connectivity of the default mode network (DMN) is measured via functional MRI. Changes in BOLD signal in each region are determined by independent component analysis and then functional connectivity is measured as a Pearson correlation (r) between the neural regions comprising the DMN and transformed into a z score.
Time frame: 90 minutes
Cerebral blood flow
Sum of blood flow in the internal carotid and vertebral arteries via phase contrast MRI in ml/min.
Time frame: 90 minutes
Working memory
Computer battery to assess working memory (n-back test) based on N2 reaction time
Time frame: 90 minutes
Executive function
Computer battery to assess executive function (Stroop test) based on Stroop Cost (reaction times to incongruent stimuli minus congruent stimuli).
Time frame: 90 minutes
Attention and working memory
Computer battery to assess working memory (digit symbol substitution task) based on the number of correct responses in 120 seconds.
Time frame: 90 minutes
Mean arterial pressure
Automated blood pressure cuff measurement of brachial artery pressure in mmHg.
Time frame: 90 minutes
Plasma beta-hydroxybutyrate
Measured via finger capillary samples in mM
Time frame: 90 minutes
Plan to share: Yes — The investigators will share individual patient data (de-identified) with researchers upon request.
Supporting information: Study protocol, Sap, Analytic code
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