Oral Ketone Monoester Supplementation and Resting-state Brain Connectivity

Not Applicable

Recruiting

• Conditions: Cerebrovascular Function; Cognition
• Interventions: Other: Placebo; Dietary Supplement: β-OHB

• Registration Number: NCT05992571
• Lead Sponsor: McMaster University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Study Start: 2023-10-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single dose of a taste-matched calorie-free placebo
β-OHB	β-OHB	Single dose of a ketone monoester (\[R\]-3-hydroxybutyl \[R\]-3-hydroxybutyrate; 0.6 g β-OHB/kg body weight)

Primary Outcome Measures

Name	Time	Method
Brain network connectivity	90 minutes	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.
Cerebral blood flow	90 minutes	Sum of blood flow in the internal carotid and vertebral arteries via phase contrast MRI in ml/min.

Secondary Outcome Measures

Name	Time	Method
Executive function	90 minutes	Computer battery to assess executive function (Stroop test) based on Stroop Cost (reaction times to incongruent stimuli minus congruent stimuli).
Attention and working memory	90 minutes	Computer battery to assess working memory (digit symbol substitution task) based on the number of correct responses in 120 seconds.
Working memory	90 minutes	Computer battery to assess working memory (n-back test) based on N2 reaction time

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada