Oral Ketone Monoester Supplementation and Resting-state Brain Connectivity

Cognition Clinical Trial

Official title:

The Impact of Acute Oral Ketone Monoester Supplementation on Resting-state Brain Connectivity in Adults With Memory Complaints

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992571
• Other study ID #: rs-KME
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: McMaster University
• Contact: Jeremy Walsh, PhD
• Phone: 905-525-9140
• Email: walshj18[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Function
• Cognition

Intervention

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

Dietary Supplement:
• ß-OHB
Ingestion of a high dose [R]-3-hydroxybutyl [R]-3-hydroxybutyrate (0.6 g ß-OHB/kg body weight) followed by 90 minutes of rest.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Alzheimer's Society of Brant, Haldimand Norfolk, Hamilton Halton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean arterial pressure	Automated blood pressure cuff measurement of brachial artery pressure in mmHg.	90 minutes
Other	Plasma beta-hydroxybutyrate	Measured via finger capillary samples in mM	90 minutes
Primary	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.	90 minutes
Primary	Cerebral blood flow	Sum of blood flow in the internal carotid and vertebral arteries via phase contrast MRI in ml/min.	90 minutes
Secondary	Working memory	Computer battery to assess working memory (n-back test) based on N2 reaction time	90 minutes
Secondary	Executive function	Computer battery to assess executive function (Stroop test) based on Stroop Cost (reaction times to incongruent stimuli minus congruent stimuli).	90 minutes
Secondary	Attention and working memory	Computer battery to assess working memory (digit symbol substitution task) based on the number of correct responses in 120 seconds.	90 minutes