Cerebrovascular FunctionNCT05992571
Oral Ketone Monoester Supplementation and Resting-state Brain Connectivity
A study testing β-OHB in people with Cerebrovascular Function and Cognition, run by McMaster University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Function, Cognition
- What is being tested?
- β-OHB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 25 Oct 2023to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario, L8S 4K1
Jeremy Walsh, PhD, 9055259140 ext. 23523, walshj18@mcmaster.ca
About this study
Official title: The Impact of Acute Oral Ketone Monoester Supplementation on Resting-state Brain Connectivity in Adults With Memory Complaints
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.
- Conditions
- Cerebrovascular Function, Cognition
- Being tested
- Placebo, β-OHB
- Keywords
- Beta-hydroxybutyrate (β-OHB), cerebral blood flow, cognition, brain connectivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Ingestion of a taste-matched calorie-free placebo drink followed by 90 minutes of rest.
β-OHBDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Single dose of a taste-matched calorie-free placebo Receives: Other: Placebo |
| β-OHB | Experimental | Single dose of a ketone monoester ([R]-3-hydroxybutyl [R]-3-hydroxybutyrate; 0.6 g β-OHB/kg body weight) Receives: Dietary Supplement: β-OHB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 minutes
Cerebral blood flow
Sum of blood flow in the internal carotid and vertebral arteries via phase contrast MRI in ml/min.
Measured: 90 minutes
Secondary outcomes (3)
Working memory
Computer battery to assess working memory (n-back test) based on N2 reaction time
Measured: 90 minutes
Executive function
Computer battery to assess executive function (Stroop test) based on Stroop Cost (reaction times to incongruent stimuli minus congruent stimuli).
Measured: 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.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start25 Oct 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular FunctionStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Society of Brant, Haldimand Norfolk, Hamilton Halton
- Responsible party
- Principal investigator, Jeremy Walsh, McMaster University
- Investigators
- Jeremy Walsh, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992571
- Sponsor's protocol ID
- rs-KME
- Status last verified
- Nov 2023
- First submitted
- 7 Jun 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share individual patient data (de-identified) with researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Acute Oral Ketone Monoester Supplementation on Resting-state Brain Connectivity in Adults With Memory Complaints
- ClinicalTrials.gov ID
- NCT05992571
- Acronym / sponsor ID
- rs-KME
- Conditions
- Cerebrovascular Function, Cognition
- Keywords
- Beta-hydroxybutyrate (β-OHB), cerebral blood flow, cognition, brain connectivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Alzheimer's Society of Brant, Haldimand Norfolk, Hamilton Halton
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboSingle dose of a taste-matched calorie-free placebo |
| β-OHB | Experimental | Dietary Supplement: β-OHBSingle dose of a ketone monoester ([R]-3-hydroxybutyl [R]-3-hydroxybutyrate; 0.6 g β-OHB/kg body weight) |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboIngestion of a taste-matched calorie-free placebo drink followed by 90 minutes of rest. | Other | Placebo |
| β-OHBIngestion of a high dose [R]-3-hydroxybutyl [R]-3-hydroxybutyrate (0.6 g β-OHB/kg body weight) followed by 90 minutes of rest. | Dietary supplement | β-OHB |
Primary outcome
Brain network connectivity
Time frame: 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
Time frame: 90 minutes
Sum of blood flow in the internal carotid and vertebral arteries via phase contrast MRI in ml/min.
3 secondary outcomes
Working memory
Time frame: 90 minutes
Executive function
Time frame: 90 minutes
Attention and working memory
Time frame: 90 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: Yes. The investigators will share individual patient data (de-identified) with researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Walsh, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing β-OHB in people with Cerebrovascular Function and Cognition, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeremy Walsh, PhD (905-525-9140 ext. 23523, walshj18@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain network connectivity (time frame: 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.