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| Name | Class |
|---|---|
| Alzheimer's Society of Brant, Haldimand Norfolk, Hamilton Halton | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single dose of a taste-matched calorie-free placebo |
|
| β-OHB | Experimental | Single dose of a ketone monoester ([R]-3-hydroxybutyl [R]-3-hydroxybutyrate; 0.6 g β-OHB/kg body weight) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Ingestion of a taste-matched calorie-free placebo drink followed by 90 minutes of rest. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cerebral blood flow | Sum of blood flow in the internal carotid and vertebral arteries via phase contrast MRI in ml/min. | 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Working memory | Computer battery to assess working memory (n-back test) based on N2 reaction time | 90 minutes |
| Executive function | Computer battery to assess executive function (Stroop test) based on Stroop Cost (reaction times to incongruent stimuli minus congruent stimuli). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean arterial pressure | Automated blood pressure cuff measurement of brachial artery pressure in mmHg. | 90 minutes |
| Plasma beta-hydroxybutyrate | Measured via finger capillary samples in mM |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Walsh, PhD | Contact | 905-525-9140 | 23523 | walshj18@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jeremy Walsh, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Recruiting | Hamilton | Ontario | L8S 4K1 | Canada |
The investigators will share individual patient data (de-identified) with researchers upon request.
Beginning 9 months and ending 36 months following article publication.
Anyone who wishes to access the data.
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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.
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| β-OHB | Dietary 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. |
|
| 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. | 90 minutes |
| 90 minutes |