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Exogenous ketone supplements are proposed to have glucose-lowering potential, provide an alternative fuel for the brain and to enhance cognitive function. No studies have tested whether exogenous ketones can lower blood glucose in people with type 2 diabetes. In addition, the impact of exogenous ketones on brain blood flow, cognitive function or brain-derived neurotrophic factor in humans is unknown. The purpose of this study is to determine if acutely ingesting exogenous ketones, in the form of a ketone monoester drink, can lower glucose and improve measures of brain/cognitive function in humans with type 2 diabetes. Participants will consume a ketone monoester drink or placebo with blood samples, brain blood flow, and cognitive function assessed over 180 minutes. The researchers will also test how the ketone monoester drink impacts appetite and measures of inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketone monoester | Experimental | Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight) |
|
| Placebo | Placebo Comparator | Acute dose of flavour-matched placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone monoester | Dietary Supplement | Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Glucose | Plasma glucose concentration after ketone or placebo ingestion | 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Insulin | Insulin across concentration after ketone or placebo ingestion | 180 minutes |
| Plasma C-peptide | C-peptide across concentration after ketone or placebo ingestion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia, Okanagan | Kelowna | British Columbia | V1V 1V7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39804761 | Derived | Baranowski BJ, Oliveira BF, Falkenhain K, Little JP, Mohammad A, Beaudette SM, Finch MS, Caldwell HG, Neudorf H, MacPherson REK, Walsh JJ. Effect of exogenous beta-hydroxybutyrate on BDNF signaling, cognition, and amyloid precursor protein processing in humans with T2D and insulin-resistant rodents. Am J Physiol Cell Physiol. 2025 Feb 1;328(2):C541-C556. doi: 10.1152/ajpcell.00867.2024. Epub 2025 Jan 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo-Ketones | Crossover design: Placebo - washout period of >2days - Ketones |
| FG001 | Ketones-Placebo | Crossover design: Ketones - washout period of >2days - Placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Total participants independent of crossover order (Placebo-Ketones and Ketones-Placebo). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Glucose | Plasma glucose concentration after ketone or placebo ingestion | Posted | Mean | Standard Deviation | mmol/L | 180 minutes |
|
About two weeks. Timeframe of first visit and second visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall | Total participants independent of crossover order (Placebo-Ketones and Ketones-Placebo). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan Little | University of British Columbia | (250) 807-9876 | jonathan.little@ubc.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 2, 2022 | Mar 14, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 2, 2022 | Mar 14, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007662 | Ketosis |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Placebo masked with flavouring and participants consume in opaque containers.
| Placebo | Dietary Supplement | Acute ingestion of taste-matched placebo prior to assessment of outcomes. |
|
| 180 minutes |
| Plasma Free Fatty Acids | Non-esterified fatty acid concentration after ketone or placebo ingestion | 180 minutes |
| Plasma Tumour Necrosis Factor Alpha | Plasma tumour necrosis factor alpha concentration after ketone or placebo ingestion | 180 minutes |
| Plasma Tumour Interleukin-1beta | Plasma tumour interleukin-1beta concentration after ketone or placebo ingestion | 180 minutes |
| Plasma Tumour Interleukin-6 | Plasma tumour interleukin-6 concentration after ketone or placebo ingestion | 180 minutes |
| Cerebral Blood Flow | Intracranial blood flow velocity measured by ultrasound | 180 minutes |
| Blood Pressure | Blood pressure measured manually and by Finipres | 180 minutes |
| Cognitive Function - Digital Symbol Substitution Task | Number of Correct Answers on the Digital Symbol Substitution Task. Measure of cognitive function using Brain Baseline battery on an iPad. | 180 minutes |
| Brain-derived Neurotrophic Factor | Brain-derived neurotrophic factor concentrations after ketone or placebo ingestion | 180 minutes |
| Number Blood Monocytes (x10^3 Cells/uL) | Total blood monocytes count (x10^3 cells/uL) after ketone or placebo ingestion | 180 minutes |
| Self Reported Hunger and Fullness | Self reported hunger and fullness by a 0 to 100 mm Visual Analog Scale (higher scores mean greater hunger or fullness) | 180 minutes |
| Gastrointestinal Symptoms | Gastrointestinal symptom questionnaire scores after ketone or placebo ingestion on a 0 to 100 mm Visual Analog Scale (higher scores mean greater symptoms) | 180 minutes |
| Total Energy Consumed | Total energy consumed in kilocalories in buffet style meal after ketone or placebo ingestion | 180 minutes after ketone or placebo ingestion |
| Monocyte Histone Acetylation | Histone acetylation status of monocytes measured after ketone or placebo ingestion | 180 minutes |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
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| Secondary | Plasma Insulin | Insulin across concentration after ketone or placebo ingestion | Posted | Mean | Standard Deviation | pg/mL | 180 minutes |
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| Secondary | Plasma C-peptide | C-peptide across concentration after ketone or placebo ingestion | Posted | Mean | Standard Deviation | pg/mL | 180 minutes |
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| Secondary | Plasma Free Fatty Acids | Non-esterified fatty acid concentration after ketone or placebo ingestion | Posted | Mean | Standard Deviation | mmol/L | 180 minutes |
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| Secondary | Plasma Tumour Necrosis Factor Alpha | Plasma tumour necrosis factor alpha concentration after ketone or placebo ingestion | Posted | Mean | Standard Deviation | pg/mL | 180 minutes |
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| Secondary | Plasma Tumour Interleukin-1beta | Plasma tumour interleukin-1beta concentration after ketone or placebo ingestion | Posted | Mean | Standard Deviation | fg/mL | 180 minutes |
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| Secondary | Plasma Tumour Interleukin-6 | Plasma tumour interleukin-6 concentration after ketone or placebo ingestion | Posted | Mean | Standard Deviation | pg/mL | 180 minutes |
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| Secondary | Cerebral Blood Flow | Intracranial blood flow velocity measured by ultrasound | Procedure not completed due to the unavailability of a specialized research staff. Data was not and will not be obtained and reported. | Posted | 180 minutes |
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| Secondary | Blood Pressure | Blood pressure measured manually and by Finipres | Posted | Mean | Standard Deviation | mmHg | 180 minutes |
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| Secondary | Cognitive Function - Digital Symbol Substitution Task | Number of Correct Answers on the Digital Symbol Substitution Task. Measure of cognitive function using Brain Baseline battery on an iPad. | Posted | Mean | Standard Deviation | number correct | 180 minutes |
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| Secondary | Brain-derived Neurotrophic Factor | Brain-derived neurotrophic factor concentrations after ketone or placebo ingestion | Posted | Mean | Standard Deviation | ng/mL | 180 minutes |
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| Secondary | Number Blood Monocytes (x10^3 Cells/uL) | Total blood monocytes count (x10^3 cells/uL) after ketone or placebo ingestion | Posted | Mean | Standard Deviation | x10^3 cells/uL | 180 minutes |
|
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| Secondary | Self Reported Hunger and Fullness | Self reported hunger and fullness by a 0 to 100 mm Visual Analog Scale (higher scores mean greater hunger or fullness) | Posted | Mean | Standard Deviation | mm | 180 minutes |
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| Secondary | Gastrointestinal Symptoms | Gastrointestinal symptom questionnaire scores after ketone or placebo ingestion on a 0 to 100 mm Visual Analog Scale (higher scores mean greater symptoms) | Posted | Median | Full Range | mm | 180 minutes |
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| Secondary | Total Energy Consumed | Total energy consumed in kilocalories in buffet style meal after ketone or placebo ingestion | Posted | Mean | Standard Deviation | kcal | 180 minutes after ketone or placebo ingestion |
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| Secondary | Monocyte Histone Acetylation | Histone acetylation status of monocytes measured after ketone or placebo ingestion | This assay was not performed due to insufficient sample quantity. | Posted | 180 minutes |
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
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| D003920 |
| Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| Diastolic blood pressure baseline |
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| Diastolic blood pressure 180min |
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| bloating |
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| belching |
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| cramping |
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