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| Name | Class |
|---|---|
| Lexaria Bioscience Corp. | INDUSTRY |
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Cannabidiol (CBD) is a bioactive cannabinoid compound in marijuana (cannabis sativa), but unlike Δ9 tetrahydrocannabinol (THC), lacks the psychoactivity effect of THC. Available evidence suggests that there are marked therapeutic CBD effects for diverse disease processes including inflammation, cancers, psychosis, and epileptic seizures. The purpose of this study, in both younger and older healthy humans, is to improve our understanding of how CBD might control and regulate blood vessel health as well as cognitive and exercise performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Sugar pill that will have no effect. |
|
| Cannabidiol and herbal capsules (1 dose) | Active Comparator | Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil. |
|
| Cannabidiol (1 dose) | Active Comparator | Only cannabidiol supplement. |
|
| Cannabidiol and herbal capsules (2 dose) | Active Comparator | Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil. |
|
| Cannabidiol only (2 dose) | Active Comparator | Only cannabidiol supplement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol supplement | Dietary Supplement | Subjects will be administered in a double-blinded, randomized and cross-over design |
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| Measure | Description | Time Frame |
|---|---|---|
| Circulating cannabidiol and nitric oxide markers | Measured by venous blood sampling | Through study completion, an average of 1 year |
| Vascular function | Duplex ultrasound system | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Height | Height in cm | Through study completion, an average of 1 year |
| Weight | Weight in kg | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Kelowna | Ontario | V1V 1V7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31512143 | Derived | Patrician A, Versic-Bratincevic M, Mijacika T, Banic I, Marendic M, Sutlovic D, Dujic Z, Ainslie PN. Examination of a New Delivery Approach for Oral Cannabidiol in Healthy Subjects: A Randomized, Double-Blinded, Placebo-Controlled Pharmacokinetics Study. Adv Ther. 2019 Nov;36(11):3196-3210. doi: 10.1007/s12325-019-01074-6. Epub 2019 Sep 12. |
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Individual values will be reported in figures if applicable.
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| Body mass index | Body mass in kilograms divided by height in meters squared | Through study completion, an average of 1 year |
| Systolic blood pressure | Measured by automated sphygmomanometer | Through study completion, an average of 1 year |
| Diastolic blood pressure | Measured by automated sphygmomanometer | Through study completion, an average of 1 year |
| Heart rate | Measured by 3-lead electrocardiogram | Through study completion, an average of 1 year |
| Respiration | Measured by spirometry | Through study completion, an average of 1 year |
| Medical History Questionnaire | Assesses inclusion/exclusion criteria and prior history of medical conditions. | Through study completion, an average of 1 year |
| Gastrointestinal Distress Questionnaire | Measured using a 10 cm visual analogue scale | Through study completion, an average of 1 year |
| Anxiety Questionnaire | Assessed with a visual analog scale | Through study completion, an average of 1 year |
| Cognitive performance | Computerized battery of neuropsychological tests | Through study completion, an average of 1 year |
| Exercise performance | Step-wise exercise test on cycle ergometer | Through study completion, an average of 1 year |