Cannabinoid Supplementation on Vascular and Cognitive Function

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Cannabinoids on Vascular and Cognitive Function in Young and Old Healthy Adults.

Conditions
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Diet Modification

Intervention / Treatment
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* Dietary Supplement: Cannabidiol supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-smoking non-obese between the ages of 18-30 & 60-75 years have no history of cardiopulmonary, liver, gastrointestinal, kidney or cerebrovascular disease. Exclusion Criteria: are obese are taking prescription drugs or over-the-counter supplements that influence cardiovascular or nitric oxide metabolism have a history of smoking have history of cardiovascular, respiratory (including asthma) or neurological disease have known intolerance to ginseng or ginkgo herbals have kidney, gastrointestinal or liver disease have epilepsy have diabetes are pregnant or breast feeding do not speak English as first language a student in the University of British Columbia (UBC) Okanagan Centre for Heart, Lung and Vascular Health medical or recreational use of cannabis clinically diagnosed anxiety or depression history of opioid use unwilling or unable to execute the informed consent documentation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Sugar pill that will have no effect. | Dietary Supplement: Cannabidiol supplement<br>* Subjects will be administered in a double-blinded, randomized and cross-over design<br>|
| Active Comparator: Cannabidiol and herbal capsules (1 dose)<br>Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil. | Dietary Supplement: Cannabidiol supplement<br>* Subjects will be administered in a double-blinded, randomized and cross-over design<br>|
| Active Comparator: Cannabidiol (1 dose)<br>Only cannabidiol supplement. | Dietary Supplement: Cannabidiol supplement<br>* Subjects will be administered in a double-blinded, randomized and cross-over design<br>|
| Active Comparator: Cannabidiol and herbal capsules (2 dose)<br>Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil. | Dietary Supplement: Cannabidiol supplement<br>* Subjects will be administered in a double-blinded, randomized and cross-over design<br>|
| Active Comparator: Cannabidiol only (2 dose)<br>Only cannabidiol supplement. | Dietary Supplement: Cannabidiol supplement<br>* Subjects will be administered in a double-blinded, randomized and cross-over design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular function, Cannabidiol supplementation