Cannabinoid Supplementation on Vascular and Cognitive Function

Early Phase 1

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Cannabidiol supplement	Sugar pill that will have no effect.
Cannabidiol (1 dose)	Cannabidiol supplement	Only cannabidiol supplement.
Cannabidiol and herbal capsules (2 dose)	Cannabidiol supplement	Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.
Cannabidiol only (2 dose)	Cannabidiol supplement	Only cannabidiol supplement.
Cannabidiol and herbal capsules (1 dose)	Cannabidiol supplement	Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.

Primary Outcome Measures

Name	Time	Method
Circulating cannabidiol and nitric oxide markers	Through study completion, an average of 1 year	Measured by venous blood sampling
Vascular function	Through study completion, an average of 1 year	Duplex ultrasound system

Secondary Outcome Measures

Name	Time	Method
Height	Through study completion, an average of 1 year	Height in cm
Weight	Through study completion, an average of 1 year	Weight in kg
Body mass index	Through study completion, an average of 1 year	Body mass in kilograms divided by height in meters squared
Systolic blood pressure	Through study completion, an average of 1 year	Measured by automated sphygmomanometer
Diastolic blood pressure	Through study completion, an average of 1 year	Measured by automated sphygmomanometer
Heart rate	Through study completion, an average of 1 year	Measured by 3-lead electrocardiogram
Respiration	Through study completion, an average of 1 year	Measured by spirometry
Medical History Questionnaire	Through study completion, an average of 1 year	Assesses inclusion/exclusion criteria and prior history of medical conditions.
Gastrointestinal Distress Questionnaire	Through study completion, an average of 1 year	Measured using a 10 cm visual analogue scale
Anxiety Questionnaire	Through study completion, an average of 1 year	Assessed with a visual analog scale
Cognitive performance	Through study completion, an average of 1 year	Computerized battery of neuropsychological tests
Exercise performance	Through study completion, an average of 1 year	Step-wise exercise test on cycle ergometer

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