Diet Modification
Conditions
Keywords
Vascular function, Cannabidiol supplementation
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.
Interventions
DIETARY_SUPPLEMENTCannabidiol supplement
Subjects will be administered in a double-blinded, randomized and cross-over design
Sponsors
Lexaria Bioscience Corp.
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Height | Through study completion, an average of 1 year | Height in cm |
| 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 |
| Medical History Questionnaire | Through study completion, an average of 1 year | Assesses inclusion/exclusion criteria and prior history of medical conditions. |
| Weight | Through study completion, an average of 1 year | Weight in kg |
Countries
Canada
Outcome results
None listed