Clinical trial NCT03295903: Cannabinoid Supplementation on Vascular and Cognitive Function
Official title: The Effects of Cannabinoids on Vascular and Cognitive Function in Young and Old Healthy Adults.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Diet Modification
Keywords: Vascular function
Cannabidiol supplementation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Lexaria Bioscience Corp.
First posted: 2017-09-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Circulating cannabidiol and nitric oxide markers
timeFrame: Through study completion, an average of 1 year
measure: Vascular function
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Height
timeFrame: Through study completion, an average of 1 year
measure: Weight
timeFrame: Through study completion, an average of 1 year
measure: Body mass index
timeFrame: Through study completion, an average of 1 year
measure: Systolic blood pressure
timeFrame: Through study completion, an average of 1 year
measure: Diastolic blood pressure
timeFrame: Through study completion, an average of 1 year
measure: Heart rate
timeFrame: Through study completion, an average of 1 year
measure: Respiration
timeFrame: Through study completion, an average of 1 year
measure: Medical History Questionnaire
timeFrame: Through study completion, an average of 1 year
measure: Gastrointestinal Distress Questionnaire
timeFrame: Through study completion, an average of 1 year
measure: Anxiety Questionnaire
timeFrame: Through study completion, an average of 1 year
measure: Cognitive performance
timeFrame: Through study completion, an average of 1 year
measure: Exercise performance
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia
state: Ontario
Study officials:
References:
citation: 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.