Cannabinoid Supplementation on Vascular and Cognitive Function

Diet Modification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03295903
• Other study ID #: H17-01957
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: January 1, 2018
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2019
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: October 1, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• Diet Modification

Intervention

Dietary Supplement:
• Cannabidiol supplement
Subjects will be administered in a double-blinded, randomized and cross-over design

Locations

Country	Name	City	State
Canada	University of British Columbia	Kelowna	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Lexaria Bioscoence Corp

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating cannabidiol and nitric oxide markers	Measured by venous blood sampling	Through study completion, an average of 1 year
Primary	Vascular function	Duplex ultrasound system	Through study completion, an average of 1 year
Secondary	Height	Height in cm	Through study completion, an average of 1 year
Secondary	Weight	Weight in kg	Through study completion, an average of 1 year
Secondary	Body mass index	Body mass in kilograms divided by height in meters squared	Through study completion, an average of 1 year
Secondary	Systolic blood pressure	Measured by automated sphygmomanometer	Through study completion, an average of 1 year
Secondary	Diastolic blood pressure	Measured by automated sphygmomanometer	Through study completion, an average of 1 year
Secondary	Heart rate	Measured by 3-lead electrocardiogram	Through study completion, an average of 1 year
Secondary	Respiration	Measured by spirometry	Through study completion, an average of 1 year
Secondary	Medical History Questionnaire	Assesses inclusion/exclusion criteria and prior history of medical conditions.	Through study completion, an average of 1 year
Secondary	Gastrointestinal Distress Questionnaire	Measured using a 10 cm visual analogue scale	Through study completion, an average of 1 year
Secondary	Anxiety Questionnaire	Assessed with a visual analog scale	Through study completion, an average of 1 year
Secondary	Cognitive performance	Computerized battery of neuropsychological tests	Through study completion, an average of 1 year
Secondary	Exercise performance	Step-wise exercise test on cycle ergometer	Through study completion, an average of 1 year