Cannabinoid Supplementation on Vascular and Cognitive Function

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

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.

Study Overview

• Status: Unknown
• Conditions: Diet Modification
• Intervention / Treatment: Dietary supplement: Cannabidiol supplement

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kelowna, Ontario, Canada, V1V 1V7
      • University of British Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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
Heart rate	Measured by 3-lead electrocardiogram	Through study completion, an average of 1 year
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
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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Lexaria Bioscoence Corp

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Vascular function; Cannabidiol supplementation
• Additional Relevant MeSH Terms: Anticonvulsants; Cannabidiol
• Other Study ID Numbers: H17-01957

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual values will be reported in figures if applicable.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No