Cannabinoid Supplementation on Vascular and Cognitive Function

NCT ID: NCT03295903

Last Updated: 2019-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diet Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Sugar pill that will have no effect.

Group Type PLACEBO_COMPARATOR

Cannabidiol supplement

Intervention Type DIETARY_SUPPLEMENT

Subjects will be administered in a double-blinded, randomized and cross-over design

Cannabidiol and herbal capsules (1 dose)

Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.

Group Type ACTIVE_COMPARATOR

Cannabidiol supplement

Intervention Type DIETARY_SUPPLEMENT

Subjects will be administered in a double-blinded, randomized and cross-over design

Cannabidiol (1 dose)

Only cannabidiol supplement.

Group Type ACTIVE_COMPARATOR

Cannabidiol supplement

Intervention Type DIETARY_SUPPLEMENT

Subjects will be administered in a double-blinded, randomized and cross-over design

Cannabidiol and herbal capsules (2 dose)

Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.

Group Type ACTIVE_COMPARATOR

Cannabidiol supplement

Intervention Type DIETARY_SUPPLEMENT

Subjects will be administered in a double-blinded, randomized and cross-over design

Cannabidiol only (2 dose)

Only cannabidiol supplement.

Group Type ACTIVE_COMPARATOR

Cannabidiol supplement

Intervention Type DIETARY_SUPPLEMENT

Subjects will be administered in a double-blinded, randomized and cross-over design

Interventions

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Cannabidiol supplement

Subjects will be administered in a double-blinded, randomized and cross-over design

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lexaria Bioscience Corp.

INDUSTRY

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Phil Ainslie

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of British Columbia

Kelowna, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 31512143 (View on PubMed)

Other Identifiers

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H17-01957

Identifier Type: -

Identifier Source: org_study_id

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