CClinicalTrials.gg
Status unknownNCT03295903Updated Oct 23, 2019

Cannabinoid Supplementation on Vascular and Cognitive Function

An Early Phase 1 interventional study of Cannabidiol supplement in Diet Modification, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-23.

Sponsored by University of British Columbia · Early Phase 1, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diet Modification

Keywords

  • Vascular function
  • Cannabidiol supplementation
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Sugar pill that will have no effect.

    Dietary Supplement: Cannabidiol supplement

  • Active comparator
    Cannabidiol and herbal capsules (1 dose)

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

    Dietary Supplement: Cannabidiol supplement

  • Active comparator
    Cannabidiol (1 dose)

    Only cannabidiol supplement.

    Dietary Supplement: Cannabidiol supplement

  • Active comparator
    Cannabidiol and herbal capsules (2 dose)

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

    Dietary Supplement: Cannabidiol supplement

  • Active comparator
    Cannabidiol only (2 dose)

    Only cannabidiol supplement.

    Dietary Supplement: Cannabidiol supplement

Interventions

  • Dietary supplementCannabidiol supplement

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

05

What researchers measure

Primary outcomes

  1. Circulating cannabidiol and nitric oxide markers

    Measured by venous blood sampling

    Time frame: Through study completion, an average of 1 year

  2. Vascular function

    Duplex ultrasound system

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Height

    Height in cm

    Time frame: Through study completion, an average of 1 year

  2. Weight

    Weight in kg

    Time frame: Through study completion, an average of 1 year

  3. Body mass index

    Body mass in kilograms divided by height in meters squared

    Time frame: Through study completion, an average of 1 year

  4. Systolic blood pressure

    Measured by automated sphygmomanometer

    Time frame: Through study completion, an average of 1 year

  5. Diastolic blood pressure

    Measured by automated sphygmomanometer

    Time frame: Through study completion, an average of 1 year

  6. Heart rate

    Measured by 3-lead electrocardiogram

    Time frame: Through study completion, an average of 1 year

  7. Respiration

    Measured by spirometry

    Time frame: Through study completion, an average of 1 year

  8. Medical History Questionnaire

    Assesses inclusion/exclusion criteria and prior history of medical conditions.

    Time frame: Through study completion, an average of 1 year

  9. Gastrointestinal Distress Questionnaire

    Measured using a 10 cm visual analogue scale

    Time frame: Through study completion, an average of 1 year

  10. Anxiety Questionnaire

    Assessed with a visual analog scale

    Time frame: Through study completion, an average of 1 year

  11. Cognitive performance

    Computerized battery of neuropsychological tests

    Time frame: Through study completion, an average of 1 year

  12. Exercise performance

    Step-wise exercise test on cycle ergometer

    Time frame: Through study completion, an average of 1 year

06

Study locations

1 site
  • University of British Columbia
    Kelowna, Ontario V1V 1V7, Canada
07

References and documents

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. PubMed 31512143 ↗

Individual participant data

Plan to share: No — Individual values will be reported in figures if applicable.

08

Registry details

Key details

Study ID
NCT03295903
Lead sponsor
University of British Columbia
Collaborators
Lexaria Bioscience Corp.
Responsible party
Phil Ainslie (Professor, University of British Columbia) — Principal investigator
First posted
Sep 28, 2017
Start date
Jan 1, 2018
Primary completion
Sep 30, 2021 (estimated)
Completion
Oct 1, 2021 (estimated)
Last update
Oct 23, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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