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Cannabinoid Supplementation on Vascular and Cognitive Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03295903
Recruitment Status : Unknown
Verified September 2017 by Phil Ainslie, University of British Columbia.
Recruitment status was:  Not yet recruiting
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
Sponsor:
Collaborators:
Lexaria Bioscoence Corp
Mitacs
Information provided by (Responsible Party):
Phil Ainslie, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Diet Modification Dietary Supplement: Cannabidiol supplement Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Cannabinoids on Vascular and Cognitive Function in Young and Old Healthy Adults.
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019

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




Primary Outcome Measures :
  1. Circulating cannabidiol and nitric oxide markers [ Time Frame: Through study completion, an average of 1 year ]
    Measured by venous blood sampling

  2. Vascular function [ Time Frame: Through study completion, an average of 1 year ]
    Duplex ultrasound system


Secondary Outcome Measures :
  1. Height [ Time Frame: Through study completion, an average of 1 year ]
    Height in cm

  2. Weight [ Time Frame: Through study completion, an average of 1 year ]
    Weight in kg

  3. Body mass index [ Time Frame: Through study completion, an average of 1 year ]
    Body mass in kilograms divided by height in meters squared

  4. Systolic blood pressure [ Time Frame: Through study completion, an average of 1 year ]
    Measured by automated sphygmomanometer

  5. Diastolic blood pressure [ Time Frame: Through study completion, an average of 1 year ]
    Measured by automated sphygmomanometer

  6. Heart rate [ Time Frame: Through study completion, an average of 1 year ]
    Measured by 3-lead electrocardiogram

  7. Respiration [ Time Frame: Through study completion, an average of 1 year ]
    Measured by spirometry

  8. Medical History Questionnaire [ Time Frame: Through study completion, an average of 1 year ]
    Assesses inclusion/exclusion criteria and prior history of medical conditions.

  9. Gastrointestinal Distress Questionnaire [ Time Frame: Through study completion, an average of 1 year ]
    Measured using a 10 cm visual analogue scale

  10. Anxiety Questionnaire [ Time Frame: Through study completion, an average of 1 year ]
    Assessed with a visual analog scale

  11. Cognitive performance [ Time Frame: Through study completion, an average of 1 year ]
    Computerized battery of neuropsychological tests

  12. Exercise performance [ Time Frame: Through study completion, an average of 1 year ]
    Step-wise exercise test on cycle ergometer



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295903


Contacts
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Contact: Philip Ainslie, PhD 2508786171 philip.ainslie@ubc.ca
Contact: Alexander Patrician, MSc 4168445954 alexander.patrician@alumni.ubc.ca

Locations
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Canada, Ontario
University of British Columbia Not yet recruiting
Kelowna, Ontario, Canada, V1V 1V7
Contact: Philip Ainslie, PhD    2508786171    philip.ainslie@ubc.ca   
Contact: Alexander Patrician, MSc    4168445954    alexander.patrician@alumni.ubc.ca   
Principal Investigator: Philip Ainslie, PhD         
Sponsors and Collaborators
University of British Columbia
Lexaria Bioscoence Corp
Mitacs

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Phil Ainslie, professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03295903     History of Changes
Other Study ID Numbers: H17-01957
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual values will be reported in figures if applicable.

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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
Keywords provided by Phil Ainslie, University of British Columbia:
Vascular function
Cannabidiol supplementation
Additional relevant MeSH terms:
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Epidiolex
Anticonvulsants