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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 : Active, not recruiting
First Posted : September 28, 2017
Last Update Posted : October 23, 2019
Sponsor:
Collaborator:
Lexaria Bioscoence Corp
Information provided by (Responsible Party):
Phil Ainslie, University of British Columbia

Tracking Information
First Submitted Date  ICMJE September 20, 2017
First Posted Date  ICMJE September 28, 2017
Last Update Posted Date October 23, 2019
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2017)
  • Circulating cannabidiol and nitric oxide markers [ Time Frame: Through study completion, an average of 1 year ]
    Measured by venous blood sampling
  • Vascular function [ Time Frame: Through study completion, an average of 1 year ]
    Duplex ultrasound system
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2017)
  • Height [ Time Frame: Through study completion, an average of 1 year ]
    Height in cm
  • Weight [ Time Frame: Through study completion, an average of 1 year ]
    Weight in kg
  • Body mass index [ Time Frame: Through study completion, an average of 1 year ]
    Body mass in kilograms divided by height in meters squared
  • Systolic blood pressure [ Time Frame: Through study completion, an average of 1 year ]
    Measured by automated sphygmomanometer
  • Diastolic blood pressure [ Time Frame: Through study completion, an average of 1 year ]
    Measured by automated sphygmomanometer
  • Heart rate [ Time Frame: Through study completion, an average of 1 year ]
    Measured by 3-lead electrocardiogram
  • Respiration [ Time Frame: Through study completion, an average of 1 year ]
    Measured by spirometry
  • Medical History Questionnaire [ Time Frame: Through study completion, an average of 1 year ]
    Assesses inclusion/exclusion criteria and prior history of medical conditions.
  • Gastrointestinal Distress Questionnaire [ Time Frame: Through study completion, an average of 1 year ]
    Measured using a 10 cm visual analogue scale
  • Anxiety Questionnaire [ Time Frame: Through study completion, an average of 1 year ]
    Assessed with a visual analog scale
  • Cognitive performance [ Time Frame: Through study completion, an average of 1 year ]
    Computerized battery of neuropsychological tests
  • Exercise performance [ Time Frame: Through study completion, an average of 1 year ]
    Step-wise exercise test on cycle ergometer
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabinoid Supplementation on Vascular and Cognitive Function
Official Title  ICMJE The Effects of Cannabinoids on Vascular and Cognitive Function in Young and Old Healthy Adults.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Diet Modification
Intervention  ICMJE Dietary Supplement: Cannabidiol supplement
Subjects will be administered in a double-blinded, randomized and cross-over design
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Sugar pill that will have no effect.
    Intervention: Dietary Supplement: Cannabidiol supplement
  • Active Comparator: Cannabidiol and herbal capsules (1 dose)
    Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.
    Intervention: Dietary Supplement: Cannabidiol supplement
  • Active Comparator: Cannabidiol (1 dose)
    Only cannabidiol supplement.
    Intervention: Dietary Supplement: Cannabidiol supplement
  • Active Comparator: Cannabidiol and herbal capsules (2 dose)
    Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.
    Intervention: Dietary Supplement: Cannabidiol supplement
  • Active Comparator: Cannabidiol only (2 dose)
    Only cannabidiol supplement.
    Intervention: Dietary Supplement: Cannabidiol supplement
Publications * Patrician A, Versic-Bratincevic M, Mijacika T, Banic I, Marendic M, Sutlović D, Dujić Ž, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2017)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03295903
Other Study ID Numbers  ICMJE H17-01957
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual values will be reported in figures if applicable.
Responsible Party Phil Ainslie, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Lexaria Bioscoence Corp
Investigators  ICMJE Not Provided
PRS Account University of British Columbia
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP