<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03295903</url>
  </required_header>
  <id_info>
    <org_study_id>H17-01957</org_study_id>
    <nct_id>NCT03295903</nct_id>
  </id_info>
  <brief_title>Cannabinoid Supplementation on Vascular and Cognitive Function</brief_title>
  <official_title>The Effects of Cannabinoids on Vascular and Cognitive Function in Young and Old Healthy Adults.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lexaria Bioscoence Corp</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cannabidiol (CBD) is a bioactive cannabinoid compound in marijuana (cannabis sativa), but&#xD;
      unlike Δ9 tetrahydrocannabinol (THC), lacks the psychoactivity effect of THC. Available&#xD;
      evidence suggests that there are marked therapeutic CBD effects for diverse disease processes&#xD;
      including inflammation, cancers, psychosis, and epileptic seizures. The purpose of this&#xD;
      study, in both younger and older healthy humans, is to improve our understanding of how CBD&#xD;
      might control and regulate blood vessel health as well as cognitive and exercise performance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">October 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Circulating cannabidiol and nitric oxide markers</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Measured by venous blood sampling</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vascular function</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Duplex ultrasound system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Height in cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Weight in kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Body mass in kilograms divided by height in meters squared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Measured by automated sphygmomanometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Measured by automated sphygmomanometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Measured by 3-lead electrocardiogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiration</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Measured by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical History Questionnaire</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Assesses inclusion/exclusion criteria and prior history of medical conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal Distress Questionnaire</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Measured using a 10 cm visual analogue scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety Questionnaire</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Assessed with a visual analog scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive performance</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Computerized battery of neuropsychological tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise performance</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Step-wise exercise test on cycle ergometer</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Diet Modification</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sugar pill that will have no effect.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cannabidiol and herbal capsules (1 dose)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cannabidiol (1 dose)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Only cannabidiol supplement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cannabidiol and herbal capsules (2 dose)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cannabidiol only (2 dose)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Only cannabidiol supplement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cannabidiol supplement</intervention_name>
    <description>Subjects will be administered in a double-blinded, randomized and cross-over design</description>
    <arm_group_label>Cannabidiol (1 dose)</arm_group_label>
    <arm_group_label>Cannabidiol and herbal capsules (1 dose)</arm_group_label>
    <arm_group_label>Cannabidiol and herbal capsules (2 dose)</arm_group_label>
    <arm_group_label>Cannabidiol only (2 dose)</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-smoking&#xD;
&#xD;
          -  non-obese&#xD;
&#xD;
          -  between the ages of 18-30 &amp; 60-75 years&#xD;
&#xD;
          -  have no history of cardiopulmonary, liver, gastrointestinal, kidney or cerebrovascular&#xD;
             disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  are obese&#xD;
&#xD;
          -  are taking prescription drugs or over-the-counter supplements that influence&#xD;
             cardiovascular or nitric oxide metabolism&#xD;
&#xD;
          -  have a history of smoking&#xD;
&#xD;
          -  have history of cardiovascular, respiratory (including asthma) or neurological disease&#xD;
&#xD;
          -  have known intolerance to ginseng or ginkgo herbals&#xD;
&#xD;
          -  have kidney, gastrointestinal or liver disease&#xD;
&#xD;
          -  have epilepsy&#xD;
&#xD;
          -  have diabetes&#xD;
&#xD;
          -  are pregnant or breast feeding&#xD;
&#xD;
          -  do not speak English as first language&#xD;
&#xD;
          -  a student in the University of British Columbia (UBC) Okanagan Centre for Heart, Lung&#xD;
             and Vascular Health&#xD;
&#xD;
          -  medical or recreational use of cannabis&#xD;
&#xD;
          -  clinically diagnosed anxiety or depression&#xD;
&#xD;
          -  history of opioid use&#xD;
&#xD;
          -  unwilling or unable to execute the informed consent documentation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of British Columbia</name>
      <address>
        <city>Kelowna</city>
        <state>Ontario</state>
        <zip>V1V 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>October 21, 2019</last_update_submitted>
  <last_update_submitted_qc>October 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Phil Ainslie</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Vascular function</keyword>
  <keyword>Cannabidiol supplementation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cannabidiol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual values will be reported in figures if applicable.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03295903
org study id: H17-01957
nct id: NCT03295903
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Circulating cannabidiol and nitric oxide markers
time frame: Through study completion, an average of 1 year
description: Measured by venous blood sampling
measure: Vascular function
time frame: Through study completion, an average of 1 year
description: Duplex ultrasound system
measure: Height
time frame: Through study completion, an average of 1 year
description: Height in cm
measure: Weight
time frame: Through study completion, an average of 1 year
description: Weight in kg
measure: Body mass index
time frame: Through study completion, an average of 1 year
description: Body mass in kilograms divided by height in meters squared
measure: Systolic blood pressure
time frame: Through study completion, an average of 1 year
description: Measured by automated sphygmomanometer
measure: Diastolic blood pressure
time frame: Through study completion, an average of 1 year
description: Measured by automated sphygmomanometer
measure: Heart rate
time frame: Through study completion, an average of 1 year
description: Measured by 3-lead electrocardiogram
measure: Respiration
time frame: Through study completion, an average of 1 year
description: Measured by spirometry
measure: Medical History Questionnaire
time frame: Through study completion, an average of 1 year
description: Assesses inclusion/exclusion criteria and prior history of medical conditions.
measure: Gastrointestinal Distress Questionnaire
time frame: Through study completion, an average of 1 year
description: Measured using a 10 cm visual analogue scale
measure: Anxiety Questionnaire
time frame: Through study completion, an average of 1 year
description: Assessed with a visual analog scale
measure: Cognitive performance
time frame: Through study completion, an average of 1 year
description: Computerized battery of neuropsychological tests
measure: Exercise performance
time frame: Through study completion, an average of 1 year
description: Step-wise exercise test on cycle ergometer
arm group label: Placebo
arm group type: Placebo Comparator
description: Sugar pill that will have no effect.
arm group label: Cannabidiol and herbal capsules (1 dose)
arm group type: Active Comparator
description: Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.
arm group label: Cannabidiol (1 dose)
arm group type: Active Comparator
description: Only cannabidiol supplement.
arm group label: Cannabidiol and herbal capsules (2 dose)
arm group type: Active Comparator
description: Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.
arm group label: Cannabidiol only (2 dose)
arm group type: Active Comparator
description: Only cannabidiol supplement.
intervention type: Dietary Supplement
intervention name: Cannabidiol supplement
description: Subjects will be administered in a double-blinded, randomized and cross-over design
arm group label: Cannabidiol (1 dose)
arm group label: Cannabidiol and herbal capsules (1 dose)
arm group label: Cannabidiol and herbal capsules (2 dose)
arm group label: Cannabidiol only (2 dose)
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Phil Ainslie
investigator title: Professor
mesh term: Cannabidiol
sharing ipd: No
ipd description: Individual values will be reported in figures if applicable.