Diet ModificationEarly Phase 1NCT03295903
Cannabinoid Supplementation on Vascular and Cognitive Function
A Early Phase 1 study testing Cannabidiol supplement in people with Diet Modification, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Modification
- What is being tested?
- Cannabidiol supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 1 Oct 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- non-smoking
- non-obese
- between the ages of 18-30 \& 60-75 years
- have no history of cardiopulmonary, liver, gastrointestinal, kidney or cerebrovascular disease.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Cannabinoids on Vascular and Cognitive Function in Young and Old Healthy Adults.
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.
- Conditions
- Diet Modification
- Being tested
- Cannabidiol supplement
- Keywords
- Vascular function, Cannabidiol supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol supplementDietary supplement
Subjects will be administered in a double-blinded, randomized and cross-over design
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Sugar pill that will have no effect. Receives: Dietary Supplement: Cannabidiol supplement |
| Cannabidiol and herbal capsules (1 dose) | Active comparator | Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil. Receives: Dietary Supplement: Cannabidiol supplement |
| Cannabidiol (1 dose) | Active comparator | Only cannabidiol supplement. Receives: Dietary Supplement: Cannabidiol supplement |
| Cannabidiol and herbal capsules (2 dose) | Active comparator | Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil. Receives: Dietary Supplement: Cannabidiol supplement |
| Cannabidiol only (2 dose) | Active comparator | Only cannabidiol supplement. Receives: Dietary Supplement: Cannabidiol supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating cannabidiol and nitric oxide markers
Measured by venous blood sampling
Measured: Through study completion, an average of 1 year
Vascular function
Duplex ultrasound system
Measured: Through study completion, an average of 1 year
Secondary outcomes (12)
Height
Height in cm
Measured: Through study completion, an average of 1 year
Weight
Weight in kg
Measured: Through study completion, an average of 1 year
Body mass index
Body mass in kilograms divided by height in meters squared
Measured: Through study completion, an average of 1 year
Systolic blood pressure
Measured by automated sphygmomanometer
Measured: Through study completion, an average of 1 year
Diastolic blood pressure
Measured by automated sphygmomanometer
Measured: Through study completion, an average of 1 year
Heart rate
Measured by 3-lead electrocardiogram
Measured: Through study completion, an average of 1 year
Respiration
Measured by spirometry
Measured: Through study completion, an average of 1 year
Medical History Questionnaire
Assesses inclusion/exclusion criteria and prior history of medical conditions.
Measured: Through study completion, an average of 1 year
Gastrointestinal Distress Questionnaire
Measured using a 10 cm visual analogue scale
Measured: Through study completion, an average of 1 year
Anxiety Questionnaire
Assessed with a visual analog scale
Measured: Through study completion, an average of 1 year
Cognitive performance
Computerized battery of neuropsychological tests
Measured: Through study completion, an average of 1 year
Exercise performance
Step-wise exercise test on cycle ergometer
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start1 Jan 2018
- Primary completion30 Sep 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Lexaria Bioscience Corp.
- Responsible party
- Principal investigator, Phil Ainslie, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295903
- Sponsor's protocol ID
- H17-01957
- Status last verified
- Oct 2019
- First submitted
- 20 Sep 2017
- Last updated
- 23 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual values will be reported in figures if applicable.
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cannabinoids on Vascular and Cognitive Function in Young and Old Healthy Adults.
- ClinicalTrials.gov ID
- NCT03295903
- Acronym / sponsor ID
- H17-01957
- Conditions
- Diet Modification
- Keywords
- Vascular function, Cannabidiol supplementation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Lexaria Bioscience Corp.
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Cannabidiol supplementSugar pill that will have no effect. |
| Cannabidiol and herbal capsules (1 dose) | Active comparator | Dietary Supplement: Cannabidiol supplementCannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil. |
| Cannabidiol (1 dose) | Active comparator | Dietary Supplement: Cannabidiol supplementOnly cannabidiol supplement. |
| Cannabidiol and herbal capsules (2 dose) | Active comparator | Dietary Supplement: Cannabidiol supplementCannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil. |
| Cannabidiol only (2 dose) | Active comparator | Dietary Supplement: Cannabidiol supplementOnly cannabidiol supplement. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- non-smoking
- non-obese
- between the ages of 18-30 \& 60-75 years
- have no history of cardiopulmonary, liver, gastrointestinal, kidney or cerebrovascular disease.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol supplementSubjects will be administered in a double-blinded, randomized and cross-over design | Dietary supplement | Cannabidiol (1 dose), Cannabidiol and herbal capsules (1 dose), Cannabidiol and herbal capsules (2 dose), Cannabidiol only (2 dose), Placebo |
Primary outcome
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
12 secondary outcomes
Height
Time frame: Through study completion, an average of 1 year
Weight
Time frame: Through study completion, an average of 1 year
Body mass index
Time frame: Through study completion, an average of 1 year
Systolic blood pressure
Time frame: Through study completion, an average of 1 year
Diastolic blood pressure
Time frame: Through study completion, an average of 1 year
Heart rate
Time frame: Through study completion, an average of 1 year
Respiration
Time frame: Through study completion, an average of 1 year
Medical History Questionnaire
Time frame: Through study completion, an average of 1 year
Gastrointestinal Distress Questionnaire
Time frame: Through study completion, an average of 1 year
Anxiety Questionnaire
Time frame: Through study completion, an average of 1 year
Cognitive performance
Time frame: Through study completion, an average of 1 year
Exercise performance
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Derived from this study: PubMed 31512143Patrician 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.
- Individual participant dataSharing planned: No. Individual values will be reported in figures if applicable.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cannabidiol supplement in people with Diet Modification, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating cannabidiol and nitric oxide markers (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03295903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.