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Trial registered on ANZCTR


Registration number
ACTRN12619001120167p
Ethics application status
Submitted, not yet approved
Date submitted
26/07/2019
Date registered
12/08/2019
Date last updated
12/08/2019
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial to determine the effects of short-term oral cannabidiol (CBD) ingestion on inflammation, muscle damage and functional recovery following downhill running in healthy untrained individuals.
Scientific title
Randomised controlled trial to determine the effects of short-term oral cannabidiol (CBD) ingestion on inflammation, muscle damage and functional recovery following downhill running.
Secondary ID [1] 298845 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammation 313798 0
Muscle damage 313799 0
Condition category
Condition code
Inflammatory and Immune System 312210 312210 0 0
Normal development and function of the immune system
Musculoskeletal 312211 312211 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The active treatment will be in the form of a 600ml sports drink containing 100mg cannabidiol (CBD). One 600ml drink is to be consumed by participants each day, orally (total dose 100mg CBD/day) for the 12-day treatment period.

At V0 the participants will be supplied with a bottle containing the 12 days’ supply of the treatment, with 3 reserve doses to allow for ± 3 day window to replace lost or damaged dose units. Participants will be required to complete a daily treatment compliance log and will be asked to bring this with them to each testing visit (V1-V5) for checking, as well as returning all unused study medication at V5.
At V1 participants will perform a downhill running maneuver on a treadmill once. The maneuver is moderate in intensity, participants will be required to keep at their VO2 max for 45 minutes. This will be overseen by an authorized researcher from the Department of Health and Medical Science, and performed in the exercise science laboratory at Swinburne University. Participants will be trained in performing the run prior to V1, and monitored continuously throughout the maneuver to ensure adherence to the exercise.

Labels on all treatments will include a list of potential ingredients, batch number, and expiry date and storage/use instructions.

Both treatments and the placebo are identical in appearance. Treatments will be provided in bottles with the participant identification number and treatment day clearly labelled by a disinterested third party. Until dispensed to the participants, the trial products will be stored in a securely locked area, only accessible to authorized personnel.
Intervention code [1] 315110 0
Treatment: Drugs
Comparator / control treatment
The placebo treatment will be identical in appearance to the active treatment, and will contain the same ingredients except for CBD.
Control group
Placebo

Outcomes
Primary outcome [1] 320847 0
Serum markers of inflammation (IL-6, IL-8, IL-10, IL-12, TFNa, IL-1A, hsCRP, CK). This is a composite primary outcome assessing differences in multiple blood inflammatory markers before and 24 hours after exercise in the active versus placebo groups.
Timepoint [1] 320847 0
24 hours post-exercise
Primary outcome [2] 320848 0
Serum markers of inflammation (IL-6, IL-8, IL-10, IL-12, TFNa, IL-1A, hsCRP, CK). This is a composite primary outcome assessing differences in multiple blood inflammatory markers before and 60 minutes after exercise in the active versus placebo groups.
Timepoint [2] 320848 0
60 minutes post-exercise
Secondary outcome [1] 373026 0
Serum markers of inflammation (IL-6, IL-8, IL-10, IL-12, TFNa, IL-1A, hsCRP, CK). This is a composite outcome assessing differences in multiple blood inflammatory markers before and 2 hours after exercise in the active versus placebo groups.
Timepoint [1] 373026 0
120 minutes post-exercise
Secondary outcome [2] 373027 0
Serum markers of inflammation (IL-6, IL-8, IL-10, IL-12, TFNa, IL-1A, hsCRP, CK). This is a composite outcome assessing differences in multiple blood inflammatory markers before and 3 hours after exercise in the active versus placebo groups.
Timepoint [2] 373027 0
180 minutes post-exercise
Secondary outcome [3] 373028 0
Serum markers of inflammation (IL-6, IL-8, IL-10, IL-12, TFNa, IL-1A, hsCRP, CK). This is a composite outcome assessing differences in multiple blood inflammatory markers before and 2 days after exercise in the active versus placebo groups.
Timepoint [3] 373028 0
48 hours post-exercise
Secondary outcome [4] 373029 0
Serum markers of inflammation (IL-6, IL-8, IL-10, IL-12, TFNa, IL-1A, hsCRP, CK). This is a composite outcome assessing differences in multiple blood inflammatory markers before and 3 days after exercise in the active versus placebo groups.
Timepoint [4] 373029 0
72 hours post-exercise
Secondary outcome [5] 373030 0
Serum markers of inflammation (IL-6, IL-8, IL-10, IL-12, TFNa, IL-1A, hsCRP, CK). This is a composite outcome assessing differences in multiple blood inflammatory markers before and 4 days after exercise in the active versus placebo groups.
Timepoint [5] 373030 0
96 hours post-exercise
Secondary outcome [6] 373031 0
Serum markers of immune cell function (monocytes, lymphocytes, CD4, CD8). This is a composite outcome assessing functional differences in multiple immune cells before and 60 minutes after exercise in the active versus placebo groups.
Timepoint [6] 373031 0
60 minutes post-exercise
Secondary outcome [7] 373032 0
Serum markers of immune cell function (monocytes, lymphocytes, CD4, CD8). This is a composite outcome assessing functional differences in multiple immune cells before and 2 hours after exercise in the active versus placebo groups.
Timepoint [7] 373032 0
120 minutes post-exercise
Secondary outcome [8] 373033 0
Serum markers of immune cell function (monocytes, lymphocytes, CD4, CD8). This is a composite outcome assessing functional differences in multiple immune cells before and 3 hours after exercise in the active versus placebo groups.
Timepoint [8] 373033 0
180 minutes post-exercise
Secondary outcome [9] 373034 0
Serum markers of immune cell function (monocytes, lymphocytes, CD4, CD8). This is a composite outcome assessing functional differences in multiple immune cells before and 1 day after exercise in the active versus placebo groups.
Timepoint [9] 373034 0
24 hours post-exercise
Secondary outcome [10] 373035 0
Serum markers of immune cell function (monocytes, lymphocytes, CD4, CD8). This is a composite outcome assessing functional differences in multiple immune cells before and 2 days after exercise in the active versus placebo groups.
Timepoint [10] 373035 0
48 hours post-exercise
Secondary outcome [11] 373036 0
Serum markers of immune cell function (monocytes, lymphocytes, CD4, CD8). This is a composite outcome assessing functional differences in multiple immune cells before and 3 days after exercise in the active versus placebo groups.
Timepoint [11] 373036 0
72 hours post-exercise
Secondary outcome [12] 373037 0
Serum markers of immune cell function (monocytes, lymphocytes, CD4, CD8). This is a composite outcome assessing functional differences in multiple immune cells before and 4 days after exercise in the active versus placebo groups.
Timepoint [12] 373037 0
96 hours post-exercise
Secondary outcome [13] 373038 0
Isokinetic muscular assessment of extension/flexion of the quadriceps group using the Biodex isokinetic dynamometer
Timepoint [13] 373038 0
180 minutes post-exercise
Secondary outcome [14] 373039 0
Isokinetic muscular assessment of extension/flexion of the quadriceps group using the Biodex isokinetic dynamometer
Timepoint [14] 373039 0
24 hours post-exercise
Secondary outcome [15] 373040 0
Isokinetic muscular assessment of extension/flexion of the quadriceps group using the Biodex isokinetic dynamometer
Timepoint [15] 373040 0
48 hours post-exercise
Secondary outcome [16] 373041 0
Isokinetic muscular assessment of extension/flexion of the quadriceps group using the Biodex isokinetic dynamometer
Timepoint [16] 373041 0
72 hours post exercise
Secondary outcome [17] 373042 0
Isokinetic muscular assessment of extension/flexion of the quadriceps group using the Biodex isokinetic dynamometer
Timepoint [17] 373042 0
96 hours post-exercise
Secondary outcome [18] 373044 0
Mood measured by the profile of mood states
Timepoint [18] 373044 0
180 minutes post-exercise
Secondary outcome [19] 373045 0
Subjective symptoms measured by Bond- Lader visual analogue scales. The outcome measures for this test allow for data to be inspected on a question-by-question basis, and will cover subjective alertness, tranquility, confidence, dejection, dizziness, confusion/disorientation, fatigue, anxiety, irritability, appetite, creative stimulation, and sociability.
Timepoint [19] 373045 0
180 minutes post-exercise
Secondary outcome [20] 373046 0
Mood measured using the Bond-Lader visual analogue scales
Timepoint [20] 373046 0
180 minutes post-exercise
Secondary outcome [21] 373052 0
Perceived muscle soreness (Delayed onset muscle soreness) of the quadriceps muscle group measured using a visual analogue scale
Timepoint [21] 373052 0
Immediately after exercise, 180 minutes post-exercise, 24 hours post-exercise, 48 hours post exercise, 72 hours post-exercise, and 96 hours post-exercise

Eligibility
Key inclusion criteria
Individuals will be screened to ensure they are deemed eligible to participate in the study. Subjects who meet the following eligibility criteria will be enrolled in the trial:
• Aged between 18 and 35 years
• Recreationally active (currently not involved in a structured exercise program (i.e. weight lifting, long distance running) more than 2 days a week for the past 6 months)
• Have experimented with cannabinoids previously (self-disclosure). This includes any cannabis product (marijuana, skunk, ‘weed’).
• No known allergic reaction to cannabis products with previous use
• Ability to speak and read English
• Have no history of past substance abuse or current abuse of illicit drugs
• Physically well with no history, or current severe psychiatric, cardiac, renal, endocrine, gastrointestinal, or bleeding disorders
• Not currently pregnant or lactating
• Not taken any form of medication within 5 days of admission (except for prophylactic antibiotics, the contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne).
• Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial
• Be willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects presenting with any of the following will not be included in the trial:
• Aged under 18 years or over 35 years
• Currently involved in a structured exercise program (i.e. weight lifting, long distance running) more than 2 days a week over the past 6 months
• Inability to speak or read English
• History of drug or substance abuse or current illicit drug abuse
• History of neurological conditions or previous or current history of severe psychiatric, cardiac, endocrine, renal, gastrointestinal, or bleeding disorders
• Currently pregnant or breastfeeding
• Currently taking medication (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne)
• Severe depression (a cut off of 20 and higher on the BDI)
• Severe anxiety (a cut off of 16 and higher on the BAI).
• No previous experience with cannabinoids
• Current participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be performed by a disinterested third party. This person will supply the randomisation code list to the study doctor in a sealed opaque envelope, to be opened only in the case of an emergency. An electronic copy of the list will also be kept in a password-protected file.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be performed using an online sequence generation tool.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Blood data will be analysed using a 2 x 9 (group x blood sample) factorial multivariate analysis of variance (MANOVA) with repeated measures and univariate follow-up tests. Isokinetic scores will be analysed using separate MANOVA with univariate follow-up.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2019
Actual
Date of last participant enrolment
Anticipated
2/03/2020
Actual
Date of last data collection
Anticipated
16/03/2020
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 27317 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 303393 0
Commercial sector/Industry
Name [1] 303393 0
Cannvalate
Country [1] 303393 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cannvalate
Address
C2 Level 1/459 Toorak Rd,
Toorak VIC 3142
Country
Australia
Secondary sponsor category [1] 303432 0
None
Name [1] 303432 0
N/A
Address [1] 303432 0
N/A
Country [1] 303432 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303922 0
Swinburne University Human Research Ethics Committee (EC00240)
Ethics committee address [1] 303922 0
Ethics committee country [1] 303922 0
Australia
Date submitted for ethics approval [1] 303922 0
02/08/2019
Approval date [1] 303922 0
Ethics approval number [1] 303922 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95262 0
Prof Con Stough
Address 95262 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H24
PO Box 218
Hawthorn
VIC 3122
Country 95262 0
Australia
Phone 95262 0
+61 3 9214 8167
Fax 95262 0
Email 95262 0
cstough@gmail.com
Contact person for public queries
Name 95263 0
Sarah Catchlove
Address 95263 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H24
PO Box 218
Hawthorn
VIC 3122
Country 95263 0
Australia
Phone 95263 0
+61 3 9214 5483
Fax 95263 0
Email 95263 0
scatchlove@swin.edu.au
Contact person for scientific queries
Name 95264 0
Con Stough
Address 95264 0
Centre for Human Psychopharmacology
Swinburne University of Technology
Mail H24
PO Box 218
Hawthorn
VIC 3122
Country 95264 0
Australia
Phone 95264 0
+61 3 9214 8167
Fax 95264 0
Email 95264 0
cstough@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is expected that the results of this trial will be disseminated via peer-reviewed publications and at academic conferences. For these purposes the data will be collated and analysed as group data. If required by the publishing journal, de-identied raw data will be uploaded to an appropriate repository. Otherwise, as the Intellectual Property of this study are owned by the sponsor and may be used for the purposes of commercialisation of the study product, the trial data will not be made available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.