Not Yet RecruitingPhase 2Phase 3ACTRN12619001120167

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.

Randomised controlled trial to determine the effects of short-term oral cannabidiol (CBD) ingestion on inflammation, muscle damage and functional recovery following downhill running.

Sponsor

Cannvalate

Enrollment

40 participants

Start Date

Sep 2, 2019

Study Type

Interventional

Conditions

Inflammation

Summary

Cannabidiol has shown much promise for its immunomodulation and anti-inflammatory properties. The purpose of this trial is to investigate the effects of short-term oral supplementation of cannabidiol (CBD) prior to and following downhill running on serum markers of inflammation and muscle damage, functional recovery and perceived muscle soreness in untrained individuals. This will be a double blind, randomised, placebo-controlled study comprising two experimental conditions (CBD versus placebo). It is hypothesised that CBD will elicit reduced pro-inflammatory blood markers, reduced recovery time, and reduced subjective muscle soreness compared to placebo.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 35 Yearss

Inclusion Criteria12

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

Exclusion Criteria12

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

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Interventions

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.