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.
- Conditions
- InflammationMuscle damageMusculoskeletal - Normal musculoskeletal and cartilage development and functionInflammatory and Immune System - Normal development and function of the immune system
- Registration Number
- ACTRN12619001120167
- Lead Sponsor
- Cannvalate
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
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
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method