The goal of this double-blind, placebo-controlled, cross over study is to learn about the neuroprotective properties of a broad-spectrum cannabinoid formulation in normal healthy adults engaged in elite contact sport competition. The main question it aims to answer : • Is the broad-spectrum cannabinoid formulation neuroprotective for athletes participating in competitive contact sports? Can this formulation facilitate recovery in those who suffer from concussion by reducing inflammation and/or reduce the number of concussions sustained without adverse physiological and psychological dysfunction when administered daily? Participants will: * be given a broad-spectrum cannabinoid gel capsule or a placebo twice daily. * have blood samples taken to analyze pharmacokinetics and pharmacodynamics of cannabinoid metabolites, liver function, complete blood count and blood differential, inflammatory biomarkers and genetic analysis * have stool samples collected for gut microbiome analysis; * undergo testing sessions, which will include psychological and health questionnaires, equipment to record signals from the brain and heart, and safety laboratory tests.
Age range
19 Years – 35 Years
Sex
MALE
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Plasma cannabidiol (CBD) metabolite concentration
Timeframe: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Plasma tetrahydrocannabinol (THC) metabolite concentration
Timeframe: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Inflammatory biomarker concentrations in blood
Timeframe: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Liver function laboratory values
Timeframe: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Hematology and clinical chemistry laboratory values
Timeframe: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Cerebral blood flow velocity
Timeframe: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Cerebral oxygenation
Timeframe: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Continuous blood pressure
Timeframe: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Changes in cardiovascular physiology
Timeframe: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).
Officially diagnosed concussion incidence
Timeframe: From enrollment to end of treatment crossover (4 weeks for football participants or 8 weeks for hockey participants).