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NCT07715864
Naturally Produced Cannabinoids for Neuroprotection From Concussion
Conditions: Healthy
Sex: Male
Ages: 19 Years – 35 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 60
Sponsor: University of Regina
Location: University of Regina Regina Saskatchewan
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Healthy male adults between 19-35 years of age that compete in contact sport athletics.
* Participants with no known cerebrovascular or cardiovascular complications.
* Participants will not be habitual recreational users of cannabis (i.e., \
Source: ClinicalTrials.gov (NCT07715864). StuddyBuddy aggregates publicly available trial information.