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Recruiting 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., \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07715864). StuddyBuddy aggregates publicly available trial information.