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Enrolling By Invitation NCT05743985

Efficacy and Safety of Hemp-derived, Full Spectrum Cannabigerol (CBG) in Adults

Conditions: Health, Subjective, Inflammatory Response, Adverse Effect, Side Effect

Sex: All
Ages: 21 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 100
Sponsor: Formula30A LLC

Location: United States

Summary

The goal of this observational study is to provide exploratory research into the in vivo physiological and psychological effects, if any, of cannabigerol (CBG) in healthy human adults age 21 or over.The main questions it aims to answer are:What effect, if any, does daily oral consumption of 50mg of full spectrum CBG have on the mental, physical, and emotional wellbeing of healthy individuals, as measured by self-report Medical Symptom Questionnaire and 36-Item Short Form Health Survey scores?Is CBG effective at reducing inflammation in the body, as measured by HSCRP, ESR, and PSA inflammatory markers?Do age, gender, weight, or state of body inflammation have an effect on the perceived efficacy of CBG?What adverse effects, if any, are associated with CBG use?Over the course of the 12-week study, participants will:Take baseline MSQ and SF-36 surveys, as well as a clinical visit with blood draws for HSCRP, ESR, and PSA testingConsume one (1) 50mg capsule of full spectrum CBG daily by mouth with food for 8 weeks, followed by a 4-week washout periodComplete biweekly SF-36 surveys as well as MSQ surveys every 4 weeksAttend a clinical visit every 4 weeks for clinical observation and blood draws for HSCRP, ESR, and PSA (male subjects)

Eligibility Criteria

Inclusion Criteria:A cohort of 100 relatively healthy participants (as determined by the supervising healthcare provider recommendation as well as no indications of Moderate or Severe conditions on the study measurement tools). Participants included must be 21 years old or over, in good overall health, and without conditions determined at risk for adverse reactions to the product ingredients. Research participants with the potential to become pregnant are eligible to be included in the study as long as they are sexually abstinent or using a contraceptive method considered effective.Exclusion Criteria:Participants will be excluded if they are under the age of 21; are pregnant or breastfeeding; initiate or change use of medication or therapies within 2 weeks prior to the start of the study; have a history of hepatic compromise (with transaminases of two times the upper limit of normal) or cirrhosis; are already using recreational marijuana, medical marijuana or other cannabinoid formulations (including CBD); have a history of substance or alcohol abuse; or are using High Dose or Extended-Release Narcotics.

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

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05743985). StuddyBuddy aggregates publicly available trial information.