Efficacy and Safety of Hemp-derived, Full Spectrum Cannabigerol (CBG) in Adults
Completed · Not applicable
Conditions studied: Health, Subjective, Inflammatory Response, Adverse Effect, Side Effect
In brief
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 testing * Consume one (1) 50mg capsule of full spectrum CBG daily by mouth with food for 8 weeks, followed by a 4-week washout period * Complete biweekly SF-36 surveys as well as MSQ surveys every 4 weeks * Attend a clinical visit every 4 weeks for clinical observation and blood draws for HSCRP, ESR, and PSA (male subjects)
Key facts
- Study ID
- NCT05743985
- Run by
- Formula30A LLC
- People needed
- 69
- Starts
- 2022-08-01
- Expected to finish
- 2024-04-30
- Last updated by the study team
- 2025-02-27
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- In good overall health (as determined by the supervising healthcare provider recommendation as well as no indications of Moderate or Severe conditions on the study measurement tools)
- 21 years old or over
- No 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.
You may not qualify if…
- Under the age of 21
- Is pregnant or breastfeeding
- Initiated or changed use of medication or therapies within 2 weeks prior to the start of the study
- Has a history of hepatic compromise (with transaminases of two times the upper limit of normal) or cirrhosis
- Is already using recreational marijuana, medical marijuana or other cannabinoid formulations (including CBD)
- Has a history of substance or alcohol abuse
- Is using High Dose or Extended-Release Narcotics
Where it is running
- Institute for Hormonal Balance — Arlington, Texas, United States
- NP Care Clinic — Denton, Texas, United States
- Infectious Disease Specialists — Edinburg, Texas, United States
- Modern Medicine — Forney, Texas, United States
- Melville Medicine — Southlake, Texas, United States
- Java Med — Ceiba, Puerto Rico, Puerto Rico
Full record on ClinicalTrials.gov
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