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

February 25, 2025 updated by: Formula30A LLC

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND AND CONTEXT

The Cannabis plant has gained significant, and increasing, interest in the medical community due to the therapeutic potential of substances such as Δ9-tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD). However, there are hundreds of different phytocannabinoids, terpenes, and flavonoids present in Cannabis plants, generating complex interactions in the human body. Cannabigerol (CBG) is one phytocannabinoid that has recently garnered a groundswell of media and commercial interest, although scientific literature on CBG is severely lacking compared with published research on Δ9-THC and CBD. Current studies suggest that CBG appears to have characteristics for affinity and activity somewhere between CBD and Δ9-THC, with additional unique interactions with 5-hydroxytryptamine (5-HT1A) receptors and α-2 adrenoceptors. Based on published research, there may be therapeutic potential for CBG in the treatment of neuroinflammatory disorders, inflammatory bowel disease, bacterial infections (such as MRSA), prostate cancer, and dental plaque. Many of these studies, however, indicate a vital need for additional research on the pharmacological effects of human CBG consumption, especially given the increase in its unregulated commercial use. This study will focus on the clinical application of CBG for healthy adults, current knowledge of its possible therapeutic utility, and its potential toxicological hazards.

PROBLEM STATEMENT

Cannabigerol is currently available for purchase in a variety of products and, as with cannabidiol (CBD) before it, many claims are being made about its benefits. Unlike CBD, however, little in-depth research has been performed on this intriguing phytocannabinoid, and much of what is known warrants further investigation to identify potential areas of therapeutic uses and hazards.

RESEARCH QUESTIONS

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?

OBJECTIVES

The long-term goal is to provide exploratory research into the in vivo physiological and psychological effects, if any, of cannabigerol in humans. The objective of the current study is to determine whether clinically applied CBG in 100 healthy adults 21 or over in the United States has an effect on inflammatory markers in the body and/or self-reported physical, mental, and emotional wellbeing. The study has the following sub-objectives:

  1. To provide initial data on the physiological and self-reported psychological effects CBG;
  2. To work towards development of a CBG administration method for easier physician dosage control and oversight;
  3. To review and document current industry practices and research in regard to CBG use;
  4. To outline a conceptual framework for the clinical application of CBG.

The result of this study will be valuable to industry practitioners as well as patient populations in developing a clear pharmacological picture of the efficacy and risks of full spectrum CBG consumption.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ceiba, Puerto Rico, 00735
        • Java Med
  • United States
    • Texas
      • Arlington, Texas, United States, 76016
        • Institute for Hormonal Balance
      • Denton, Texas, United States, 76201
        • NP Care Clinic
      • Edinburg, Texas, United States, 78539
        • Infectious Disease Specialists
      • Forney, Texas, United States, 75126
        • Modern Medicine
      • Southlake, Texas, United States, 76092
        • Melville Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 50mg CBG Capsule
50mg cannabigerol (CBG) oil capsule taken daily for 8 weeks. Study surveys and bloodwork completed for 12 weeks total, including 8 weeks of CBG treatment and subsequent 4-week washout period
Other: Cannabigerol
Hemp-derived full spectrum cannabigerol oil carried in an organic coconut (MCT) oil within hydroxypropyl methylcellulose capsules.
Other Names:
  • Formula30A Cannabigerol (CBG) 50mg Capsules
  • Formula30A CBG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Medical Symptom Questionnaire (MSQ) Score at 8 weeks
Time Frame: 8 weeks
Change from baseline scores as measured by the Medical Symptom Questionnaire after 8 weeks. A total score of 20 or less is not clinically significant, 20 to 49 indicates mild toxicity, 50 to 99 indicates moderate toxicity, and 100 and above indicates severe toxicity.
8 weeks
Change from Baseline RAND 36-Item Short Form Survey (SF-36) Scores at 8 weeks
Time Frame: 8 weeks
Change from baseline scores as measured by the RAND 36-Item Short Form Survey after 8 weeks. Scores range from 0-100 for the 8 scales included (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health), with higher scores representing a more favorable health state.
8 weeks
Change from Baseline High-Sensitivity C-reactive Protein (hsCRP) at 8 weeks
Time Frame: 8 weeks
Blood concentration, measured in mg/L
8 weeks
Change from Baseline Erythrocyte Sedimentation Rate (ESR) at 8 weeks
Time Frame: 8 weeks
Blood concentration, measured in mm/hour
8 weeks
Change from Baseline Prostate-Specific Antigen (PSA) Score at 8 weeks [Male Subjects]
Time Frame: 8 weeks
Blood concentration, measured in ng/mL
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Formula30A LLC

Investigators

  • Principal Investigator: Cory Rice, D.O., Modern Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • F30A-CBG-EAS2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication, shared upon request.

IPD Sharing Time Frame

Starting 6 months after publication.

IPD Sharing Access Criteria

IPD and additional supporting information shared upon request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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