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

NCT05743985 | Completed DMC

• 1 other identifier: F30A-CBG-EAS2022
• Study Type: interventional
• Target: 69
• Locations: 2 countries
• Sites: 6

Brief 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 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)

Conditions

Health, Subjective; Inflammatory Response; Adverse Effect; Side Effect

Keywords

Endocannabinoid System; Cannabis; Cannabigerol; CBG; Cannabinoids; Cannabinoid; Hemp

Outcome Measures

Primary Outcomes (5)

• Change from Baseline Medical Symptom Questionnaire (MSQ) Score at 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

  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

  Blood concentration, measured in mg/L

  8 weeks

• Change from Baseline Erythrocyte Sedimentation Rate (ESR) at 8 weeks

  Blood concentration, measured in mm/hour

  8 weeks

• Change from Baseline Prostate-Specific Antigen (PSA) Score at 8 weeks [Male Subjects]

  Blood concentration, measured in ng/mL

  8 weeks

Study Arms (1)

50mg CBG Capsule

EXPERIMENTAL

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

Interventions

Cannabigerol OTHER

Hemp-derived full spectrum cannabigerol oil carried in an organic coconut (MCT) oil within hydroxypropyl methylcellulose capsules.

Also known as: Formula30A Cannabigerol (CBG) 50mg Capsules, Formula30A CBG

50mg CBG Capsule

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• 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

Sponsors & Collaborators

• Formula30A LLC: lead

Study Sites (6)

Institute for Hormonal Balance

Arlington, Texas, 76016, United States

Location

NP Care Clinic

Denton, Texas, 76201, United States

Location

Infectious Disease Specialists

Edinburg, Texas, 78539, United States

Location

Modern Medicine

Forney, Texas, 75126, United States

Location

Melville Medicine

Southlake, Texas, 76092, United States

Location

Java Med

Ceiba, Puerto Rico, 00735, Puerto Rico

Location

Related Publications (7)

• Nachnani R, Raup-Konsavage WM, Vrana KE. The Pharmacological Case for Cannabigerol. J Pharmacol Exp Ther. 2021 Feb;376(2):204-212. doi: 10.1124/jpet.120.000340. Epub 2020 Nov 9.

  PMID: 33168643 BACKGROUND

• Navarro G, Varani K, Reyes-Resina I, Sanchez de Medina V, Rivas-Santisteban R, Sanchez-Carnerero Callado C, Vincenzi F, Casano S, Ferreiro-Vera C, Canela EI, Borea PA, Nadal X, Franco R. Cannabigerol Action at Cannabinoid CB1 and CB2 Receptors and at CB1-CB2 Heteroreceptor Complexes. Front Pharmacol. 2018 Jun 21;9:632. doi: 10.3389/fphar.2018.00632. eCollection 2018.

  PMID: 29977202 BACKGROUND

• De Petrocellis L, Ligresti A, Moriello AS, Allara M, Bisogno T, Petrosino S, Stott CG, Di Marzo V. Effects of cannabinoids and cannabinoid-enriched Cannabis extracts on TRP channels and endocannabinoid metabolic enzymes. Br J Pharmacol. 2011 Aug;163(7):1479-94. doi: 10.1111/j.1476-5381.2010.01166.x.

  PMID: 21175579 BACKGROUND

• Echeverry C, Prunell G, Narbondo C, de Medina VS, Nadal X, Reyes-Parada M, Scorza C. A Comparative In Vitro Study of the Neuroprotective Effect Induced by Cannabidiol, Cannabigerol, and Their Respective Acid Forms: Relevance of the 5-HT1A Receptors. Neurotox Res. 2021 Apr;39(2):335-348. doi: 10.1007/s12640-020-00277-y. Epub 2020 Sep 4.

  PMID: 32886342 BACKGROUND

• Fellous T, De Maio F, Kalkan H, Carannante B, Boccella S, Petrosino S, Maione S, Di Marzo V, Iannotti FA. Phytocannabinoids promote viability and functional adipogenesis of bone marrow-derived mesenchymal stem cells through different molecular targets. Biochem Pharmacol. 2020 May;175:113859. doi: 10.1016/j.bcp.2020.113859. Epub 2020 Feb 14.

  PMID: 32061773 BACKGROUND

• Crocq MA. History of cannabis and the endocannabinoid system . Dialogues Clin Neurosci. 2020 Sep;22(3):223-228. doi: 10.31887/DCNS.2020.22.3/mcrocq.

  PMID: 33162765 BACKGROUND

• Russo EB, Cuttler C, Cooper ZD, Stueber A, Whiteley VL, Sexton M. Survey of Patients Employing Cannabigerol-Predominant Cannabis Preparations: Perceived Medical Effects, Adverse Events, and Withdrawal Symptoms. Cannabis Cannabinoid Res. 2022 Oct;7(5):706-716. doi: 10.1089/can.2021.0058. Epub 2021 Sep 27.

  PMID: 34569849 BACKGROUND

MeSH Terms

Conditions

Marijuana Abuse

Interventions

cannabigerol; Calcium Gluconate

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Cory Rice, D.O.

  Modern Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 24, 2023
• Study Start: August 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: April 30, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Starting 6 months after publication.
• Access Criteria: IPD and additional supporting information shared upon request.

Locations

US (5); PR (1)