First human clinical trial also demonstrates safe and well-tolerated BCP doses as high as 100 mg
Nutraceuticals Innovator TruGen3® has announced the results of a first ever human-based clinical trial, proving its proprietary TruEase® CBD formula with patented VESIsorb® Technology achieves 360% greater bioavailability of β-caryophyllene (BCP).
BCP is a natural bicyclic sesquiterpene and a common constituent of the essential oils of numerous food plants such as hemp (Cannabis sativa L) and is thought to interact with the endocannabinoid system by binding selectively to cannabinoid receptors type 2 (CB2). Decades of preclinical research have investigated the potential therapeutic benefits of BCP, such as analgesic, anti-inflammatory, and anti-depressive.
The clinical trial, a randomized, double-blind, cross-over design, single oral dose study [100 mg β-caryophyllene (BCP)] in 24 healthy subjects (12 men/12 women) was performed under fasted conditions and evaluated the relative bioavailability of BCP formulated with VESIsorb® to that of the same BCP neat oil.
In addition to the superior PK results of the BCP VESIsorb® formulation, there are significant findings that highlight the scientific and medical contributions from this new study:
- This is the first published study to demonstrate safe and well-tolerated BCP doses as high as
100 mg, a 10x increase compared to the natural daily human exposure
- This is the first published study to demonstrate that BCP has poor bioavailability in humans
- This is the first published study to reveal there is no significant difference between men and
women for both investigated formulations and all investigated PK endpoints
The new clinical trial was conducted by Geocann®, a global cannabis organization that combines clinically researched cannabinoids and terpenes with technologically advanced drug delivery system technologies that increase absorption and bioavailability for maximum health benefits. (Reference more on the new human clinical trial here): https://www.mdpi.com/1420-3049/27/9/2860)
Widely regarded as today’s best-in-class CBD product produced under the highest ethical and quality standards, TruEase® has also been validated as a superior CBD product in a previously published Clinical Trial Study: “A Novel Self-Emulsifying Drug Delivery System (SEDDS) Based on VESIsorb® Formulation Technology Improving the Oral Bioavailability of Cannabidiol in Healthy Subjects.” #
Unlike typical CBD products, TruEase® delivers a lipid-based, natural, hemp oil product to be delivered in a water-soluble form with no loss in bio-efficacy or absorption. Its patented VESIsorb® delivery system has been proven in previously conducted human clinical trials to increase absorption by more than 400 times other CBD products. TruEase® softgels disperse uniformly, transferring the CBD bioactives directly to the intestinal lymphatic system for boosted bioavailability and faster results. Benefits start in 90 seconds, and users will feel the full effect within 30 to 60 minutes. TruEase® is 4.4 times more bioavailable than the leading CBD brand made with MCT oil. Tests show that the human body needs only 25 mg of TruEase® CBD to their 100 mg.
According to TruGen3® VP Operations and Co-Founder, Michael Lioon, “We are very excited by the results of this first ever human-based clinical trial, validating our proprietary TruEase® formula with VESIsorb®’s superior potency and absorbency of β-caryophyllene (BCP). Our commitment to providing the highest quality, clinically proven products is stronger than ever today.”
TruGen3 is offering health professionals a limited-time opportunity to receive free TruEase® samples by calling 1-844-3TRUGEN or 1-844-387-8436.
TruGen3® continues its legacy of three Lioon family generations and 70 years of nutraceutical experience, with products produced under the highest ethical standards, available exclusively through health professionals. More information is available at trugen3.com.
*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. **EpiCor® is a registered trademark of Embria Health Sciences.