Gencor’s Levagen ingredient sidesteps regulatory pitfalls on its way to endocannabinoid system
Levegen is Gencor’s branded version of palmitoylethanolamide (PEA), an endocannabinoid-like molecule with potent anti inflammatory properties. PEA was first identified in the 1950s as a potentially therapeutic substance. According to Gencor it is an endogenous substance, produced in the body as a biological response and as a repair mechanism for inflammation.
Culmination of development process
Gencor introduced the ingredient, which is synthesized from palmitic acid, in 2018 after a lengthy development process. At that time one of the ingredient’s differentiators was a GRAS dossier that Gencor has compiled. Now the ingredient has another distinction: an absportion boost via the LipiSperse technology developed by Gencor’s partner Pharmako Biotechnologies of Australia.
Gencor said one of the things holding PEA back from wider application has been the limited data on bioavailability of PEA in human plasma. A new study the company says proves the efficacy of the crystalline LipiSperse technology now puts those concerns to rest.
The parallel, double-blind, absorption study published in the Journal of Nutraceuticals and Food Science measured the uptake of PEA over a 4-hour period in 28 healthy male and female participants. The aim of this trial was to determine whether the use of LipiSperse could improve the absorption of PEA. According to Gencor the results demonstrated that the Levagen+ formulation significantly increased plasma PEA concentration by 1.75 times compared to standard PEA.
Hitting the same targets
CBD products have been associated with a number of health concerns. Addressing chronic pain issues is one of these, which often flies under the flag of quelling chronic inflamation via modulation of the endocannabiond receptors. Gencor says Levagen can hit the same targets without the regulatory concerns that afflcit hemp ingredients.
The company says it has data that shows Legaven (which when offered with the LipiSperse technology is marketed as Levagan+) works on multiple pathways. It binds with the CB1 receptor (CB2 being the other receptor in the endogenous endocannabinoid system that was identified in the 1990s). But Gencor managing director Ramasay Venkatesh and product development executive Mariko Hill said it also inhibits Fatty Acid Amide Hydrolase and by so doing indirectly increases level of anandamide - an endocannabinoid that has profound analgesic effects. Its primary mode of action is through the PPAR Alpha pathway for acute modulation of pain sensory effects.
“In our opinion Levagen is a far better and well studied alternative to CBD and it also acts through the endocannabinoid system. Unlike CBD, it is naturally present in the body and by supplementing with exogenous PEA, we're helping to restore natural levels of PEA in the body (e.g. giving vitamins to a tissue with hypo-vitaminosis). Moreover, there are no adverse effects seen on PEA at any time. The mechanisms of action and ADME are well understood and proven,” Venkatesh and Hill said.
Osteoarthritis data
Gencor has done a number of studies on the ingredient including research on its effects on knee osteoarthritis pain that showed a significant reduction in subject’s reported pain via the WOMAC assessment tool. The company says it is planning additional research short term joint pain study (covering any joint in the body), headache study and a migraine study. We are also conducting a human clinical study on seasonal allergies / allergic rhinitis with PEA's known anti-inflammatory properties.
“Levagen has also been tested by both NSF and LGC, proving it to be absent of any WADA-banned substances, thus is an ingredient athletes can trust to enhance performance and recovery, “ Venkatech and Hill said.
“To sumarize, PEA is a legal, safe, well studied and efficacious dietary supplement with proven benefits,” they added.
