Gencor builds science for endocannabinoid-like molecule for joint health and sports recovery
Interest in the endocannabinoid system has never been higher, and consumer demand for CBD (cannabidiol) products continues to grow, despite FDA’s repeated statements that it is not recognized as a legal dietary ingredient. Many brands that currently offer CBD-containing products acknowledge it as a calculated risk, a strategy that is bearing fruit as the FDA acknowledged recently that any enforcement against products was unlikely, except against companies that are making outrageous drug claims.
For companies seeking a way to impact the endocannabinoid system without the potential legal risk, an option is palmitoylethanolamide (PEA).
Speaking with NutraIngredients-USA at the recent Expo West event in Anaheim, R.V. Venkatesh, CEO of Gencor, explained that palmitoylethanolamide was first discovered in 1957 as a component in egg yolk, when egg yolk was being researched for it's anti-inflammatory properties.
PEA is produced by our body as a first responder to pain, stress, inflammation and is used up locally in all tissues, he said.
The company’s Levagen-branded PEA is positioned for joint health and the potential benefits are supported by data from an eight-week week, randomized, double blind, placebo controlled clinical study in individuals with mild to moderate osteoarthritis.
The results, which are slated to be published in a peer-review journal soon, showed that both 300 mg per day and 600 mg per day doses produced statistically significant reductions in total WOMAC [Western Ontario and McMaster Universities Osteoarthritis Index] score, as well as in pain, stiffness and function subdomains.
“We also observed a reduction in anxiety among the study population,” said Venkatesh.
A cold-water dispersible form is also available, said Venkatesh, that uses LipiSperse technology from Gencor’s sister company Pharmako Biotechnologies to boost bioavailability, which is known to be poor.
A pharmacokinetic study performed by the company comparing Levagen+ (as the water dispersible form is called) showed that absorption was increased 1.8 times, compared to normal palmitoylethanolamide.
Gencor subsequently commissioned an acute exercise recovery study using the Levagen+ product at a low dose of 150 mg.
The results, which have not yet been submitted to a peer-review journal for publication, showed that Levagen+ was associated with significant reductions in myoglobin levels, compared to placebo. Myoglobin is a marker of muscle damage.
There were also reductions in lactate formation, which indicated a reduction in exercise related pain, said Venkatesh.
Increase in Protein Kinase B levels. PKB/Akt is the pathway for mTOR and increased muscle synthesis.
“So, the product could be an excellent addition to the sports nutrition arena to support recovery from exercise, at a low dosage,” Venkatesh told us. “More research is being done on the product by us, consistent with our policy of constant cutting-edge research and innovation.”
GMPs and GRAS self-affirmation
The ingredients are produced at a cGMP Pharmaceutical facility, said Venkatesh, and the company has completed a self- affirmed GRAS dossier on the ingredient.