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.