ChromaDex Corp. has initiated a second human clinical study for PURENERGY, its patented caffeine ingredient.
The Institutional Review Board (IRB)-approved, crossover design study will be administered by Medicus Research and will build on the results from the first PURENERGY human study, which was performed in 2013.
The new clinical trial will study the bioavailability and pharmacokinetics of the ingredient as compared to caffeine and pTeroPure pterostilbene alone at repeated doses.
The company says PURENERGY is a cocrystal combination of caffeine and patented pTeroPure pterostilbene, which forms a crystalline structure that has superior benefits as compared to caffeine.
As caffeinated energy products have come under increased regulatory and political scrutiny due to the possible risks associated with consuming high amounts of caffeine, the company says PURENERGY can offer product formulators a solution to reduce total caffeine content while optimizing the consumer experience, as well as delivering the benefits of pTeroPure.
An alternative to caffeine in formulating products
Results from the first study conducted in 2013 showed that the ingredient delivers 30% more caffeine to the bloodstream and also extends the half-life of caffeine by 25% as compared to caffeine.
The study results suggest:
•Formulators of energy products can reduce the total amount of caffeine in their products without sacrificing consumers’ expectations from such products.
•A rapid and sustained energy boost for at least six hours.
Besides being a caffeine alternative, the company says the ingredient has shown great promise for supporting heart health, cognitive function, anti-aging, weight loss and other metabolic functions.
The findings from the first clinical trial of the pure compound, which were presented in September 2012 at the American Heart Association’s High Blood Pressure Research 2012 Scientific Sessions, showed that pTeroPure (pterostilbene) significantly reduced blood pressure in adults.
pTeroPure was named the 2010 North American Most Promising Ingredient of the Year by research company Frost & Sullivan.
