CHICAGO—A new open-label study supported by SourceOne Global Partners found the company’s Cholesstrinol™HP formulation could reduce high-sensitivity C-reactive protein (hsCRP), a marker of inflammation associated with increased risk of cardiovascular disease (CVD). The study, conducted by Dr. Andreas Biller and team from Dr. Loges & Co. in Winsen, Germany, involved hypercholesterolemic men and women (n=84) who received the Cholesstrinol HP formula—a combination of polymethoxylated flavones (PMFs) and tocotrienols—for 12 weeks. At the end of the intervention, the subjects taking Cholesstrinol HP had reductions in hsCRP levels from 2.4 mg/L to 1.4 mg/L, a 42 percent reduction; among subjects considered best responders, the hsCRP level dropped from 3.6 mg/L to 1.7 mg/L, a 57 percent decrease.
SourceOne noted CRP is considered an increasingly definitive factor in cardiovascular status. The “Jupiter Study," published in the New England Journal of Medicine (2008;359:2195-207), noted higher levels of hsCRP “predict cardiovascular events." In the study’s discussion section, the researchers stated: “We hope the data presented here spur the further development of targeted anti-inflammatory drugs as potential vascular therapeutic agents and lead to innovative trials that can directly address whether the inhibition of inflammation by agents other than statins can reduce rates of vascular events."
Jesse Lopez, founder and CEO of SourceOne, commented, “We are delighted with these results because they validate and complement previous study results that revealed compelling heart-health benefits." He cited previous studies showing the benefits of two ingredients in Cholesstrinol—TocoSource® Palm Tocotrienols and PMF-source™ Citrus Flavonoids—in improving cholesterol levels, and how using the VESIsorb® delivery system increased the bioavailability of PMFs.
Biller noted the current study, which he plans to submit for publication, yielded consistent improvements in CRP levels in all subjects, and using the VESIsorb delivery system improved the bioavailability of the actives. Andreas Supersaxo, director of research and development for Vesifact and member of Source One’s Medical and Scientific Board, added the company plans to start another study with Biller in September 2010 to compare multiple formulations and measure several clinical end points in cardiovascular health.
Lopez concluded, “There are numerous new product launches featuring one of our Cholesstrinol formulations and more on the horizon, thanks to this study and other study results we have that are soon to be released."
