NEW BRUNSWICK, N.J. – CAPROS® from Natreon gets a U.S.Patent (8,962,576) for endothelial function improvement, a publication of another clinical study from Ohio State University Medical Center on its cardiovascular benefits in the Journal of Medicinal Food and a “No Questions” GRAS letter from FDA.
U.S.Patent 8,962,576 – The claims in this patent cover endothelial function improvement, increase in production of nitric oxide and lipid levels by an extract of Phyllanthus emblica. This patent is based on the clinical data in type 2 diabetics as well as pre-diabetic subjects.
Clinical Study Publication – “Supplementation of a Standardized Extract from Phyllanthus emblica Improves Cardiovascular Risk Factors and Platelet Aggregation in Overweight/Class-1 Obese Adults
J Med Food 18 (4) 2015, 415–420
http://online.liebertpub.com/doi/pdf/10.1089/jmf.2014.0178
The objective of this study (clinicaltrials.gov NCT01858376) was to determine the effect of oral supplementation of CAPROS® on cardiovascular disease (CVD) risk factors in overweight adult human subjects from the US population. Overweight/Class-1 obese (body–mass index: 25–35) adult subjects received 500 mg of CAPROS® supplement b.i.d for 12 weeks. The study design included two baseline visits followed by 12 weeks of supplementation and then 2 weeks of washout. At all visits, peripheral venous blood was collected in sodium citrate tubes. Lipid profile measurements demonstrated a significant decrease in calculated low-density lipoprotein cholesterol and total cholesterol/high-density lipoprotein following 12 weeks of CAPROS® supplementation when compared to averaged baseline visits. Circulatory high-sensitivity C reactive protein (hs-CRP) levels were significantly decreased after 12 weeks of supplementation. In addition, both ADP- and collagen-induced platelet aggregation was significantly down-regulated following 12 weeks of supplementation. Overall, the study suggests that oral CAPROS® supplementation may provide beneficial effects in overweight/Class-1 obese adults by lowering multiple global CVD risk factors.
GRAS Status – FDA has sent a “No Questions” letter to Natreon for the use of Capros in non-alcoholic beverages, processed fruits and fruit juices, and cereals at levels up to 150 milligrams per serving. Natreon estimated mean and 90th percentile intakes of Capros® to be 445 and 868 mg/person/day, which corresponds to 7.7 and 14.5 mg/kg body weight/day respectively. Natreon also has a self-affirmed GRAS status for Capros®.
Dr. Sanni Raju, CEO of Natreon, says that Capros®, backed by a total of nine clinical studies and an ischemia-reperfusion study from University of Connecticut Medical Center, is the next generation cardiovascular supplement, as it offers much more comprehensive heart health benefits than the current heart health products in the market at a lower dose. Capros® is suitable for solid dosage forms as well as solutions since it is water-soluble and stable with neutral taste and flavor.
For more information, visit Natreon at www.natreoninc.com or contact:
Sanni Raju, Ph.D., R.Ph
sanni@natreoninc.com
Tel: +1 732-296-1080
Cell: +1 908-239-6955
