Natreon, New Brunswick, NJ, has received a U.S. patent (8,962,576) regarding its Capros ingredient. The claims in this patent cover endothelial function improvement, increase in production of nitric oxide and lipid levels by an extract of Phyllanthus emblica. The patent is based on the clinical data in type 2 diabetics as well as pre-diabetic subjects.

The company has also obtained a “No Questions” letter from FDA regarding the Generally Recognized As Safe (GRAS) status of Capros, which can be used in 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.

A clinical study from Ohio State University Medical Center has also been published in the Journal of Medicinal Food. 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 U.S. 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.

Dr. Sanni Raju, CEO of Natreon, said that Capros is backed by a total of nine clinical studies and an ischemia-reperfusion study from University of Connecticut Medical Center. Capros is suitable for solid dosage forms as well as solutions since it is water-soluble and stable with neutral taste and flavor.