Carotech Inc. Launches NUTRITION Clinical Trial

EDISON, N.J.Carotech Inc. announced the commencement of a new human clinical trial, "Natural Tocotrienol Against Ischemic Stroke Event," (NUTRITION).

This randomized, double blind, placebo-controlled, phase I and II human clinical trial is a collaborative study between the Government of Malaysia and Professor Chandan K. Sen. a researcher from The Ohio State University. NUTRITION will evaluate the effects of orally supplemented natural palm mixed tocotrienols (as Tocomin SupraBio^® from Carotech Inc.) on platelet function and blood lipid profile including high-density lipoprotein (HDL), low-denisty lipoprotein LDL and total cholesterol.

Volunteers (n=210) will be recruited and divided into two groups, Healthy (Phase I) and Hyperlipidemic (Phase II). Volunteers who consent to participate and meet predefined inclusion and exclusion criteria will be randomized to receive placebo, 400 mg or 800 mg tocotrienols, low-dose 81 mg aspirin, or tocotrienols and aspirin together. Phase I subjects will receive six months of supplementation, undergo three times of blood test, monthly tape stripping and blood pressure measurements. Phase II subjects will be studied for 12 months with five times blood test plus monthly tape stripping and blood pressure measurements.

For the past decade, Professor Sen and his research team have been studying the effects of natural palm mixed tocotrienols  (Tocomin^® and Tocomin SupraBio^®) in neuroprotection presented in a webinar by Natural Products Insider. They found convincing evidence on the potent neuroprotective effects of tocotrienols. Funded by the NIH, the researchers have elucidated four major mechanisms in which tocotrienols protect brain cells from stroke-induced injuries or death. These include inhibition of c-Src and 12-Lox pathways, induction of a survival factor MRP-1 and improvement of blood supply to ischemic brain tissue via enhanced collateral flow.