Clinical trials on effects of tocotrienols on stroke risks begin

EDISON, New Jersey, USA – New human clinical trials on the effects of orally supplemented natural palm mixed tocotrienols on stroke risks -- “NUTRITION”, which is the acronym for “Natural Tocotrienol Against Ischemic Stroke Event” -- have begun, announced Carotech Inc.

This randomised, 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 – the lead researcher from The Ohio State University.

NUTRITION will evaluate the effects of orally supplemented natural palm mixed tocotrienols (Tocomin SupraBio, Carotech Inc.) on platelet function and blood lipid profile including HDL, LDL and total cholesterol. Dyslipidemia and hypercoagulable states are established risk factors of stroke.

Carotech is the world’s largest and only GMP-certified natural full spectrum palm tocotrienol complex supplier.

This study aims to clarify the potential of Tocomin SupraBio patented and bioenhanced natural full spectrum palm tocotrienol complex to mitigate these important stroke risks.

Volunteers (210) will be recruited and divided into two groups – Healthy (Phase I) and Hyperlipidemic (Phase II). They will be randomised to receive placebo, 400 or 800mg tocotrienols, low-dose 81mg aspirin, or tocotrienols and aspirin together.

Phase I subjects will receive 6 months of supplementation, undergo 3 times of blood test, monthly tape stripping and blood pressure measurements. On the other hand, Phase II subjects will be studied for 12 months with 5 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. They found convincing evidence on the potent neuroprotective effects of tocotrienols. Funded by the US National Institutes of Health (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 & 12-Lox pathways, induction of a survival factor MRP-1 and improvement of blood supply to ischemic brain tissue via enhanced collateral flow.

A recently published human distribution study* proved that tocotrienols (Tocomin SupraBio, Carotech Inc.) were orally absorbed and well distributed to various tissues and vital organs including brain, skin, adipose, heart and liver. Most importantly, alpha-tocotrienol was transported to human brain at a concentration reported to be neuroprotective.

“Natural palm mixed tocotrienol complex shows promising neuroprotective and hypocholesterolemic properties. As such, it is potentially a useful agent for people at risk of ischemic stroke including patientsRunners Alliance