“NUTRITION” (Natural Tocotrienol Against Ischemic Stroke Event) Trial
author : Carotech
Date :09 May 2012
Edison, New Jersey, USA.
Carotech Inc., the world’s largest and only GMP-certified natural full spectrum palm tocotrienol complex supplier is pleased to announce the commencement of a new human clinical trial - “NUTRITION”, which is the acronym for “Natural Tocotrienol Against Ischemic Stroke Event”.
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 – 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. 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.
210 volunteers will be recruited and divided into two groups – Healthy (Phase I) and Hyperlipidemic (Phase II). Volunteers who consent to participate and meeting predefined inclusion and exclusion criteria will be randomized 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 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 (Patel, V., 2012) 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 patients with transient ischemic attack (TIA) or mini-stroke. These findings have set the stage for this large scale “NUTRITION” trial”, says Dr. Sharon Ling, Vice President, Scientific Affairs.
“We have come a long way in researching the use of natural compound in neuroprotection, especially in stroke prevention. It started with Professor. Sen’s NIH funded studies more than 10 years ago that showed extremely low concentration of alpha-tocotrienol prevented glutamate-induced neuronal cell death,” says Mr. WH Leong, Vice President, Carotech Inc.
“The “NUTRITION” human clinical trial is a significant step forward in the search for a prophylactic and therapeutic agent against stroke; especially one that does not cause severe adverse effect in human even after long term consumption. We look forward to the success of this clinical trial,” adds Mr. Leong.
The NUTRITION clinical trial is listed on FDA’s ClinicalTrials.gov website.
For more information, please go to: http://clinicaltrials.gov/show/NCT01579227
1.Patel V, et al. "Oral Tocotrienols are Transported to Human Tissues and Delay the Progression of the Model for End-Stage Liver Disease Score in Patients." The Journal of Nutrition, Feb 2012: (Epub ahead of print).
Carotech Ltd, incorporated in 1990, is the first and largest producer of natural full spectrum tocotrienol/tocopherol complex (Tocomin®& Tocomin SupraBio®), natural mixed carotene complex (Caromin®) and phytosterol complex (Stelessterol™) in the world via its patented technology.
Carotech is the only GMP-Certified tocotrienol producer in the world. Its laboratory is accredited with ISO/ISE 17025 accreditation.
Tocomin SupraBio® is a patented (US Patent No. 6,596,306) self emulsifying palm tocotrienol complex that ensures optimal oral absorption of each individual tocotrienols.
Carotech is an investment of Hovid Ltd (www.hovid.com), one of the largest GMP-certified pharmaceutical companies in Malaysia.
Carotech manufactures these products under the tradenames: Tocomin®, Tocomin SupraBio®, Caromin® and Stelessterol™. Carotech has also launched a natural lycopene extract from tomatoes (Maxopene™).
Carotech’s branded ingredients are 100% Non-GMO, Kosher and Halal certified.