Human clinical study linking tocotrienols and brain health begins
By Robin Miller and Kalyana Sundram
Malaysia’s GMP-certified palm tocotrienol complex producer, has proudly announced the commencement of its latest human clinical trial “NUTRITION” Phase IIB using a patented and bioenhanced full spectrum palm tocotrienol complex.
The NUTRITION Phase I human clinical trial (Natural Tocotrienol Against Ischemic Stroke Event) began in 2012. It aimed to evaluate the efficacy of a patented and bio-enhanced natural full spectrum tocotrienols in platelet function and blood lipid profile in ischemic stroke event.
The NUTRITION trial was conducted at the Ohio State University Medical Center in collaboration with the Malaysian Palm Oil Board. The research was spearheaded by Professor Chandan K Sen of Ohio State University Wexner Medical Center. He is renowned for his over 15 years of NIH-funded studies on natural full-spectrum tocotrienol’s neuroprotection (protection against stroke-induced injuries) which have continued to establish convincing evidence of benefit since early 2000s.
Upon obtaining significant and positive findings from the NUTRITION Phase I trial, the research team has started the Phase IIB trial to determine the blood thinning and cholesterol lowering properties of palm tocotrienol complex in stroke or mini-stroke (transient ischemic attack or TIA) survivors who are taking standard treatment for the prevention of recurrent stroke. Blood thinning effect or platelet aggregation activity, and cholesterol will be measured using established and recognized clinical laboratory procedures.
Approximately 300 patients who have had an ischemic stroke or TIA event within six months and meet predefined inclusion and exclusion criteria are enrolled in this clinical study. These patients have been randomized and divided into three groups to receive placebo, 400 or 800 milligram tocotrienol capsules for up to one year.
During the past 15 years, Professor Chandan Sen and his research team have elucidated five major mechanisms (molecular checkpoints) in which tocotrienols protect brain cells from stroke-induced injuries or death which led to the current ongoing human clinical trial NUTRITION.
“The “NUTRITION” human clinical trial is a significant step forward in the search for a natural alternative prophylactic and therapeutic agent for stroke and underscores Malaysia’s commitment to science for clinical substantiation of its flagship palm tocotrienols product. This Phase IIB trial that looks at blood thinning and cholesterol lowering effects of in stroke or mini-stroke patients will further provide another compelling evidence on the beneficial effects of tocotrienols in post-stroke management.
The New England Journal of Medicine recently reported that immediate and intensive treatment of TIA may reduce recurrent stroke risk by half. Since the occurrence of TIA has been linked to increased white matter lesions volume (WML) in the brain, and that palm tocotrienols has been shown to attenuate WML progression, the supplementation with tocotrienols for pre- and post-stroke management is an interesting proposition. We eagerly look forward to the success of this clinical trial.
For more information, please go to: https://clinicaltrials.gov/ct2/show/NCT01858311
About Robin Miller
Robin Miller is a health and nutrition editor with more than 30 years of industry experience. She researches and writes about the nutritional benefits of palm fruit oil, with the goal of giving readers factual, science-based information that will be useful in their daily lives.