The only GMP-certified palm tocotrienol complex producer, ExcelVite proudly announces the commencement of its latest human clinical trial “NUTRITION” Phase IIB using its patented and bioenhanced EVNol SupraBio 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 (EVNol SupraBio, ExcelVite Inc.) 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 (EVNol SupraBio) 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 EV’s commitment to science for clinical substantiation of its flagship product – EVNol SupraBio. This Phase IIB trial that looks at blood thinning and cholesterol lowering effects of EVNol SupraBio in stroke or mini-stroke patients will further provide another compelling evidence on the beneficial effects of EVNol SupraBio in post-stroke management,” said ExcelVite, Inc. CEO W.H. Leong.
“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 EVNol SupraBio 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,” added Leong.
For more information, please go to: https://clinicaltrials.gov/ct2/show/NCT01858311