The NUTRITION human clinical trial is a significant step forward in the search for a natural alternative prophylactic and therapeutic agent for stroke
The only GMP-certified palm tocotrienol complex producer, ExcelVite, proudly announces the commencement of the latest human clinical trial, NUTRITION Phase IIB, with 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 and evaluated the efficacy of a patented and bioenhanced natural full spectrum tocotrienols (EVNol SupraBio, ExcelVite) in platelet function and blood lipid profile in ischaemic stroke event.
The NUTRITION trial is being conducted at the Ohio State University Medical Center, in collaboration with the Malaysian Palm Oil Board. The research is spearheaded by Professor Chandan K. Sen of Ohio State University Wexner Medical Center, who is renowned for his more than 15 years of NIH-funded studies on natural full spectrum tocotrienols complex (EVNol and EVNol SupraBio) in neuroprotection — vis-a-vis protection against stroke-induced injuries — that have continued to establish convincing evidence of benefit since early 2000s.
On obtaining significant and positive findings from the current NUTRITION Phase I trial, the research team has started the Phase II B trial to determine the blood thinning and cholesterol lowering properties of palm tocotrienol complex (EVNol SupraBio) in stroke or mini-stroke (transient ischemic attack, 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 recognised clinical laboratory procedures.
Approximately 300 patients who have had an ischaemic stroke or TIA event within 6 months and meet predefined inclusion and exclusion criteria are enrolled in this clinical study. These patients are then randomised and divided into three groups to receive a placebo, 400 or 800mg 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 have subsequently 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,' says W.H. Leong, CEO, ExcelVite.
'The New England Journal of Medicine recently reported that immediate and intensive treatment of TIA may reduce recurrent stroke risk by half. As the occurrence of TIA has been linked to increased white matter lesions volume (WMLs) in the brain, and that EVNol SupraBio has been shown to attenuate WML progression, the supplementation with tocotrienol for pre- and post-stroke management is an interesting proposition. We eagerly look forward to the success of this clinical trial,' adds Mr Leong.