The NUTRITION human clinical trial (Natural Tocotrienol Against Ischemic Stroke Event) was designed as a single-centre, randomised, double-blind trial
The incidence of aspirin resistance was significantly decreased in patients taking aspirin and clopidogrel with supplementation of tocotrienol. This important finding was observed in the NUTRITION Trial - a randomised double-blind human clinical trial conducted at the Ohio State University Medical Center, in collaboration with the Malaysia Palm Oil Board.
The NUTRITION human clinical trial (Natural Tocotrienol Against Ischemic Stroke Event), designed as a single-centre, randomised double-blind clinical trial, was conducted to determine the effects of orally supplemented tocotrienol (patented & bioenhanced EVNol SupraBio) on platelet function in patients with transient ischemic attack (TIA) or stroke in addition to the standard treatment for stroke prevention.
In the clinical trial, 150 patients were randomised into 3 groups - (i) placebo, (ii) 400 mg tocotrienol, and (iii) 800 mg tocotrienol. The tocotrienol used in this study was based on the patented and bioenhanced EVNol SupraBio full spectrum palm tocotrienol complex (encapsulated as Tocovid SupraBio).
In addition to the intervention assigned to the patients, the patients also took either aspirin or clopidogrel (antiplatelet medicine) or aspirin plus clopidogrel. In the setting of TIA, aspirin has been shown to reduce the relative risk of recurrent stroke by inhibiting platelet aggregation.
Dual antiplatelet therapy with clopidogrel and aspirin may provide greater protection in reducing the risk of recurrent stroke. However, some of the recurrent strokes that occurred in the intervention cohort may relate to the failure of these antiplatelet agents such as aspirin to inhibit platelet aggregation (i.e. aspirin resistance). Aspirin resistance is a condition where the patients are resistant or only partially responsive to the antiplatelet effects and may correlate independently with increasing risk of stroke or cardiovascular events. In this study, the platelet function test was performed at baseline and at 3-month intervals for 1 year. The aspirin resistance was defined by residual platelet aggregation reading of more than 19%.
In addition to human trials in supporting brain and heart health, we are also currently carrying out human studies on metabolic health conditions
It was observed in the study that there is no decrease in the incidence of aspirin resistance in patients treated with aspirin alone, regardless of the dosage of tocotrienol taken by the patients. There was also no difference in the aspirin responders in patients taking clopidogrel alone between the 3 groups.
However, in those patients who take both aspirin and clopidogrel, a much higher rate of 40% aspirin resistance was observed in the placebo group than in any of the 3 treatment groups of patients taking aspirin alone. More interestingly, there is a significant reduction in aspirin resistance (p=0.04) in patients who took both aspirin and clopidogrel, as well as supplementation of either 400 or 800 mg tocotrienol. This result suggests the unique effect of tocotrienol in that it may help in attenuating or reducing the incidence of aspirin resistance in patients who take both aspirin and clopidogrel together.
"Over the past 20 years, Professor Chandan Sen and his research team have elucidated 5 major mechanisms in which tocotrienol protect brain cells from stroke-induced injuries. Pre-clinical study published in 2011 also demonstrates that prophylactic supplementation of tocotrienol (EVNol SupraBio) reduces brain injury post-stroke. Given the promising and significant effect from past studies and the promising results in this NUTRITION Clinical Trial, it underscores another unique effect of EVNol SupraBio and potentially as natural therapeutic natural phytonutrient supporting brain and heart health," said WH Leong, CEO of ExcelVite.
"We are delighted with these results - EVNol SupraBio's complementary effect in attenuating aspirin resistance and its safety, even at a very high dose of 800mg per day, from these Phase I and II trials. We definitely look forward to carrying out the Phase III trial, especially the effectiveness of EVNol SupraBio in conjunction with the standard drug therapy for TIA / Stroke."
"In addition to human trials in supporting brain and heart health, we are also currently carrying out human studies on metabolic health conditions. Promising results have been published in high-impact peer-reviewed journals and the detailed results will be discussed in an upcoming webinar. Visit our website for more information," said Bryan See, Business Development Manager of ExcelVite.