In a Phase II Clinical Trial recently published in the journal Nutrients, 12 months of supplementation of EVNol SupraBio™ exhibited a significant improvement in the conduction velocity of median and sural sensory nerves among type 2 diabetes patients.
Diabetic peripheral neuropathy (DPN) is one of the diabetic complications that causes nerve damage in diabetic patients. It is said to be the most common diabetic complication, affecting roughly 50% of type-2-diabetes (T2D) patients in their lifetime. The painful neuropathic symptoms and serious complications of DPN can lead to innumerable poor outcomes including impaired mobility and quality of life.
In this regard, Dato’ Dr. Khalid Abdul Kadir, who is a Professor of Medicine at Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia has put in many years of effort and dedication into diabetes research. Under Professor Khalid’s lead, a phase II double-blinded, placebo-controlled clinical trial was recently conducted to explore the effect of tocotrienol on DPN (1). A total of 88 T2D participants from the Clinical Research Centres (CRCs) of Monash University have been recruited in this study, and they are assigned randomly either into the intervention group or control group.
The intervention group was required to consume 200mg of EVNol SupraBio™ (encapsulated in soft gels branded as Tocovid SupraBio™) twice per day whereas the control group was required to consume matching placebo, for 12 months. Health condition of the participants was accessed during the 2nd, 6th, 12th months from baseline and 6th months after washout, by looking at their nerve conduction parameters and serum biomarkers.
This study has revealed a significant improvement in the conduction velocity of nerves among the intervention group, particularly in the median and sural sensory nerves. The effect was found to last for 12 months within the supplementary period. For the tibial motor nerve, it showed an improvement up to 6 months of supplementation. Since there are no significant changes in measured serum biomarkers in this study, it is postulated that the regulation of tocotrienol-rich Vitamin E (EVNol SupraBio™) is through an alternative pathway. In respect of neuropathic pain, symptoms such as freezing pain and numbness were reduced among a subgroup of participants (with neuropathic pain) after 12 months of EVNol SupraBio™ administration.
This latest finding has further confirmed the outcome of a previous 8-week preliminary research which proved the efficacy of EVNol SupraBio™ in improving the nerves’ velocity parameters (2). In addition, the potential effect of EVNol SupraBio™ on neuropathic symptoms was also reported in the Vitamin E in Neuroprotection Study (VENUS) at 2018 (3). In the study, a subgroup of DPN participants who consumed 200mg EVNol SupraBio™ twice daily for 12 months has experienced a reduction in lancinating pain.
“As evidenced in our latest study, we believed that the patented EVNol SupraBio™ with bio-enhanced property could be a promising supplementary phytonutrient in improving nerve conduction velocity and subsequently, alleviates diabetic peripheral neuropathy,” says Professor Khalid.
“Diabetes is a silent killer which can impact humans with a slew of serious complications if it is left uncontrolled. Nevertheless, diabetes is not invincible as it can be effectively treated especially when it is discovered early. As of now, we have several EVNol SupraBio™ clinical research on diabetes and its microvascular complications, namely neuropathy, retinopathy as well as nephropathy. To the best of our knowledge, these studies present novel and beneficial findings in the association of tocotrienol and diabetic complications. Through these concrete scientific data from the research studies, we hope it can give a high societal impact to the community,” says Ms. Chan Yuen Teng, Head of Quality, Applications, Research and Development (QARD) at ExcelVite.
References
[1] Chuar, P. F., Ng, Y. T., Phang, S. C. W., Koay, Y. Y., Ho, J. I., Ho, L. S., … & Abdul Kadir, K. (2021). Tocotrienol-Rich Vitamin E (Tocovid) Improved Nerve Conduction Velocity in Type 2 Diabetes Mellitus Patients in a Phase II Double-Blind, Randomized Controlled Clinical Trial. Nutrients, 13(11), 3770.
[2] Ng, Y. T., Phang, S. C. W., Tan, G. C. J., Ng, E. Y., Botross Henien, N. P., M Palanisamy, U. D., … & Abdul Kadir, K. (2020). The Effects of Tocotrienol-Rich Vitamin E (Tocovid) on Diabetic Neuropathy: A Phase II Randomized Controlled Trial. Nutrients, 12(5), 1522.
[3] Hor, C. P., Fung, W. Y., Ang, H. A., Lim, S. C., Kam, L. Y., Sim, S. W., … & Yuen, K. H. (2018). Efficacy of oral mixed tocotrienols in diabetic peripheral neuropathy: a randomized clinical trial. JAMA neurology, 75(4), 444-452.