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EVNol SupraBio™ Benefits Diabetic Neuropathy Subjects in RCT

7 May 2021

Oral supplementation of EVNol SupraBio™ significantly improved nerve growth factor and nerve conduction velocities in the nerves of diabetic peripheral neuropathy (DPN) patients, as demonstrated in a Phase II study published in Nutrients (1).

This multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was conducted by a group of researchers from Jeffrey Cheah School of Medicine and Health Sciences, Monash University (Malaysia Campus).

In the study, 80 eligible participants were randomized into 2 groups; (i) received 200mg EVNol SupraBio™ (encapsulated in a softgel branded as Tocovid SupraBio™), or, (ii) placebo, twice a day. The nerve conduction velocity test was carried out on 3 nerves – median, sural, and tibial; and a conduction velocity test measures how fast the nerves could send important signals. In DPN patients, loss of large myelinated fibers leads to slowing of nerve conduction velocity. After 8 weeks of supplementation, the results showed that there was a highly significant improvement in nerve conduction velocities of all nerves (median nerve - +1.25 m/s; sural nerve - +1.60 m/s; tibial nerve - +0.75 m/s) in participants receiving EVNol SupraBio™ as compared to placebo.

Chronic hyperglycemia increases oxidative stress, activates inflammatory pathways and reduces nerve growth factor (NGF) among diabetic patients, which contribute to development of DPN. As a potent antioxidant and anti-inflammatory agent, it is thought that EVNol SupraBio™ will improve DPN by acting on oxidative stress and chronic inflammation. However, the result of this study showed the serum biomarkers reflecting oxidative stress (MDA) and inflammatory activities (VCAM-1 and TNFR-1) remained similar between the 2 supplementation groups.

Surprisingly, this study discovered that serum nerve growth factor (NGF) is significantly elevated among the participants on EVNol SupraBio™’s supplementation compared to placebo’s at eight weeks post-intervention. This increase in serum NGF reflects the reversal of neuronal injuries as well as the restoration of nerve function, and thus suggesting that EVNol SupraBio™ most probably acts through the pathway involving NGF—and not the oxidative stress or chronic inflammatory pathogeneses—to improve DPN.

The researchers subsequently hypothesized that EVNol SupraBio™’s ability to significantly improve nerve growth factor (NGF) could be the possible alternative pathway in enhancing nerve conduction velocities, as shown in this particular human trial. This finding is fascinating as no other study in the past has shown that tocotrienol-rich Vitamin E can increase serum NGF level among the diabetic population and correlated it to improvements in terms of peripheral nerve conduction velocities.

References

1.       Ng, Y.T., Phang, S.C.W., Tan, G.C.J., Ng, E.Y., Botross Henien, N.P., M. Palanisamy, U.D., Ahmad, B., Abdul Kadir, K. (2020). The Effects of Tocotrienol-Rich Vitamin E (Tocovid) on Diabetic Neuropathy: A Phase II Randomized Controlled Trial. Nutrients, 12, 1522.

2.       Hor, C.P., Fung, W.Y., Ang, H.A., Lim, S.C., Kam, L.Y., Sim, S.W. (2018). Efficacy of Oral Mixed Tocotrienols in Diabetic Peripheral Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 75, 444–452.

3.       Sadikan, M. Z., Nasir, N. A. A., Agarwal, R., & Ismail, N. M. (2020). Protective Effect of Palm Oil-Derived Tocotrienol-Rich Fraction against Retinal Neurodegenerative Changes in Rats with Streptozotocin-Induced Diabetic Retinopathy. Biomolecules, 10(4), 556.

4.       Tan, S. M. Q., Chiew, Y., Ahmad, B., & Kadir, K. A. (2018). Tocotrienol-Rich Vitamin E from Palm Oil (Tocovid) and Its Effects in Diabetes and Diabetic Nephropathy: A Pilot Phase II Clinical Trial. Nutrients, 10(9), 1315.