This multi-centre, prospective, randomised, 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 randomised into two groups: they either received 200 mg of EVNol SupraBio (encapsulated in a softgel branded as Tocovid SupraBio) or a placebo, twice a day.
The nerve conduction velocity test was done on three 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 fibres 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 with the 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 two supplementation groups.
Surprisingly, this study discovered that serum nerve growth factor (NGF) is significantly elevated among the participants on EVNol SupraBio’s supplementation compared with the placebo at 8 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 hypothesised 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.
“DPN is one of the most common diabetic complications that impairs the quality of life and causes significant morbidity as well as mortality. Given that approximately 50% of adults with diabetes will be affected by peripheral neuropathy in their lifetime, it is crucial to find an intervention that could help these patients,” says Bryan See, Business Development Manager of ExcelVite.
“Our clinical works on EVNol SupraBio in diabetic complications started in 2016. To date, a total of four clinical papers have been published and reported the efficacy of this patented bioenhanced natural full spectrum palm tocotrienol complex as a complementary therapy for diabetic nephropathy (reducing creatinine level) and DPN (reducing lancinating pain and improving nerve conduction velocities)."
"My colleagues and I are extremely excited with this novel finding in DPN patients. We are now planning a new clinical trial – a dose-dependent study of EVNol SupraBio in diabetic complications. Together, it underscores the importance of EVNol SupraBio as a potential natural phytonutrient in managing diabetes complications for healthy kidney and nerve functions,” added Bryan See.
