June 15th, 2020 – New Jersey, USA. 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.
“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 4 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)(3, 4) and DPN (reducing lancinating pain(2) 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.
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.
About ExcelVite
ExcelVite Sdn. Bhd., incorporated in Malaysia in 2013, is the leading and largest producer of natural full spectrum tocotrienol / tocopherol complex (EVNol™, and EVNol SupraBio™), natural mixed-carotene complex (EVTene™), phytosterol complex (EVRol™), and red palm oil concentrate (EVSpectra™) in the world via a patented technology.
ExcelVite is the only tocotrienol producer that operates in accordance to GMP (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products. Its laboratory is accredited with ISO/IEC 17025 accreditation.
EVNol SupraBio™ is a patented (US Patent No. 6,596,306) self-emulsifying palm tocotrienol complex that ensures optimal tocotrienols oral absorption.
EVTene™ natural palm mixed-carotenes is a natural source for vitamin A and a natural coloring agent (yellow - orange) for food and beverage products such as margarine, ghee, juices etc.
ExcelVite manufactures and markets its products under the tradenames: EVNol™, EVNol SupraBio™, EVTene™, EVRol™, and EVSpectra™. These branded ingredients are Non-GMO, Kosher and Halal certified.
ExcelVite supports the use and production of certified sustainable palm oil (CSPO) and is certified under the Supply Chain Certification Standards of the MSPO (Malaysian Sustainable Palm Oil) and RSPO (Roundtable on Sustainable Palm Oil).
Websites: www.excelvite.com, www.tocotrienol.organd www.carotene.org
Contacts:
Disclaimer: The statements in the above article have not been evaluated by the Food and Drug Administration. They are not intended to diagnose, treat, cure or prevent any disease.
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.
“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 4 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)(3, 4) and DPN (reducing lancinating pain(2) 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.
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.
ExcelVite Sdn. Bhd., incorporated in Malaysia in 2013, is the leading and largest producer of natural full spectrum tocotrienol / tocopherol complex (EVNol™, and EVNol SupraBio™), natural mixed-carotene complex (EVTene™), phytosterol complex (EVRol™), and red palm oil concentrate (EVSpectra™) in the world via a patented technology.
ExcelVite is the only tocotrienol producer that operates in accordance to GMP (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products. Its laboratory is accredited with ISO/IEC 17025 accreditation.
EVNol SupraBio™ is a patented (US Patent No. 6,596,306) self-emulsifying palm tocotrienol complex that ensures optimal tocotrienols oral absorption.
EVTene™ natural palm mixed-carotenes is a natural source for vitamin A and a natural coloring agent (yellow - orange) for food and beverage products such as margarine, ghee, juices etc.
ExcelVite manufactures and markets its products under the tradenames: EVNol™, EVNol SupraBio™, EVTene™, EVRol™, and EVSpectra™. These branded ingredients are Non-GMO, Kosher and Halal certified.
ExcelVite supports the use and production of certified sustainable palm oil (CSPO) and is certified under the Supply Chain Certification Standards of the MSPO (Malaysian Sustainable Palm Oil) and RSPO (Roundtable on Sustainable Palm Oil).
Websites: www.excelvite.com, www.tocotrienol.organd www.carotene.org
Contacts:
WH Leong, CEO | Tel: +61 (03) 9801 3881 |
Email: info@excelvite.com |
Bryan See, Business Dev. Manager | Tel: +1 (732) 906 1901 |
Email: klsee@excelvite.com |
Diyanah Roslan, Nutritionist | Tel: +60 5 2014 192 |
Email: diyanah@excelvite.com |
Fatin Fathihah, Business Dev. Executive | Tel: +60 5 2014 192 |
Email: fatin@excelvite.com |
Huda Rashid, Business Dev. Executive | Tel: +60 5 2014 192 | Email: nurhuda@excelvite.com |
Disclaimer: The statements in the above article have not been evaluated by the Food and Drug Administration. They are not intended to diagnose, treat, cure or prevent any disease.