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Pilot Phase II Clinical Trial Shows EVNol SupraBio™ Attenuate Retinal Bleeding In Diabetic Retinopathy

8 weeks supplementation of EVNol SupraBio™ resulted insignificant reduction in retinal hemorrhage.

A pilot phase II clinical trial revealed that 8 weeks supplementation of EVNol SupraBio™ (encapsulated in softgels branded Tocovid SupraBio™) resulted in significant reduction in retinal hemorrhage in the right eye of diabetic retinopathy patients.

Diabetic retinopathy is one of the diabetic complications. It occurs when prolong high blood sugar level causes damage to the blood vessels in the retina. At the early stage, diabetic retinopathy may present no symptom or only mild vision problem. However, this complication could progress and diabetic retinopathy is now the leading cause of new onset blindness among individuals aged 20 to 64 years old. Hence, it is crucial to find an effective treatment strategy to manage the onset and progression of diabetic retinopathy.

In this study led by Emeritus Professor Dr. Khalid Kadir, an endocrinologist from the School of Medicine and Health Sciences, Monash University Malaysia; forty-three (43) diabetes type II patients with diabetic retinopathy were randomized into 2 different groups which are (i) Placebo, and (ii) Intervention receiving EVNol SupraBio™ 200mg twice daily.

The ophthalmic parameters and analytes of the patients were measured at baseline and after a short 8-weeks supplementation of either 400 mg/day EVNol SupraBio™ or placebo.

EVNol SupraBio™, bioenhanced full spectrum palm tocotrienol complex, demonstrated significantly reduced retinal hemorrhage in the right eye. In addition, it is also demonstrated in this study that 8 weeks of EVNol SupraBio™ supplementation caused a significant improvement in liver enzymes aspartate transaminase (AST) and ALT (alanine aminotransferase). Both AST and ALT enzymes are usually used to screen for abnormal liver function.

No significant improvement were observed in serum biomarkers AGE, sRAGE, Nε-CML and Cystatin C in the diabetic retinopathy patients in this study. This lack of effect may be attributed to the short supplementation duration. The patients in this study have a long duration of diabetes (average 18.5 years), causing a long-term and difficult-to-reverse accumulation of these biomarkers in the body. Thus, the researcher suggested that a future study with a longer treatment duration is warranted to allow more time for the tocotrienol to take effect. Besides, more extensive research is also needed to investigate the pathway of tocotrienol improving retinal hemorrhage. Nevertheless, the result suggested that EVNol SupraBio™ could be an adjunct to the current treatment strategy of diabetic retinopathy.

“Previously, 4 research papers have been published on the efficacy of EVNol SupraBio™ on two other diabetic complications, which are diabetic nephropathy and diabetic peripheral neuropathy. To the best of our knowledge, this is a new finding on tocotrienol and diabetic retinopathy in human. We are excited with this result as it further underscores the importance of EVNol SupraBio™ as a potential natural phytonutrient in managing conditions associated with long term diabetes,” says Diyanah Roslan, Nutritionist at ExcelVite.

Reference

Chiew, Y., Tan, S. M. Q., Ahmad, B., Khor, S. E., & Kadir, K. A. (2021). Tocotrienol-rich vitamin E from palm oil (Tocovid) and its effects in diabetes and diabetic retinopathy: a pilot phase II clinical trial. Asian Journal of Ophthalmology, 17(4), 375-399.