Phase II clinical trial shows EVNol SupraBio attenuates retinal bleeding in diabetic retinopathy

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

Diabetic retinopathy, a diabetic complication, occurs when prolonged high blood sugar levels cause damage to the blood vessels in the retina.

At the early stage, diabetic retinopathy may present no symptoms or only mild vision problems. However, this complication could progress and diabetic retinopathy is now the leading cause of new onset blindness among individuals aged 20–64.

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, 43 diabetes type II patients with diabetic retinopathy were randomised into two different groups (placebo and those receiving EVNol SupraBio).

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

EVNol SupraBio, a bioenhanced full spectrum palm tocotrienol complex, demonstrated significantly reduced retinal haemorrhage in the right eye. In addition, the study showed that 8 weeks of EVNol SupraBio supplementation caused a significant improvement in liver enzyme function (aspartate transaminase [AST] and ALT [alanine aminotransferase]).

Both AST and ALT enzymes are usually used to screen for abnormal liver function.

No significant improvements were observed in the 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 researchers 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 how tocotrienols improve retinal haemorrhage. Nevertheless, the result suggested that EVNol SupraBio could be an adjunct to the current treatment strategy of diabetic retinopathy.

“Previously, four 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 humans. 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,” said Diyanah Roslan, Nutritionist at ExcelVite.

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