EVNol SupraBio™ Improves Diabetic Nephropathy and Effect Persists 6-9 Months after Washout: A Phase IIa Trial

Twelve weeks supplementation of EVNol SupraBio™ significantly improved renal function in diabetic nephropathy patients, as demonstrated in a study published in Therapeutic Advances in Endocrinology and Metabolism(1). This prospective, multicenter, double-blinded, placebo-controlled study was conducted by a group researcher from the Jeffrey Cheah School of Medicine and Health Sciences, Monash University (Malaysia Campus).

Diabetic nephropathy (DN), also known as diabetic kidney disease, is one of the major complications of diabetes. Diabetes is responsible for over 40% of new cases of end-stage renal disease and now has become the leading cause of kidney failure.

In this study, a total of 54 diabetic nephropathy patients were randomized into two groups; (i) receiving 200mg EVNol SupraBio™ twice daily, or, (ii) receiving placebo daily. Overall, most patients in the study have stage 3A chronic kidney disease as indicated by low estimated glomerular filtration rate (eGFR) and moderate to severe albuminuria. Kidney parameters such as eGFR and serum creatinine were measured and compared to baseline. An increase in eGFR and a decrease in serum creatinine denotes the improvement of renal function.

After 12 weeks of supplementation of EVNol SupraBio™, the study discovered that there was a significant decrease in serum creatinine and thereby resulting in an increase in eGFR. The patients in the placebo group showed a contrasting result. These results confirmed the previous study published in 2018 where it was found that 8 weeks of EVNol SupraBio™ supplementation significantly reduced serum creatinine in patients with diabetic nephropathy(2).

This study also shows a significant reduction in VCAM-1 level after 12 weeks supplementation of EVNol SupraBio™ in patients with low Vitamin E levels at the baseline. VCAM-1 is an adhesion molecule that has been shown to contribute in diabetic kidney inflammation. Since tocotrienol has anti-inflammatory properties, it is hypothesized in the study that tocotrienol helps to improve renal function by reducing VCAM-1.

What is more interesting and a phenomenon not known before is that this study shows that patients in EVNol SupraBio™ group still had stable renal function (serum creatinine reading) for 6 – 9 months after cessation of EVNol SupraBio™ supplementation. This legacy effect is of utmost interest in that the tocotrienols’ effect persisted for more than 6 months, after stopping of supplementation.

The researchers conclude that EVNol SupraBio™ may be an adjunct to standard diabetic therapy to delay the progression of diabetic nephropathy.

“The prevalence of diabetes has reached epidemic proportion globally. To make things worse, diabetes comes with complications such as diabetic nephropathy. The US Centers for Disease Control and Prevention (CDC) has even reported that one in three adults with diabetes are estimated to have chronic kidney disease and most of them are not aware of this complication! Based on this Phase IIA human clinical trial, I’m pleased to read that EVNol SupraBio™ may help to attenuate the progression of diabetic nephropathy,”

“As indicated above, another interesting finding from this study is the ‘Legacy Effect’ of EVNol SupraBio™. It demonstrates the continuous protective effect of EVNol SupraBio™ with regard to diabetic nephropathy, after stoppage of supplementation. This phenomenon was not known before for tocotrienols and as such, I’m definitely looking forward to seeing more research on this legacy effect of EVNol SupraBio™ not just for this health indication but for others as well. It may lead to opening up a new research area for tocotrienols,” – ExcelVite.

References:

 

  1. Tocotrienol-rich vitamin E improves diabetic nephropathy and persists 6–9 months after washout: a phase IIa randomized controlled trial. Therapeutic Advances in Endocrinology and Metabolism, 10; doi:2042018819895462.
  2. Tocotrienol-Rich Vitamin E from Palm Oil (Tocovid) and Its Effects in Diabetes and Diabetic Nephropathy: A Pilot Phase II Clinical Trial, Nutrients2018, 10(9), 1315; doi:10.3390/nu10091315

 

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.