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EVNol SupraBio™ Improves Diabetic Nephropathy and Effect Persists 6-9 Months after Washout: A Phase IIa Trial
10 May 2021Twelve weeks supplementation of EVNol SupraBio™ significantly improved renal function in diabetic nephropathy patients.
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.
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, Nutrients 2018, 10(9),
1315; doi:10.3390/nu10091315