Tocotrienol-Rich Vitamin E (Tocovid) Improved Nerve Conduction Velocity in Type 2 Diabetes Mellitus Patients in a Phase II Double-Blind, Randomized Controlled Clinical Trial

Diabetic peripheral neuropathy (DPN) is the most common microvascular complication of diabetes that affects approximately half of the diabetic population. Up to 53% of DPN patients experience neuropathic pain, which leads to a reduction in the quality of life and work productivity. Tocotrienols have...

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Autores principales: Pei Fen Chuar, Yeek Tat Ng, Sonia Chew Wen Phang, Yan Yi Koay, J-Ian Ho, Loon Shin Ho, Nevein Philip Botross Henien, Badariah Ahmad, Khalid Abdul Kadir
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spelling oai:doaj.org-article:f2abb8c3b6a74bf8bd9fad08f7ef07622021-11-25T18:33:54ZTocotrienol-Rich Vitamin E (Tocovid) Improved Nerve Conduction Velocity in Type 2 Diabetes Mellitus Patients in a Phase II Double-Blind, Randomized Controlled Clinical Trial10.3390/nu131137702072-6643https://doaj.org/article/f2abb8c3b6a74bf8bd9fad08f7ef07622021-10-01T00:00:00Zhttps://www.mdpi.com/2072-6643/13/11/3770https://doaj.org/toc/2072-6643Diabetic peripheral neuropathy (DPN) is the most common microvascular complication of diabetes that affects approximately half of the diabetic population. Up to 53% of DPN patients experience neuropathic pain, which leads to a reduction in the quality of life and work productivity. Tocotrienols have been shown to possess antioxidant, anti-inflammatory, and neuroprotective properties in preclinical and clinical studies. This study aimed to investigate the effects of tocotrienol-rich vitamin E (Tocovid Suprabio<sup>TM</sup>) on nerve conduction parameters and serum biomarkers among patients with type 2 diabetes mellitus (T2DM). A total of 88 patients were randomized to receive 200 mg of Tocovid twice daily, or a matching placebo for 12 months. Fasting blood samples were collected for measurements of HbA1c, renal profile, lipid profile, and biomarkers. A nerve conduction study (NCS) was performed on all patients at baseline and subsequently at 2, 6, 12 months. Patients were reassessed after 6 months of washout. After 12 months of supplementation, patients in the Tocovid group exhibited highly significant improvements in conduction velocity (CV) of both median and sural sensory nerves as compared to those in the placebo group. The between-intervention-group differences (treatment effects) in CV were 1.60 m/s (95% CI: 0.70, 2.40) for the median nerve and 2.10 m/s (95% CI: 1.50, 2.90) for the sural nerve. A significant difference in peak velocity (PV) was also observed in the sural nerve (2.10 m/s; 95% CI: 1.00, 3.20) after 12 months. Significant improvements in CV were only observed up to 6 months in the tibial motor nerve, 1.30 m/s (95% CI: 0.60, 2.20). There were no significant changes in serum biomarkers, transforming growth factor beta-1 (TGFβ-1), or vascular endothelial growth factor A (VEGF-A). After 6 months of washout, there were no significant differences from baseline between groups in nerve conduction parameters of all three nerves. Tocovid at 400 mg/day significantly improve tibial motor nerve CV up to 6 months, but median and sural sensory nerve CV in up to 12 months of supplementation. All improvements diminished after 6 months of washout.Pei Fen ChuarYeek Tat NgSonia Chew Wen PhangYan Yi KoayJ-Ian HoLoon Shin HoNevein Philip Botross HenienBadariah AhmadKhalid Abdul KadirMDPI AGarticletype 2 diabetes mellitus (T2DM)diabetic peripheral neuropathytocotrienolvitamin Etransforming growth factor beta-1 (TGFβ-1)vascular endothelial growth factor A (VEGF-A)Nutrition. Foods and food supplyTX341-641ENNutrients, Vol 13, Iss 3770, p 3770 (2021)
institution DOAJ
collection DOAJ
language EN
topic type 2 diabetes mellitus (T2DM)
diabetic peripheral neuropathy
tocotrienol
vitamin E
transforming growth factor beta-1 (TGFβ-1)
vascular endothelial growth factor A (VEGF-A)
Nutrition. Foods and food supply
TX341-641
spellingShingle type 2 diabetes mellitus (T2DM)
diabetic peripheral neuropathy
tocotrienol
vitamin E
transforming growth factor beta-1 (TGFβ-1)
vascular endothelial growth factor A (VEGF-A)
Nutrition. Foods and food supply
TX341-641
Pei Fen Chuar
Yeek Tat Ng
Sonia Chew Wen Phang
Yan Yi Koay
J-Ian Ho
Loon Shin Ho
Nevein Philip Botross Henien
Badariah Ahmad
Khalid Abdul Kadir
Tocotrienol-Rich Vitamin E (Tocovid) Improved Nerve Conduction Velocity in Type 2 Diabetes Mellitus Patients in a Phase II Double-Blind, Randomized Controlled Clinical Trial
description Diabetic peripheral neuropathy (DPN) is the most common microvascular complication of diabetes that affects approximately half of the diabetic population. Up to 53% of DPN patients experience neuropathic pain, which leads to a reduction in the quality of life and work productivity. Tocotrienols have been shown to possess antioxidant, anti-inflammatory, and neuroprotective properties in preclinical and clinical studies. This study aimed to investigate the effects of tocotrienol-rich vitamin E (Tocovid Suprabio<sup>TM</sup>) on nerve conduction parameters and serum biomarkers among patients with type 2 diabetes mellitus (T2DM). A total of 88 patients were randomized to receive 200 mg of Tocovid twice daily, or a matching placebo for 12 months. Fasting blood samples were collected for measurements of HbA1c, renal profile, lipid profile, and biomarkers. A nerve conduction study (NCS) was performed on all patients at baseline and subsequently at 2, 6, 12 months. Patients were reassessed after 6 months of washout. After 12 months of supplementation, patients in the Tocovid group exhibited highly significant improvements in conduction velocity (CV) of both median and sural sensory nerves as compared to those in the placebo group. The between-intervention-group differences (treatment effects) in CV were 1.60 m/s (95% CI: 0.70, 2.40) for the median nerve and 2.10 m/s (95% CI: 1.50, 2.90) for the sural nerve. A significant difference in peak velocity (PV) was also observed in the sural nerve (2.10 m/s; 95% CI: 1.00, 3.20) after 12 months. Significant improvements in CV were only observed up to 6 months in the tibial motor nerve, 1.30 m/s (95% CI: 0.60, 2.20). There were no significant changes in serum biomarkers, transforming growth factor beta-1 (TGFβ-1), or vascular endothelial growth factor A (VEGF-A). After 6 months of washout, there were no significant differences from baseline between groups in nerve conduction parameters of all three nerves. Tocovid at 400 mg/day significantly improve tibial motor nerve CV up to 6 months, but median and sural sensory nerve CV in up to 12 months of supplementation. All improvements diminished after 6 months of washout.
format article
author Pei Fen Chuar
Yeek Tat Ng
Sonia Chew Wen Phang
Yan Yi Koay
J-Ian Ho
Loon Shin Ho
Nevein Philip Botross Henien
Badariah Ahmad
Khalid Abdul Kadir
author_facet Pei Fen Chuar
Yeek Tat Ng
Sonia Chew Wen Phang
Yan Yi Koay
J-Ian Ho
Loon Shin Ho
Nevein Philip Botross Henien
Badariah Ahmad
Khalid Abdul Kadir
author_sort Pei Fen Chuar
title Tocotrienol-Rich Vitamin E (Tocovid) Improved Nerve Conduction Velocity in Type 2 Diabetes Mellitus Patients in a Phase II Double-Blind, Randomized Controlled Clinical Trial
title_short Tocotrienol-Rich Vitamin E (Tocovid) Improved Nerve Conduction Velocity in Type 2 Diabetes Mellitus Patients in a Phase II Double-Blind, Randomized Controlled Clinical Trial
title_full Tocotrienol-Rich Vitamin E (Tocovid) Improved Nerve Conduction Velocity in Type 2 Diabetes Mellitus Patients in a Phase II Double-Blind, Randomized Controlled Clinical Trial
title_fullStr Tocotrienol-Rich Vitamin E (Tocovid) Improved Nerve Conduction Velocity in Type 2 Diabetes Mellitus Patients in a Phase II Double-Blind, Randomized Controlled Clinical Trial
title_full_unstemmed Tocotrienol-Rich Vitamin E (Tocovid) Improved Nerve Conduction Velocity in Type 2 Diabetes Mellitus Patients in a Phase II Double-Blind, Randomized Controlled Clinical Trial
title_sort tocotrienol-rich vitamin e (tocovid) improved nerve conduction velocity in type 2 diabetes mellitus patients in a phase ii double-blind, randomized controlled clinical trial
publisher MDPI AG
publishDate 2021
url https://doaj.org/article/f2abb8c3b6a74bf8bd9fad08f7ef0762
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