A Randomized Pilot Study on the Effects of Combined Tocotrienol-Tocopherol Mixed Fraction and Vitamin C on Inflammatory Status and Lipid Profile in Statin-Treated High Risk Patients

Abstract

Previous studies have suggested that combination of Tocotrienoltocopherol mixed fraction (TTMF) vitamin E and vitamin C supplementation act synergistically in vivo to enhance their anti-oxidant properties. However, additional effects beyond that of anti-oxidation of combined vitamin E and vitamin C in statin-treated high coronary risk patients remains unclear. The aim of this study was to investigate pleiotropic effects of TTMF and vitamin C on inflammatory biomarkers and lipid profile in statin-treated high coronary risk patients.This was a pilot, randomized, double-blind, placebo controlled clinical trial. Twenty nine high coronary risk hypercholesterolaemic subjects were randomized into TTMF+C (160mg TTMF, 75% tocotrienol: 25% alpha-tocopherol plus 500mg vitamin C) intervention or placebo groups for 12 months. Blood samples were collected at entry, baseline, 2 weeks, 3, 6 and 12 months post-randomization for analysis of inflammatory biomarkers [(high sensitive C-reactive protein (hsCRP), interleukin-6 (IL-6), tumour necrosis factor alpha (TNFα)] and serum lipid profile [Total cholesterol (TC), low density lipoprotein cholesterol (LDL-c), high density lipoprotein cholesterol (HDL-c) and triglycerides (TG)]. There was no significant difference observed between TTMF+C and placebo groups with regards to percent change of hsCRP, IL-6 and TNF-α concentrations (p>0.05) and TC, at baseline, 2 weeks, 3, 6 and 12 months of intervention. There was also no significant change seen in the mean concentration of all inflammatory biomarkers and serum lipid profile between TTMF+C and placebo groups at all timelines. TTMF and vitamin C supplementation did not significantly improve the inflammatory status and lipid profile. This could in part be con-

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