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

Previous studies have suggested that combination of Tocotrienol-tocopherol 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, LDL-c, TG and HDL-c (p>0.05) 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 contributed to the masking effect of statin’s pleiotropic properties and the possibility of alpha tocopherol in the TTMF mixture attenuating the beneficial effects of pure tocotrienols.