Safety Assessment of tocotrienol supplementation in subjects with metabolic syndrome: A randomised control trial

Previous studies have reported that tocotrienols (t3) possess many distinct properties such as antioxidant,cardioprotective,neuroprotective,anti-cancer,anti-inflammatory and anti-angiogenic,which are beneficial for the improvement of human health. however,there is limited data available on the safety assessment of t3 compared to tocopherols (t). a randomised,double-blinded,cross-over and placebo-controlled human clinical trial was conducted to determine the safety and tolerance of t3 supplementation in 31 subjects with metabolic syndrome. the subjects were supplemented with tocotrienol-rich fraction (trf) 200 mg or placebo capsules twice daily for two weeks followed by a post-intervention visit. results showed that t3 supplementation had no significant adverse effect on the red blood cell (rbc),white blood cell (wbc) and platelet counts between trf (5.10 ± 0.78 × 1012 litre-1,7.35 ± 1.59 × 109 litre-1,279.45 ± 73.86 × 109 litre-1,respectively) and placebo interventions (5.13 ± 0.76 × 1012 litre-1,7.25 ± 1.95 × 109 litre-1,267.45 ± 68.72 × 109 litre-1,respectively). measures of serum aspartate aminotransferase (ast),serum alanine aminotransferase (alt)) and albumin did not differ between trf (25.68 ± 10.72 iu litre-1,38.26 ± 24.74 iu litre-1,43.61 ± 2.26 g litre-1,respectively) and placebo interventions (27.39 ± 16.44 iu litre-1,42.23 ± 33.58 iu litre-1,43.68 ± 2.15 g litre-1,respectively).this study indicated that supplementation with t3 at the dosage of 400 mg per day for 14 days did not induce haematoxicity and hepatotoxicity in subjects with metabolic syndrome.