Delta-tocotrienol supplementation improves biochemical markers of hepatocellular injury and steatosis in patients with nonalcoholic fatty liver disease: A randomized, placebo-controlled trial

Objective: The aim of this study was to examine the effects of delta-tocotrienol (delta-tocotrienol) supplementation on biochemical markers of hepatocellular injury and steatosis in patients with nonalcoholic fatty liver disease (NAFLD). Design: The study design was a two-group, randomized, double-blind, placebo-controlled trial. The patients with NAFLD were randomly assigned to receive 8-tocotrienol 300 mg twice daily or placebo for 24 weeks. Endpoints: The primary endpoints were change from baseline in fatty liver index (FLI) and homeostasis model of insulin resistance (HOMA-IR) after 24 weeks. Secondary endpoints included change from baseline in high sensitivity C-reactive protein (hs-CRP), malondialdehyde (MDA), alanine transaminase (ALT), aspartate transaminase (AST) and grading of hepatic steatosis on ultrasound. Between-group differences were tested for significance using ANCOVA. Mean differences (MD) with 95 % CIs are reported. Results: A total of 71 patients (tocotrienol = 35, placebo = 36) were randomized and included in the intention to treat analysis. Compared with placebo, delta-tocotrienol significantly reduced (MD [95 % CI]) FLI (- 8.52 [-10.7, -6.3]; p < 0.001); HOMA-IR (- 0.37 [- 0.53, - 0.21]; p < 0.001), hs-CRP (- 0.61 [- 0.81, - 0.42]; p < 0.001), MDA (- 0.91 [-1.20, - 0.63]; p < 0.001), ALT (- 8.86 [-11.5, - 6.2]; p < 0.001) and AST (- 6.6 [-10.0, - 3.08]; p < 0.001). Hepatic steatosis was also reduced by a significantly greater extent with toco-trienol than with placebo (p = 0.047). No adverse events were reported. Conclusion: delta-tocotrienol effectively improved biochemical markers of hepatocellular injury and steatosis in patients with NAFLD. delta-tocotrienol supplementation might be considered as a therapeutic option in the management of patients with NAFLD.