Comparison of delta-tocotrienol and alpha-tocopherol effects on hepatic steatosis and inflammatory biomarkers in patients with non-alcoholic fatty liver disease: A randomized double-blind active-controlled trial

• Published in: Complementary therapies in medicine Vol. 70; p. 102866
• Main Authors: Pervez, Muhammad Amjad, Khan, Dilshad Ahmed, Mirza, Shakeel Ahmed, Slehria, Atiq Ur Rehman, Nisar, Uzma, Aamir, Mohammad
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 01.11.2022; Elsevier Limited; Elsevier
• Subjects: Adipocytes; Adiponectin; Apoptosis; Armed forces; Biochemical analysis; Biomarkers; Body weight; Cholesterol; Clinical trials; Computed tomography; Cytokeratin; Dietary supplements; Double-blind studies; Enzymes; Fatty liver; Fatty liver index; Inflammation; Inflammatory biomarkers; Insulin; Insulin resistance; Interleukin 6; Interleukins; Laboratories; Leptin; Liver; Liver diseases; Liver-to-spleen attenuation ratio; Non-alcoholic fatty liver disease; Nutrition research; Oxidation resistance; Oxidative stress; Patients; Steatosis; Tocopherol; Triglycerides; Tumor necrosis factor-TNF; Tumor necrosis factor-α; Vitamin E; Weight reduction; α-tocopherol; δ-tocotrienol; Rawalpindi Pakistan; United States > US; Pakistan; Inflammatory biomarkers; Fatty liver index; δ-tocotrienol; Liver-to-spleen attenuation ratio; Non-alcoholic fatty liver disease; α-tocopherol
• ISSN: 0965-2299; 1873-6963
• DOI: 10.1016/j.ctim.2022.102866

We aimed to compare the efficacy of δ-tocotrienol with α-tocopherol in the treatment of patients with non-alcoholic fatty liver disease (NAFLD). This study was a double-blinded, active-controlled trial. The patients with NAFLD were randomly assigned to receive either δ-tocotrienol 300 mg or α-tocopherol 268 mg twice daily for 48 weeks. The primary endpoints were change from baseline in fatty liver index (FLI), liver-to-spleen attenuation ratio (L/S ratio), and homeostatic model assessment for insulin resistance (HOMA-IR) at 48 weeks. Key secondary endpoints were change in markers of inflammation, oxidative stress, and hepatocyte apoptosis. Clinical assessment, biochemical analysis, and computed tomography scan of the liver were conducted at baseline, 24 and 48 weeks. A total of 100 patients (δ-tocotrienol = 50, α-tocopherol = 50) were randomized and included in the intention to treat analysis. Compared with baseline, there was a significant improvement (p < .001) in FLI, L/S ratio, HOMA-IR, and serum malondialdehyde in both groups at 48 weeks that was not significant between the two groups. However, there was a significantly greater decrease in body weight, serum interleukin-6, tumor necrosis factor-alpha, leptin, cytokeratin-18, and increase in adiponectin in the δ-tocotrienol group compared to the α-tocopherol group at 48 weeks (p < .05). No adverse events were reported. δ-tocotrienol and α-tocopherol exerted equally beneficial effects in terms of improvement in hepatic steatosis, oxidative stress, and insulin resistance in patients with NAFLD. However, δ-tocotrienol was more potent than α-tocopherol in reducing body weight, inflammation, and apoptosis associated with NAFLD. Sri Lankan Clinical Trials Registry (https://slctr.lk/SLCTR/2019/038). •The first human study to compare the efficacy of δT3 with αTF in the treatment of patients with NAFLD.•δT3 exerted equally beneficial effects as of αTF in improving hepatic steatosis, insulin resistance and oxidative stress.•δT3 was more potent than αTF in improving body weight, inflammation and hepatocyte apoptosis.