Abstract
BackgroundNonalcoholic fatty liver disease (NAFLD) is one of the commonest liver disorders. Obesity, insulin resistance, lipid peroxidation and oxidative stress have been identified amongst the possible hits leading to the onset and progression of this disease. Nutritional evaluation of NAFLD patients showed a lower-than-recommended intake of vitamin E. Vitamin E is a family of 8 isoforms, 4 tocopherols and 4 tocotrienols. Alpha-tocopherol has been widely investigated in liver diseases, whereas no previous clinical trial has investigated tocotrienols for NAFLD. Aim of the study was to determine the effects of mixed tocotrienols, in normalising the hepatic echogenic response in hypercholesterolaemic patients with ultrasound-proven NAFLD.MethodsEighty-seven untreated hypercholesterolaemic adults with ultrasound-proven NAFLD were enrolled and randomised into control group (n = 44) and tocotrienols group (n = 43). The treatment, either mixed tocotrienols 200 mg twice daily or placebo, had a 1-year duration.Normalisation of hepatic echogenic response, being the trial primary aim, was used in sample size calculations. The data were assessed according to intention to treat principle as primary outcome. Per protocol analysis was also carried out as secondary outcome measurement.ResultsThirty and 34 participants concluded the study in the tocotrienols and placebo group respectively. Alpha-tocopherol levels were within the normal range for all subjects. As primary outcome, the normalisation of hepatic echogenic response was significantly higher for the tocotrienols treated group compared to the placebo group in the intention to treat analysis (P = 0.039; 95% CI = 0.896-6.488). As secondary objective, the per protocol assessment also showed significant rate of remission (P = 0.014; 95% CI = 1.117-9.456). Worsening of NAFLD grade was recorded in two patients in the placebo group, but none in the group treated with tocotrienols. No adverse events were reported for both groups.ConclusionThis is the first clinical trial that showed the hepatoprotective effects of mixed palm tocotrienols in hypercholesterolemic adults with NAFLD.Trial registrationClinicaltrials.gov, NCT00753532.
Highlights
Nonalcoholic fatty liver disease (NAFLD) is one of the commonest liver disorders
Other homologues of vitamin E, namely tocotrienols, exist in isomers designated as alpha, beta, gamma and delta, and they differentiate from analogous isomers of tocopherol by the presence of an unsaturated phytyl chain (‘tail’) as opposed to a saturated one in tocopherols
Patients characteristics The study participants self-reported mostly sedentary lifestyles, with none of them engaged in regular physical exercise of minimum 30 minutes 3-time weekly
Summary
Insulin resistance, lipid peroxidation and oxidative stress have been identified amongst the possible hits leading to the onset and progression of this disease. Nutritional evaluation of NAFLD patients showed a lower-than-recommended intake of vitamin E. Alpha-tocopherol has been widely investigated in liver diseases, whereas no previous clinical trial has investigated tocotrienols for NAFLD. Aim of the study was to determine the effects of mixed tocotrienols, in normalising the hepatic echogenic response in hypercholesterolaemic patients with ultrasound-proven NAFLD. In recent years research on non-alcoholic fatty liver disease (NAFLD) has been intensified indicating an increased interest in this common hepatic disorder. Nutritional assessment of NAFLD patients showed a lower-than-recommended intake of vitamin E [3], possibly leading to low plasma concentration of antioxidants. The most common homologue of the vitamin E family investigated is alpha-tocopherol. Other homologues of vitamin E, namely tocotrienols, exist in isomers designated as alpha, beta, gamma and delta, and they differentiate from analogous isomers of tocopherol by the presence of an unsaturated phytyl chain (‘tail’) as opposed to a saturated one in tocopherols
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