NAFLD generally follows a benign course selleck compound and remains stable for years, but many undiagnosed cases may evolve to nonalcoholic steatohepatitis (NASH), liver fibrosis and cryptogenic liver cirrhosis [1-4]. NAFLD management involves dietary modification and weight loss [6-9]. Although some treatments (insulin sensitizers, antioxidants, lipid-lowering drugs, and ursodeoxycholic acid, among others), have proven beneficial in patients with NFALD, no fully successful pharmacological intervention is available [1,6-12]. In the search for effective and safe alternative therapies, the effects of some natural products on NAFLD have been investigated. The use of n-3 polyunsaturated fatty acids (PUFA) (2 g/day) from seal oils has proven to safely and effectively improve symptoms and normalize ultrasonographic features, as well as improve serum alanine aminotransferase (ALT) and lipid levels .
Also, p olicosanol, a mixture of high molecular weight alcohols isolated from sugarcane wax, has effectively treated IR in hyperlipidemic patients with fatty liver disease, significantly lowering the homeostatic model assessment (HOMA) index and total cholesterol (TC) and low density lipoprotein cholesterol (LDL) levels , consistent with the fact that octacosanol, its main component, attenuates the disrupted metabolism of hepatic reactive oxygen species linked with acute liver injury in carbon tetrachloride (CCl4)-intoxicated rats .
D-002, a substance purified from beeswax, contains a mixture of six of the higher aliphatic alcohols (C26, C26, C28, C30, C32, and C34) present in policosanol [16,17], but in different proportions, so that the major component of D-002 is triacontanol (C30), followed by octacosanol (C28) and docotriacontanol (C32). Oral administration of D-002 has been shown to produce antioxidant effects in experimental [18-20] and clinical studies [21-23], and to exhibit hepatoprotective effects in experimental models of CCl4-induced liver injury . The effects of D-002 treatment in patients with NALFD, however, had not been previously investigated. This study was therefore performed to investigate the efficacy and safety of D-002 in patients with NALFD. METHODS Study design This study was a prospective, single-center, randomized, double-blind, placebo-controlled trial Brefeldin_A consisting of a screening visit and a 24-week treatment period. The study protocol was approved by the Ethics Committee of the Medical Surgical Research Centre (Havana, Cuba), a Good Clinical Practices-accredited institution. The study was conducted in accordance with the principles of the Declaration of Helsinki.