NAFLD Clinical Trial
Official title:
The Effects of Choline,Vitamin C, Vitamin E and Ampelopsis Grossedentata Natural Extracts Supplementation on NASH Patients
The global wave of obesity has affected dramatically the incidence of non-alcoholic fatty liver disease (NAFLD) making it the leading cause of liver disease in the western world. NAFLD is considered the hepatic manifestation of metabolic syndrome and is strongly associated with type II diabetes, sleep apnea and cardiovascular disease. Although cardiovascular disease is the leading cause of death in patients with NAFLD, a subset of patients who meet the histological criteria for steatohepatitis have the highest risk for liver-related morbidity and mortality. Reviewing literature, it appears that several pathophysiologic mechanisms related to metabolism, inflammation and fibrosis are deregulated in NAFLD. Choline, Vitamin C, Vitamin E and Ampelopsis Grossedentata natural extracts exhibit high antioxidant activity. In contrast to Vitamin E, which has been extensively studied and has a role as a drug of choice in non-diabetic patients with NAFLD, epidemiological or clinical data for the use of Choline, Vitamin C, Ampelopsis Grossedentata natural extracts or their combination in NAFLD are limited.
The study will be randomized, placebo-controlled and double-blinded in order to avoid a number of systemic errors, such as selection bias and the placebo effect. Patients will be randomly assigned to one of the two categories: (A) a placebo group (B) a Choline - Vitamin C, E and Ampelopsis Grossedentata natural extracts tablets supplementation group (two tablets twice per day). The duration of the intervention will be 12 months. ;
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