Abstract
Purpose: Non-alcoholic fatty liver disease (NAFLD) is a global epidemic. NAFLD progresses to non-alcoholic steatohepatitis (NASH), cirrhosis and cancer. Obesity and insulin insensitivity is the hallmark. Liver participates in glucose and fatty acid homeostasis. Nonexpelled free fatty acid and its toxic metabolites impact oxidative stress; free radicals influx which initiate inflammatory cascade to steatohepatitis (NASH) and activate fibrotic path causing cirrhosis. This clinical trial highlights the effects of anti-oxidants in NAFLD. Methods: One hundred fifty-five (n=155) with BMI over 28% with NAFLD and NASH were recruited and randomized into Group A (n=35) - Control, Group B (n=40) ALA 300 mg, Group C (n=40) Vitamin E 700 IU and Group D (n=40) ALA plus Vitamin E orally for six months. Pre and Post BMI, HOMA, Triglyceride, Hemoglobin A1c, Alanine aminotransferase (ALT), Retinol Binding Protein 4, Tumor Necrosis factor Alfa (TNFα), Leptin and adiponectin levels were compared. Everyone was allowed 1600 cal/day with modest exercise. Exclusion criteria: Diabetics, BMI >33%, Alcohol intake >30 grams/day, Hepatitis B, C, Hypothyroidism, medications including herbs and supplements. Results: Pre and post analysis between ALA plus Vitamin E over placebo in six month; TG 43%, HbA1c 14%, HOMA 62.8%, ALT 14.4%, RBR4 50%, Leptin 23%, Adiponectin 19% TNF alfa 70%, and Steatotic score 70.7%. See Table 1.Table 1: ResultsConclusion: This clinical trial demonstrates the additive effects of ALA and vitamin E in NAFLD and NASH with significant improvements of inflammatory and steatotic score but no difference in the fibrotic score. Therapeutic application of ALA and Vitamin E should be considered for NAFLD.
Published Version
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