Combined Effect of Omega-3 Fatty Acids and Phytosterol Ester on alleviating Hepatic Steatosis in NAFLD Subjects: A Double-blind Placebo-controlled Clinical Trial.

The aim of this study was to investigate the combined effect of omega-3 fatty acids (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), at an EPA:DHA ratio of 150:500) and phytosterol esters (PS) on Nonalcoholic fatty liver disease (NAFLD) patients. We conducted a randomized, double-blind, placebo-controlled trial. Ninety-six NAFLD subjects were randomly assigned to the following groups: the PS group (receiving 3.3 g/day phytosterol ester); the FO group (receiving 450mg EPA+1500mg DHA/day); the PS+FO combination group (receiving 3.3 g/day phytosterol ester and 450mg EPA+1500mg DHA/day); and the PO group (a placebo group). The baseline clinical characteristics of the four groups were similar. The primary outcome was liver/spleen attenuation ratio (L/S ratio). The percentage increase in liver/spleen attenuation (≤1) in the PS+FO group was 36% (P=0.083), higher than those in the other three groups (PS group, 11%, P= 0.519; FO group, 18%, P=0.071; PO group, 15%, P=0.436). Compared with baseline, transforming growth factor beta (TGF-β) was significantly decreased in the three study groups at the end of the trial (PS, P=0.000; FO, P=0.002; PS+FO, P=0.001), and tumour necrosis factor alpha (TNF-α) was significantly decreased in the FO group (P=0.036), PS+FO group (P=0.005) and PO group (P=0.032) at the end of the intervention. Notably, TGF-β was reduced significantly more in the PS+FO group than in the PO group (P=0.032). The TG and TC levels of the PS+FO group was reduced by 11.57% and 9.55%, respectively. In conclusion, co-supplementation of PS and EPA+DHA could increase the effectiveness of treatment for hepatic steatosis.