Evaluation of a High Concentrate Omega-3 for Correcting the Omega-3 Fatty Acid Nutritional Deficiency in Non-alcoholic Fatty Liver Disease and effects on Hepatic Steatosis (CONDIN)

Abstract

This RCT investigated the safety and efficacy of MF4637, a high concentrate omega-3 fatty acid preparation, in correcting the omega-3 fatty acid nutritional deficiency in non-alcoholic fatty liver disease (NAFLD). Whether MF4637 could lower liver fat was evaluated in a subset of patients. 176 subjects with NAFLD were randomised to receive MF4637 (n=87) or placebo (n=89) for 24 weeks, in addition to following standard-of-care dietary guidelines. The omega-3 index, omega-6:omega-3 fatty acid ratio and quantitative measurements of red blood cell (RBC) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) were determined at baseline and study completion. Magnetic resonance imaging of liver fat was conducted in a subset of patients. Administration of MF4637 for 24 weeks significantly increased the omega-3 index and absolute values of RBC EPA and DHA, and decreased the omega-6:omega-3 fatty acid ratio (p<0.0001). A significant reduction in liver fat content was reported in both groups. An inverse relationship between change in absolute RBC EPA+DHA and change in liver fat, AST and ALT was observed. Post-hoc analysis demonstrated a significant liver fat-lowering effect of MF4637 in a subset of patients with baseline fatty liver index score ≥ 40. In conclusion, MF4637 corrected the omega-3 fatty acid nutritional deficiency in NAFLD patients.

The influence of dietary and supplemental omega-3 fatty acids on the omega-3 index: A scoping review

“…Twenty of these intervention protocols (34%) improved participant O3i ≥8%, plus three that significantly increased O3i despite baseline levels ≥8% ( 23 , 24 ). The most conservative dose to raise O3i ≥8% was 840 mg/d EPA and DHA ethyl esters for 6 months in American adults with non-alcoholic fatty liver disease, whose O3i rose from 5 to 8% ( 33 ). Four months of a smaller dose (415 mg/d) mixed with fruit and vegetable juice showed similar 3% improvement in Austrian participants whose baseline O3i exceeded 8% ( 23 ).…”

“…Other 3–4 week interventions had ~1% increase in O3i at lower doses, ranging from 300 mg/d in fortified mushrooms to 2,454 mg/d from supplements ( 19 , 27 , 35 ). Most intervention periods were 3–5 months, with many longer interventions showing plateau in O3i following 3 months of supplementation ( 33 , 36 , 37 ).…”

“…Research suggests that erythrocyte n-3 FA concentrations respond in a dose-dependent manner until reaching equilibrium, typically 4–6 months from the start of intervention ( 52 ). Studies included in this review that assessed midpoint O3i values showed mixed results, with one showing a plateau after only 6 weeks ( 53 ), and others after 3 months ( 33 , 36 , 37 ). One study, however, found continued O3i increases through 4 months of supplementation ( 23 ), while another found small decreases from 6 months to 1 year ( 16 ).…”