Abstract

Background: Non-alcoholic fatty liver disease (NAFLD) is the most frequent cause of chronic liver disease in the world. The current interventional trial aimed to evaluate the effects of supplementation with oleoylethanolamide (OEA) in combination with weight loss intervention on some atherogenic indices as well as hematological parameters in patients newly diagnosed with NAFLD. Methods: In this triple-blinded, randomized, placebo-controlled clinical trial, 76 obese patients with NAFLD confirmed by ultra-sonographic findings were randomly assigned to receive a weight reduction diet plus either 250 mg OEA (n=38) or placebo (n=38) for 12 weeks. Atherogenic factors including total cholesterol/high-density lipoprotein cholesterol (HDL-C),low-density lipoprotein cholesterol (LDL-C)/HDL-C, triglyceride (TG)/HDL-C, non-HDL-C/HDL-C ratios and non-HDL-C level, as well as hematological parameters were assessed before and after intervention. Results : After adjustment for potential confounding factors, between group analyses demonstrated a significantly lower LDL-C/HDL-C, TG/HDL-C, and non-HDL-C/HDL-C ratios in the OEA group compared to the placebo, post-intervention (95% confidence interval [CI]:0.06 to 0.85, P = 0.024; 95% CI: -2.06 to -0.05, P = 0.039; 95% CI: -1.05 to -0.02, P = 0.042,respectively). Additionally, OEA supplementation could significantly decrease the levels of red blood cell distribution width (RDW) compared to the placebo at the endpoint after considering potential confounding variables (95% CI: -0.56 to -0.003, P = 0.041). No significant differences were found between the two study groups in terms of other hematological parameters. Conclusion: The results of the current study indicated that OEA supplementation had beneficial effects on LDL-C/HDL-C, TG/HDL-C, and non-HDL-C/HDL-C ratios as well as RDW in obese patients with NAFLD. Trial Registration: IRCT20110530006652N2; https://www.irct.ir/trial/37228.

Highlights

  • Non-alcoholic fatty liver disease (NAFLD), caused by accumulation of triglyceride (TG) in the cytoplasm of hepatocytes, is regarded as one of the most common liver pathologies worldwide.[1]

  • NAFLD encompasses a wide range of liver disorders including simple hepatic steatosis, non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis and eventually hepatocellular carcinoma, with a complex ‘multi-hit’ pathophysiology.[2]

  • It has been suggested that peroxisome proliferator-activated receptor (PPAR) agonists ameliorate metabolic disorders, inflammation, and Oxidative stress (OS) related to NAFLD

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Summary

Introduction

Non-alcoholic fatty liver disease (NAFLD), caused by accumulation of triglyceride (TG) in the cytoplasm of hepatocytes, is regarded as one of the most common liver pathologies worldwide.[1]. Previous studies have demonstrated that lifestyle interventions, principally dietary modification and regular exercise, are the cornerstones of NAFLD treatment.[19,20] In addition, it has been suggested that peroxisome proliferator-activated receptor (PPAR) agonists ameliorate metabolic disorders, inflammation, and OS related to NAFLD. These drugs are attractive targets to tackle NAFLD.[21,22,23] Fibrates, lowaffinity ligands for PPAR‐α receptors, are recommended in patients with NAFLD. Considering the lack of randomized clinical trial assessing the impacts of OEA administration on atherogenic indices and hematologic parameters in patients with NAFLD, the present study aimed to investigate the impacts of OEA treatment in combination with calorie restriction on some atherogenic indices and hematological parameters in these patients

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