Does naringenin supplementation improve lipid profile, severity of hepatic steatosis and probability of liver fibrosis in overweight/obese patients with NAFLD? A randomised, double‐blind, placebo‐controlled, clinical trial

Abstract

Background and Objectives: Naringenin has been reported to have some promising pharmacological effects on the management of obesity and related metabolic complications including non-alcoholic fatty liver disease (NAFLD). Therefore, the present clinical trial study was done to assess the effects of naringenin supplementation on lipid profile, aminotransferase levels, severity of steatosis, as well as probability of fibrosis in overweight/obese patients with NAFLD. Materials and Methods: This placebo-controlled, parallel randomised, double-blind clinical trial study was conducted on 44 eligible overweight/obese patients with NAFLD (naringenin-treated group (n = 22), control group (n = 22)) referred to the national Iranian oil company (NIOC) Central Hospital, Tehran City, Tehran Province, Iran. Participants were randomly assigned to receive naringenin capsules (100 mg)and identical placebo capsules twice a day, before lunch and dinner, for 4 weeks.The primary outcomes were improvement of liver steatosis and NAFLD fibrosis score (NFS), and secondary outcomes included changes in levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and lipid profile.Results: Naringenin consumption significantly reduced percentages of NAFLD grades (P < .001), as well as, serum levels of triglyceride (TG) (P < .001), total cholesterol (TC) (P = .01), and low-density lipoprotein (LDL) (P = .02) and increased serum level of high-density lipoprotein (HDL) (P = .02) compared with the control group. Even after adjusting for the confounders, the results were significant. However, there were no significant changes in AST, ALT and NFS. Conclusion:Our findings revealed that daily intake of 200 mg of naringenin for 4 weeks had beneficial effects on lipid profile and percentages of NAFLD grades as an indicator for the severity of hepatic steatosis. Although, NFS values and serum levels of aminotransferase enzymes including AST and ALT did not remarkably change.Non-alcoholic fatty liver disease (NAFLD), an umbrella term for a broad spectrum of liver disorders affecting individuals who are not heavy alcohol users, is characterised by excess deposition of triglycerides in hepatocytes. 1 The disease is developed by simple steatosis and can progress to more progressive steatosis, non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis and ultimately hepatocellular carcinoma (HCC). 2 Real prevalence of NAFLD, as one of the most prevailing liver dysfunctions in the world, may differ based on the sensitivity of the applied diagnosis method. 3,4 It has been forecasted that the prevalence of NAFLD and NASH cases will increase by 21 and 63% in 2030, respectively. 5 As a result of high frequency of metabolic comorbidities in patients with NAFLD and also the growing burden of disability related to chronic liver diseases, global policies are required to address the disability burden of NAFLD worldwide. 6 Pathogenesis of NAFLD is complicated and multifactorial. 7According to the "two-hit" theory proposed by Day and Jams, insulin resistance...

Helichrysum italicum (Roth) G. Don and Helichrysum arenarium (L.) Moench infusions in reversing the traits of metabolic syndrome: a double-blind randomized comparative trial

“…Previously, an HA methanol extract was shown to diminish the glucose rise after sucrose ingestion, 42 while a reduction of triacylglycerols was only demonstrated in investigations of separate compounds, such as naringenin. 22 Apigenin, present in HA but not in HI, was also efficient in reducing serum triglycerides and total cholesterol in mice. 43 The influence of HA on the metabolism of cholesterol is well known.…”

“…18 Of the bioactive compounds, isosalipurposide has been shown to exert a cytoprotective effect against oxidative damage in hepatocytes. 52 Naringenin successfully reduced the NAFLD grade in human together with a decrease in serum cholesterol but not ALT and AST, 22 whereas in an animal model it prevented a nanoparticle-induced rise in ALT and AST. 53 In our HI group, ALT and AST were not significantly changed but the decrease in bilirubin was similar in both groups, pointing to a positive influence of both infusions on liver health.…”

“…21 In a clinical trial, the consumption of naringenin, the main flavonoid in HA, reduced total and LDL cholesterol and triglycerides, and increased HDL levels in overweight/obese adults. 22 HI has not yet been evaluated by the European Medicines Agency (EMA). However, we have recently shown in in vitro experiments in cell lines that HI exerts a higher antioxidative potential than HA.…”

“…21 In a clinical trial, the consumption of naringenin, the main flavonoid in HA, reduced total and LDL cholesterol and triglycerides, and increased HDL levels in overweight/obese adults. 22…”

A review of edible plant-derived natural compounds for the therapy of liver fibrosis

“…More importantly, the natural bioactive compounds derived from edible plants may possess therapeutic and protective effects but only minimal toxicity, thus these compounds are recognized as promising sources for developing safe therapeutic drugs or nutritional supplements to treat liver fibrosis. Especially, the edible plant-derived natural compounds as nutritional supplements have been proven highly effective and safe in treating liver diseases in several randomized controlled clinical trials [11][12][13][14].…”