Synbiotic supplementation in lean patients with non-alcoholic fatty liver disease: a pilot, randomised, double-blind, placebo-controlled, clinical trial

Abstract

Although non-alcoholic fatty liver disease (NAFLD) is the leading aetiology of liver disorders in the world, there is no proven treatment for NAFLD patients with normal or low BMI. The aim of this study was to evaluate the efficacy of synbiotics supplementation in NAFLD patients with normal or low BMI. In this randomised, double-blind, placebo-controlled, clinical trial, fifty patients with NAFLD were assigned to take either a synbiotic supplement or a placebo capsule for 28 weeks. Both groups were advised to follow a healthy lifestyle. At the end of the study, hepatic steatosis and fibrosis reduced in both groups; however, the mean reduction was significantly greater in the synbiotic group rather than in the placebo group (P<0·001). Furthermore, serum levels of fasting blood sugar, TAG and most of the inflammatory mediators reduced in the synbiotic group significantly compared with the placebo group (P<0·05). Our results provide evidence that synbiotic supplementation improves the main features of NAFLD in patients with normal and low BMI, at least partially through reduction in inflammatory indices. Further studies are needed to address the exact mechanism of action of these effects.

A Multi-strain Probiotic Reduces the Fatty Liver Index, Cytokines and Aminotransferase levels in NAFLD Patients: Evidence from a Randomized Clinical Trial

“…However, despite the abundance of clinical trials, several pharmacological treatments J Gastrointestin Liver Dis, March 2018 Vol. 27 No 1: 41-49 for NAFLD/NASH have been proposed, such as diabetes medications [6][7][8][9], lipid-lowering drugs [10], antioxidants [8,9], and anti-tumor necrosis factor (TNF)-α agents [11].…”

The effects of black seed supplementation on cardiovascular risk factors in patients with nonalcoholic fatty liver disease: A randomized, double‐blind, placebo‐controlled clinical trial

“…Currently, there is no approved treatment for NAFLD although health promotion strategies and lifestyle modifications are recommended as the primary steps in disease management (Emamat et al, ; Hekmatdoost et al, ; Mokhtari, Poustchi, Eslamparast, & Hekmatdoost, ; Noori, Jafari, & Hekmatdoost, ; Rahimlou, Ahmadnia, & Hekmatdoost, ; Rahimlou, Yari, Hekmatdoost, Alavian, & Keshavarz, ). Over the past few years, numerous studies have been conducted to find plant‐based biological compounds for treatment of NAFLD (Bahrami et al, ; Mofidi et al, ; Saadati et al, ). Black seed ( Nigella sativa ) is one of the plant‐based compounds with protecting effects on the liver, kidney, digestive system, nervous system, and cardiovascular system, as well as antiinflammatory and antimalignancy effects (Darand, Alavian, & Hekmatdoost, ).…”

“…compounds for treatment of NAFLD (Bahrami et al, 2019;Mofidi et al, 2017;Saadati et al, 2019). Black seed (Nigella sativa) is one of the plant-based compounds with protecting effects on the liver, kidney, digestive system, nervous system, and cardiovascular system, as well as antiinflammatory and antimalignancy effects (Darand, Alavian, & Hekmatdoost, 2018).…”

Gut Microbiota and Nonalcoholic Fatty Liver Disease: Insights on Mechanism and Therapy

“…Malaguarnera et al revealed that therapy with synbiotic ( B. longum and Fos) and lifestyle intervention in NASH patients produced much more improvement compared lifestyle intervention alone including reduction of serum TNFα, CRP, endotoxin and AST levels, improvement in HOMA-IR and extent of NASH activity index [142]. Synbiotic therapy also showed improvement in levels of fasting blood glucose, TG and inflammatory cytokines in NAFLD patients [143,144]. Therefore, symbiotic is one of the promising gut microbiotatargeted interventions on NAFLD prevention or therapy, nevertheless, the therapeutic efficacy needs further clinical validation.…”