Nigella sativa and inflammatory biomarkers in patients with non-alcoholic fatty liver disease: Results from a randomized, double-blind, placebo-controlled, clinical trial.

OBJECTIVE The aim of this study was to assess the effects of Nigella sativa consumption on inflammatory biomarkers in patients with Non-alcoholic fatty liver disease (NAFLD). METHODS This is a randomized, double-blind, placebo-controlled clinical trial. Fifty NAFLD patients were assigned to receive either two gram/day Nigella sativa seed as Nigella sativa group (NSG), or two gram/day starch as placebo group (PG) for 12 weeks. RESULTS At the end of the study, the serum levels of tumor necrosis factor-α (TNF-α) decreased significantly compared with the beginning of the study in both groups, while the levels of high sensitive C reactive protein (hs-CRP) and nuclear factor kappa-B (NF-κB) only decreased significantly in the NSG (P 0 < 0.05). Only reduction in the serum levels of TNF-α was significantly more in NSG compared to the PG (P = 0.001). After adjusting the effects of confounding factors, the results remained unchanged. According to Fibroscan exam, hepatic steatosis and its percentage decreased significantly only in the NSG (P 0 < 0.005); however, the changes were not significantly different between two groups. After adjusting for confounding factors, only steatosis percentage reduction was significantly more in the NSG compared to PG (P = 0.005). CONCLUSION Our results have shown that two gram/day consumption of Nigella sativa can reduce inflammatory biomarkers in patients with NAFLD. Further studies with different doses are highly recommended to find the optimal dosage.