The Effects of Saffron (Crocus sativus L) Supplementation on Cardiovascular Risk Factors, Liver Steatosis, and Fibrosis in Patients With Non-alcoholic Fatty Liver Disease: A Randomised, Double-Blind, Placebo-Controlled Study

Introduction:This study was designed to investigate the effects of Saffron supplementation on liver FibroScan test, liver enzymes, lipid profile, total and direct bilirubin, glycemic profile, and blood pressure in non-alcoholic fatty liver disease (NAFLD) patients. The researchers hypothesised that supplementation with Saffron could further improve the efficacy of lifestyle modifications in managing NAFLD. Methods: This randomised, double-blind, placebo-controlled trial was conducted on 76 NAFLD patients, whose age range was from 18 to 65. All of them were given a specified weight loss diet and a physical activity programme. They were randomly assigned into two groups to intake 100 mg of a Saffron-coated tablet (n = 38) or a placebo tablet (n = 38) for 12 weeks. Liver FibroScan test, liver enzymes (as primary outcome), lipid profile, total and direct bilirubin, fasting blood sugar (FBS), insulin, insulin resistance (homoeostasis model assessmentinsulin resistance), insulin sensitivity (quantitative insulin sensitivity check index), blood pressure, dietary intake, and physical activity were measured at baseline and also after 12 weeks. Both the participants and the dietitians were blindly assigned to the groups. Statistical analysis was carried out using SPSS software version 22. Results: Finally, 36 patients completed the study, and 38 patients were included in the intention-to-treat analysis. Accordingly, Saffron supplementation reduced steatosis score (P > 0.001), steatosis percent (P > 0.001), steatosis stage (P > 0.001), total cholesterol (P = 0.001), triacylglycerol (P > 0.001), low-density lipoprotein (P = 0.005), and FBS (P = 0.009) more than placebo. There was no significant difference in liver fibrosis, aminotransferase (-1.33 IU/L, 95% CI = -5.10, 2.43, P = 0.482), aminotransferase (-0.20 IU/L, 95% CI = -2.94, 2.52, P = 0.880), gamma-glutamyltransferase, insulin, homoeostasis model assessment-insulin resistance, and quantitative insulin sensitivity check indexes, total and direct bilirubin, and blood pressure between the two groups (P > 0.05). Conclusions: Overall, the 12-week consumption of 100 mg Saffron, along with lifestyle modification, compared with placebo, had insignificant reducing effects on liver steatosis score, steatosis percent, steatosis stage, total cholesterol, triacylglycerol, low-density lipoprotein, and FBS among NAFLD patients. Saffron may exert considerable beneficial consequences that need further assessment in future clinical trials.