ect of Saffron consumption on metabolic factors, serum oxidative stress indices and gene expression rate of pyroptosis related inflammatory factors in patients with type 2 diabetes: A Double-blind randomized controlled clinical trial

Abstract

Abstract Background & Aims: Diabetes mellitus is one of the common metabolic disorders that characterized by hyperglycemia and is a worldwide health problom. The present study examined the effect of Saffron consumption on glycemic status, lipid profile, serum oxidative stress indices and gene expression rate of pyroptosis related inflammatory factors in type 2 diabetic patients. Methods: This study was done as a double-blind placebo controlled clinical trial on 70 patients with type 2 diabetes who have been referred to Endocrine and Metabolism clinic of Tabriz University of Medical Sciences. Patients were randomly allocated into two groups to receive 100 mg/day of saffron or placebo (Maltodextrin with similiar color and smell of saffron) for 8 weeks. All the study participants were given a full explanation of the study objectives and the methodology, after which, they signed an informed consent form. Height, weight, blood pressure, and waist and hip circumference were obtained. BMI and waist to hip ratio were calculated. General information and physical activity level, were measured using relevant questionnaires. Dietary intakes of subjects was assessed by food record questionnaire. Blood samples of 70 subjects were obtained after an overnight fast of 12 h. Serum fasting glucose, insulin, HbA1c, lipid profile (TC, TG, HDL-C, LDL-C), MDA, NO, TAC and antioxidant enzymes (SOD, GPx, CAT) were measure during standard techniques. HOMA-IR and LDL-C was calculated. To evaluate the expression of pyroptosis related genes, peripheral blood mononuclear cell (PBMCs) were isolated from peripheral blood. In the next step, RNA was extracted and cDNA was synthesized. Finally, the expression of the desired genes were measured by RT-PCR. Data were analysed by SPSS 21. Results: Our results showed that, 100 mg/day saffron supplementation led to significant reductions in FPG, insulin, HOMA-IR, TG, MDA and NO (p<0.05). In addition, there was a significant increase in TAC and GPx in intervention group compared with the placebo (p<0.05). The study group showed lower TLR-4, NLRP3, TXNIP and IL-1 mRNA expression level after supplementation, while there was no significant difference in Caspas1 expression level compared to the placebo group. We did not find any significant effect of saffron supplementation on dietary intake, anthropometric measures and blood pressure. Conclusion: Saffron consumption at the dose of 100 mg for 8 weeks in patients with type 2 diabetes have beneficial effects on glycemic status, lipid profile and oxidant/antioxidant balance in type 2 diabetic patients. In addition, saffron supplementation plays a protective role in pancreatic beta cell function and insulin resistance by decreasing pyroptosis related inflammatory markers gene expressin level. Overall, more clinical studies are required for better interpretion of the findings. Keywords: Saffron, Type 2 diabetes, Inflammation, Pyroptosis, Oxidative stress, Glycemic control