The effect of hydroalcoholic Saffron (Crocus sativus L.) extract on fasting plasma glucose, HbA1c, lipid profile, liver, and renal function tests in patients with type 2 diabetes mellitus: A randomized double-blind clinical trial.

Diabetes mellitus is a metabolic disease that manifested as hyperglycemia due to the defect in secretion or function of insulin. Studies have shown that saffron and its derivatives cause a significant reduction in plasma glucose levels in experimental models. The purpose of this study was to investigate the effect of the saffron extract on fasting plasma glucose (FPG), glycated hemoglobin level (HbA1c), lipid profile, liver enzymes, and renal function tests in type 2 diabetic patients. In this double-blind randomized clinical trial, 64 type 2 diabetic patients who were on oral anti-diabetic drugs were examined. Participants received either 15 mg of saffron or placebo capsules (two pills per day) for 3 months. Anthropometric indices, dietary intake, FPG, HbA1c, lipid profiles, liver enzymes (ALT, AST, ALP), and renal function (BUN, Cr.) tests were measured pre and post intervention after 3 months. Independent t test and paired t test were used for data analysis. After 3-months intervention, mean difference of FPG, Cholesterol, LDL-c, and LDL/HDL ratio between two groups showed significant reduction(p < 0.0001), but HbA1c, HDL-C, API, TG showed no significant differences (p > 0.05). In saffron group, FPG, HbA1c, cholesterol, LDL-c, and LDL/HDL ratio decreased significantly after 3-months intervention compare with baseline (p < 0.0001).

RCT Entities:   Population Interventions Outcomes