Saffron (Crocus sativus L.) Supplements Modulate Circulating MicroRNA (miR-21) in Atherosclerosis Patients; A Randomized, Double-Blind, Placebo-Controlled Trial

microRNAs (miRNAs) are endogenous gene expression regulators, which are involved in the physiopathology of diseases, and potentially make biomarkers in diseases, such as Cardiovascular Disease (CVD).

Since miR-21 is a robust regulator in plaque formation, this study aimed at identifying the effect of saffron as a functional food and traditional food additive antioxidant in fighting against the progress of atherosclerosis, by modulation of miR-21, as a new circulating marker of inflammation.

In this randomized, double-blind clinical trial, 63 subjects with atherosclerosis were recruited from Emam Sajjad Hospital, Valiasr Hospital, and Zafaranieyh Clinic in Tehran, Iran, and divided randomly to two groups. They received 100 mg/d saffron or a placebo capsule for six weeks. The expression levels of miR-21 were quantified by real-time quantitative-PCR (RT-qPCR) in the blood of patients. Furthermore, fasting blood sugar, lipid profile, and anthropometric index of participants were evaluated before and after the intervention.

Statistical analysis showed significant differences in the expression level of miR-21 between atherosclerosis patients, who received placebo, and those, who consumed saffron (P value = 0.02). Moreover, a significant decrease was seen in hip circumference after saffron supplementation (P = 0.049, P = 0.006). Nevertheless, consumption of saffron did not significantly influence other anthropometric indexes and blood biochemical parameters, such as FBS and lipid profile.

In the present study, different expression levels of miR-21 were observed between patients with atherosclerosis, who received saffron supplements and placebo; thus saffron may be considered as a novel therapeutic target in cardiovascular disease management