Saffron improves life and sleep quality, glycemic status, lipid profile and liver function in diabetic patients: A double-blind, placebo-controlled, randomized clinical trial.

BACKGROUND Type 2 diabetes (T2D) is a metabolic disorder that is related to hyperglycemia, hyperlipidemia, and liver dysfunction and has detrimental effects on a patient's mental health. Hence, the current study investigated the effects of saffron supplementation on dietary intake, anthropometric measures, mood, sleep quality, and metabolic biomarkers in overweight/obese patients with T2D. METHODS In a double-blind, randomized controlled trial, 70 overweight/obese patients with T2D were randomly allocated to two groups and received 100 mg/day saffron or placebo for eight weeks. Participants completed the Beck depression inventory-II (BDI-II), Hurlbert index of sexual desire (HISD), Pittsburgh Sleep Quality Index (PSQI), and Diabetes-specific Quality-of-Life Brief Clinical Inventory questionnaires (DQOL-BCI). Dietary intake, anthropometric measures, fasting plasma glucose (FPG), hemoglobin A1C (HbA1C), insulin, lipid profile and liver enzymes were determined at baseline and the end of the study. RESULTS At the end of the eighth week, saffron supplementation significantly decreased FPG, triglyceride (TG), insulin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (p < 0.001). Moreover, significant improvements in BDI-II scores and total quality of life were observed in the intervention group (p<0.001). The saffron group showed more significant improvements in PSQI scores than the placebo group, such that at the post-intervention analysis, only the saffron group achieved a "good" sleep band. At this relatively high dose, saffron supplementation improved glycemic status, lipid profile, and liver enzyme measures in patients with T2D while also improving sleep and overall quality of life. CONCLUSION Our results indicate that saffron notably reduced hyperglycemia and hyperlipidemia and improved liver function in patients with T2D in an 8-week randomized clinical trial. Saffron also significantly improved depression, sleep quality, and overall quality of life in diabetic patients. However, further investigation is necessary to confirm whether saffron is an effective complementary therapy for T2D.