Effect of Crocus sativus Extract Supplementation in the Metabolic Control of People with Diabetes Mellitus Type 1: A Double-Blind Randomized Placebo-Controlled Trial
What this study found
The active supplement was associated with improved metabolic control over 6 months, with reductions in HbA1c and triglycerides. In the active arm, HbA1c decreased from 6.89 ± 0.8% to 6.5 ± 0.7% (p = 0.046) and triglycerides from 75.4 ± 14.9 mg/dL to 65.03 ± 23.03 mg/dL (p = 0.021); the between-group end difference for triglycerides was also significant (p = 0.049). Fasting glucose did not change significantly (127.4 ± 63.3 to 136.8 ± 48.8 mg/dL; p = 0.531), and other lipids and blood pressure measures were not significant. The supplement was well tolerated, with diarrhea reported in 1…
- Study & population
- Double-blind randomized placebo-controlled trial conducted in Greece.
- Intervention
- The active intervention was an oral sachet supplement containing Crocus sativus extract, given as 84 mg/day (3 sachets/day, 28 mg per sachet) for 6 months.
- Key limitation
- The active arm was small (N=31) and treatment lasted only 6 months, limiting confidence in durability and generalizability.
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Open PDFOriginal abstract
Introduction–Background: Data from experimental trials show that Crocus sativus L. (saffron) is considered to improve glycemia, lipid profile, and blood pressure and reduce oxidative stress. So far, clinical trials have been conducted in individuals with metabolic syndrome and Diabetes Mellitus type 2 (DMT-2). The purpose of this study is to assess the effectiveness of saffron in individuals with Diabetes Mellitus type 1 (DMT-1). Patients–Methods: 61 individuals with DMT-1, mean age 48 years old (48.3 ± 14.6), 26 females (42.6%) were randomized to receive a new oral supplement in sachets containing probiotics, prebiotics, magnesium, and Crocus sativus L. extract or placebo containing probiotics, prebiotics and magnesium daily for 6 months. Glycemic control was assessed with a continuous glucose monitoring system and laboratory measurement of HbA1c and lipid profile was also examined. Blood pressure at baseline and end of intervention was also measured. Individuals were either on a continuous subcutaneous insulin infusion with an insulin pump or in multiple daily injection regimens. Diabetes distress and satiety were assessed through a questionnaire and body composition was assessed with bioelectrical impedance. Results: At the end of the intervention, the two groups differed significantly only in serum triglycerides (p = 0.049). After 6 months of treatment, a significant reduction in the active group was observed in glycated hemoglobin (p = 0.046) and serum triglycerides (p = 0.021) compared to baseline. The other primary endpoints (glycemic control, lipid profile, blood pressure) did not differ within the groups from baseline to end of intervention, and there was no significant difference between the two groups. Diabetes distress score improved significantly only in the active group (p = 0.044), suggesting an overall improvement in diabetes disease burden in these individuals but that was not significant enough between the two groups. Conclusions: A probiotic supplement with saffron extract improves serum triglycerides in well-controlled people with DMT-1 and may potentially be a valuable adjunct for enhancing glycemic control.