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).
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.

To investigate the effects of saffron (Crocus sativus L.) on lipid profile, glycemic and antioxidant status in overweight/obese individuals with prediabetes.
In this randomized, double-blind, placebo-controlled trial, the prediabetic patients were randomly assigned to receive saffron (15 mg/d) pills or placebo for eight weeks. Serum levels of lipid profile, fasting blood sugar (FBS), glycosylated hemoglobin (HbA1c), blood urea nitrogen (BUN), creatinine, and diphenylpycrylhydrazyl (DPPH) radical scavenging activity were assessed biochemically at baseline and at 8 weeks after treatment. The adverse events, if any, were also recorded.
Seventy-five of participants (36 in treatment and 39 in placebo groups) completed the study. Within-group comparisons revealed a significant effect of saffron supplementation on FBS (118.11 ± 3.55 vs. 109.14 ± 6.23), HbA1c (5.85 ± 0.12 vs. 5.70 ± 0.11), and DPPH (11.06 ± 3.24 vs. 13.46 ± 3.33) levels (P < 0.005 for all). In adjusting models, there was a significant reduction in FBS by -7.97 mg/dL, and HbA1c by -0.15% in saffron group compared to placebo. Moreover, saffron intake tended to increase in DPPH radical scavenging activity (2.4% vs. -0.85% in saffron and placebo groups, respectively). However, no significant changes in anthropometric measures, lipid profile, and renal markers were observed after saffron intake compared with placebo.
Saffron supplementation could improve glycemic and antioxidant indices in overweight/obese individuals with prediabetes, however, no beneficial effect was observed on lipid profile and anthropometric parameters. (IRCT20120913010826N19).

While there is sufficient evidence that Crocus Sativus L. (saffron) improves symptoms of depression in young and middle-aged adults, research on older people are missing. The purpose of the double-blind, randomized intervention study was to compare the effect of saffron and sertraline on MDD among a sample of older people.
A total of 50 older out-patients with MDD (mean age = =65 years; 70% males) were randomly assigned either to the saffron condition (60 mg/d) or to the sertraline condition (100 mg/day) for six consecutive weeks. Experts employed the Hamilton Depression Rating Scale (HDRS) to rate participants\' degree of depression. Timepoints were baseline, week 2, week 4 and week 6, the end of the study.
Symptoms of depression decreased over time, with no advantages or disadvantages for the saffron or sertraline condition.
The pattern of results suggests that both saffron and sertraline have the potential to significantly decrease symptoms of depression. The results are clinically relevant, because major depressive disorders in older people is a health concern. The results are further relevant, because saffron appears to be a powerful antidepressant for older people, who might be more reluctant to the use of synthetic drugs.

OBJECTIVE: Limited pharmacological options are available for the management of Alzheimer\'s disease (AD) in severe stages. Cognitive-enhancing properties of saffron, the dried stigma of Crocus sativus L., have been evidenced in different studies. We aimed to compare the efficacy and safety of saffron extract versus memantine in reducing cognitive deterioration of patients with moderate to severe AD.
METHODS: In this randomized double-blind parallel-group study, 68 patients with moderate to severe AD (Mini-Mental State Examination score of 8-14) received memantine (20 mg/day) or saffron extract (30 mg/day) capsules for 12 months. Participants were evaluated every month by Severe Cognitive Impairment Rating Scale (SCIRS) and Functional Assessment Staging (FAST) in addition to recording the probable adverse events.
RESULTS: Both treatment groups showed similar outcomes as demonstrated by insignificant effect for time × treatment interaction on SCIRS scores [F(2.95, 194.78) = 2.25, p = 0.08]. There was no significant difference between the two groups in the scores changes from baseline to the endpoint on SCIRS (p = 0.38) and FAST (p = 0.87). The frequency of adverse events was not significantly different between the two groups as well.
CONCLUSIONS: In addition to its favorable safety profile, 1-year administration of saffron extract capsules showed to be comparable with memantine in reducing cognitive decline in patients with moderate to severe AD. Confirmatory studies with larger sample sizes and longer follow-up periods are warranted.

OBJECTIVE: Reactive oxygen species have effects on gamete quality and gamete interaction; they influence spermatozoa, oocytes, embryos, and their environment. In this study, we evaluated the antioxidant effect of different concentrations of saffron (Crocus sativus L.) aqueous extract (SAE) and its ingredient, crocin, on the improvement of in vitro maturation (IVM) and subsequent in vitro fertilization (IVF) and embryo development of mouse oocytes.
METHODS: Cumulus oocyte complexes were collected from ovaries, and germinal vesicle oocytes were cultured in the presence of SAE and crocin. SAE was added at dosages of 5 μg/mL, 10 μg/mL, and 40 μg/mL; dosages of crocin were 50 μg/mL, 100 μg/mL, and 400 μg/mL. All dosages were added to maturation medium and a group without SAE or crocin was considered as the control group. Following IVM, metaphase II oocytes were fertilized and cultured in vitro in order to observe embryo development.
RESULTS: Both SAE and crocin improved the rate of IVM, IVF, and in vitro culture. Addition of 40 μg/mL SAE to maturation medium significantly increased the rate of IVM, IVF, and in vitro culture (p < 0.05). Furthermore 100 μg/mL crocin significantly increased the IVM rate compared to the control group (p < 0.05).
CONCLUSIONS: Use of SAE during IVM can affect on IVM, IVF, and early embryo development in a dose-dependent manner. SAE appears to have a stronger effect than pure crocin.

OBJECTIVE: A significant correlation exists between coronary artery diseases and depression. The aim of this trial was to compare the efficacy and safety of saffron versus fluoxetine in improving depressive symptoms of patients who were suffering from depression after performing percutaneous coronary intervention (PCI).
METHODS: In this randomized double-blind parallel-group study, 40 patients with a diagnosis of mild to moderate depression who had undergone PCI in the last six months were randomized to receive either fluoexetine (40mg/day) or saffron (30mg/day) capsule for six weeks. Participants were evaluated by Hamilton depression rating scale (HDRS) at weeks 3 and 6 and the adverse events were systemically recorded.
RESULTS: By the study endpoint, no significant difference was detected between two groups in reduction of HDRS scores (P=0.62). Remission and response rates were not significantly different as well (P=1.00 and P=0.67; respectively). There was no significant difference between two groups in the frequency of adverse events during this trial.
CONCLUSIONS: Relatively small sample size and short observational period were the major limitations of this study.
CONCLUSIONS: Short-term therapy with saffron capsules showed the same antidepressant efficacy compared with fluoxetine in patients with a prior history of PCI who were suffering from depression.