PDF(Pubmed)
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).
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.
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.
摘要：
简介-背景：来自实验试验的数据表明，藏红花（藏红花）被认为可以改善血糖，血脂谱,和血压，减少氧化应激。到目前为止,在代谢综合征和2型糖尿病(DMT-2)患者中进行了临床试验.这项研究的目的是评估藏红花在1型糖尿病（DMT-1）患者中的有效性。
方法：61例DMT-1患者，平均年龄48岁（48.3±14.6），26名女性（42.6％）随机接受含有益生菌的小袋新的口服补充剂，益生元,镁，和藏红花提取物或含有益生菌的安慰剂，益生元和镁每天6个月。使用连续葡萄糖监测系统评估血糖控制，并检查HbA1c和脂质分布的实验室测量。还测量了基线和干预结束时的血压。个体使用胰岛素泵连续皮下胰岛素输注或每日多次注射方案。通过问卷调查评估糖尿病的痛苦和饱腹感，并通过生物电阻抗评估身体成分。
结果：在干预结束时，两组仅在血清甘油三酯方面存在显著差异(p=0.049).经过6个月的治疗，与基线相比,活性组的糖化血红蛋白(p=0.046)和血清甘油三酯(p=0.021)显著降低.其他主要终点（血糖控制，血脂谱,血压）从基线到干预结束，组间没有差异，两组间差异无统计学意义。糖尿病困扰评分仅在活动组显著改善（p=0.044），提示这些个体的糖尿病疾病负担总体改善,但这在两组间还不够显著.
结论：含藏红花提取物的益生菌补充剂可改善DMT-1控制良好的患者的血清甘油三酯，可能是增强血糖控制的有价值的辅助手段。
方法：61例DMT-1患者，平均年龄48岁（48.3±14.6），26名女性（42.6％）随机接受含有益生菌的小袋新的口服补充剂，益生元,镁，和藏红花提取物或含有益生菌的安慰剂，益生元和镁每天6个月。使用连续葡萄糖监测系统评估血糖控制，并检查HbA1c和脂质分布的实验室测量。还测量了基线和干预结束时的血压。个体使用胰岛素泵连续皮下胰岛素输注或每日多次注射方案。通过问卷调查评估糖尿病的痛苦和饱腹感，并通过生物电阻抗评估身体成分。
结果：在干预结束时，两组仅在血清甘油三酯方面存在显著差异(p=0.049).经过6个月的治疗，与基线相比,活性组的糖化血红蛋白(p=0.046)和血清甘油三酯(p=0.021)显著降低.其他主要终点（血糖控制，血脂谱,血压）从基线到干预结束，组间没有差异，两组间差异无统计学意义。糖尿病困扰评分仅在活动组显著改善（p=0.044），提示这些个体的糖尿病疾病负担总体改善,但这在两组间还不够显著.
结论：含藏红花提取物的益生菌补充剂可改善DMT-1控制良好的患者的血清甘油三酯，可能是增强血糖控制的有价值的辅助手段。
