Investigation of the Impact of the Administration of Crocus Sativus L Extract on the Metabolic Control of Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- blood glucose
研究概览
简要总结
Administration of 4 strain of probiotics, prebiotic, magnesium and crocus sativus extract in a sachet to people with diabetes mellitus type 1 for 6 months
详细描述
Double blind placebo controlled randomized trial: A sachet of a combination of 4 strains of probiotics (Lactobacillus rhamnosus, Bifidobacterium animalis lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides, Magnesium and Saffron extract was administered 3 times per day in people with diabetes type 1 for 6 months on continuous glucose monitoring systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
No participant or personnel knew the randomization process and the only knew did not had to do with participants or administration of supplement or collecting data. The company providing the supplement did not know either.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with diabetes mellitus type 1 (with diabetes duration over 1 year) (adults <18 years old) wearing a continuous glucose monitoring system with or without an insulin pump
排除标准
- •People with diabetes mellitus type 2
- •Breastfeeding women
- •People with liver disease
- •People with chronic kidney disease (over stage 3)
- •People with allergy in crocus sativus
- •People that consume everyday herbs or supplements
- •People on anti platelet treatment not for prevention
研究组 & 干预措施
Active Group
A sachet of a combination of 4 strains of probiotics (1billion CFU) (Lactobacillus rhamnosus, Bifidobacterium animalis lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides 100mg, Magnesium 75mg and Crocus sativus (Saffron extract 28mg) was administered 3 times per day in people with diabetes type 1 for 6 months on continuous glucose monitoring systems.
干预措施: dietary supplement with probiotics, prebiotics, magnesium and saffron extract (Dietary Supplement)
Placebo group
A sachet of a combination of 4 strains of probiotics (1billion CFU(Lactobacillus rhamnosus, Bifidobacterium animalis lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides 100mg, Magnesium 75mg without crocus sativus was administered 3 times per day in people with diabetes type 1 for 6 months on continuous glucose monitoring systems.
干预措施: dietary supplement with probiotics, prebiotics, magnesium (Dietary Supplement)
结局指标
主要结局
blood glucose
时间窗: 6 months
Fasting blood glucose (mg/dl)
serum low density lipoprotein cholesterol
时间窗: 6 months
Low density lipoprotein cholesterol mg/dl
Diastolic Blood pressure
时间窗: 6 months
Diastolic blood pressure mmHg
serum cholesterol
时间窗: 6 months
Total Cholesterol mg/dl
Systolic Blood pressure
时间窗: 6 months
Systolic blood pressure mmHg
glycated hemoglobin
时间窗: 6 months
glycated hemoglobin %
serum High density lipoprotein cholesterol
时间窗: 6 months
High density lipoprotein Cholesterol mg/dl
triglycerides
时间窗: 6 months
serum Triglycerides mg/dl
次要结局
- Continuous glucose monitoring data(6 months)
- Sural nerve conduction velocity(6 months)
- Continuous glucose monitoring glycemic data(6 months)
- Continuous glucose monitoring time(6 months)
- Continuous glucose monitoring time data(6 months)
- Continuous glucose monitoring statistic data(6 months)
- Continuous glucose monitoring data(6 months)
- Continuous glucose monitoring time(6 months)
- Continuous glucose monitoring time data(6 months)
- Continuous glucose monitoring glycemic data(6 months)
- Continuous glucose monitoring statistic data(6 months)
- Electrochemical skin conductance(6 months)
- Cardiovascular Autonomic Reflex tests(6 months)
研究者
Prof. Triantafyllos Didangelos
Professor of Internal Medicine- Diabetology
Aristotle University Of Thessaloniki