Crocus Sativus Extract Impact in Metabolic Control of Patients With Diabetes Mellitus Type 1

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Investigation of the Impact of the Administration of Crocus Sativus L Extract on the Metabolic Control of Patients With Type 1 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 1, Diabetes type1

Intervention / Treatment
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* Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium and saffron extract
* Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pregnant 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind placebo controlled randomized trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Group<br>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. | Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium and saffron extract<br>* A sachet of a combination of 4 strains of probiotics (1billion CFU) (Lactobacillus rhamnosus, Bifidobacterium animalis subscp. lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides 100mg, Magnesium 75mg and Saffron extract 28mg was administered 3 times per day<br>* Other names: Probiotics and saffron extract;|
| Placebo Comparator: Placebo group<br>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. | Dietary Supplement: dietary supplement with probiotics, prebiotics, magnesium<br>* A sachet of a combination of 4 strains of probiotics (1billion CFU) (Lactobacillus rhamnosus, Bifidobacterium animalis subscp. lactis, Bifidobacterium breve, Bifidobacterium longum), Fructooligosaccharides 100mg, Magnesium 75mg was administered 3 times per day<br>* Other names: Probiotics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycated hemoglobin | glycated hemoglobin % | 6 months | 
| blood glucose | Fasting blood glucose (mg/dl) | 6 months | 
| serum cholesterol | Total Cholesterol mg/dl | 6 months | 
| serum High density lipoprotein cholesterol | High density lipoprotein Cholesterol mg/dl | 6 months | 
| serum low density lipoprotein cholesterol | Low density lipoprotein cholesterol mg/dl | 6 months | 
| triglycerides | serum Triglycerides mg/dl | 6 months | 
| Systolic Blood pressure | Systolic blood pressure mmHg | 6 months | 
| Diastolic Blood pressure | Diastolic blood pressure mmHg | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous glucose monitoring data | Time in range % | 6 months | 
| Continuous glucose monitoring time | Time below range % | 6 months | 
| Continuous glucose monitoring time data | Time above range % | 6 months | 
| Continuous glucose monitoring glycemic data | Glucose Management Indicator % | 6 months | 
| Continuous glucose monitoring statistic data | Coefficient of variance | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus type 1, diabetes type 1, saffron, saffron extract, continuous glucose monitoring