Diabetes Mellitus, Type 1, Diabetes type1
Conditions
Keywords
diabetes mellitus type 1, diabetes type 1, saffron, saffron extract, continuous glucose monitoring
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTdietary supplement with probiotics, prebiotics, magnesium and saffron extract
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
DIETARY_SUPPLEMENTdietary supplement with probiotics, prebiotics, magnesium
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
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Double blind placebo controlled randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood pressure | 6 months | Diastolic blood pressure mmHg |
| glycated hemoglobin | 6 months | glycated hemoglobin % |
| blood glucose | 6 months | Fasting blood glucose (mg/dl) |
| serum cholesterol | 6 months | Total Cholesterol mg/dl |
| serum High density lipoprotein cholesterol | 6 months | High density lipoprotein Cholesterol mg/dl |
| serum low density lipoprotein cholesterol | 6 months | Low density lipoprotein cholesterol mg/dl |
| triglycerides | 6 months | serum Triglycerides mg/dl |
| Systolic Blood pressure | 6 months | Systolic blood pressure mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continuous glucose monitoring data | 6 months | Time in range % |
| Continuous glucose monitoring time | 6 months | Time below range % |
| Continuous glucose monitoring time data | 6 months | Time above range % |
| Continuous glucose monitoring glycemic data | 6 months | Glucose Management Indicator % |
| Continuous glucose monitoring statistic data | 6 months | Coefficient of variance |
| Sural nerve conduction velocity | 6 months | Nerve conduction velocity is measured in the sural sensory nerve of both feet with Neurometrix DPNCheck |
| Electrochemical skin conductance | 6 months | Sudomotor function was assessed with SUDOSCAN, which measures electrochemical skin conductance in the feet (ESCF) and hands (ESCH) |
| Cardiovascular Autonomic Reflex tests | 6 months | Autonomic neuropathy testing included cardiovascular autonomic reflex tests (CARTs) such as heart rate variability to obtain mean circular resultant (MCR), and the 30:15 stand up test to obtain postural index and blood pressure measurement to test for orthostatic hypotension |
Countries
Greece
Outcome results
None listed