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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
61
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
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
University General Hospital of Thessaloniki AHEPA
Thessaloniki, Central Macedonia, Greece
glycated hemoglobin
glycated hemoglobin %
Time frame: 6 months
blood glucose
Fasting blood glucose (mg/dl)
Time frame: 6 months
serum cholesterol
Total Cholesterol mg/dl
Time frame: 6 months
serum High density lipoprotein cholesterol
High density lipoprotein Cholesterol mg/dl
Time frame: 6 months
serum low density lipoprotein cholesterol
Low density lipoprotein cholesterol mg/dl
Time frame: 6 months
triglycerides
serum Triglycerides mg/dl
Time frame: 6 months
Systolic Blood pressure
Systolic blood pressure mmHg
Time frame: 6 months
Diastolic Blood pressure
Diastolic blood pressure mmHg
Time frame: 6 months
Continuous glucose monitoring data
Time in range %
Time frame: 6 months
Continuous glucose monitoring time
Time below range %
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Time frame: 6 months
Continuous glucose monitoring time data
Time above range %
Time frame: 6 months
Continuous glucose monitoring glycemic data
Glucose Management Indicator %
Time frame: 6 months
Continuous glucose monitoring statistic data
Coefficient of variance
Time frame: 6 months
Sural nerve conduction velocity
Nerve conduction velocity is measured in the sural sensory nerve of both feet with Neurometrix DPNCheck
Time frame: 6 months
Electrochemical skin conductance
Sudomotor function was assessed with SUDOSCAN, which measures electrochemical skin conductance in the feet (ESCF) and hands (ESCH)
Time frame: 6 months
Cardiovascular Autonomic Reflex tests
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
Time frame: 6 months