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| ID | Type | Description | Link |
|---|---|---|---|
| 1.46-21/11/2018 | Other Identifier | Aristotle University of Thessaloniki |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Group | Experimental | 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. |
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| Placebo group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary supplement with probiotics, prebiotics, magnesium and saffron extract | Dietary Supplement | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous glucose monitoring data | Time in range % | 6 months |
| Continuous glucose monitoring time | Time below range % | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Triantafyllos Didangelos, Professor | Aristotle University Of Thessaloniki | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University General Hospital of Thessaloniki AHEPA | Thessaloniki | Central Macedonia | 54636 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32423173 | Background | Giannoulaki P, Kotzakioulafi E, Chourdakis M, Hatzitolios A, Didangelos T. Impact of Crocus Sativus L. on Metabolic Profile in Patients with Diabetes Mellitus or Metabolic Syndrome: A Systematic Review. Nutrients. 2020 May 14;12(5):1424. doi: 10.3390/nu12051424. |
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There is no plan for sharing individual participant data due to bioethics committee restrictions on personal data privacy
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Double blind placebo controlled randomized trial
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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.
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| dietary supplement with probiotics, prebiotics, magnesium | Dietary Supplement | 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 |
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| 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 |
| Sural nerve conduction velocity | Nerve conduction velocity is measured in the sural sensory nerve of both feet with Neurometrix DPNCheck | 6 months |
| Electrochemical skin conductance | Sudomotor function was assessed with SUDOSCAN, which measures electrochemical skin conductance in the feet (ESCF) and hands (ESCH) | 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 | 6 months |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D019936 | Probiotics |
| D056692 | Prebiotics |
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
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