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The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels.
The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycolysated hemoglobin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIO 25 (food supplements)twice a day for 8 weeks | Active Comparator | BIO 25 - Innovative Formula contains 11 different strains of probiotic bacteria patents and more than 25 billion active bacteria in each capsule. |
|
| Placebo twice a day for 8 weeks | Placebo Comparator | Placebo twice a day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food supplement | Other |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL-Cholesterol levels. | The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C | The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycosylated hemoglobin | 8 weeks |
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Inclusion Criteria:
1) Patients on maximal tolerated dose of conventional statins treated for at least eight weeks on simvastatin 40, pravastatin 40, atorvastatin 40-80 or rosuvastatin 20-40 mg, who failed to achieve target values of LDL-cholesterol according to the European Socety Cardiology guidelines 2012.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Morris Mosseri, MD | Contact | 97297472587 | morris.mosseri@clalit.org.il | |
| Tatiana Berlin, MD | Contact | 97297472587 | tatiana.berlin@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Tatiana Berlin, MD | Division of Cardiology Meir MC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology Meir MC | Kfar Saba | 44281 | Israel |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| D009750 |
| Nutritional and Metabolic Diseases |