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A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of a red yeast rice based nutraceutical (monacolin K 10 mg/dose) plus probiotic (Bifidobacterium longum BB536 ®), versus placebo, in patients with moderate hypercholesterolemia, in terms of improvement of the lipid profile and cardiovascular risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactoflorene colesterolo | Experimental | Red Yeast Rice titrated in 10 mg monacolin K per daily dose plus Bifidobacterium longum 50 mg, powder form, 1 packet per day |
|
| Placebo Lactoflorene colesterolo | Placebo Comparator | placebo, powder form, 1 packet per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactoflorene colesterolo | Dietary Supplement | 1.8 g + 1.8 g once a day per os |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in LDL-C From Baseline | Percent change from baseline in LDL-C after 12 weeks of treatment in patients with moderate hypercholesterolemia | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of Lactoflorene colesterolo (Incidence of treatment-related adverse events) | Incidence of treatment-related adverse events | 12 weeks |
| Changes in Other Lipids (non HDL-C, TG, HDL-C) and Apolipoproteins |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuliana G Mombelli, MD | ASST Grande Ospedale Metropolitano Niguarda CÃ Granda | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Dislipidemie Dip. Cardiotoracovasc ASST Grande Ospedale Metropolitano Niguarda CÃ Granda | Milan | Mi | 20162 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30795775 | Result | Ruscica M, Pavanello C, Gandini S, Macchi C, Botta M, Dall'Orto D, Del Puppo M, Bertolotti M, Bosisio R, Mombelli G, Sirtori CR, Calabresi L, Magni P. Nutraceutical approach for the management of cardiovascular risk - a combination containing the probiotic Bifidobacterium longum BB536 and red yeast rice extract: results from a randomized, double-blind, placebo-controlled study. Nutr J. 2019 Feb 22;18(1):13. doi: 10.1186/s12937-019-0438-2. |
| Label | URL |
|---|---|
| Related Info | View source |
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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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Double-blind (subjects, investigators)
| Placebo lactoflorene colesterolo |
| Dietary Supplement |
1.8 g + 1.8 g once a day per os |
|
| 12 weeks |
| Changes in Vital Signs | 12 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |