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This will be a double-blind randomized clinical trial carried out on subjects with suboptimal control of LDL-cholesterolemia, following a Mediterranean diet, and treated with a red yeast rice extract (containing 10 mg monacolin K per daily dose) or placebo, in order to evaluate the middle-term effects on vascular health evaluated by non invasive methods (Vicorder(R) apparatus)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Red yeast rice | Active Comparator | Red yeast rice extract 200 mg, containing 10 mg monacolin K per daily dose, 1 capsule per day, per 6 months |
|
| Placebo | Placebo Comparator | Placebo 200 mg (neutral fibre), 1 capsule per day, per 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red yeast rice | Dietary Supplement | 1 capsule to be taken before to sleep, each day, for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flow mediated dilation (FMD) change from the baseline to the end of treatment period | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 12 hour fasting LDL-cholesterolemia change from the baseline to the end of treatment period | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S. Orsola-Malpighi University Hospital | Bologna | BO | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27055107 | Result | Cicero AF, Morbini M, Rosticci M, D''Addato S, Grandi E, Borghi C. Middle-Term Dietary Supplementation with Red Yeast Rice Plus Coenzyme Q10 Improves Lipid Pattern, Endothelial Reactivity and Arterial Stiffness in Moderately Hypercholesterolemic Subjects. Ann Nutr Metab. 2016;68(3):213-9. doi: 10.1159/000445359. Epub 2016 Apr 8. | |
| 28687937 |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C117343 | red yeast rice |
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| Placebo | Dietary Supplement |
|
| Cicero AFG, Fogacci F, Bove M, Veronesi M, Rizzo M, Giovannini M, Borghi C. Short-Term Effects of a Combined Nutraceutical on Lipid Level, Fatty Liver Biomarkers, Hemodynamic Parameters, and Estimated Cardiovascular Disease Risk: A Double-Blind, Placebo-Controlled Randomized Clinical Trial. Adv Ther. 2017 Aug;34(8):1966-1975. doi: 10.1007/s12325-017-0580-1. Epub 2017 Jul 7. |