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Aim of the study is to assess the effect of a long-term nutraceutical multitarget approach on lipid profile, inflammatory mediators and vascular remodeling in primary cardiovascular prevention in a setting of controlled dietary habits. The nutraceutical combination used in this study consists of a single pill containing 333 mg of RYR, equivalent to 10 mg of Monacolin K, and 30 mg of Coenzyme Q10 (CoQ10).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RYR plus CoQ | 333 mg of red yeast rice (RYR, equivalent to 10 mg of Monacolin K) plus 30 mg of Coenzyme Q10 (CoQ10) in a single pill once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposcudil Plus | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in cholesterol levels at one year | Total Cholesterol will be measured in the blood sample from each patient and expressed as mg/dl | Baseline and one year |
| Change from baseline in carotid intima media thickening at one year | Carotid ultrasound examination is performed at baseline and after one year to measure intima-media thickness (IMT). IMT is defined as the distance in mm between the lumen-intima and the media-adventitia interfaces, it is measured at end diastole in the far wall of the right and left sides of the common carotid artery, the bulb and the internal carotid artery. Carotid IMT measurements are expressed as cumulative mean of mean-IMT (m-IMT) recorded in each vascular segment . | Baseline and one year |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with mild hypercholeterolemia and low-to moderate cardiovascular risk profile
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera di Padova | Padova | 35125 | Italy |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |