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A large body of evidence confirm the cholesterol lowering effect of phytosterols and red yeast rice. Because their mechanisms of action mime the ones of chemical statins and cholesterol absorption inhibitors, it is plausible that their association will provide a more relevant (and safe) LDL cholesterolemia reduction.
A large body of literature suggest that the patients are strongly interested in self-medicating them with "natural" products aimed at reducing their plasma level of LDL-cholesterol. Plant sterols and red yeast rice are among the most widely marketed product with these properties in Western countries. However plant sterols per se have a limited effect on cholesterolemia, while full dosed red yeast rice can induce myalgias and myopathies as statins do. In this context, the aim of the investigators' study was to evaluate if the association of both products at low dosage could induce an additive or synergistic effect in term of LDL-reduction in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant sterols | Active Comparator | Plant sterols 800 mg per dose, 1 liquid stick per day, per 8 weeks |
|
| Red Yeast Rice | Active Comparator | Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks |
|
| Red Yeast Rice plus Plant sterols | Experimental | lant sterols 800 mg per dose + Red Yeast Rice 200 mg containing 5 mg monacolin K per daily dose, 1 liquid stick per day, per 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant sterols | Dietary Supplement | Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL cholesterolemia reduction from baseline and between groups | Absolute and % reduction of LDL cholesterolemia after 8 weeks of treatment | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Non-HDL cholesterolemia reduction from baseline and between groups | Absolute and % reduction of of non-HDL cholesterolemia after 8 weeks of treatment | 8 weeks |
| Number of Participants With Treatment-Related Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Borghi, MD | University of Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S. Orsola-Malpighi University Hospital | Bologna | 40038 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29021813 | Result | Cicero AFG, Fogacci F, Rosticci M, Parini A, Giovannini M, Veronesi M, D'Addato S, Borghi C. Effect of a short-term dietary supplementation with phytosterols, red yeast rice or both on lipid pattern in moderately hypercholesterolemic subjects: a three-arm, double-blind, randomized clinical trial. Nutr Metab (Lond). 2017 Sep 25;14:61. doi: 10.1186/s12986-017-0214-2. eCollection 2017. |
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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 |
|---|---|
| D010840 | Phytosterols |
| C117343 | red yeast rice |
| ID | Term |
|---|---|
| D013261 | Sterols |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Red Yeast Rice | Dietary Supplement | Red Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks |
|
| Red Yeast Rice plus Plant sterols | Dietary Supplement | Red Yeast Rice titrated in 5 mg monacolin K per daily dose plus Plant sterols 800 mg/dose, together in 1 liquid stick per day, for 8 weeks |
|
Subjective tolerability of the tested treatment
| 8 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D064209 | Phytochemicals |
| D001685 | Biological Factors |