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| Name | Class |
|---|---|
| Centro Tecnológico de Nutrición y Salud | OTHER |
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The aim of this study is to demonstrate whether, along with dietary recommendations, Armolipid Plus ® can improve the profile of patients with elevated plasma LDL-C acting as a change of lifestyle therapy (TLC) according to the definition of Adult Treatment Panel III (ATP III)
Recently reported that the combination of extract of red yeast rice policosanol composed, berberine, folic acid and coenzyme Q10 (Armolipid Plus ®, Rottapharm) produced a significant improvement in lipid profile in patients with moderately elevated cholesterol levels of low density lipoprotein (LDL-C) plasma.
Taking into account the potential effect of Armolipid Plus ® on the lipid profile, it is important to investigate the effectiveness in the field of cardiovascular prevention to define its position in prevention programs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary supplement | Experimental | red yeast, astaxanthin, berberine, policosanol, coenzyme Q10, folic acid |
|
| microcrystalline cellulose | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Armolipid Plus | Dietary Supplement | one tablet per day during 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| investigate whether the addition of Armolipid Plus ® decreases by 20% LDL-C levels compared to baseline in patients with initial levels of LDL-C ≥ 130 mg / dL. | twelve weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular risk (according to the Framingham tables). | twelve weeks | |
| Criteria for Metabolic Syndrome | twelve weeks | |
| Levels of triglycerides and cholesterol high density lipoprotein (HDL-C). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rosa Solà , MD PhD | Hosp. Universitari Sant Joan de Reus (Tarragona) | Study Director |
| Jesús Millán, MD PhD | Hosp. Universitario Gregorio Marañón (Madrid) | Principal Investigator |
| José R Calabuig, MD PhD | Hosp. Universitario La Fe (Valencia) | Principal Investigator |
| José Villar, MD PhD | Hosp. Universitario Virgen del RocÃo (Sevilla) | Principal Investigator |
| José Puzo, MD PhD | Hosp. Universitario San Jorge (Huesca) | Principal Investigator |
| Angel Brea, MD | Hosp. Universitario San Pedro ( Logroño) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hosp. Universitario San Joan | Reus | Tarragona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25084280 | Derived | Sola R, Valls RM, Puzo J, Calabuig JR, Brea A, Pedret A, Morina D, Villar J, Millan J, Anguera A. Effects of poly-bioactive compounds on lipid profile and body weight in a moderately hypercholesterolemic population with low cardiovascular disease risk: a multicenter randomized trial. PLoS One. 2014 Aug 1;9(8):e101978. doi: 10.1371/journal.pone.0101978. eCollection 2014. |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D015228 | Hypertriglyceridemia |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| placebo |
| Dietary Supplement |
one tablet per day during 12 weeks |
|
| twelve weeks |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |