Combined Effects of Bioactive Compounds in Lipid Profile

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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Combined Effects of Bioactive Compounds (ARMOLIPID PLUS ®) on Lipid Profile and Clinical Criteria of Metabolic Syndrome in Patients With Serum Elevated LDL-C

Conditions
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Hyperlipidemia, Low-density-lipoprotein-type, Elevated Triglycerides

Intervention / Treatment
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* Dietary Supplement: Armolipid Plus
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients > 18 years old LDL-c plasma levels ≥130 mg/dL and ≤ 189 mg/dL Patients not requiring lipid-lowering drug treatment according to ATPIII guidelines,that do not have cardiovascular disease, stroke or intermittent claudication, diabetes mellitus, renal or Patients who have demonstrated effects or contraindications to lipid-lowering drug therapy (in this case, treatment should be discontinued 1 month before baseline. Signed and dated informed consent before any study specific procedure. Exclusion Criteria: Patients on drug therapy to reduce LDL-C, for example, statins, bile acid sequestrants, nicotinic acid, fibrates or similar (up to 1 month before baseline). History of cardiovascular disease, stroke or intermittent claudication. Diabetes mellitus (at least 2 blood fasting glucose greater than 126 mg / dL). Having taken any functional food with sterols, stanols or similar or any nutraceutical with lipid-lowering effects during the previous 7 days. Plasma levels of triglycerides > 350 mg/dl Diagnosis of familial hypercholesterolemia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary supplement<br>red yeast, astaxanthin, berberine, policosanol, coenzyme Q10, folic acid | Dietary Supplement: Armolipid Plus<br>* one tablet per day during 12 weeks<br>|
| Placebo Comparator: microcrystalline cellulose<br> | Dietary Supplement: placebo<br>* one tablet per day during 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). |  | twelve weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperlipidemia, metabolic syndrome, yeast red, berberine, policosanol, astaxanthin