Elevated Triglycerides, Hyperlipidemia, Low-density-lipoprotein-type
Conditions
Keywords
hyperlipidemia, metabolic syndrome, yeast red, berberine, policosanol, astaxanthin
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTArmolipid Plus
one tablet per day during 12 weeks
DIETARY_SUPPLEMENTplacebo
one tablet per day during 12 weeks
Sponsors
Centro Tecnológico de Nutrición y Salud
Rottapharm Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Spain
Outcome results
None listed