Trial | NCT01562080  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    118
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.
Study Started
Jan 31
2012
Primary Completion
Jun 30
2012
Study Completion
Oct 31
2012
Last Update
Feb 28
2013
Estimate

Dietary Supplement Armolipid Plus

one tablet per day during 12 weeks

Dietary Supplement placebo

one tablet per day during 12 weeks

Dietary supplement Experimental

red yeast, astaxanthin, berberine, policosanol, coenzyme Q10, folic acid

microcrystalline cellulose Placebo Comparator

Criteria 

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
No Results Posted