Combined Effects of Bioactive Compounds in Lipid Profile

Phase 2

Completed

• Conditions: Hyperlipidemia; Low-density-lipoprotein-type; Elevated Triglycerides
• Interventions: Dietary Supplement: Armolipid Plus; Dietary Supplement: placebo

• Registration Number: NCT01562080
• Lead Sponsor: Rottapharm Spain

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Primary Completion: 2012-06
• Study Completion: 2012-10
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-27
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary supplement	Armolipid Plus	red yeast, astaxanthin, berberine, policosanol, coenzyme Q10, folic acid
microcrystalline cellulose	placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hosp. Universitario San Joan; 🇪🇸 Reus, Tarragona, Spain