Combined Effects of Bioactive Compounds in Lipid Profile (ARM-PLUS-LDL)

Rottapharm

Status and phase: Completed; Phase 3; Phase 2

Conditions: Elevated Triglycerides; Hyperlipidemia; Low-density-lipoprotein-type

Treatments: Dietary Supplement: placebo; Dietary Supplement: Armolipid Plus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01562080

ARM-PLUS-LDL

Details and patient eligibility

About

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)

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 2 patient groups, including a placebo group

Dietary supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Armolipid Plus

microcrystalline cellulose

Placebo Comparator group

Treatment:

Dietary Supplement: placebo