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OpenTrials
Completed

NCT Number: NCT01562080

Combined Effects of Bioactive Compounds in Lipid Profile

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hosp. Universitario San Joan

Reus, Tarragona, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Armolipid Plus

Dietary Supplement

one tablet per day during 12 weeks

Placebo

Dietary Supplement

one tablet per day during 12 weeks

Primary outcomes

  1. 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.

    Time frame: twelve weeks

Secondary outcomes

  1. Cardiovascular risk (according to the Framingham tables).

    Time frame: twelve weeks

  2. Criteria for Metabolic Syndrome

    Time frame: twelve weeks

  3. Levels of triglycerides and cholesterol high density lipoprotein (HDL-C).

    Time frame: twelve weeks

Sponsors and collaborators

Lead sponsor

Rottapharm Spain

Industry

Collaborators

  • Centro Tecnológico de Nutrición y Salud

Registry information

Official study title

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

Acronym: ARM-PLUS-LDL

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 23, 2012
Registry last updated
Feb 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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