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

February 27, 2013 updated by: Rottapharm Spain

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Tarragona
      • Reus, Tarragona, Spain
        • Hosp. Universitario San Joan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary supplement
red yeast, astaxanthin, berberine, policosanol, coenzyme Q10, folic acid
Dietary supplement: Armolipid Plus
one tablet per day during 12 weeks
Placebo Comparator: microcrystalline cellulose
Dietary supplement: placebo
one tablet per day during 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: twelve weeks
twelve weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular risk (according to the Framingham tables).
Time Frame: twelve weeks
twelve weeks
Criteria for Metabolic Syndrome
Time Frame: twelve weeks
twelve weeks
Levels of triglycerides and cholesterol high density lipoprotein (HDL-C).
Time Frame: twelve weeks
twelve weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rottapharm Spain

Collaborators

Centro Tecnológico de Nutrición y Salud

Investigators

  • Study Director: Rosa Solà, MD PhD, Hosp. Universitari Sant Joan de Reus (Tarragona)
  • Principal Investigator: Jesús Millán, MD PhD, Hosp. Universitario Gregorio Marañón (Madrid)
  • Principal Investigator: José R Calabuig, MD PhD, Hosp. Universitario La Fe (Valencia)
  • Principal Investigator: José Villar, MD PhD, Hosp. Universitario Virgen del Rocío (Sevilla)
  • Principal Investigator: José Puzo, MD PhD, Hosp. Universitario San Jorge (Huesca)
  • Principal Investigator: Angel Brea, MD, Hosp. Universitario San Pedro ( Logroño)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

March 21, 2012

First Submitted That Met QC Criteria

March 22, 2012

First Posted (Estimate)

March 23, 2012

Study Record Updates

Last Update Posted (Estimate)

February 28, 2013

Last Update Submitted That Met QC Criteria

February 27, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARM-PLUS-LDL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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