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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01562080
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : February 28, 2013
Centro Tecnológico de Nutrición y Salud
Information provided by (Responsible Party):
Rottapharm Spain

March 21, 2012
March 23, 2012
February 28, 2013
January 2012
June 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01562080 on Archive Site
  • Cardiovascular risk (according to the Framingham tables). [ Time Frame: twelve weeks ]
  • Criteria for Metabolic Syndrome [ Time Frame: twelve weeks ]
  • Levels of triglycerides and cholesterol high density lipoprotein (HDL-C). [ Time Frame: twelve weeks ]
Same as current
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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
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.

Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Hyperlipidemia
  • Low-density-lipoprotein-type
  • Elevated Triglycerides
  • Dietary Supplement: Armolipid Plus
    one tablet per day during 12 weeks
  • Dietary Supplement: placebo
    one tablet per day during 12 weeks
  • Experimental: Dietary supplement
    red yeast, astaxanthin, berberine, policosanol, coenzyme Q10, folic acid
    Intervention: Dietary Supplement: Armolipid Plus
  • Placebo Comparator: microcrystalline cellulose
    Intervention: Dietary Supplement: placebo
Solà R, Valls RM, Puzo J, Calabuig JR, Brea A, Pedret A, Moriña D, Villar J, Millán J, Anguera A. Effects of poly-bioactive compounds on lipid profile and body weight in a moderately hypercholesterolemic population with low cardiovascular disease risk: a multicenter randomized trial. PLoS One. 2014 Aug 1;9(8):e101978. doi: 10.1371/journal.pone.0101978. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2012
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Rottapharm Spain
Rottapharm Spain
Centro Tecnológico de Nutrición y Salud
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)
Rottapharm Spain
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP