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CompletedNCT01562080ARM-PLUS-LDLUpdated Feb 28, 2013

Combined Effects of Bioactive Compounds in Lipid Profile

A Phase 2/3 interventional study of Armolipid Plus and placebo in Hyperlipidemia, Low-density-lipoprotein-type and Elevated Triglycerides, sponsored by Rottapharm Spain. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-28.

Sponsored by Rottapharm Spain · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
118
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Hyperlipidemia
  • Low-density-lipoprotein-type
  • Elevated Triglycerides

Keywords

  • hyperlipidemia
  • metabolic syndrome
  • yeast red
  • berberine
  • policosanol
  • astaxanthin
03

In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 118 is above the median of 87 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

Rottapharm Spain is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
118 participants (actual)

Study arms

  • Experimental
    Dietary supplement

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

    Dietary Supplement: Armolipid Plus

  • Placebo comparator
    microcrystalline cellulose

    Dietary Supplement: placebo

Interventions

  • Dietary supplementArmolipid Plus

    one tablet per day during 12 weeks

  • Dietary supplementplacebo

    one tablet per day during 12 weeks

06

What researchers measure

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

07

Study locations

1 site
  • Hosp. Universitario San Joan
    Reus, Tarragona, Spain
08

References and documents

Publications

  • Sola R, Valls RM, Puzo J, Calabuig JR, Brea A, Pedret A, Morina D, Villar J, Millan 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. PubMed 25084280 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01562080
Lead sponsor
Rottapharm Spain
Collaborators
Centro Tecnológico de Nutrición y Salud
Responsible party
Sponsor
First posted
Mar 23, 2012
Start date
Jan 2012
Primary completion
Jun 2012
Completion
Oct 2012
Last update
Feb 28, 2013

Study contacts

Rosa Solà, MD PhD
study director · Hosp. Universitari Sant Joan de Reus (Tarragona)
Jesús Millán, MD PhD
principal investigator · Hosp. Universitario Gregorio Marañón (Madrid)
José R Calabuig, MD PhD
principal investigator · Hosp. Universitario La Fe (Valencia)
José Villar, MD PhD
principal investigator · Hosp. Universitario Virgen del Rocío (Sevilla)
José Puzo, MD PhD
principal investigator · Hosp. Universitario San Jorge (Huesca)
Angel Brea, MD
principal investigator · Hosp. Universitario San Pedro ( Logroño)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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