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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.
 
ClinicalTrials.gov Identifier: NCT01562080
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : February 28, 2013
Sponsor:
Collaborator:
Centro Tecnológico de Nutrición y Salud
Information provided by (Responsible Party):
Rottapharm Spain

Study Description
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Brief 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)

Condition or disease Intervention/treatment Phase
Hyperlipidemia Low-density-lipoprotein-type Elevated Triglycerides Dietary Supplement: Armolipid Plus Dietary Supplement: placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Combined Effects of Bioactive Compounds (ARMOLIPID PLUS ®) on Lipid Profile and Clinical Criteria of Metabolic Syndrome in Patients With Serum Elevated LDL-C
Study Start Date : January 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : October 2012
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562080


Locations
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Spain
Hosp. Universitario San Joan
Reus, Tarragona, Spain
Sponsors and Collaborators
Rottapharm Spain
Centro Tecnológico de Nutrición y Salud
Investigators
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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)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rottapharm Spain
ClinicalTrials.gov Identifier: NCT01562080    
Other Study ID Numbers: ARM-PLUS-LDL
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013
Keywords provided by Rottapharm Spain:
hyperlipidemia
metabolic syndrome
yeast red
 berberine
policosanol
astaxanthin
Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Hypertriglyceridemia
 Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders