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Long Term Efficacy and Tolerability of a Nutraceutical Combination (Red Yeast Rice, Policosanols and Berberine) in Low-moderate Risk Hypercholesterolemic Patients: a Double-blind, Placebo Controlled Study

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ClinicalTrials.gov Identifier: NCT02078167
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : March 5, 2014
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Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Background: Statins are at the forefront of strategies to manage hypercholesterolemia. However, 10-15% of patients result to be intolerant to any statins, even at low daily doses and almost one- third of statin users discontinue therapy within one year. Some nutraceuticals are prescribed as lipid- lowering substances, but doubts remain about their efficacy and tolerability. In this study we investigated the effects of a nutraceutical combination consisting mainly of red yeast rice extract 200 mg (equivalent to 3 mg monacolins), berberine 500 mg and policosanols 10 mg (MBP-NC).

Methods: In this single centre, randomized, double-blind, placebo-controlled study 60 consecutive outpatients (age range: 18-60 years), with newly diagnosed primary hypercholesterolemia not previously treated, after a run-in period of 3 weeks on a stable hypolipidic diet, were randomized to receive a pill of MBP-NC (N=30) or placebo (N=30) once a day after dinner, in addition to the hypolipidic diet. The efficacy and the tolerability of the proposed nutraceutical treatment were fully assessed after 4, 12 and 24 weeks of treatment.


Condition or disease Intervention/treatment Phase
Hypercholesterolemia Other: nutraceutical combination (red yeast rice, policosanols and berberine) Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Long Term Efficacy and Tolerability of a Nutraceutical Combination (Red Yeast Rice, Policosanols and Berberine) in Low-moderate Risk Hypercholesterolemic Patients: a Double-blind, Placebo Controlled Study
Study Start Date : January 2009
Primary Completion Date : January 2011
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Other: nutraceutical combination (red yeast rice, policosanols and berberine)
    Other Name: ARMOLIPID

Outcome Measures

Primary Outcome Measures :
  1. level of cholesterol [ Time Frame: 24 weeks ]
  2. level of tryglicerides [ Time Frame: 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • The inclusion criteria were (1) age between 18 and 60 years , (2) body mass index(BMI) between 18,5 ad 29,9 Kg/m2, (3) serum low-density lipoprotein cholesterol (LDL-C) above 150 mg/dL and an estimated 10-year cardiovascular risk < 20% according to Framingham risk scoring.

Exclusion Criteria:

  • The exclusion criteria were (1) history of cardiovascular disease or coronary risk equivalents, (2) secondary hyperlipidemia caused by diabetes mellitus, renal, liver or thyroid diseases, (3)alcohol consumption of > 40 g/day, (4) estimated 10-year cardiovascular risk > 20% according to Framingham risk scoring, (5) muscular diseases or abnormally elevated creatine phosphokinase (CPK) levels or drug treatment with anti-platelet, anti-inflammatory, hypolipidemic agents or hormone replacement therapy, either on-going or any time in the previous 2 months.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stefano Gonnelli, Comitato Etico di Area Vasta Sud Est
ClinicalTrials.gov Identifier: NCT02078167     History of Changes
Other Study ID Numbers: ARMOLIPID
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Stefano Gonnelli, Comitato Etico di Area Vasta Sud Est:
ipercholesterolemia not familiarity

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Red yeast rice
Policosanol
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Platelet Aggregation Inhibitors