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

This study has been completed.
Sponsor:
Collaborator:
Carla Caffarelli
Information provided by (Responsible Party):
Stefano Gonnelli, Comitato Etico di Area Vasta Sud Est
ClinicalTrials.gov Identifier:
NCT02078167
First received: March 3, 2014
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Hypercholesterolemia
Other: nutraceutical combination (red yeast rice, policosanols and berberine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Comitato Etico di Area Vasta Sud Est:

Primary Outcome Measures:
  • level of cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • level of tryglicerides [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: January 2009
Study Completion Date: December 2013
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: nutraceutical combination (red yeast rice, policosanols and berberine)
    Other Name: ARMOLIPID
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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  More Information

No publications provided

Responsible Party: Stefano Gonnelli, Comitato Etico di Area Vasta Sud Est
ClinicalTrials.gov Identifier: NCT02078167     History of Changes
Other Study ID Numbers: ARMOLIPID
Study First Received: March 3, 2014
Last Updated: March 4, 2014
Health Authority: Italy: The Italian Medicines Agency

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

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

ClinicalTrials.gov processed this record on September 14, 2014