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Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

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ClinicalTrials.gov Identifier: NCT00654459
Recruitment Status : Completed
First Posted : April 8, 2008
Last Update Posted : April 16, 2008
Sponsor:
Collaborator:
Rottapharm
Information provided by:
Federico II University

Brief Summary:

Some nutraceuticals are often advised for their lipid lowering effects. Although many clinical trials have been conducted to assess their efficacy many doubts remain whether they could be considered an effective alternative to statins therapy.

The aim of this study was to evaluate the lipid lowering effects and the improvement of endothelial dysfunction in patients with hyperlipidemia, treated with a nutraceutical product (Armolipid Plus)


Condition or disease Intervention/treatment
Hyperlipidemia Endothelial Dysfunction Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function
Study Start Date : July 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
A Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo
A tablet one a day for 6 weeks
Other Name: Armolipid Plus

B Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo
A tablet one a day for 6 weeks
Other Name: Armolipid Plus




Primary Outcome Measures :
  1. The primary outcome measure of this study was the percentage change from baseline of total cholesterol (C), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C),and Triglycerides (Tg) plasma concentrations. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Secondary end point included improvement of endothelial dysfunction assessed by an echo flow mediated distribution test. [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
males and females aged between 18 and 70 with hypercholesterolemya
Criteria

Inclusion Criteria:

  • Males and females aged between 18 and 70
  • Total cholesterol levels > 220 mg/dl and LDL-Cholesterol > 130 mg/dl;
  • Patients with concomitant pathology such as diabetes, chronic heart failure, coronary artery disease, arterial hypertension, dysthyroidism, were admitted as long as stable in the previous three months

Exclusion Criteria:

  • Proven intolerance to an Armolipid Plus compound
  • Pregnant women, and women planning to conceive
  • Patients in therapy with lipid lowering drugs within the previous 6 weeks
  • Triglycerides concentration > 500mg/dl were excluded.

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): NCT00654459


Locations
Italy
Department of internal medicine University Federico II
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Rottapharm
Investigators
Principal Investigator: Serafino Fazio, MD Federico II University

Responsible Party: Serafino Fazio MD, Federico II University
ClinicalTrials.gov Identifier: NCT00654459     History of Changes
Other Study ID Numbers: ARM 02-07
First Posted: April 8, 2008    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Policosanol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Platelet Aggregation Inhibitors