Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

April 14, 2008 updated by: Federico II University

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Department of internal medicine University Federico II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

males and females aged between 18 and 70 with hypercholesterolemya

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Dietary supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo
A tablet one a day for 6 weeks
Other Names:
  • Armolipid Plus
B
Dietary supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo
A tablet one a day for 6 weeks
Other Names:
  • Armolipid Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Collaborators

Rottapharm

Investigators

  • Principal Investigator: Serafino Fazio, MD, Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

April 2, 2008

First Submitted That Met QC Criteria

April 7, 2008

First Posted (Estimate)

April 8, 2008

Study Record Updates

Last Update Posted (Estimate)

April 16, 2008

Last Update Submitted That Met QC Criteria

April 14, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARM 02-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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