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OpenTrials
Completed

NCT Number: NCT00654459

Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

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)

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Key information

Conditions

Hyperlipidemia Dyslipidemias Endothelial Dysfunction Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of internal medicine University Federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mixture of Berberine, Policosanol, Red Yeast, Placebo

Dietary Supplement

A tablet one a day for 6 weeks

Other names: Armolipid Plus

Primary outcomes

  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 outcomes

  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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Sponsors and collaborators

Lead sponsor

Federico II University

Other

Collaborators

  • Rottapharm

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 8, 2008
Registry last updated
Apr 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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