Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

NCT00654459 | Completed DMC

• 1 other identifier: ARM 02-07
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

Hyperlipidemia; Endothelial Dysfunction

Outcome Measures

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.

  6 weeks

Secondary Outcomes (1)

• Secondary end point included improvement of endothelial dysfunction assessed by an echo flow mediated distribution test.

  6 weeks

Study Arms (2)

A

Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo

B

Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo

Interventions

Mixture of Berberine, Policosanol, Red Yeast, Placebo DIETARY_SUPPLEMENT

A tablet one a day for 6 weeks

Also known as: Armolipid Plus

A; B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

males and females aged between 18 and 70 with hypercholesterolemya

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead
• Rottapharm: collaborator

Study Sites (1)

Department of internal medicine University Federico II

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

policosanol

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Serafino Fazio, MD

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 8, 2008
• Study Start: July 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 16, 2008

Record last verified: 2008-04

Locations

IT (1)