Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

Hyperlipidemia Clinical Trial

Official title:

Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654459
• Other study ID #: ARM 02-07
• Status: Completed
• Phase: Phase 4
• First received: April 2, 2008
• Last updated: April 14, 2008
• Start date: July 2007
• Est. completion date: April 2008

Study information

• Verified date: April 2008
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• Mixture of Berberine, Policosanol, Red Yeast, Placebo
A tablet one a day for 6 weeks

Locations

Country	Name	City	State
Italy	Department of internal medicine University Federico II	Naples

Sponsors (2)

Lead Sponsor	Collaborator
Federico II University	Rottapharm

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary end point included improvement of endothelial dysfunction assessed by an echo flow mediated distribution test.		6 weeks