Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

Completed

• Conditions: Hyperlipidemia; Endothelial Dysfunction
• Interventions: Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo

• Registration Number: NCT00654459
• Lead Sponsor: 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-01
• Status Verified: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2008-04-02
• Study First Submitted QC: 2008-04-07
• Study First Posted: 2008-04-08
• Last Update Submitted: 2008-04-14
• Last Update Posted: 2008-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Mixture of Berberine, Policosanol, Red Yeast, Placebo	-
B	Mixture of Berberine, Policosanol, Red Yeast, Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point included improvement of endothelial dysfunction assessed by an echo flow mediated distribution test.	6 weeks

Trial Locations

Locations (1)

Department of internal medicine University Federico II; 🇮🇹 Naples, Italy