Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

Federico II University

Status: Completed

Conditions: Endothelial Dysfunction; Hyperlipidemia

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00654459

ARM 02-07

Details and patient eligibility

About

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)

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups

A

Treatment:

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

B

Treatment:

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