Endothelial Dysfunction, Hyperlipidemia
Conditions
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)
Interventions
DIETARY_SUPPLEMENTMixture of Berberine, Policosanol, Red Yeast, Placebo
A tablet one a day for 6 weeks
Sponsors
Rottapharm
Federico II University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point included improvement of endothelial dysfunction assessed by an echo flow mediated distribution test. | 6 weeks |
Countries
Italy
Outcome results
None listed