Nutraceutical in Cardiovascular Primary Prevention

• Status: Completed
• Trial end date: 2017-12-02
• Target enrollment: 0
• Participant gender: All

Summary

Nutraceuticals have attracted interest as possible approach to be associated with lifestyle changes for lowering plasma cholesterol levels in patients with moderate hypercholesterolemia. Ruscica and colleagues showed that a 8-weeks treatment with a nutraceutical combination containing red yeast rice extract, berberine, policosanol, astaxanthin, coenzyme Q10, and folic acid was able to reduce significantly total cholesterol (-12.8%) and low-density lipoprotein-cholesterol (-21.1%) [11]. These nutraceutical compounds exert their lipid-lowering effect through different ways, like the inhibition of the hydroxymethylglutaryl coenzyme A (CoA) enzyme, increasing the hepatic expression of low density lipoprotein (LDL) receptor and the LDL degradation via enhanced hepatic binding and internalization. In addition, they up regulate the numbers and function of circulating endothelial progenitor cells increasing nitric oxide (NO) production. The purpose of the present study was to assess the effectiveness of CARDIOVIS COLESTEROLO 3 mg (containing red rice fermented with Monascus purpureus titrated with 3% monacolin K, hydrol mixture of olive fruit titrated with vitamin E, Coenzyme Q10 and polymethoxyflavones) in terms of cholesterol, endothelial and inflammatory parameters reduction.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital of Ferrara

Criteria

Inclusion Criteria:

Age ≥18 years; Ability to provide informed written consent and to participate in the 16 weeks follow-up period And one of the following criteria

• Cardiovascular risk (SCORE) <1% and LDL levels ≥ 190 mg/dl (confirmed after a 4-week period of life style changes)

• Cardiovascular risk (SCORE) 1% to <5% and LDL levels ≥ 100 mg/dl (confirmed after a 4- week period of life style changes)

Exclusion Criteria:

Chronic liver disease Renal disease (creatinine clearance <60 mg/dl) Intolerance to nutraceutical compounds Thyroid disease Alcohol consumption >40 g/die Treatment with lipid lowering products in the previous 4 weeks Known coronary artery disease (CAD) or cerebrovascular disease Cardiovascular risk (SCORE) ≥5%