title: Nutraceutical approach to moderate cardiometabolic risk: results of a randomized, double-blind and crossover study with Armolipid Plus.
abstract: BACKGROUND
  Primary cardiovascular prevention may be achieved by lifestyle/nutrition improvements and specific drugs, although a relevant role is now emerging for specific functional foods and nutraceuticals.
  
  
  OBJECTIVE
  The aim of this study was to evaluate the usefulness of a nutraceutical multitarget approach in subjects with moderate cardiovascular risk and to compare it with pravastatin treatment.
  
  
  METHODS
  Thirty patients with moderate dyslipidemia and metabolic syndrome (according to the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults) were included in an 8-week randomized, double-blind crossover study and took either placebo or a nutraceutical combination that contained red yeast rice extract, berberine, policosanol, astaxanthin, coenzyme Q10, and folic acid (Armolipid Plus). Subsequently, they were subjected to another 8-week treatment with pravastatin 10 mg/d. This dosage was selected on the basis of its expected -20% efficacy in reducing low-density lipoprotein-cholesterol.
  
  
  RESULTS
  Treatment with Armolipid Plus led to a significant reduction of total cholesterol (-12.8%) and low-density lipoprotein-cholesterol (-21.1%), similar to pravastatin (-16% and -22.6%, respectively), and an increase of high-density lipoprotein-cholesterol (4.8%). Armolipid Plus improved the leptin-to-adiponectin ratio, whereas adiponectin levels were unchanged.
  
  
  CONCLUSIONS
  These results indicate that this nutraceutical approach shows a lipid-lowering activity comparable to pravastatin treatment. Hence, it may be a safe and useful option, especially in conditions of moderate cardiovascular risk, in which a pharmacologic intervention may not be appropriate.
authors: Centro Dislipidemie, A. O. Ospedale Niguarda Cà Granda, Milano, Italy; Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Via Balzaretti 9, 20133 Milano, Italy.
authors: Massimiliano
authors: M
authors: Ruscica
authors: Centro Dislipidemie, A. O. Ospedale Niguarda Cà Granda, Milano, Italy; Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Via Balzaretti 9, 20133 Milano, Italy.
authors: Monica
authors: M
authors: Gomaraschi
authors: Centro Dislipidemie, A. O. Ospedale Niguarda Cà Granda, Milano, Italy.
authors: Giuliana
authors: G
authors: Mombelli
authors: Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Via Balzaretti 9, 20133 Milano, Italy.
authors: Chiara
authors: C
authors: Macchi
authors: Centro Dislipidemie, A. O. Ospedale Niguarda Cà Granda, Milano, Italy.
authors: Raffaella
authors: R
authors: Bosisio
authors: Centro Dislipidemie, A. O. Ospedale Niguarda Cà Granda, Milano, Italy; Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Via Balzaretti 9, 20133 Milano, Italy.
authors: Franco
authors: F
authors: Pazzucconi
authors: Centro Dislipidemie, A. O. Ospedale Niguarda Cà Granda, Milano, Italy.
authors: Chiara
authors: C
authors: Pavanello
authors: Centro Dislipidemie, A. O. Ospedale Niguarda Cà Granda, Milano, Italy; Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Via Balzaretti 9, 20133 Milano, Italy.
authors: Laura
authors: L
authors: Calabresi
authors: Centro Dislipidemie, A. O. Ospedale Niguarda Cà Granda, Milano, Italy; Dipartimento di Scienze Farmaceutiche, Università degli Studi di Milano, Milano, Italy.
authors: Anna
authors: A
authors: Arnoldi
authors: Centro Dislipidemie, A. O. Ospedale Niguarda Cà Granda, Milano, Italy; Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Via Balzaretti 9, 20133 Milano, Italy. Electronic address: cesare.sirtori@unimi.it.
authors: Cesare R
authors: CR
authors: Sirtori
authors: Centro Dislipidemie, A. O. Ospedale Niguarda Cà Granda, Milano, Italy; Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Via Balzaretti 9, 20133 Milano, Italy.
authors: Paolo
authors: P
authors: Magni
mesh_terms: D001599:Berberine / Q000627:therapeutic use; D001688:Biological Products / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D002318:Cardiovascular Diseases / Q000188:drug therapy* / Q000378:metabolism*; D008078:Cholesterol, LDL / Q000097:blood; D018592:Cross-Over Studies; D019587:Dietary Supplements; D004311:Double-Blind Method; D023381:Endpoint Determination; D005233:Fatty Alcohols / Q000627:therapeutic use; D005260:Female; D005492:Folic Acid / Q000627:therapeutic use; D006801:Humans; D018836:Inflammation Mediators / Q000097:blood; D008297:Male; D008875:Middle Aged; D017035:Pravastatin / Q000627:therapeutic use; D013997:Time Factors; D014451:Ubiquinone / Q000031:analogs & derivatives / Q000627:therapeutic use; D024341:Xanthophylls / Q000627:therapeutic use
chemical_list: D001688:Biological Products; D015415:Biomarkers; D008078:Cholesterol, LDL; D005233:Fatty Alcohols; D018836:Inflammation Mediators; D024341:Xanthophylls; C117343:red yeast rice; D001599:Berberine; D014451:Ubiquinone; C080710:policosanol; C005948:astaxanthine; D005492:Folic Acid; C024989:coenzyme Q10; D017035:Pravastatin
keywords: Berberine; Cardiovascular risk; HDL-cholesterol; LDL-cholesterol; Monacolin K