title: Red yeast rice improves lipid pattern, high-sensitivity C-reactive protein, and vascular remodeling parameters in moderately hypercholesterolemic Italian subjects.
abstract: Despite a recent health claim by the European Agency on Food Safety, the effect of high doses of dietary monacolin supplements from red yeast rice on cholesterolemia has not been tested in Italian subjects. Our aim via a crossover, double-blind, placebo-controlled randomized clinical trial was to test if a short-term treatment with 10 mg monacolins could improve lipid pattern, high-sensitivity C-reactive protein (hs-CRP), and vascular remodeling biomarkers in a small cohort of Mediterranean subjects. Thus, 25 healthy, mildly hypercholesterolemic subjects were enrolled, and after 4 weeks of a stabilization diet, subjects were randomized to the sequence placebo-washout-monacolins or monacolins-washout-placebo, with each period being 4 weeks long. At each study step, a complete lipid pattern, safety parameters, hs-CRP, and matrix metalloproteinases 2 and 9 levels were measured. When compared to the placebo group, monacolins-treated patients experienced a more favorable percent change in total cholesterol (-12.45%, 95% CI -16.19 to -8.71), low-density lipoprotein cholesterol (-21.99%, 95% CI -26.63 to -17.36), non-high-density lipoprotein cholesterol (-14.67%, 95% CI -19.22 to -10.11), matrix metalloproteinase 2 (-28.05%, 95% CI -35.18 to -20.93), matrix metalloproteinase 9 (-27.19%, 95% CI -36.21 to -18.15), and hs-CRP (-23.77%, 95% CI -30.54 to -17.01). No significant differences were observed in regards to triglycerides, high-density lipoprotein cholesterol, and safety parameters. On the basis of our data, we demonstrate that a 10-mg monacolin nutraceutical appears to safely reduce cholesterolemia, hs-CRP, and markers of vascular remodeling in Italian subjects. These results have to be confirmed in larger patient samples and longer studies.
authors.affiliation: Medical and Surgical Sciences Department, University of Bologna, Bologna, Italy. afgcicero@cardionet.it
authors.forename: Arrigo F G
authors.initials: AF
authors.lastname: Cicero
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Derosa
authors.forename: Angelo
authors.initials: A
authors.lastname: Parini
authors.forename: Pamela
authors.initials: P
authors.lastname: Maffioli
authors.forename: Sergio
authors.initials: S
authors.lastname: D'Addato
authors.forename: Alessandra
authors.initials: A
authors.lastname: Reggi
authors.forename: Marina
authors.initials: M
authors.lastname: Giovannini
authors.forename: Claudio
authors.initials: C
authors.lastname: Borghi
mesh_terms: D001203:Ascomycota; D001688:Biological Products / Q000737:chemistry / Q000494:pharmacology / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D002097:C-Reactive Protein / Q000378:metabolism*; D002784:Cholesterol / Q000097:blood*; D008078:Cholesterol, LDL / Q000097:blood; D017364:Collagenases / Q000097:blood*; D018592:Cross-Over Studies; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D007558:Italy; D008297:Male; D020778:Matrix Metalloproteinase 2 / Q000097:blood; D020780:Matrix Metalloproteinase 9 / Q000097:blood; D008875:Middle Aged; D009281:Naphthalenes / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D001688:Biological Products; D015415:Biomarkers; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D009281:Naphthalenes; C117343:red yeast rice; D002097:C-Reactive Protein; D002784:Cholesterol; D017364:Collagenases; D020778:Matrix Metalloproteinase 2; D020780:Matrix Metalloproteinase 9
keywords: CPK; CVs; Clinical trial; HDL-C; High-sensitivity C-reactive protein; LDL cholesterol; LDL-C; MMP; Metalloproteinases; Monacolins; Nutraceutical; TC; TG; apoAI; apoB; apolipoprotein AI; apolipoprotein B; coefficients of variation; creatinine-phosphokinase; high-density lipoprotein cholesterol; high-sensitivity C-reactive protein; hs-CRP; low density lipoprotein cholesterol; matrix metalloproteinase; total cholesterol; triglycerides