Red yeast rice improves lipid pattern, high-sensitivity C-reactive protein, and vascular remodeling parameters in moderately hypercholesterolemic Italian subjects

• Published in: Nutrition research (New York, N.Y.) Vol. 33; no. 8; pp. 622 - 628
• Main Authors: Cicero, Arrigo F.G., Derosa, Giuseppe, Parini, Angelo, Maffioli, Pamela, D’Addato, Sergio, Reggi, Alessandra, Giovannini, Marina, Borghi, Claudio
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.08.2013; Elsevier
• Subjects: Ascomycota; Biological and medical sciences; Biological Products; Biological Products - chemistry; Biological Products - pharmacology; Biological Products - therapeutic use; biomarkers; Biomarkers - blood; blood; C-reactive protein; C-Reactive Protein - metabolism; chemistry; cholesterol; Cholesterol - blood; Cholesterol, LDL; Cholesterol, LDL - blood; Clinical trial; Collagenases; Collagenases - blood; Cross-Over Studies; Dietary Supplements; Disorders of blood lipids. Hyperlipoproteinemia; Double-Blind Method; drug therapy; Feeding. Feeding behavior; Female; food safety; Fundamental and applied biological sciences. Psychology; Gastroenterology and Hepatology; gelatinase A; gelatinase B; health claims; high density lipoprotein; High-sensitivity C-reactive protein; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hydroxymethylglutaryl-CoA Reductase Inhibitors - pharmacology; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Hypercholesterolemia; Hypercholesterolemia - blood; Hypercholesterolemia - drug therapy; Hypercholesterolemia - pathology; Italy; LDL cholesterol; low density lipoprotein; Male; Matrix Metalloproteinase 2; Matrix Metalloproteinase 2 - blood; Matrix Metalloproteinase 9; Matrix Metalloproteinase 9 - blood; Medical sciences; Metabolic diseases; metabolism; Metalloproteinases; Middle Aged; Monacolins; Naphthalenes; Naphthalenes - pharmacology; Naphthalenes - therapeutic use; Nutraceutical; Oryza sativa; pathology; patients; pharmacology; randomized clinical trials; red rice; therapeutic use; triacylglycerols; Vertebrates: anatomy and physiology, studies on body, several organs or systems; Italy; CVs; apoAI; LDL-C; Nutraceutical; Metalloproteinases; apoB; TC; HDL-C; MMP; High-sensitivity C-reactive protein; TG; Clinical trial; Monacolins; LDL cholesterol; hs-CRP; CPK; creatinine-phosphokinase; high-sensitivity C-reactive protein; total cholesterol; high-density lipoprotein cholesterol; coefficients of variation; apolipoprotein AI; triglycerides; matrix metalloproteinase; apolipoprotein B; low density lipoprotein cholesterol; Human; Yeast; Nutrition; Metabolic diseases; Cholesterol LDL; Lipids; Hyperlipoproteinemia; Lipoprotein; Red; Sensitivity; Hypercholesterolemia; Cereal; Dyslipemia; C reactive protein; Rice
• ISSN: 0271-5317; 1879-0739; 1879-0739
• DOI: 10.1016/j.nutres.2013.05.015

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.