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.
Italian Researchers form Bologna and Pavia Universities carried out a crossover, double-blind, placebo-controlled randomized clinical trial in order 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. The results were published on August 2013 issue of Nutritional Research.
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 favourable 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 these data, the Researchers demonstrate that a 10-mg monacolin nutraceutical appears to safely reduce cholesterolemia, hs-CRP, and markers of vascular remodelling in Italian subjects. These results have to be confirmed in larger patient samples and longer studies.