Clinical Studies

Scientific Opinion on the substantiation of a health claim related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDLcholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006 EFSA Journal 2013;11(2):3084 [13 pp.]. doi:10.2903/j.efsa.2013.3084 EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)Panel Members Acknowledgment Contact Type: Opinion of the Scientific Committee/ Scientific Panel On request from: the Competent Authority of the Netherlands following an application by Sylvan Bio Europe BV Question number: EFSA-Q-2012-00736 Adopted: 24 January 2013 Published: 12 February 2013 Affiliation: European Food Safety Authority (EFSA), Parma, Italy

[...]Was asked to deliver an opinion on the scientific substantiation of a health claim related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL-cholesterol concentrations. The food, monacolin K in SYLVAN BIO red yeast rice, that is the subject of the health claim is sufficiently characterised. The claimed effect, maintenance of normal blood LDL cholesterol concentrations, is a beneficial physiological effect. A claim on monacolin K from red yeast rice and maintenance of normal blood LDL-cholesterol concentrations has already been assessed with a favourable outcome at daily intakes of 10 mg monacolin K from any red yeast rice preparation (which would include SYLVAN BIO red yeast rice). The evidence provided by the applicant for the present application does not establish that monacolin K in SYLVAN BIO red yeast rice is different from monacolin K in other red yeast rice preparations with respect to its effect on blood LDL-cholesterol concentrations. [...]

Beneficial effects of pomegranate juice on oxidation-sensitive genes and endothelial nitric oxide synthase activity at sites of perturbed shear stress Proc Natl Acad Sci U S A. 2005 Mrch 29; 102(13): 4896-4901. Published on line 2005 March 21. doi: 10.1073/pnas.0500998102

The vascular endothelium is constantly subject to oxidative stress-induced hemodynamic forces. In the presence of other classic risk factors for the onset of atherosclerosis, this can lead to endothelium dysfunction and favor the process of atherogenesis. Clinical evidence has shown that the antioxidant polyphenols contained in pomegranate juice can help reduce oxidative stress and atherogenesis. The purpose of this study is to assess the effect that the polyphenols contained in pomegranate juice have on the genes responsible for the oxidation of the vascular endothelium. The clinical data collected during the in vitro and in vivo phases of this study show that these polyphenols promote a substantial improvement in circulatory flows that have been disrupted by oxidative stress [...]

Pomegranare Juice Improves Carotid Artery Health and lowers Blood Pressure in Patients with Carotid Artery Stenosis Herbal Gram. 2005;65:28-30 © American Botanical Council

The results of this study suggest that a regular intake of pomegranate juice brings noteworthy benefits to individuals with severe carotid artery stenosis. In addition to the juice’s antisclerotic properties, its antioxidant power contributes to reduce the lipoperoxidation of LDL in individuals with hypercholesterolemia, diabetes and cardiovascular disease. Another noteworthy effect that emerged during this study was a significant reduction in systolic pressure [...]

Pomegranate Juice May Affect the Progression of Coronary Heart Disease, New Study Shows Sumner MD, Elliott-Eller M, Weidner G, Daubenmier JJ, Chew MH, Marlin R, Raisin CJ, Ornish D. Effects of pomegranate juice consumption on mycardial perfusion in patients with coronary heart disease. Am J Cardiol. 2005 Sep 15;96(6):810-4.

A study published in the American Journal of Cardiology highlights the beneficial effects of pomegranate juice on a group of patients with coronary heart disease. After only three months of regular pomegranate juice intake, the patients show a significant improvement in blood circulation [...]

Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary supplement David Heber, lan Yip, Judith M Ashley, David A Elahoff and Vay Liang W Go

This study examined the effect that a preparation based on red yeast rice had on the cholesterol level of a group of Americans. The study was double-blind and included a control placebo group. It was conducted for 12 weeks at a university research center. The experimental results showed a significant decrease in total cholesterol, LDL and triglyceride levels in the active group, in contrast to the placebo group […]

Journal of Alternative and Complementary Medicine An Analysis of Nine Proprietary Chinese Red Yeast Rice Dietary Supplements: Implications of Variability in Chemical Profile and Contents Apr 2001, Vol. 7, No. 2 133-139 David Heber, MD, PhD, Audra Lembertas, PhD, Susan Bowerman, MS, RD UCLA Center for Human Nutrition, UCLA School of Medicine, Los Angeles, California.

Up to 10 different types of monacolins were found in certain types of red yeast rice. These compounds inhibit the production of cholesterol. The consumption of red yeast rice preparations helps to improve cholesterol levels and maintain them at healthy values, reducing the risk of heart disease in vulnerable individuals. Different preparations based on red yeast rice are commercially available, with variable concentrations of 10 types of monacolins. This study demonstrated that the preparations that can guarantee a significant and relevant reduction of cholesterol levels must contain certain standardized amounts and types of titrated monacolins [...]

A multi-center, self controlled study of red Yeast Rice in subjects with elevated cholesterol October 11, 1999 K.Bonovich, bel Air, MD; H Colfer, petokey, MI; M. Davidson, chicago, IL.

Different red yeast rice preparations were tested on 187 patients with moderately elevated levels of total cholesterol, and of LDL-cholesterol in particular. This clinical study shows that treatment with red yeast rice is well tolerated and leads to an effective reduction in the levels of total cholesterol, LDL-cholesterol and triglycerides, while helping to increase levels of HDL-cholesterol in patients with hyperlipidemia. [...]