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Clinical Trials

  • Scientific Opinion on the Substantiation of a Health Claim Related to Sylvan Bio Red Yeast Rice and Maintenance of Normal Blood LDL-Cholesterol Concentrations

    Following an application from Sylvan Bio Europe BV, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the Panel on Dietetic Products, Nutrition and Allergies (NDA) 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.

    EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Scientific Opinion on the substantiation of a health claim related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL-cholesterol 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. Available

  • Lifestyle Changes and Supplements

    The goal of this study was to compare the lipid-lowering effects of an alternative regimen (lifestyle changes, red yeast rice, and fish oil) with a standard dose of a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin). The randomized, controlled study concluded that lifestyle changes combined with ingestion of Red Yeast Rice and fish oil is a promising alternative approach to the standard therapy of Simvastatin.

    There was a statistically significant reduction in LDL-C levels in both the AG (-42.4%±15%) (P<.001) and the simvastatin group (-39.6%±20%) (P<.001). No significant differences were noted between groups. The AG also demonstrated significant reductions in triglycerides (-29% vs -9.3%; 95% confidence interval, -61 to -11.7; P=.003) and weight (-5.5% vs -0.4%; 95% confidence interval, -5.5 to -3.4; P<.001) compared with the simvastatin group.

    David J. Becker, Ram Y. Gordon, Patti B. Morris, Jacqueline Yorko, Y. Jerold Gordon, Mingyao Li, Nayyar Iqbal. Simvastatin vs Therapeutic Lifestyle Changes and Supplements: Randomized Primary Prevention Trial.

    Mayo Clinic Proceedings - July 2008 (Vol. 83, Issue 7, Pages 758-764, DOI: 10.4065/83.7.758)

  • Red Yeast Rice and Cholesterol Levels, Inflammatory Markers: Italian Study

    A daily dose of red yeast rice safely reduces elevated cholesterol levels, decreases a marker of inflammation, and lowers markers of vascular remodeling, says a study from Italy that further supports the safety and efficacy of the supplement.

    Nutrition Research 2013 Aug;33(8):622-8. doi: 10.1016/j.nutres.2013.05.015. Epub 2013 Jul

    NutraIngredients USA:

  • Can Red Yeast Rice Lower Cholesterol?

    According to, a recent study supports previous research that suggests red yeast rice may lower cholesterol.

    Red yeast rice is the product of yeast (Monascus purpureus) grown on rice. A staple in some Asian countries, it contains substances known as monacolins, which inhibit the accumulation of cholesterol. In fact, monacolin K is also known as mevinolin or lovastatin--generic for Mevacor, a drug produced by Merck and Company, Inc.,

    Studies of red yeast rice's cholesterol-lowering properties date back to the 1970s. Red yeast rice has been shown to lower total cholesterol, low-density lipoprotein (also called LDL or "bad cholesterol"), and triglycerides. Products containing red yeast rice extract are available for purchase, but these products may not be standardized and the effects may not be predictable. Quality is important, and it is recommended that a healthcare provider be consulted before using red yeast rice.

    In the study, researchers randomly assigned 52 physicians and their spouses with high cholesterol to either take red yeast rice extract or a placebo for eight weeks.

    Natural Standard:

  • Renewed Support for Red Yeast Rice

    A study in the American Heart Journal reinforces that red yeast rice, a popular supplement, along with lifestyle changes, can help lower weight and LDL cholesterol.

    While statins like Lipitor and Zocor are better at treating high levels of low-density lipoprotein (LDL), or bad cholesterol, many patients can't tolerate or refuse the drugs due to side effects or cost. This has led to an explosion in the use of over-the-counter alternatives like red yeast rice and phytosterols, another plant-based supplement.

    American Heart Journal: 2013 Jul;166(1):187-96. doi: 10.1016/j.ahj.2013.03.019. Epub 2013 Apr 30.

    Philadelphia Inquirer:

  • Supplement May Be an Alternative for Maintaining Healthy Cholesterol

    A statin can be a lifesaver if you're at risk of heart disease, but some people who take the cholesterol-lowering drugs -- up to 20%, by some estimates -- have to stop because of muscle pain, the most common side effect. (Nearly 30 million people filled a statin prescription in 2005, according to the Agency for Healthcare Research and Quality. Statins include popular drugs such as Crestor, Lipitor, and Zocor).

    Now a new study suggests that an over-the-counter dietary supplement sold at pharmacies and health-food stores may be a workable alternative for people who have statin-related muscle pain. It seems that when combined with diet and lifestyle changes, red yeast rice supplements can lower LDL, or bad cholesterol, levels by more than 20 percent without a substantial risk of muscle pain (also known as myalgia), according to a study published in the Annals of Internal Medicine.


  • Tolerability of Red Yeast Rice in Patients With Previous Statin Intolerance

    Currently, no consensus has been reached regarding the management of hyperlipidemia in patients who develop statin-associated myalgia (SAM). Many statin-intolerant patients use alternative lipid-lowering therapies, including red yeast rice. The present trial evaluated the tolerability of red yeast rice versus pravastatin in patients unable to tolerate other statins because of myalgia. The study was conducted in a community-based setting in Philadelphia, Pennsylvania. A total of 43 adults with dyslipidemia and a history of statin discontinuation because of myalgia were randomly assigned to red yeast rice 2,400 mg twice daily or pravastatin 20 mg twice daily for 12 weeks.

    All subjects were concomitantly enrolled in a 12-week therapeutic lifestyle change program. The primary outcomes included the incidence of treatment discontinuation because of myalgia and a daily pain severity score. The secondary outcomes were muscle strength and plasma lipids. The incidence of withdrawal from medication owing to myalgia was 5% (1 of 21) in the red yeast rice group and 9% (2 of 22) in the pravastatin group (p = 0.99). The mean pain severity did not differ significantly between the 2 groups. No difference was found in muscle strength between the 2 groups at week 4 (p = 0.61), week 8 (p = 0.81), or week 12 (p = 0.82). The low-density lipoprotein cholesterol level decreased 30% in the red yeast rice group and 27% in the pravastatin group. In conclusion, red yeast rice was tolerated as well as pravastatin and achieved a comparable reduction of low-density lipoprotein cholesterol in a population previously intolerant to statins.

    American Journal of Cardiology: 15 January 2010 (Vol. 105, Issue 2, Pages 198-204, DOI: 10.1016/j.amjcard.2009.08.672).

  • Red Yeast Rice and Dyslipidemia

    A randomized, controlled trial through a community based cardiology practice found that Red Yeast Rice and therapeutic lifestyle change decrease LDL cholesterol level without increasing CPK or pain levels and may be a treatment option for dyslipidemic patients who cannot tolerate statin therapy. Below are the results and a link to the original article.

    In the red yeast rice group, LDL cholesterol decreased by 1.11 mmol/L (43 mg/dL) from baseline at week 12 and by 0.90 mmol/L (35 mg/dL) at week 24. In the placebo group, LDL cholesterol decreased by 0.28 mmol/L (11 mg/dL) at week 12 and by 0.39 mmol/L (15 mg/dL) at week 24. Low-density lipoprotein cholesterol level was significantly lower in the red yeast rice group than in the placebo group at both weeks 12 (PÂ &lt; 0.001) and 24 (PÂ = 0.011). Significant treatment effects were also observed for total cholesterol level at weeks 12 (PÂ &lt; 0.001) and 24 (PÂ = 0.016). Levels of HDL cholesterol, triglyceride, liver enzyme, or CPK; weight loss; and pain severity scores did not significantly differ between groups at either week 12 or week 24.

    Annals of Internal Medicine. 2009 Jun;150(12):830-839.

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