Abstract

Red yeast rice (RYR), produced by the fermentation of the Monascus purpureus mold, has been used for a long time in Asian cuisine and traditional medicine. It consists of multiple bioactive substances, including monacolins, which potentially can be used as a nutraceutical. Monacolin K, which is chemically identical to lovastatin, has been recognized as responsible for the cholesterol-reducing effect of this compound. While the European Food Safety Authority maintains that the use of monacolin K from RYR preparations of at least 10 mg can produce a normal blood cholesterol level, the United States Food and Drug Administration considers monacolin K, due to its similarity with lovastatin, an unapproved drug, and therefore marketing of products that label the monacolin content is prohibited. This mini-review summarizes the benefit of RYR in hyperlipidemia, maintains RYR use as a food, and addresses the importance of regulation regarding RYR and the need for clinical data and clear label information for consumers with reference to a toxin-free, non-augmented, standardized amount of monacolins.

Highlights

  • Boca Raton Hospital Campus, Internal Medicine Residency Program, FAU/ Schmidt School of Medicine, Department of Pharmacy, University of Napoli Federico II, Via D

  • At least 13 monacolins have been isolated from Red yeast rice (RYR), of which monacolin K is chemically similar to lovastatin, a cholesterol-lowering drug [6]

  • A recent meta-analysis in 2015 examined 20 randomized trials consisting of 6663 patients and showed a reduction in low density lipoprotein (LDL) cholesterol when comparing RYR to placebo groups

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Summary

Introduction

Attention should be paid to potential risk factors related to the use of vegetal- or animal-origin foodstuffs as starting matrices to constitute a nutraceutical, e.g., the safety of the starting material, the presence of allergenic compounds, the absence of toxicity, the absence of exogenous and endogenous contaminants, the possible presence of toxic secondary metabolites and/or environmental pollutants, which could potentially cause a health threat [2,3]. At least 13 monacolins have been isolated from RYR, of which monacolin K is chemically similar to lovastatin, a cholesterol-lowering drug [6]. A recent meta-analysis in 2015 examined 20 randomized trials consisting of 6663 patients and showed a reduction in low density lipoprotein (LDL) cholesterol when comparing RYR to placebo groups

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