Nutraceutical alternatives to red yeast rice extract/monacolin K for moderate hypercholesterolaemia: Current evidence and knowledge gaps

The nutraceutical approach to moderate hypercholesterolaemia is an interesting option in the context of appropriate conditions associated with low cardiovascular risk, and red yeast rice (RYR) extract is one of the most utilized products in this field. Monacolin K, the RYR main active component, reduces serum LDL-C levels via inhibition of β-Hydroxy β-methylglutaryl-CoA reductase, similarly to statins. In 2011, EFSA approved the claim regarding monacolin K from RYR extract and maintenance of normal cholesterol levels. However, in 2018, EFSA issued a warning about potential adverse effects of this nutraceutical and, in 2022, the European Commission published a Regulation with several limitations of its use. Therefore, current research and development efforts are aiming at assessing efficacy and safety of other known and novel nutraceutical products which may benefit patients with moderate hypercholesterolaemia. These active agents range from phytosterols, probiotics and berberine to bergamot, cabbage, artichoke extracts and soy protein. Moreover, plant extracts from traditional medicine, for example from African countries, are also a subject of study in this field. The full clinical exploitation of many of them, however, still requires robust clinical evidence, which should be the objective of future research.