What is monacolin K? What's new in the supplementation world
For years it was a valuable support for those who could not keep their cholesterol under control but did not need or want to take statins. Today, however, monacolin K can no longer be used as it has been in the past: in fact, the European Food Safety Authority (Efsa) decided that the dosages allowed in supplements were too high for a substance that behaves in all respects like a drug. That is why, from now on, dietary supplements will only be allowed to provide doses of less than 3 mg per day of total monacolines.
Cholesteroland Health Cholesterol
is an extremely important molecule for health; it is a key component of cell membranes and is the precursor of several substances that are essential for the proper functioning of the body-for example, steroid hormones (such as estrogen and cortisol), or vitamin D. Given its importance, it is not surprising that the liver is able to synthesize it. Unfortunately, however, excessively high cholesterol levels are a risk factor for cardiovascular disease. In particular, cholesterol encased within low-density lipoprotein (LDL) can be deposited in the artery wall, contributing toatherosclerosis and, therefore, to an increased risk of events such as strokes and heart attacks. To keep total and LDL cholesterol levels in the normal range, it is first necessary to act on one's diet. Contrary to what one might think, the foods to be consumed sparingly are not so much those containing cholesterol such and such, but those containing trans fats (such as some old margarines) and those rich in saturated fats.
The latter are particularly abundant in foods of animal origin, generally used as a source of protein, such as processed meats, milk and cheese. Replacing their consumption with that of protein sources that are leaner or lower in saturated fat (e.g., oily fish, a source of Omega 3 polyunsaturated fats) can help bring cholesterol back to normal. Sometimes, however, acting on diet is not enough. In these cases, it may be helpful to try the route of dietary supplements before turning to drugs.
What is Monacolin K?
Monacolin K is the most abundant of the monacolins obtained from the fermentation of rice with yeasts, specifically Monascus purpureus; this is why supplements containing it are often called " fermented red rice."
In China, this fermented red rice is traditionally used both as a food coloring and as a remedy against poor digestion and to promote good blood circulation. In the European Union, its use as a food coloring is not authorized; supplements containing it, however, have been marketed for decades.
Chemically, the form of monacolin K found in fermented red rice (lactone) is virtually identical to lovastatin, a molecule belonging to the group of drugs most widely used in the management of high cholesterol: statins. Given this high similarity, the success of monacolin K supplements against high cholesterol is not surprising. Until recently, Efsa itself authorized the use of the claim that " monacolin K from fermented red rice contributes to the maintenance of normal blood cholesterol values."
With a caveat: only products with a daily dosage of 10 mg of monacolin K could carry this statement, along with the clarification that to get the benefits of monacolin K, 10 mg per day must be taken. Unfortunately, however, the similarity between monacolin K and lovastatin is so high that it carries with it not only cholesterol-lowering effects but also undesirable ones. In fact, just like statins, monacolin K can also trigger side effects such as pain and muscle injury. What's more, the safety of the other monacolins found, along with monacolin K, in fermented red rice products has not yet been established.
Efsa's new opinion
As early as 2013, a scientific evaluation conducted by German authorities concluded that fermented red rice was not safe for food consumption. Then, in 2016, the Belgian Board of Health had pointed out the existence of subpopulations in whose case the use of monacolin K might have contraindications: pregnant women, people with liver, kidney, or muscle disorders, children, adolescents, and the elderly over the age of 70. This was compounded in 2018 by Efsa's scientific opinion on the safety of monacolins in fermented red rice, according to which taking fermented red rice supplements could lead to taking a dose of monacolin K equal to therapeutic dosages of lovastatin.
Concerns expressed by several parties about the risks associated with the free use of a substance identical to a drug has led experts to redraw the limits within which monacolin K and, more generally, monacolines can be used as ingredients in dietary supplements. Indeed, according to Efsa, concerns about possible adverse events are real; at risk are not only muscles but also connective tissue, liver, nervous system, gastrointestinal system, skin and subcutaneous tissue.
What's more, the Authority also reported serious adverse effects at monacolin k dosages of less than one-third of the 10 mg daily dosage previously reported as being able to promote the desired cholesterol reduction. Based on these observations and with the publication in the Official Journal of the European Union on June 2, 2022 of Commission Regulation (EU) 2022/860, monacolin K was added to thelist of substances whose use is permitted only under specific conditions.
The new regulations set the maximum daily intake of monacolin K and other monacolins that can be taken with supplements at less than 3 mg per day. As a result, the claim about the benefits of fermented red rice can no longer be used. Now, in addition to having to state "the number of individual doses of product for the maximum daily intake and a warning not to consume a daily amount of 3 mg or more of monacolins from fermented red rice" and the amount of monacolins "per dose of product," supplements with fermented red rice must state these warnings:
- It should not be consumed by pregnant or lactating women, children under the age of 18 and adults over the age of 70.
- Consult a physician about consuming this product if health problems occur.
- It should not be consumed if you are taking cholesterol-lowering medications.
- It should not be consumed if you already consume other products containing fermented red rice.
The solution: Cardiol® Forte New
The solution from U.G.A. Nutraceuticals is Cardiol® Forte New, the supplement designed to protect cardiometabolic health with a combination of:
- Omega 3 EPA and DHA of marine origin that support normal heart function with a daily intake of 250 mg;
- monacolins from fermented red rice, in doses less than 3 mg per capsule;
- Artichoke extract, supported by a clinical study, with effects on lipid profile and hepatoprotective activity;
- olive polyphenols to counteract oxidation that makes LDL cholesterol even more dangerous to cardiovascular health;
- coenzyme Q10 to counteract the deficiency often associated with reduced cholesterol synthesis-a possible cause of muscle problems associated with taking statins and monacolins.
Sources: Official Journal of the European Union. COMMISSION REGULATION (EU) 2022/860 of June1, 2022. MedlinePlus. Cholesterol. Last accessed: 30/06/22 NIH. National Center for Complementary and Integrative Health. Red Yeast Rice. Last accessed: 30/06/22 FarmaImpresa Group. EFSA opinion on safety of monacolin K in fermented red yeast rice published. Last accessed: 30/06/22. [Author sc2].
