After having described the regulatory process involving Monacolin K, we will now respond to the most frequently asked questions regarding Colesan’s revised formulation.

Because Naturando’s objective is to always be by your side, especially in these more complex situations.

What has changed in the Colesan formulation?

  • A reduction in the red yeast rice content: it was reduced from 200 mg per capsule to 50 mg per capsule. This reduction, considering that we recommend 1 capsule per day, allows us to comply with the new EU Regulation to be published soon, which calls for providing less than a total 3 mg of Monacolins.

The regulation also requires that the total amount of Monacolins be indicated on the label, which is why you will find differences in the ingredient table on boxes in the future. Below you will find an image of the new table. Please note that the restrictions apply to total Monacolins and not just Monacolin K.

  • Increased amount of Policosanols: increased from 5 mg to 20 mg per capsule

Why is the Monacolin K – Policosanols association important?

That Monacolin K is able to inhibit enzyme HMG-CoA reductase, which is involved in the cholesterol synthesis, has been well established by numerous scientific studies[1]; let’s have a look at the functions of policosanols instead.

Policosanols, natural substances derived from rice and wheat, also act on the enzyme HMG-CoA reductase, however, with a differently acting mechanism. Studies have shown that, with dosages of 20 mg/day, policosanols are able to inhibit transcription of the gene coding for this enzyme[2].

The association of Policosanols with Monacolin K results in a powerful synergistic action as the two substances act on the same target but with different mechanisms. But that’s not all! Scientific evidence shows that Policosanols decrease the sensitivity of LDL to oxidative changes[3]. It is precisely this (bad) LDL cholesterol which, when oxidised, forms deposits in blood vessels.

The additional advantage of the Monacolin K – Policosanol association is found in the dual action it exerts on both endogenous cholesterol production and LDL oxidation.

Does Colesan still work?

Yes, first of all, as we have just seen, increasing the dosage of Policosanols leads to an important synergistic action. Furthermore, various clinical studies demonstrate the effectiveness of Monacolin K even in lower concentrations (<3 mg)[4].

Please note that Naturando was one of the first herbal companies to test its first version of Colesan (which provided 3 mg of Monacolin K per day) in a clinical study.

May I continue to recommend Monacolin K confidently?

Absolutely, the Monacolin K contained in Red Yeast Rice is the nutraceutical approach par excellence for managing cholesterol levels, with a long history of usage. This Italian meta-analysis[5] is interesting which, after analysing 52 clinical studies, showed that dosages of Monacolin K between 3 and 12 mg/ per day were safe and not correlated with increased musculoskeletal problems.

A Coenzyme Q10 supplement can be taken to further reduce the possible risks associated with the use of Monacolin K,  Administering Monacolin K can in fact lead to a reduction in Coenzyme Q10 levels in the body, with consequences mainly on a muscular level. Our Colesan provides 10 mg of Coenzyme Q10 per day. We hope we have cleared up any doubts you may have in this article.

Under the supervision of Dr. Laura Rubini

[1] Endo A. Monacolin K, a new hypocholesterolemic agent that specifically inhibits 3-hydroxy-3-methylglutaryl coenzyme A reductase. J Antibiot (Tokyo). 1980
[2] Menéndez R, Amor AM, Rodeiro I, González RM, González PC, Alfonso JL, Más R. Policosanol modulates HMGCoA reductase activity in cultured fibroblasts. Arch Med Res. 2001
[3] Menéndez R, Más R, Amor AM, González RM, Fernández JC, Rodeiro I, Zayas M, Jiménez S. Effects of policosanol treatment on the susceptibility of low density lipoprotein (LDL) isolated from healthy volunteers to oxidative modification in vitro. Br J Clin Pharmacol. 2000
[4]Heinz T, Schuchardt JP, Möller K, Hadji P, Hahn A. Low daily dose of 3 mg monacolin K from RYR reduces the concentration of LDL-C in a randomized, placebo-controlled intervention. Nutr Res. 2016
[5] 6Fogacci F et al. Safety of red yeast rice supplementation: A systematic review and meta-analysis of randomized controlled trials. Pharmacol Res. 2019