Does EFSA statement on Monacolin content of nutraceutical combinations impair their lipid lowering effect? The LopiGLIK experience.

Clinical Diabetes and Endocrinology Pub Date : 2024-11-30 DOI:10.1186/s40842-024-00204-6

Alessia Izzo, Rosa Costanzo, Lucia De Martino, Salvatore Di Napoli

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Abstract

Background: Monacolin-K, the active component of red yeast rice (RYR), reduces cholesterol by inhibiting HMG-CoA reductase. Following safety concerns, the European Food Safety Authority (EFSA) recommended limiting Monacolin-K intake to less than 3 mg/day due to adverse effects at higher doses.

Case presentation: A study comparing Armolipid Plus^® and LopiGLIK^® found LopiGLIK^® more effective in lowering LDL cholesterol, possibly due to slightly higher dosages of Berberine and Monacolin-K. Despite reducing Monacolin-K content to 2.99 mg following EFSA guidelines, LopiGLIK^® maintained its cholesterol-lowering efficacy.

Conclusions: Taken together, our results indicate that other ingredients, such as Morus alba, may contribute to LopiGLIK^®'s enhanced effectiveness, challenging the notion that minor differences in Monacolin-K dosage account for the observed efficacy.

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欧洲食品安全局对营养保健品组合莫纳可林含量的声明是否会损害其降脂效果？LopiGLIK体验。

背景：红曲米（RYR）的活性成分Monacolin-K通过抑制HMG-CoA还原酶来降低胆固醇。出于安全考虑，欧洲食品安全局（EFSA）建议将Monacolin-K的摄入量限制在每天3毫克以下，因为高剂量会产生副作用。案例介绍：一项比较Armolipid Plus®和LopiGLIK®的研究发现，LopiGLIK®在降低LDL胆固醇方面更有效，可能是由于小檗碱和Monacolin-K的剂量略高。尽管按照EFSA的指导方针将Monacolin-K含量降低到2.99 mg， LopiGLIK仍保持其降胆固醇的功效。结论：综上所述，我们的研究结果表明，其他成分，如桑叶，可能有助于LopiGLIK®的有效性增强，挑战了Monacolin-K剂量的微小差异导致观察到的疗效的概念。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Diabetes and Endocrinology

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审稿时长

8 weeks

期刊介绍： Clinical Diabetes and Endocrinology is an open access journal publishing within the field of diabetes and endocrine disease. The journal aims to provide a widely available resource for people working within the field of diabetes and endocrinology, in order to improve the care of people affected by these conditions. The audience includes, but is not limited to, physicians, researchers, nurses, nutritionists, pharmacists, podiatrists, psychologists, epidemiologists, exercise physiologists and health care researchers. Research articles include patient-based research (clinical trials, clinical studies, and others), translational research (translation of basic science to clinical practice, translation of clinical practice to policy and others), as well as epidemiology and health care research. Clinical articles include case reports, case seminars, consensus statements, clinical practice guidelines and evidence-based medicine. Only articles considered to contribute new knowledge to the field will be considered for publication.