Effect of Monacolin K and COQ10 supplementation in hypertensive and hypercholesterolemic subjects with metabolic syndrome

Mazza, Alberto; Lenti, Salvatore; Schiavon, Laura; Giacomo, Ezio Di; Tomasi, Monica; Manunta, Roberto; Torin, Gioia; Townsend, Danyelle M.; Rubello, Domenico

doi:10.1016/j.biopha.2018.06.076

Cited by 27 publications

(16 citation statements)

References 36 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Several RYR-based supplements are available on the market, some contain only RYR, whereas other products contain additional ingredients [8] such as policosanol [9], berberine [9][10][11], co-enzyme Q 10 (CoQ 10 ) [12][13][14].…”

Section: Introductionmentioning

confidence: 99%

Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia

et al. 2021

View full text Add to dashboard Cite

IntroductionIn the absence of a European standardized postmarketing food supplement surveillance system (nutrivigilance), some member states and companies have developed their own approaches to monitoring potential adverse reactions to secure a high level of product safety. This paper describes the use of a nutrivigilance system in monitoring the incidence of spontaneously reported suspected adverse reactions associated with food supplements containing red yeast rice (RYR).Material and methodsWe report the data from a widely used product marketed under the trademark Armolipid/Armolipid Plus. Postmarketing information was collected in a voluntary nutrivigilance system established by the manufacturing company (Meda Pharma SpA, a Viatris Company, Monza, Italy). From 1st October 2004 to 31st December 2019, this system captured cases of suspected adverse reactions spontaneously reported by consumers, healthcare professionals, health authorities, regardless of causality.ResultsThe total number of case reports received mentioning the RYR food supplement product line was 542, in which 855 adverse events (AEs) were reported. The total reporting rate of AEs was estimated to be 0.037% of 2,287,449 exposed consumers. Of the 542 cases, 21 (0.0009% of exposed consumers) included suspected serious adverse events (SAEs). After careful investigation, 6 cases (0.0003% of consumers exposed) and 6 AEs were assessed by the manufacturer as serious and potentially related to exposure to the above-mentioned RYR-based nutraceutical.ConclusionsThis nutrivigilance-derived data analysis clearly demonstrates a low prevalence of suspected adverse events associated with the red yeast rice product line. Consumer safety of food supplements could be generally improved by raising awareness of the importance of following the indications and warnings detailed in a food supplement’s labeling.

show abstract

Section: Introductionmentioning

confidence: 99%

Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia

et al. 2021

View full text Add to dashboard Cite

show abstract

“…Fifth, subgroups analysis shows that subjects with metabolic syndrome had a lower reduction of LDL compared to subject without the syndrome, even though the difference is not significant. Many NC have been tested with success in subjects with metabolic syndrome, but we are not aware of studies of comparison between these groups ( Ruscica et al, 2014 ; Verhoeven et al, 2015 ; Mazza et al, 2018 ). This finding is confirmed by a significant lower response to NC in subjects with abnormal WHR, an index of abdominal adiposity associated with metabolic abnormalities and increased CV risk ( Emdin et al, 2017 ).…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of a Novel Nutraceutical Compound Containing Red Yeast Rice, Polymethoxyflavones and Antioxidants in the Modulation of Cholesterol Levels in Subjects With Hypercholesterolemia and Low-Moderate Cardiovascular Risk: The NIRVANA Study

et al. 2019

View full text Add to dashboard Cite

Background: Red yeast rice supplements are broadly accepted as treatment for dyslipidaemia in subjects without high cardiovascular (CV) risk. Their effect on lipid profile is well known, but few data are available on their effect on endothelial function.Objectives: To study the effect of a novel nutraceutical compound (NC) containing low monacolin K dose, polymethoxyflavones and antioxidants on lipid profile, endothelial function and oxidative stress.Methods: Fifty-two subjects with low-moderate CV risk and dyslipidaemia (according to European guidelines) were enrolled and treated for 8 weeks with the NC. Blood samples were collected at baseline and at the end of treatment to assess changes in lipid profile, endothelial function and oxidative stress. The primary endpoint was the reduction of low density lipoprotein (LDL) cholesterol. Endothelial function was assessed through measurement of rate of apoptosis and nitric oxide (NO) production in human umbilical vein endothelial cells (HUVECs) treated with subject’s serum. High-sensitivity C-reactive protein, 4-hydroxynonenal (HNE) and oxidized LDL (oxLDL) were markers of oxidative stress.Results: Fifty subjects completed the study. The treatment caused a significant decrease in LDL (−15.6%, p < 0.001), oxLDL (−21.5%, p < 0.001), total cholesterol (TC), triglycerides, and ApoB. Apoptosis rate of HUVECs significantly decreased (−15.9%, p < 0.001). No changes were noted for NO levels and 4-HNE protein adducts. The reduction of the apoptosis rate was correlated to the reduction of oxLDL.Conclusion: An 8-week treatment based on a novel NC containing low manocolin K dose, polymethoxyflavones and antioxidants improved lipid profile in subjects with dyslipidaemia and low-moderate CV risk. Secondarily, we observed an improvement in surrogate markers of endothelial function that may result from the reduction of oxLDL (Registered at www.clinicaltrials.gov, NCT03216811).

show abstract

“…An efficient and better tolerance in hypercholesterolemic patients was seen when FRMR was combined with other bioactive compounds. For instance, combining FRMR with guggulipid extract, chromium picolinate, berberine, and coenzyme Q 10 showed a better tolerance and efficiency (Yang and Mousa, 2012;Di Pierro et al, 2016;Cicero et al, 2017;D'Addato et al, 2017;Stefanutti et al, 2017;Mazza et al, 2018;Formisano et al, 2019;Wang et al, 2019;Iskandar et al, 2020).…”

Section: Functions Of Frmrmentioning

confidence: 99%

Perspectives on Functional Red Mold Rice: Functional Ingredients, Production, and Application

Feng

2020

Front. Microbiol.

View full text Add to dashboard Cite

Monacolin K (MK) is a secondary metabolite of the Monascus species that can inhibit cholesterol synthesis. Functional red mold rice (FRMR) is the fermentation product of Monascus spp., which is rich in MK. FRMR is usually employed to regulate serum cholesterol, especially for hypercholesterolemic patients who refuse statins or face statin intolerance. The present perspective summarized the bioactive components of FRMR and their functions. Subsequently, efficient strategies for FRMR production, future challenges of FRMR application, and possible directions were proposed. This perspective helps to understand the present situation and developmental prospects of FRMR.

show abstract

Effect of Monacolin K and COQ10 supplementation in hypertensive and hypercholesterolemic subjects with metabolic syndrome

Abstract: In patients with MetS, NC supplementation was safe, well tolerated and effective in improving clinic BP, lipid and glucose profile.

Cited by 27 publications

References 36 publications

Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia

Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia

Effectiveness of a Novel Nutraceutical Compound Containing Red Yeast Rice, Polymethoxyflavones and Antioxidants in the Modulation of Cholesterol Levels in Subjects With Hypercholesterolemia and Low-Moderate Cardiovascular Risk: The NIRVANA Study

Perspectives on Functional Red Mold Rice: Functional Ingredients, Production, and Application

Contact Info

Product

Resources

About