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

Abstract

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).

Influence of Altitude on Phytochemical Composition of Hemp Inflorescence: A Metabolomic Approach

“…This compound has not been reported for any variety of hemp so far. Furthermore, it belongs to the class of polymethoxyflavones that have anti-inflammatory and anti-carcinogenic activities and occur as "novel nutraceutical compounds" [36]. In order to perform its absolute identification, it is necessary to isolate it from the inflorescence and define it with a more detailed analytical approach, also including NMR analysis.…”

Effects of a Novel Nutraceutical Combination (Aquilea Colesterol®) on the Lipid Profile and Inflammatory Biomarkers: A Randomized Control Trial

“…With mean reductions of 13.9% and 19.7%, respectively, the cholesterol-lowering efficacy of the nutraceutical tested in the current trial compares favorably with the results of this meta-analysis, probably because of a higher dose of monacolin K in Aquilea Colesterol ® compared with that nutraceutical. A 15.6% LDL-c reduction was observed in a recent clinical trial of a novel nutraceutical also containing 3 mg monacolin K plus various antioxidants [40]. In this trial hs-CRP was not lowered, but LDL oxidation was reduced and endothelial function improved, pointing to an added cardiovascular benefit of such nutraceutical combinations.…”

Ticagrelor Increases SIRT1 and HES1 mRNA Levels in Peripheral Blood Cells from Patients with Stable Coronary Artery Disease and Chronic Obstructive Pulmonary Disease

“…We have shown that the levels of apoptosis in HUVECs treated with serum from stable and acute CAD patients reflect the gravity of the disease [53,54]. Furthermore, we have reported that this assay can reliably detect a reduction in apoptosis in HUVECs treated with serum from stable CAD/COPD patients following treatment with ticagrelor [6] or from subjects with hypercholesterolemia and low-moderate cardiovascular risk, following eight weeks consumption of a red yeast rice, polymethoxyflavones, and antioxidants containing nutraceutical supplement [55]. In another study by our group, this approach was used, in parallel with measurements of changes in brachial wall shear stress and flow mediated dilation, to assess ED in patients that underwent surgical or transcatheter aortic valve replacement [56].…”