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).
Highlights
Dyslipidaemia represents an important CV risk factor
Inclusion criteria were: (i) age > 18 years; (ii) ability to provide informed written consent; (iii) low-moderate CV risk according to systemic coronary risk estimation (SCORE) (Piepoli et al, 2016), plus one of the following criteria: low-density lipoprotein cholesterol (LDL) > 190 mg/dl if SCORE < 1% or LDL > 100 mg/dl if SCORE 1–4% (Catapano et al, 2016)
We demonstrated that a nutraceutical compound (NC) with monacolin K, beside the reduction of LDL, improves endothelial function assessed in vitro as a reduction of the rate of apoptosis in human umbilical vein endothelial cells (HUVECs) incubated with serum from treated subjects, a methodology that was previously validated and related to clinical outcomes (Agnoletti et al, 1999; Valgimigli et al, 2003; Campo et al, 2017; Pavasini et al, 2017)
Summary
Dyslipidaemia represents an important CV risk factor. Reduction of low-density lipoprotein cholesterol (LDL) leads to a reduction of major adverse cardiovascular events (MACE), independently of the drug used (Silverman et al, 2016).In primary prevention, according to international guidelines, a healthy lifestyle represents the first approach to dyslipidaemia, in case of unsuccess, drugs are needed. Beside monacolin K, NC contain other molecules (e.g., berberin, policosanols, plant sterols, vitamins, and antioxidants) in various concentrations and compositions. These cofactors have lipidlowering activities that are in synergy with monacolin K action, and the effectiveness of the compounds is generally assessed in term of LDL reduction. 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
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