Abstract
Background: Dietary supplements have been proposed to help manage blood cholesterol, including red yeast rice (RYR) extracts, plant sterols and stanols, beta-glucans, and some probiotics. This study was conducted to evaluate the efficacy of RYR (containing 10 mg of monacolin K) combined with 109 CFU of three Lactoplantibacillus plantarum strains (CECT7527, CECT7528, and CECT7529). Methods: A 12-week randomized, double-blinded, placebo-controlled clinical trial was conducted. In total, 39 adult patients were enrolled, having total cholesterol (TC) ≥200 mg/dL, and being statin-naïve or having recently stopped statin treatment because of intolerance. Active product or placebo were taken once daily, and subjects were evaluated at baseline, 6, and 12 weeks. Results: Study groups were comparable at baseline, except for history of recent hypercholesterolemia treatment (81% in active vs. 22% in placebo). Changes in LDL cholesterol and TC became significant compared to placebo (mean difference between groups and standard error of the mean = 23.6 ± 1.5 mg/dL, p = 0.023 and 31.4 ± 1.9 mg/dL, p = 0.011, respectively) upon adjusting for the baseline imbalance in hypercholesterolemia treatment. No adverse effects were noted during the study. Conclusion: This combination of 10 mg of monacolin K and L. plantarum strains was well tolerated and achieved a statistically significant greater reduction in LDL-C and TC in the intervention group compared to the placebo, once adjusting for recent history of hypercholesterolemia treatment.
Highlights
Cardiovascular diseases (CVDs) are the number one cause of death globally, representing 31% of all global deaths [1]
Compelling evidence shows that elevated low-density lipoprotein cholesterol (LDL-C) level is a major modifiable risk factor for CVD [3], making LDL-C a major target for risk reduction [4,5]
Statins are the mainstay of atherosclerosis treatment with a reduction in cardiovascular risk, CVD, and mortality, with a risk–benefit profile that appears to differ according to statin type, age, and gender [7]
Summary
Cardiovascular diseases (CVDs) are the number one cause of death globally, representing 31% of all global deaths [1]. Compelling evidence shows that elevated low-density lipoprotein cholesterol (LDL-C) level is a major modifiable risk factor for CVD [3], making LDL-C a major target for risk reduction [4,5]. Statins are the mainstay of atherosclerosis treatment with a reduction in cardiovascular risk, CVD, and mortality, with a risk–benefit profile that appears to differ according to statin type, age, and gender [7]. In this line, concerns have been raised regarding statin-related adverse effects, such as statin-associated muscle symptoms (SAMSs), reported in 5% to. This study was conducted to evaluate the efficacy of RYR (containing 10 mg of monacolin K) combined with 109 CFU of three Lactoplantibacillus plantarum strains (CECT7527, CECT7528, and CECT7529)
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