A Combination of Lactoplantibacillus plantarum Strains CECT7527, CECT7528, and CECT7529 Plus Monacolin K Reduces Blood Cholesterol: Results from a Randomized, Double-Blind, Placebo-Controlled Study

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.

Keywords: LDL-cholesterol; Lactoplantibacillus plantarum; bile-salt hydrolases; monacolin K; probiotic bacteria; statins.

Figure 1

CONSORT flowchart of recruited patients.

Figure 2

Mean blood levels of LDL-C (a) and TC (b) in the placebo (dashed line) and active (continuous line) groups, adjusted for history of recent hypercholesterolemia treatment. Error bars indicate standard errors of the adjusted means. In repeated measures general linear model analysis (GLM), the effect of treatment was statistically significant both in LDL-C (p = 0.023) and TC (p = 0.011), as well as the effect of history of recent hypercholesterolemia treatment (p < 0.001 for both).