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.

Impact of Gut Microbiota and Microbiota-Related Metabolites on Hyperlipidemia

“…Consistent with animal experiments, probiotic supplementation also significantly reduces serum TC and LDL-C in patients with hyperlipidemia ( Sharma et al., 2016 ). A 12-week randomized, double-blind, placebo-controlled clinical trial has shown that the combination of three Lactobacillus plantarum strains can reduce blood cholesterol in patients ( Guerrero-Bonmatty et al., 2021 ). Additionally, a study involving 70 healthy adults has demonstrated that the daily supplementation of Lactobacillus plantarum Q180 can significantly improve blood-lipid indicators such as LDL-C and TC after meals by adjusting the composition of the intestinal flora ( Park et al., 2020 ).…”

The Effect of Probiotic Supplementation on Glucolipid Metabolism in Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis

“…Therefore, the effect of probiotic dose levels on glycaemic control in patients with T2DM requires confirmation in other studies. Guerrero-Bonmatty et al showed that the combination of monacolin K (a statin) and L. plantarum strains was more effective in reducing LDL-C and TC levels in the treatment of hypercholesterolemia [ 76 ]. Therefore, in the future, some studies concerning probiotics in combination with statins, versus probiotics alone, could be considered.…”

Distinct microbial taxa are associated with LDL-cholesterol reduction after 12 weeks of Lactobacillus plantarum intake in mild hypercholesterolemia

“…Placebo capsule contained 440 mg maltodextrin, 0.5 mg silicon dioxide and 95 mg capsule shell (hydroxypropyl cellulose, dyed with titanium dioxide). Manufacturing procedures of the Lactobacillus preparation have been described elsewhere [17]. The sample size was n = 42 per group calculated based on a previous study with hypercholesteremic patients [13], estimating a moderate effect size of 0.3, a signi cance level of 5% (two-sided) at a power of 80%.…”