Abstract
Background/Objectives:
The percentage of hypercholesterolemic individuals not reaching their LDL-cholesterol (LDL-C) goal remains high and additional therapeutic strategies should be evaluated. The objective of this study was to evaluate the cholesterol-lowering efficacy and mechanism of action of bile salt hydrolase-active Lactobacillus reuteri NCIMB 30242 capsules in hypercholesterolemic adults.
Subjects/Methods:
A total of 127 subjects completed a randomized, double-blind, placebo-controlled, parallel-arm, multicenter study. Subjects were randomized to consume L. reuteri NCIMB 30242 capsules or placebo capsules over a 9-week intervention period. The primary outcome was LDL-C relative to placebo at the study end point.
Results:
L. reuteri NCIMB 30242 capsules reduced LDL-C by 11.64% (P<0.001), total cholesterol by 9.14%, (P<0.001), non-HDL-cholesterol (non-HDL-C) by 11.30% (P<0.001) and apoB-100 by 8.41% (P=0.002) relative to placebo. The ratios of LDL-C/HDL-cholesterol (HDL-C) and apoB-100/apoA-1 were reduced by 13.39% (P=0.006) and 9.00% (P=0.026), respectively, relative to placebo. Triglycerides and HDL-C were unchanged. High-sensitivity C-reactive protein and fibrinogen were reduced by 1.05 mg/l (P=0.005) and 14.25% (P=0.004) relative to placebo, respectively. Mean plasma deconjugated bile acids were increased by 1.00 nmol/l (P=0.025) relative to placebo, whereas plasma campesterol, sitosterol and stigmasterol were decreased by 41.5%, 34.2% and 40.7%, respectively.
Conclusions:
The present results suggest that the deconjugation of intraluminal bile acids results in reduced absorption of non-cholesterol sterols and indicate that L. reuteri NCIMB 30242 capsules may be useful as an adjunctive therapy for treating hypercholesterolemia.
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Acknowledgements
We thank J Lahovský, V Voštiňáková, M Svobodová and K Beber for their contribution to the study. We also thank all volunteers who participated in the study. This work was supported by Micropharma Limited. MLJ, SP and CJM designed the study and prepared the manuscript. JL, VV and MS conducted the research. KB and CJM performed the statistical analysis. All authors have read and approved the final manuscript.
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MLJ and SP acknowledge a conflict of interest as they are cofounders and shareholders of Micropharma. CJM is employed by and is a shareholder of Micropharma.
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Jones, M., Martoni, C. & Prakash, S. Cholesterol lowering and inhibition of sterol absorption by Lactobacillus reuteri NCIMB 30242: a randomized controlled trial. Eur J Clin Nutr 66, 1234–1241 (2012). https://doi.org/10.1038/ejcn.2012.126
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DOI: https://doi.org/10.1038/ejcn.2012.126
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