Nutraceutical approach for the management of cardiovascular risk - a combination containing the probiotic Bifidobacterium longum BB536 and red yeast rice extract: results from a randomized, double-blind, placebo-controlled study

Massimiliano Ruscica, Chiara Pavanello, Sara Gandini, Chiara Macchi, Margherita Botta, Daria Dall'Orto, Marina Del Puppo, Marco Bertolotti, Raffaella Bosisio, Giuliana Mombelli, Cesare R Sirtori, Laura Calabresi, Paolo Magni, Massimiliano Ruscica, Chiara Pavanello, Sara Gandini, Chiara Macchi, Margherita Botta, Daria Dall'Orto, Marina Del Puppo, Marco Bertolotti, Raffaella Bosisio, Giuliana Mombelli, Cesare R Sirtori, Laura Calabresi, Paolo Magni

Abstract

Background: Probiotics incorporated into dairy products have been shown to reduce total (TC) and LDL cholesterolemia (LDL-C) in subjects with moderate hypercholesterolemia. More specifically, probiotics with high biliary salt hydrolase activity, e.g. Bifidobacterium longum BB536, may decrease TC and LDL-C by lowering intestinal cholesterol reabsorption and, combined with other nutraceuticals, may be useful to manage hypercholesterolemia in subjects with low cardiovascular (CV) risk. This study was conducted to evaluate the efficacy and safety of a nutraceutical combination containing Bifidobacterium longum BB536, red yeast rice (RYR) extract (10 mg/day monacolin K), niacin, coenzyme Q10 (Lactoflorene Colesterolo®). The end-points were changes of lipid CV risk markers (LDL-C, TC, non-HDL-cholesterol (HDL-C), triglycerides (TG), apolipoprotein B (ApoB), HDL-C, apolipoprotein AI (ApoAI), lipoprotein(a) (Lp(a), proprotein convertase subtilisin/kexin type 9 (PCSK9)), and of markers of cholesterol synthesis/absorption.

Methods: A 12-week randomized, parallel, double-blind, placebo-controlled study. Thirty-three subjects (18-70 years) in primary CV prevention and low CV risk (SCORE: 0-1% in 24 and 2-4% in 9 subjects; LDL-C: 130-200 mg/dL) were randomly allocated to either nutraceutical (N = 16) or placebo (N = 17).

Results: Twelve-week treatment with the nutraceutical combination, compared to placebo, significantly reduced TC (- 16.7%), LDL-C (- 25.7%), non-HDL-C (- 24%) (all p < 0.0001), apoB (- 17%, p = 0.003). TG, HDL-C, apoAI, Lp(a), PCSK9 were unchanged. Lathosterol:TC ratio was significantly reduced by the nutraceutical combination, while campesterol:TC ratio and sitosterol:TC ratio did not change, suggesting reduction of synthesis without increased absorption of cholesterol. No adverse effects and a 97% compliance were observed.

Conclusions: A 12-week treatment with a nutraceutical combination containing the probiotic Bifidobacterium longum BB536 and RYR extract significantly improved the atherogenic lipid profile and was well tolerated by low CV risk subjects.

Trial registration: NCT02689934 .

Keywords: Cardiovascular risk; Hypercholesterolemia; LDL-cholesterol; Monacolin K; Non-HDL cholesterol; Nutraceutical; Probiotic.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Ethics Committee of ASST Grande Ospedale Metropolitano Niguarda. A written informed consent was obtained from each subject.

Consent for publication

All the authors have read and approved the manuscript.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
CONSORT statement flow diagram

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