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

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 hydrolaseactivity, e.g.Bifidobacterium longumBB536, may decrease TC and LDL-C by lowering intestinal cholesterol reabsorptionand, combined with other nutraceuticals, may be useful to manage hypercholesterolemia in subjects with lowcardiovascular (CV) risk. This study was conducted to evaluate the efficacy and safety of a nutraceutical combinationcontainingBifidobacterium longumBB536, 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 convertasesubtilisin/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) inprimary CV prevention and low CV risk (SCORE: 0–1% in 24 and 2–4% in 9 subjects; LDL-C: 130–200 mg/dL) wererandomly 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%) (allp< 0.0001), apoB (−17%,p= 0.003). TG, HDL-C, apoAI, Lp(a), PCSK9were unchanged. Lathosterol:TC ratio wassignificantly reduced by the nutraceutical combination, while campesterol:TCratio and sitosterol:TC ratio did not change, suggesting reduction of synthesis without increased absorption of cholesterol.Noadverseeffectsanda97%compliancewereobserved. Conclusions:A 12-week treatment with a nutraceutical combination containing the probiotic Bifidobacterium longum BB536 and RYR extract significantly improved the atherogeniclipid profile and was well tolerated by low CV risk subjects.Trial registration:NCT02689934.