Abstract
BackgroundProbiotics 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.MethodsA 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).ResultsTwelve-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.ConclusionsA 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 registrationNCT02689934.
Highlights
Probiotics incorporated into dairy products have been shown to reduce total (TC) and LDL cholesterolemia (LDL-C) in subjects with moderate hypercholesterolemia
TG, High-density lipoprotein cholesterol (HDL-C), body weight and Body mass index (BMI), waist circumference and blood pressure were within the reference range [23, 24]
low-density lipoprotein-cholesterol (LDL-C) was reduced by 45 mg/dL (p < 0.0001), corresponding to a − 25.7% reduction, total cholesterol (TC) decreased by 45 mg/dL (p < 0.0001), a − 16.7%, Apolipoprotein B (apoB) by 27 mg/dL (p = 0.003), corresponding to a − 17% decrease, and non-HDL-C by 45 mg/dL
Summary
Probiotics incorporated into dairy products have been shown to reduce total (TC) and LDL cholesterolemia (LDL-C) in subjects with moderate hypercholesterolemia. In addition to some subjects with severe hypercholesterolemia, mostly related to genetic conditions [2], the majority of subjects with low or medium CV risk show moderate cholesterol elevation, together with moderate rise of related biomarkers [1] This CV risk is often underdiagnosed and undertreated, representing a significant burden for the individual, especially in combination with unhealthy lifestyle habits [3]. Statins are well-known to be associated with important side-effects, such as muscle symptoms of different entity [5] and, to a lower extent, de novo diabetes mellitus development [6] indicating the need for additional drug and nutraceutical treatment options In all these conditions, nutraceutical approach may be a reasonable option, since in several instances a moderate-intensity (multi)treatment may offer relevant advantages over the no-treatment option or the presence of inadequate adherence to a drug therapy, due for example to adverse effects [7] or even as an add-on to low dose statins in secondary prevention patients intolerant to high dose statin [8]. Comparative studies between RYR and statins observed a smaller incidence of muscular side effects with the former treatment [12]
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