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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.
Ruscica, M, Pavanello, C, Gandini, S, Macchi, C, Botta, M, Dall'Orto, D, Del Puppo, M, Bertolotti, M, Bosisio, R, Mombelli, G, et al
Nutrition journal. 2019;18(1):13
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Probiotics have been shown to reduce total cholesterol (TC) and low-density lipoprotein (LDL-C – often called ‘bad’ cholesterol) in people with moderately raised cholesterol levels. A specific strain of probiotic called Bifidobacterium longum BB536, may decrease TC and LDL-C by reducing the reabsorption of cholesterol from the intestine, and, combined with other natural supplements, may be useful to manage high cholesterol in people at low risk of heart disease. This study was conducted to evaluate the effect of a nutraceutical (Lactoflorene Colesterolo®), containing Bifidobacterium longum BB536 (1bn CFUs) combined with red yeast rice (RYR) extract (10 mg/day monacolin K), niacin (16mg) and coenzyme Q10 (20mg) on levels of cholesterol and fats in the blood. This was a 12-week randomised, parallel, double-blind, placebo-controlled study, in which 33 adults at low risk of heart disease were given either the Bifidobacterium combination, or a placebo. Treatment with the Bifidobacterium combination significantly reduced total cholesterol by 16.7%, LDL-C by 25.7%, non-HDL-C by 24% and apolipoprotein-B by 17%. Triglycerides, HDL-C, apolipoprotein AI, lipoprotein (a) and proprotein convertase subtilisin/kexin type 9 (PCSK9) were unchanged. Markers of cholesterol synthesis and absorption suggested that a reduction in the synthesis of cholesterol had occurred without increased absorption of cholesterol. No adverse effects were reported in the study and the compliance rate was high at 97%. The use of nutraceuticals in the prevention of cardiovascular disease, as well as in other areas related to chronic diseases like cancer, is currently expanding.
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 .
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Nutraceutical approach to moderate cardiometabolic risk: results of a randomized, double-blind and crossover study with Armolipid Plus.
Ruscica, M, Gomaraschi, M, Mombelli, G, Macchi, C, Bosisio, R, Pazzucconi, F, Pavanello, C, Calabresi, L, Arnoldi, A, Sirtori, CR, et al
Journal of clinical lipidology. 2014;(1):61-8
Abstract
BACKGROUND Primary cardiovascular prevention may be achieved by lifestyle/nutrition improvements and specific drugs, although a relevant role is now emerging for specific functional foods and nutraceuticals. OBJECTIVES The aim of this study was to evaluate the usefulness of a nutraceutical multitarget approach in subjects with moderate cardiovascular risk and to compare it with pravastatin treatment. SUBJECTS Thirty patients with moderate dyslipidemia and metabolic syndrome (according to the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults) were included in an 8-week randomized, double-blind crossover study and took either placebo or a nutraceutical combination that contained red yeast rice extract, berberine, policosanol, astaxanthin, coenzyme Q10, and folic acid (Armolipid Plus). Subsequently, they were subjected to another 8-week treatment with pravastatin 10 mg/d. This dosage was selected on the basis of its expected -20% efficacy in reducing low-density lipoprotein-cholesterol. RESULTS Treatment with Armolipid Plus led to a significant reduction of total cholesterol (-12.8%) and low-density lipoprotein-cholesterol (-21.1%), similar to pravastatin (-16% and -22.6%, respectively), and an increase of high-density lipoprotein-cholesterol (4.8%). Armolipid Plus improved the leptin-to-adiponectin ratio, whereas adiponectin levels were unchanged. CONCLUSIONS These results indicate that this nutraceutical approach shows a lipid-lowering activity comparable to pravastatin treatment. Hence, it may be a safe and useful option, especially in conditions of moderate cardiovascular risk, in which a pharmacologic intervention may not be appropriate.
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Hypocholesterolaemic effects of lupin protein and pea protein/fibre combinations in moderately hypercholesterolaemic individuals.
Sirtori, CR, Triolo, M, Bosisio, R, Bondioli, A, Calabresi, L, De Vergori, V, Gomaraschi, M, Mombelli, G, Pazzucconi, F, Zacherl, C, et al
The British journal of nutrition. 2012;(8):1176-83
Abstract
The present study was aimed to evaluate the effect of plant proteins (lupin protein or pea protein) and their combinations with soluble fibres (oat fibre or apple pectin) on plasma total and LDL-cholesterol levels. A randomised, double-blind, parallel group design was followed: after a 4-week run-in period, participants were randomised into seven treatment groups, each consisting of twenty-five participants. Each group consumed two bars containing specific protein/fibre combinations: the reference group consumed casein+cellulose; the second and third groups consumed bars containing lupin or pea proteins+cellulose; the fourth and fifth groups consumed bars containing casein and oat fibre or apple pectin; the sixth group and seventh group received bars containing combinations of pea protein and oat fibre or apple pectin, respectively. Bars containing lupin protein+cellulose ( - 116 mg/l, - 4·2%), casein+apple pectin ( - 152 mg/l, - 5·3%), pea protein+oat fibre ( - 135 mg/l, - 4·7%) or pea protein+apple pectin ( - 168 mg/l, - 6·4%) resulted in significant reductions of total cholesterol levels (P<0·05), whereas no cholesterol changes were observed in the subjects consuming the bars containing casein+cellulose, casein+oat fibre or pea protein+cellulose. The present study shows the hypocholesterolaemic activity and potential clinical benefits of consuming lupin protein or combinations of pea protein and a soluble fibre, such as oat fibre or apple pectin.
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Virgin Olive Oil Study (VOLOS): vasoprotective potential of extra virgin olive oil in mildly dyslipidemic patients.
Visioli, F, Caruso, D, Grande, S, Bosisio, R, Villa, M, Galli, G, Sirtori, C, Galli, C
European journal of nutrition. 2005;(2):121-7
Abstract
BACKGROUND In vitro, olive phenols exert potent antioxidant and enzyme-modulating activities. AIM OF THE STUDY We comparatively evaluate, in mildly dyslipidemic patients, the vasoprotective potential of extra virgin olive oil. METHODS 22 patients were administered 40 mL/day of either extra-virgin, i. e. phenol rich, or refined, i. e. phenol poor, olive oils (EVOO or ROO, respectively, with nearly identical fatty acid composition), with a crossover design. Each treatment was carried out for seven weeks, with four weeks of washout in between. Plasma antioxidant capacity, serum thromboxane B2 (TXB2) formation, and urinary isoprostane excretion were evaluated as surrogate markers of cardioprotective potential and vascular function. RESULTS No effects on plasma lipid/lipoprotein profile were observed. Conversely, EVOO consumption was associated with favorable effects on circulating markers. Namely, decreased serum TXB2 production and increased plasma antioxidant capacity were observed when EVOO was administered in both treatment arms. Neither treatment had any significant effect on isoprostane excretion. CONCLUSIONS EVOO consumption by mildly dyslipidemic patients is associated with favorable changes in circulating markers of cardiovascular condition. Based on current knowledge, these effects may be associated with cardioprotection.
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Soy milk with a high glycitein content does not reduce low-density lipoprotein cholesterolemia in type II hypercholesterolemic patients.
Sirtori, CR, Bosisio, R, Pazzucconi, F, Bondioli, A, Gatti, E, Lovati, MR, Murphy, P
Annals of nutrition & metabolism. 2002;(2):88-92
Abstract
In order to evaluate acceptability and effectiveness of a partial addition of soy protein to the daily diet in well-established type II hypercholesterolemic individuals, a double-blind study was carried out with a soy milk providing 25 g/day of protein versus an identically formulated cow's milk. Twenty patients with type II hypercholesterolemia, 4 males and 16 females, age range 38-76 years, all with cholesterol levels >7 mmol/l and low-density lipoprotein cholesterol <5.5 mmol/l, were selected. Significant triglyceride elevations (WHO Fredrickson type IIB) were present in 4 patients, and the body mass index was 24.2 +/- 3.47 kg/m(2). Different from prior studies, either with isoflavone-free products or with a moderately isoflavone-rich milk, the milk in the present study did not reduce total and low-density lipoprotein cholesterolemia. A detailed analysis of the composition showed significant differences in the isoflavone content versus products used in prior studies with a positive outcome. Soy milk isoflavones were, in fact, characterized by a high glycitein content and a low genistein/daidzein ratio. Glycitein is a minor component in most soy products, and its role in cholesterol regulation is unclear. In view of the high interest in the use of soy products for the prevention of coronary diseases, the metabolic behavior of different isoflavones in man should be better characterized, and the role of isoflavone composition of soy products given for the control of cholesterolemia needs further clarification.