Effects of a new combination of nutraceuticals with Morus alba on lipid profile, insulin sensitivity and endotelial function in dyslipidemic subjects. A cross-over, randomized, double-blind trial

Valentina Trimarco, Raffaele Izzo, Eugenio Stabile, Francesco Rozza, Mario Santoro, Maria Virginia Manzi, Federica Serino, Gabriele Giacomo Schiattarella, Giovanni Esposito, Bruno Trimarco, Valentina Trimarco, Raffaele Izzo, Eugenio Stabile, Francesco Rozza, Mario Santoro, Maria Virginia Manzi, Federica Serino, Gabriele Giacomo Schiattarella, Giovanni Esposito, Bruno Trimarco

Abstract

Introduction: Nutraceuticals (NUT) are forms of compounds with biological activity commonly used to improve health in dosage largely exceeding those obtainable in food.

Aim: We compared, in a double blind randomized cross-over trial, the effects of two NUT combinations on the control of glico-lipidic metabolism in patients with hypercholesterolemia not on statins.

Methods: At study start patients were given dietary counseling and received placebo for 2 weeks. After this run-in period, patients were randomized: (1) Combination A [Policosanol, Red yeast rice (Monakolin K 3 mg), Berberine 500 mg, Astaxantine, Folic Acid and Coenzyme Q10] for 4 weeks followed by 4 weeks of Combination B [Red yeast rice (Monakolin K 3.3 mg), Berberine 531.25 mg and leaf extract of Morus alba]; (2) Combination B for 4 weeks followed by 4 weeks of Combination A.

Results: Combination B reduced LDL cholesterol below 130 mg/dl in 56.5 % of the patients, and Cambination A only in 21.7 % of them (p ≤ 0.027). Both treatments reduced plasma levels of triglycerides, total and LDL cholesterol and increased HDL cholesterol (all p < 0.03). Total and LDL cholesterol reduction was more pronounced in patients taking Combination B (p < 0.005). Combination B reduced also glycated hemoglobin, fasting glucose and insulin plasma levels as well as HOMA index (p < 0.005).

Conclusions: An increased content of Berberin and Monacolin K and the addition of Morus alba extract improves the effect on plasma cholesterol and on glucose metabolism of the NUT Combination. These effects may allow the speculation of a more marked improvement in cardiovascular prognosis.

Figures

Fig. 1
Fig. 1
Percentage of subjects with LDL 2 = 0.027)
Fig. 2
Fig. 2
Percentage changes in lipid profile (each bar represent mean ± ST; N = 23; *p < 0.005)

References

    1. European Association for Cardiovascular P, Rehabilitation. Reiner Z, Catapano AL, De Backer G, Graham I, et al. ESC/EAS guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) Eur Heart J. 2011;32(14):1769–1818. doi: 10.1093/eurheartj/ehr158.
    1. Izzo R, de Simone G, Giudice R, Chinali M, Trimarco V, De Luca N, et al. Effects of nutraceuticals on prevalence of metabolic syndrome and on calculated Framingham Risk Score in individuals with dyslipidemia. J Hypertens. 2010;28(7):1482–1487. doi: 10.1097/HJH.0b013e3283395208.
    1. Libby P. The forgotten majority: unfinished business in cardiovascular risk reduction. J Am Coll Cardiol. 2005;46(7):1225–1228. doi: 10.1016/j.jacc.2005.07.006.
    1. Khaw KT, Wareham N, Bingham S, Luben R, Welch A, Day N. Association of hemoglobin A1c with cardiovascular disease and mortality in adults: the European prospective investigation into cancer in Norfolk. Ann Intern Med. 2004;141(6):413–420. doi: 10.7326/0003-4819-141-6-200409210-00006.
    1. Gast KB, Tjeerdema N, Stijnen T, Smit JW, Dekkers OM. Insulin resistance and risk of incident cardiovascular events in adults without diabetes: meta-analysis. PLoS One. 2012;7(12):e52036. doi: 10.1371/journal.pone.0052036.
    1. Wang Y, Xiang L, Wang C, Tang C, He X. Antidiabetic and antioxidant effects and phytochemicals of mulberry fruit (Morus alba L.) polyphenol enhanced extract. PLoS One. 2013;8(7):e71144. doi: 10.1371/journal.pone.0071144.
    1. Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, et al. 2013 ESH/ESC guidelines for the management of arterial hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC) Eur Heart J. 2013;34(28):2159–2219. doi: 10.1093/eurheartj/eht151.
    1. Gargiulo P, Marciano C, Savarese G, D’Amore C, Paolillo S, Esposito G, et al. Endothelial dysfunction in type 2 diabetic patients with normal coronary arteries: a digital reactive hyperemia study. Int J Cardiol. 2013;165(1):67–71. doi: 10.1016/j.ijcard.2011.07.076.
    1. Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004;23(12):1921–1986. doi: 10.1002/sim.1783.
    1. Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985;28(7):412–419. doi: 10.1007/BF00280883.
    1. Affuso F, Ruvolo A, Micillo F, Sacca L, Fazio S. Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study. Nutr Metab Cardiovasc Dis. 2010;20(9):656–661. doi: 10.1016/j.numecd.2009.05.017.
    1. Yang X, Yang L, Zheng H. Hypolipidemic and antioxidant effects of mulberry (Morus alba L.) fruit in hyperlipidaemia rats. Food Chem Toxicol. 2010;48(8–9):2374–2379. doi: 10.1016/j.fct.2010.05.074.
    1. Nathan DM, Kuenen J, Borg R, Zheng H, Schoenfeld D, Heine RJ, et al. Translating the A1C assay into estimated average glucose values. Diabetes care. 2008;31(8):1473–1478. doi: 10.2337/dc08-0545.
    1. Marciano C, Galderisi M, Gargiulo P, Acampa W, D’Amore C, Esposito R, et al. Effects of type 2 diabetes mellitus on coronary microvascular function and myocardial perfusion in patients without obstructive coronary artery disease. Eur J Nucl Med Mol Imaging. 2012;39(7):1199–1206. doi: 10.1007/s00259-012-2117-9.
    1. Van de Laar FA, Lucassen PL, Akkermans RP, Van de Lisdonk EH, Rutten GE, Van Weel C. Alpha-glucosidase inhibitors for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2005(2):CD003639.
    1. Derosa G, Romano D, D’Angelo A, Maffioli P. Berberis aristata combined with Silybum marianum on lipid profile in patients not tolerating statins at high doses. Atherosclerosis. 2015;239(1):87–92. doi: 10.1016/j.atherosclerosis.2014.12.043.
    1. Di Pierro F, Putignano P, Villanova N, Montesi L, Moscatiello S, Marchesini G. Preliminary study about the possible glycemic clinical advantage in using a fixed combination of Berberis aristata and Silybum marianum standardized extracts versus only Berberis aristata in patients with type 2 diabetes. Clin Pharmacol. 2013;5:167–174.

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