Abstract
Introducion
Treatment strategies for patients with pre-hypertension and low–moderate cardiovascular (CV) risk may include nutraceutical compounds (NCs).
Aim
To investigate the efficacy and safety of a new-generation of NC in lowering BP values and improving metabolic profile, in a group of hyper-cholesterolemic subjects with pre-hypertension.
Methods
131 subjects with pre-hypertension (systolic BP 130–139 mmHg and/or diastolic BP 85–89 mmHg) without organ damage and history of CV diseases were enrolled. 66 subjects were treated with a once-daily oral formulation of a NC (red yeast rice, Berberine, Coenzyme Q10, folic acid and chrome) added to diet for 3 months, while 65 patients followed a diet only. Differences in serum total cholesterol (TC), low- and high-density lipoprotein cholesterol (LDLC and HDLC), triglycerides (TG), glycemia, creatine phosphokinase (CPK), aspartate aminotransferase (AST) alanine aminotransferase (ALT) and body mass index (BMI) were evaluated.
Results
At the end of treatment, significant reductions of TC, LDLC, TG glucose levels were observed in both treatment groups, while HDLC values increased in the active treatment group only. A greater reduction of TC, LDLC and glycemia was observed in the treatment group. TG levels were not different within the two groups. BP and BMI levels remained unchanged, as well AST, ALT; CPK slightly increased in both groups, but it remained in the normal range.
Conclusions
In patients with pre-hypertension, NC supplementation was safe, well tolerated and effective in improving lipid pattern and glucose levels and in preventing the progression to overt hypertension.
Similar content being viewed by others
References
Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M et al. ESC/ESH guidelines for the management of arterial hypertension. Eur Heart J. 2018;39:3021–104.
Julius S, Jamerson K, Mejia A, Krause L, Schork N, Jones K. The association of borderline hypertension with target organ changes and higher coronary risk. Tecumseh Blood Pressure Study. JAMA. 1990;264(3):354–8.
Leitschuh M, Cupples LA, Kannel W, Gagnon D, Chobanian A. High-normal blood pressure progression to hypertension in the Framingham Heart Study. Hypertension. 1991;17(1):22–7.
Luders S, Schrader J, Berger J, Ungerj T, Walter Zidekk W, Bohm M, et al. The PHARAO study: prevention of hypertension with the angiotensin-converting enzyme inhibitor ramipril in patients with pre-hypertension—a prospective, randomized, controlled prevention trial of the German Hypertension League. J Hypertens. 2008;26:1487–96.
Thomopoulos C, Parati G, Zanchetti A. Effects of blood-pressure-lowering treatment on outcome incidence. 12. Effects in individuals with high-normal and normal blood pressure: overview and meta-analyses of randomized trials. J Hypertens. 2017;35:2150–60.
Yusuf S, Bosch G, Dagenais G, Zhu J, Xavier D, Liu L, Pais P, et al. Cholesterol lowering in intermediate-risk persons without cardiovascular disease. N Engl J Med. 2016;374:2021–31.
Nieuwlaat R, Schwalm JD, Khatib R, Yusuf S. Why are we failing to implement effective therapies in cardiovascular disease? Eur Heart J. 2013;34:1262–9.
Borghi C, Cicero AFG. Nutraceuticals with a clinically detectable blood pressure-lowering effect: a review of available randomized clinical trials and their meta-analyses. Br J Clin Pharmacol. 2017;83:163–71.
Tang JL, Armitage JM, Lancaster T, Silagy CA, Fowler GH, Neil HA. Systematic review of dietary intervention trials to lower blood total cholesterol in free-living subjects. BMJ. 1998;316:1213–20.
Mazza A, Lenti S, Schiavon L, D’Avino M, Ramazzina E, Casiglia E. Nutraceuticals for serum lipid and blood pressure control in hypertensive and hypercholesterolemic subjects at low cardiovascular risk. Adv Ther. 2015;32(7):680–90.
Sirtori CR, Galli C, Anderson JW, Arnoldi A. Nutritional and nutraceutical approaches to dyslipidemia and atherosclerosis prevention: focus on dietary proteins. Atherosclerosis. 2009;203:8–17.
Li Y, Jiang L, Jia Z, Xin W, Yang S, Yang Q, Wang L. A meta-analysis of red yeast rice: an effective and relatively safe alternative approach for dyslipidemia. PLoS One. 2014;9:e98611.
Estruch R, Ros E, Martinez-Gonzalez MA. Mediterranean diet for primary prevention of cardiovascular disease. N Engl J Med. 2013;69:676–7.
Rivellese AA, Ciciola P, Costabile G, Vetrani C, Vitale M. The possible role of nutraceuticals in the prevention of cardiovascular disease. High Blood Press Cardiovasc Prev. 2019;26(2):101–11.
Affuso F, Ruvolo A, Micillo F, Saccà 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):656–61.
Pirro M, Lupattelli G, Del Giorno R, Schillaci G, Berisha S, Mannarino MR, et al. Nutraceutical combination (red yeast rice, berberine and policosanols) improves aortic stiffness in low moderate risk hypercholesterolemic patients. Pharma-Nutrition. 2013;1:73–7.
Alissa EM, Ferns GA. Functional foods and nutraceuticals in the primary prevention of cardiovascular diseases. J Nutr Metab. 2012;2012:569486.
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;28:1482–7.
Trimarco B, Benvenuti C, Rozza F, Pagnano G, Manzi MV, Piglia A, et al. Clinical evidence of efficacy of red yeast rice and berberine in a large controlled study versus diet. Med J Nutr Metab. 2011;4:133–9.
Cicero AFG, Derosa G, Bove M, Imola F, Borghi C, Gaddi AV. Long term effectiveness and safety of a nutraceutical-based approach to reduce cholesterolemia in statin intolerant subjects with and without metabolic syndrome. Curr Top Nutrac Res. 2009;7(3–4):121–6.
Marazzi G, Cacciotti L, Pelliccia F, Iaia L, Volterrani M, Caminiti G, et al. Long-term effects of nutraceuticals (berberine, red yeast rice, policosanol) in elderly hypercholesterolemic patients. Adv Ther. 2011;28:1105–13.
Cicero AFG, Colletti A, Bajraktari G, Olivier D, Djuric DM, Ezhov M, et al. Lipid-lowering nutraceuticals in clinical practice: position paper from an International Lipid Expert Panel. Nutr Rev. 2017;75(9):731–67.
Barbagallo CM, Cefalù AB, Noto D, Averna MR. Role of nutraceuticals in hypolipidemic therapy. Front Cardiovasc Med. 2015;2:22. https://doi.org/10.3389/fcvm.2015.00022.
Chander V, Asval JS, Dobhal R, Uniyal DP. A review on Pharmacological potential of Berberine; an active component of Himalayan Berberis aristata. J Phytopharmacol. 2017;6(1):53–8.
Cameron J, Ranheim T, Kulseth MA, Leren TP, Berge KE. Berberine decreases PCSK9 expression in HepG2 cells. Atherosclerosis. 2008;201(2):266–73.
Dong H, Zhao Y, Zhao L, Lu F. The effects of berberine on blood lipids: a systemic review and meta-analysis of randomized controlled trials. Planta Med. 2013;79:437–46.
Kong W, Wei J, Abidi P, Lin M, Inaba S, Li C, et al. Berberine is a novel cholesterol-lowering drug working through a unique mechanism distinct from statins. Nat Med. 2004;10:1344–51.
Derosa G, Maffioli P, Cicero AFG. Berberine on metabolic and cardiovascular risk factors: an analysis from preclinical evidences to clinical trials. Expert Opin Biol Ther. 2012;12(8):1113–24.
Tabeshpour J, Imenshahidi M, Hosseinzadeh H. A review of the effects of Berberis vulgaris and its major component, berberine, in metabolic syndrome. Iran J Basic Med Sci. 2017;20:557–68.
Poli A, Barbagallo CM, Cicero AFG, Corsini A, Manzato E, Trimarco B, et al. Nutraceuticals and functional foods for the control of plasma cholesterol levels. An intersociety position paper. Pharmacol Res. 2018;134:51–60.
Poli A, Visioli F. Pharmacology of nutraceuticals with lipid lowering properties. High Blood Press Cardiovasc Prev. 2019;26(2):113–8.
Cicero AFG, Fogacci F, Colletti A. Food and plant bioactives for reducing cardiometabolic disease risk: an evidence based approach. Food Funct. 2017;8(6):2076–88.
Pisciotta L, Bellocchio A, Bertolini S. Nutraceutical pill containing berberine versus ezetimibe on plasma lipid pattern in hypercholesterolemic subjects and its additive effect in patients with familial hypercholesterolemia on stable cholesterol-lowering treatment. Lipids Health Dis. 2012;11:123.
Houston MC. The role of nutrition, nutraceuticals, vitamins, antioxidants, and minerals in the prevention and treatment of hypertension. Altern Ther Health Med. 2013;19(S1):32–49.
Ho MJ, Bellusci A, Wright JM. Blood pressure lowering efficacy of coenzyme Q10 for primary hypertension. Cochrane Database Syst Rev. 2009;(4):CD007435. https://doi.org/10.1002/14651858.cd007435.pub2.
Balk EM, Tatsioni A, Lichtenstein A, Lau J, Pittas AG. Effect of chromium supplementation on glucose metabolism and lipids. A systematic review of randomized controlled trials. Diabetes Care. 2007;30(8):2154–63.
Ostman E, Forslund A, Oste R, Bjorck I. A drink containing amino acids and chromium picolinate improves postprandial glycemia at breakfast in healthy, overweight subjects. Funct Foods Health Dis. 2017;7(2):88–97.
Acknowledgements
The authors thank Dr. Maria Carla Marrè Brunenghi for the technical assistance during the study.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Conflict of interest
The authors’ declares that they have no conflict of interest.
Ethical approval
The study protocol was approved by local Ethics Committee and institutional review boards and conducted in accordance with ICH Harmonized Tripartite Guidelines for Good Clinical Practice and the Declaration of Helsinki Principles.
Informed consent
All patients gave informed consent for the study participation.
Additional information
This article is part of the topical collection on Nutraceuticals in Hypertension & Cardiovascular Prevention.
Rights and permissions
About this article
Cite this article
Mazza, A., Schiavon, L., Rigatelli, G. et al. The Effects of a New Generation of Nutraceutical Compounds on Lipid Profile and Glycaemia in Subjects with Pre-hypertension. High Blood Press Cardiovasc Prev 26, 345–350 (2019). https://doi.org/10.1007/s40292-019-00332-6
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40292-019-00332-6