Abstract
Introduction
Beyond the well-known effects on blood pressure (BP) of the dietary approaches to stop hypertension (DASH) and the Mediterranean diets associated to a correct lifestyle, often a lifestyle change is not simple and can show only long-time results: in this sense, a possible support might be derived from the use of some anti-hypertensive supplements or nutraceuticals, which may provide a significant reduction in blood pressure.
Aim
We conducted a randomized, double-blind, placebo-controlled clinical trial in a group of 36 pre-hypertensive and first-degree hypertensive patients.
Methods
The treatment period with a mix of bioactive substances (BPLN®, containing a donor of nitric oxide, magnesium, and vitamins) or placebo was 16-week long and was preceded by 4 weeks of diet stabilization.
Results
At the end of the intervention, patients treated with the nutraceutical product showed a significant reduction of all morning pressure parameters and of evening systolic blood pressure, both versus the baseline and versus the group treated with placebo. These effects were maintained even after the first 16 weeks of treatment, confirming that the preliminary results were not due to simple changes in volume and do not lead to adaptation/tachyphylaxis. No patient complained of any side effects while taking the active treatment and placebo.
Conclusions
The tested nutraceutical composite reduces systolic and diastolic blood pressure in the medium term, leading to a significant reduction in the estimated cardiovascular risk in a sample of patients with pre-hypertension or first-degree hypertension.
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References
Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corrà U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FD, Løchen ML, Löllgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, Bart van der Worp H, van Dis I, Verschuren WM. Europe- an Guidelines on cardiovascular disease prevention in clinical practice: the Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts) Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Atherosclerosis. 2016;2016(252):207–74.
Schwingshackl L, Hoffmann G. Diet quality as assessed by the healthy eating index, the alternate healthy eating index, the dietary approaches to stop hypertension score, and health out- comes: a systematic review and meta-analysis of cohort studies. J Acad Nutr Diet. 2015;115(5):780–800.e5. https://doi.org/10.1016/j.jand.2014.12.009.
Cicero AF, Colletti A. Nutraceuticals and blood pressure control: results from clinical trials and meta-analyses. High Blood Press Cardiovasc Prev. 2015;22(3):203–13. https://doi.org/10.1007/s40292-015-0081-8.
Sirtori CR, Arnoldi A, Cicero AF. Nutraceuticals for blood pressure control. Ann Med. 2015;47(6):447–56. https://doi.org/10.3109/07853890.2015.1078905.
Borghi C, Cicero AF. Nutraceuticals with a clinically detectable blood pressure-lowering effect: a review of availablerandomizedclinical trials and their meta-analyses. Br J Clin Pharmacol. 2017;83(1):163–71. https://doi.org/10.1111/bcp.12902.
Cicero AF, Borghi C. Evidence of clinically relevant efficacy for dietary supplements and nutraceuticals. Curr Hypertens Rep. 2013;15(3):260–7. https://doi.org/10.1007/s11906-013-0333-8.
Patti AM, Toth PP, Giglio RV, Banach M, Noto M, Nikolic D, Montalto G, Rizzo M. Nutraceuticals as an important part of combination therapy in dyslipidaemia. Curr Pharm Des. 2017;23(17):2496–503. https://doi.org/10.2174/1381612823666170317145851.
Whelton PK, Carey RM, Aronow WS, Jr Casey DE, Collins KJ, Dennison Himmelfarb C, De Palma SM, Gidding S, Jamerson KA, Jones DW, Mac Laughlin EJ, Muntner P, Ovbiagele B, Jr Smith SC, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Sr Williams KA, Williamson JD, Jr Wright JT. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: a Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2017;23(17):2496–503. https://doi.org/10.1161/hyp.0000000000000065.
Muntner P, Carey RM, Gidding S, Jones DW, Taler SJ, Jr Wright JT, Whelton PK. Potential US Population Impact of the 2017 American College of Cardiology/American Heart Association High Blood Pressure Guideline. J Am Coll Cardiol. 2017;23(17):2496–503. https://doi.org/10.1016/j.jacc.2017.10.073.
Cicero AFG, Fogacci F, Colletti A. Food and plant bioactives for reducing cardiometabolic disease risk: an evidence basedapproach. Food Funct. 2017;8(6):2076–88. https://doi.org/10.1039/c7fo00178a.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all individual participants included in the study.
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This article is part of the topical collection on Nutraceuticals in Hypertension & Cardiovascular Prevention.
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Cicero, A.F.G., Colletti, A., Fogacci, F. et al. Is it Possible to Significantly Modify Blood Pressure with a Combined Nutraceutical on Top of a Healthy Diet? The Results of a Pilot Clinical Trial. High Blood Press Cardiovasc Prev 25, 401–405 (2018). https://doi.org/10.1007/s40292-018-0289-5
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DOI: https://doi.org/10.1007/s40292-018-0289-5