Evaluation in Patients with High NORMAL Blood Pressure of a Supplement Containing Arginine, Lactobacillus Plantarum Lp-LDL, Coenzime Q10 and Vitamin B1: A PILOT Study

Giuseppe Derosa^{1, 2,} , Giovanni Gaudio³, Angela D’Angelo^{1, 4} and Pamela Maffioli¹

¹Department of Internal Medicine and Therapeutics, University of Pavia, PAVIA, Italy

²Laboratory of Molecular Medicine, University of Pavia, PAVIA, Italy;Responsible Diabetes Area of Italian Nutraceutical Society (SINut)

³Internal Medicine Division, Ospedale Angelo Bellini, Somma Lombardo, VARESE, Italy

⁴Laboratory of Molecular Medicine, University of Pavia, PAVIA, Italy

Cite this paper:
Giuseppe Derosa, Giovanni Gaudio, Angela D’Angelo and Pamela Maffioli. Evaluation in Patients with High NORMAL Blood Pressure of a Supplement Containing Arginine, Lactobacillus Plantarum Lp-LDL, Coenzime Q10 and Vitamin B1: A PILOT Study. Journal of Food and Nutrition Research. 2020; 8(6):273-278. doi: 10.12691/jfnr-8-6-5

Abstract

Aim: to evaluate the effects of a nutraceutical containing Arginine, Lactobacillus Plantarum Lp-LDL, Coenzyme Q10 and Vitamin B1 in patients with high normal blood pressure on the levels of systolic (SBP) and diastolic blood pressure (DBP). Methods: we enrolled 40 patients of both sexes, with high normal pressure (SBP values between 130-139 mmHg and/or DBP between 85-89 mmHg) according to the 2018 ESC/ESH Guidelines for the management of arterial hypertension. Patients were consecutively enrolled to take nutraceutical for 3 months and it is self-administered once a day during the breakfast. Results: no significant variations of BMI or circumferences were recorded with nutraceutical from baseline. A slight reduction of FPG was recorded, although this variation was not significant. Significant reductions were obtained in SBP (p< 0.05) and DBP (p< 0.05). No significant HR variation was observed from baseline. A significant TC and LDL-C decrease were observed after 3 months (p< 0.05, respectively). No significant HDL-C, and Tg variations were obtained after 3 months. No significant reduction of Hs-CRP was recorded compared to baseline. No significant variations of transaminases were recorded during the study, and creatinine value was not significantly modified compared to baseline. Conclusions: a nutraceutical containing Arginine, Lactobacillus Plantarum Lp-LDL, Coenzyme Q10 and Vitamin B1 could be helpful in improving high normal blood pressure, and hypercholesterolemia, two of the major risk factors for vascular events.

Keywords:
arginine Lactobacillus Plantarum Lp-LDL Coenzime Q10 Vitamin B1 blood pressure

This work is licensed under a Creative Commons Attribution 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/

References:

[1]	Williams, B., Mancia, G., Spiering, W., Agabiti Rosei, E., Azizi, M., Burnier, M., Clement, D.L., Coca, A., de Simone, G., Dominiczak, A., Kahan, T., Mahfoud, F., Redon, J., Ruilope, L., Zanchetti, A., Kerins, M., Kjeldsen, S.E., Kreutz, R., Laurent, S., Lip, G.Y.H., McManus, R., Narkiewicz, K., Ruschitzka, F., Schmieder, R.E., Shlyakhto, E., Tsioufis, C., Aboyans, V., Desormais, I.; ESC Scientific Document Group, “,” Eur Heart J, 39(33). 3021-3104. Sep.2018.
[2]	Derosa, G., Maffioli, P., “The cardiometabolic risk: a new concept for old diseases,” Nutrafoods, 1. 40-43. 2019.
[3]	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, 115(5). 780-800. May.2015.
[4]	Cicero, A.F., Colletti, A., “Nutraceuticals and blood pressure control: results from clinical trials and meta-analyses,” High Blood Press Cardiovasc Prev, 22(3). 203-213. Sep.2015.
[5]	Sirtori, C.R., Arnoldi, A., Cicero, A.F., “Nutraceuticals for blood pressure control,” Ann Med, 47(6). 447-456. Jun.2015.
[6]	Cicero, A.F.G., Colletti, A., Fogacci, F., Bove, M., Giovannini, M., Borghi, C., “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(4). 401-405. Dec.2018.
[7]	Borghi, C., Cicero, A.F., “Nutraceuticals with a clinically detectable blood pressure-lowering effect: a review of available randomized clinical trials and their meta-analyses,” Br J Clin Pharmacol, 83(1). 163-171. Jan.2017.
[8]	Cicero, A.F., Borghi, C., “Evidence of clinically relevant efficacy for dietary supplements and nutraceuticals,” Curr Hypertens Rep, 15(3). 260-267. Jun.2013.
[9]	Das, U.N., “Nutritional factors in the prevention and management of coronary artery disease and heart failure”, Nutrition, 31(2). 283-291. Feb.2015.
[10]	Menzel, D., Haller, H., Wilhelm, M., Robenek, H., “L-Arginine and B vitamins improve endothelial function in subjects with mild to moderate blood pressure elevation,” Eur J Nutr, 57(2). 557-568. Nov.2018.
[11]	Borghi, C., Cicero, A.F.G., “Nutraceuticals with a clinically detectable blood pressure-lowering effect: a review of available randomized clinical trials and their meta-analyses,” Br J Clin Pharmacol, 83(1), 163-171. Jan.2017.
[12]	Yang, G., Jiang, Y., Yang, W., Du, F., Yao, Y., Shi, C., Wang, C., “Effective treatment of hypertension by recombinant Lactobacillus Plantarum expressing angiotensin converting enzyme inhibitory peptide”. Microb Cell Fact 14. 202. Dec.2015.
[13]	The Council for International Organisation of Medical Sciences, “Proposed International Guidelines for Biomedical Research Involving Human Subjects, Geneva,” 1982.
[14]	European Diabetes Policy Group 1999., “A desktop guide to type 2 diabetes mellitus,” Diabet Med, 16(9). 716-730, Sep.1999.
[15]	Klose, S., Borner, K., “Enzymatische Bestimmung des Gesamtcholesterins mit dem [Enzymatic dosage of total cholesterolemia by Greiner Selective Analyzer (GSA II)]”, J Clin Chem Clin Biochem 15(3). 121-130. Mar.1978.
[16]	Wahlefeld, A.W., Triglycerides determination after enzymatic hydrolysis, In: Methods of Enzymatic Analysis. Ed. H. U. Bergmeyer, 2nd English ed. Academic Press, New York (USA) 1974; pp. 18-31.
[17]	Havel, R.J., Eder, H.A., Bragdon, J.H., “The distribution and chemical composition of ultracentrifugally separated lipoproteins in human serum”, J Clin Invest 34(9). 1345-1353. Sep.1955.
[18]	Friedewald, W.T., Levy, R.I., Fredrickson, D.S., “Estimation of the concentration of low density lipoprotein in plasma, without use of the preparative ultracentrifuge”, Clin Chem, 18(6). 499-502. Jun.1972.
[19]	Rifai, N., Tracy, R.P., Ridker, P.M., “Clinical Efficacy of an Automated High-Sensitivity C-Reactive Protein Assay”, Clin Chem, 45(12). 2136-2141. Dec.1999.
[20]	Winer, B.J., Statistical Principles in Experimental Design. 2nd ed., McGraw-Hill, New York (USA) 1971.
[21]	Yusuf, S., Sleight, P., Pogue, J., Bosch, J., Davies, R., Dagenais, G., The Heart Outcomes Prevention Evaluation Study Investigators, “Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients,” N Engl J Med, 342(3). 145-153. Jan.2000.
[22]	Heart Outcomes Prevention Evaluation (HOPE) Study Investigators, “Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy,” Lancet, 355 (9200). 253-259. Jan.2000.
[23]	Collins, R., Peto, R., MacMahon, S., ., ., ., ., ., ., ., “Blood pressure, stroke, and coronary heart disease. Part 2, Short-term reductions in blood pressure: overview of randomised drug trials in their epidemiological context”, Lancet, 335. 827-838. Apr.1990.
[24]	Arnold, J.M., Yusuf, S., Young, J., ., ., ., ., ., .; ., “Prevention of heart failure in patients in the Heart Outcomes Prevention Evaluation (HOPE) study”, Circulation, 107)(9). 1284-1290. Mar.2003.
[25]	Shen, T., Xing, G., Zhu, J., Zhang, S., Cai, Y., Li, D., Xu, G., Xing, E., Rao, J., Shi, R. “Effects of 12-week supplementation of marine Omega-3 PUFA-based formulation Omega3 Q10 in older adults with prehypertension and/or elevated blood cholesterol”, Lipids Health Dis, 16(1). 253. Dec.2017.
[26]	Mazza, A., Schiavon, L., Rigatelli, G., Torin, G., Lenti, S., “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(4). 345-350. Aug.2019.