Botanicals and Food Supplement Combination in Patients with Polygenic Hypercholesterolemia: Evaluation at Fasting and after Oral Fat Load Test

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

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

²Laboratory of Molecular Medicine, University of Pavia, PAVIA, Italy

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

Cite this paper:
Giuseppe Derosa, Giovanni Gaudio, Angela D’Angelo and Pamela Maffioli. Botanicals and Food Supplement Combination in Patients with Polygenic Hypercholesterolemia: Evaluation at Fasting and after Oral Fat Load Test. Journal of Food and Nutrition Research. 2020; 8(12):700-706. doi: 10.12691/jfnr-8-12-2

Abstract

The aim of this study was to evaluate, in hypercholesterolemic patients, the effects on lipid profile both at fasting and after an oral fat load (OFL), of 3 months of treatment with a nutraceutical combination containing monacolin K, Cynara scolymus, Thea sinensis L., Oryza sativa L., Brassica campestris L., folic acid, coenzyme Q10, and Resveratrol compared to placebo. We enrolled 63 Caucasian patients, aged ≥18 of either sex, at low cardiovascular risk (≤ 2%) and randomized them to take the nutraceutical or placebo for 3 months. We evaluated fasting plasma glucose, lipid profile, high sensitivity C-reactive protein and safety parameters at baseline and after 3 months. Patients also underwent an OFL at baseline and at the end of the study. Nutraceutical combination gave a reduction of total cholesterol (TC), triglycerides (Tg), and low-density lipoprotein-cholesterol (LDL-C), both compared to baseline (p < 0.05), and compared to placebo (p < 0.05). High-sensitivity C-reactive protein decreased in the active group both compared to baseline and to placebo (p < 0.05 for both). During the OFL performed at the end of the study, TC, and LDL-C recorded in the group treated with the nutraceutical combination were lower compared to the values recorded during the baseline OFL (p < 0.05), and also compared to values recorded in placebo group (p< 0.01) at every time of OFL. Regarding Tg, the value recorded during the OFL at the end of the study was lower at 6 hours compared to baseline OFL (p < 0.05 vs baseline), and to placebo (p < 0.05). A nutraceutical containing monacolin K, Cynara scolymus, Thea sinensis L., Oryza sativa L., Brassica campestris L., folic acid, coenzyme Q10, and Resveratrol could be helpful in improving lipid profile in hypercholesterolemic patients, both at fasting and in post-prandial phase.

Keywords:
Monascus purpureus Cynara scolymus Thea sinensis L. Oryza sativa L. Brassica campestris L. polygenic hypercholesterolemia

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References:

[1]	WHO Media Centre., “Cardiovascular diseases (CVDs). Updated may 2017”, http://www.who.int/cardiovascular_diseases/en/. Accessed 30 Aug 2020.
[2]	Piepoli, M.F., Hoes, A.W., Agewall, S., Albus, C., Brotons, C., Catapano, A.L., et al., “2016 European 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 & amp; rehabilitation (EACPR)”, Eur Heart J, 37(29). 2315-2381.Aug.2016.
[3]	The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS)., “ESC/EAS Guidelines for the management of dyslipidaemias”, Eur Heart J, 32(14). 1769-1818. Jul.2011.
[4]	Nordestgaard, B.G., Benn, M., Schnohr, P., Tybjaerg-Hansen, A., “Nonfasting triglycerides and risk of myocardial infarction, ischemic heart disease, and death in men and women”, JAMA, 298 (3). 299-308. Jul.2007.
[5]	Karpe, F., Steiner, G., Uffelman, K., Olivecrona, T., Hamsten, A., “Postprandial lipoproteins and progression of coronary atherosclerosis”, Atherosclerosis, 106 (1). 83-97. Mar.1994.
[6]	Parks, E.J., “Recent findings in the study of postprandial lipemia”, Curr Atheroscler Rep, 3 (6). 462-470. 2001.
[7]	Halkes, C.J., Van Dijk, H., De jaegere, P.P., Plokker, H.W., Van der Helm, Y., Erkelens D.W., Cabezas, M.C., “Postprandial increase of complement component 3 in normolipidemic patients with coronary artery disease: effects of expanded-dose simvastatin”, Arterioscler Thromb Vasc Biol, 21 (9). 1526-1530. 2010.
[8]	Alipour, A., Elte, J.W., Van Zaanen, H.C., Rietveld, A.P., Cabezas, M.C., “Postprandial inflammation and endothelial dysfuction”, Biochem Soc Trans, 35 (3). 466-469. 2007.
[9]	Derosa, G., D'Angelo, A., Romano, D., Maffioli, P., “Response to an oral fat load and effects on lipid profile, glycemia and high-sensitivity C-reactive protein after soybean extract consumption”, Arch Med Sci, 14(4). 760-765. Jun.2018.
[10]	Derosa, G., Cicero, A.F., Fogari, E., D'Angelo, A., Bonaventura, A., Romano, D., Maffioli, P., “Effects of n-3 PUFAs on postprandial variation of metalloproteinases, and inflammatory and insulin resistance parameters in dyslipidemic patients: evaluation with euglycemic clamp and oral fat load”, J Clin Lipidol, 6(6): 553-564. Nov-Dec2012.
[11]	Derosa, G., Maffioli, P., “Nutraceuticals for the treatment of metabolic diseases: evidence from clinical practice”, Expert Rev Endocrinol Metab, 10(3). 297-304. May.2015.
[12]	Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults., “Executive summary of the third report of the national cholesterol education program (NCEP) expert panel on detection, evaluation and treatment of high blood cholesterol in adults (Adult Treatment Panel III)”, JAMA, 285(19). 2486-2497. May.2001.
[13]	World Health Organization., “Obesity: Preventing and Managing the Global Epidemic. Report of WHO Consultation on Obesity”, Geneva: WHO; June.1997.
[14]	Lichtenstein, A.H., Appel, L.J., Brands, M., Carnethon, M., Daniels, S., Franch, H.A., Franklin, B., Kris-Etherton, P., Harris, W.S., Howard, B., Karanja, N., Lefevre, M., Rudel, L., Sacks, F., Van Horn, L., Winston, M., Wylie-Rosett, J., “Summary of American Heart Association Diet and Lifestyle Recommendations Revision 2006”, Arterioscler Thromb Vasc Biol, 26(10). 2186-2191. Oct.2006.
[15]	European Diabetes Policy Group., “A desktop guide to type 2 diabetes mellitus”, Diabet Med, 16(9). 716-730.Sep.1999.
[16]	Klose, S., Borner, K., “Enzymatische Bestimmung des Gesamtcholesterins mit dem Greiner Selective Analyzer (GSA II)”. J Clin Chem Clin Biochem 15(3), 121-130.Mar.1978.
[17]	Wahlefeld, A.W. Methods of Enzymatic Analysis: Triglycerides determination after enzymatic hydrolysis, 2nd English ed, Academic Press., Inc., New York, 18-31, 1974.
[18]	Havel, R.J., Edr, 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.
[19]	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.
[20]	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.
[21]	Winer, B.J., “Statistical Principles in Experimental Design”, 2nd ed, McGraw-Hill, New York, 1971.
[22]	EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), “Scientific opinion on the safety of monacolins in red yeast rice. EFSA Journal” 16(8). 5368. Aug.2018.
[23]	Cicero, A.F.G., Red yeast rice, monacolin K, and pleiotropic effects. Recenti Prog Med, 109(2). 154e-157e. Feb.2018.
[24]	Heinz, T., Schuchardt, J.P., Möller, K., Hadji, P., Hahn, A., “Low daily dose of 3 mg monacolin K from RYR reduces the concentration of LDL-C in a randomized, placebo-controlled intervention”, Nutr Res, 36(10). 1162-1170. Oct.2016.
[25]	Batista-Jorge, G.C., Barcala-Jorge, A.S., Silveira, M.F., Lelis, D.F., Andrade, J.M.O., de Paula, A.M.B., Guimarães, A.L.S., Santos, S.H.S., “Oral resveratrol supplementation improves metabolic syndrome features in obese patients submitted to a lifestyle-changing program”, Life Sci 256. 117962. Sep.2020.
[26]	Derosa, G., D'Angelo, A., Maffioli, P., “Coenzyme q10 liquid supplementation in dyslipidemic subjects with statin-related clinical symptoms: a double-blind, randomized, placebo-controlled study”, Drug Des Devel Ther, 13. 3647-3655. Oct.2019.
[27]	D’Addato, S., Scandiani, L., Mombelli, G., Focanti, F., Pelacchi, F., Salvatori, E., Di Loreto, G., Comandini, A., Maffioli, P., Derosa, G., “Effect of a food supplement containing berberine, monacolin K, hydroxytyrosol and coenzyme Q10 on lipid levels: a randomized, double-blind, placebo controlled study”, Drug Des Devel Ther, 11. 1585-1592. May.2017.
[28]	Derosa, G., Catena, G., Raddino, R., Gaudio, G., Maggi, A., D'Angelo, A., Maffioli, P., “Effects on oral fat load of a nutraceutical combination of fermented red rice, sterol esters and stanols, curcumin, and olive polyphenols: a randomized, placebo controlled trial”, Phytomedicine 42. 75-82. Mar.2018.
[29]	Derosa, G., Raddino, R., Maggi, A., Pasini, G., D’Angelo, A., Maffioli, P., Effect of Esterol Tens® compared to placebo in hypercolesterolemic hypertensive patients after an oral fat load. J Food Nutr Res 8(4). 183-188. Apr.2020.