Effects of poly-bioactive compounds on lipid profile and body weight in a moderately hypercholesterolemic population with low cardiovascular disease risk: A multicenter randomized trial

PLoS ONE

Volumn 9, Issue 8, 2014, Pages

  Sola, Rosa ^a   Valls, Rosa M ^a   Puzo, José ^b   Calabuig, José Raḿon ^c   Brea, Angel ^d   Pedret, Anna ^a   Morinã, David ^e   Villar, José ^f   Millán, Jesús ^g   Anguera, Anna ^h  

^a UNIVERSITAT ROVIRA I VIRGILI   (Spain)

^b San Jorge University Hospital   (Spain)

^c HOSPITAL UNIVERSITARIO LA FE   (Spain)

^d HOSPITAL SAN PEDRO   (Spain)

^e Centre Tecnològic de Nutrició I Salut   (Spain)

^f HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

^g HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^h Sant Joan Despi   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

ANTILIPEMIC AGENT; APOLIPOPROTEIN A1; APOLIPOPROTEIN B100; ARMOLIPID PLUS; CHOLESTEROL; GLUCOSE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INSULIN; LIPID; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; TRIACYLGLYCEROL; UNCLASSIFIED DRUG; BIOLOGICAL MARKER; BIOLOGICAL PRODUCT;

ADULT; ARTICLE; BODY MASS; BODY WEIGHT; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CHOLESTEROL BLOOD LEVEL; CONTROLLED STUDY; DIET SUPPLEMENTATION; DIETARY INTAKE; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG TOLERABILITY; FEMALE; FOOD COMPOSITION; GLUCOSE METABOLISM; HUMAN; HYPERCHOLESTEROLEMIA; INSULIN METABOLISM; LACTATION; LIFESTYLE MODIFICATION; LIPID BLOOD LEVEL; LIPOPROTEIN BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; MEDICAL HISTORY; MULTICENTER STUDY; OUTCOME ASSESSMENT; OUTPATIENT DEPARTMENT; PARALLEL DESIGN; PREGNANT WOMAN; RANDOMIZED CONTROLLED TRIAL; SPAIN; TREATMENT DURATION; TRIACYLGLYCEROL BLOOD LEVEL; UNSPECIFIED SIDE EFFECT; WEIGHT REDUCTION; BLOOD; CLINICAL TRIAL; DIET; DRUG EFFECTS; LIPID METABOLISM; METABOLISM; MIDDLE AGED; TREATMENT OUTCOME;

ADULT; BIOLOGICAL MARKERS; BIOLOGICAL PRODUCTS; BODY WEIGHT; CARDIOVASCULAR DISEASES; DIET; DIETARY SUPPLEMENTS; FEMALE; GLUCOSE; HUMANS; HYPERCHOLESTEROLEMIA; INSULIN; LIPID METABOLISM; LIPIDS; MALE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 84905402529     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0101978     Document Type: Article

References (44)

1. World Health Organization. Media centre. Cardiovascular diseases (CVDs) (2012). Fact sheet N u 317 September. Available: http://www.who.int/mediacentre/ factsheets/fs317/en/index.html# (accessed 28 January 2013).
2. Redberg RF, Benjamin EJ, Bittner V, Braun LT, Goff DC Jr, et al. (2009) American Academy of Family Physicians; American Association of Cardiovascular and Pulmonary Rehabilitation; Preventive Cardiovascular Nurses Association. AHA/ACCF [corrected] 2009 performance measures for primary prevention of cardiovascular disease in adults: a report of the American College of Cardiology Foundation/American Heart Association task force on performance measures (writing committee to develop performance measures for primary prevention of cardiovascular disease): developed in collaboration with the American Academy of Family Physicians; American Association of Cardiovascular and Pulmonary Rehabilitation; and Preventive Cardiovascular Nurses Association:endorsed by the American College of Preventive Medicine, American College of Sports Medicine, and Society for Women's Health Research. Circulation 120(13):1296-336. doi: 10.1161/CIRCULATIONAHA.109.192617. Epub 2009 Sep 21. Erratum in: Circulation. 2010 Jun 15;121(23):e445-6.
3. ESC/EAS Guidelines for the management of dyslipidaemias (2011) European Heart Journal 2:1769-818.
4. European Guidelines on cardiovascular disease prevention in clinical practice (2012) European Heart Journal 33:1635-701.
5. Cleeman JI (2001) Executive summary of the trial 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 285:2486-97.
6. Stone NJ, Robinson J, Lichtenstein AH, Bairey Merz CN, Lloyd-Jones DM, et al. (2013) 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol pii: S0735-1097(13)06028-2. doi: 10.1016/j.jacc.2013.11.002. [Epub ahead of print].
7. Needham M, Mastaglia FL (2013) Statin myotoxicity: A review of genetic susceptibility factors. Neuromuscul Disord. Sep 30. doi:pii:S0960-8966(13)00978- 4. 10.1016/j.nmd.2013.09.011. [Epub ahead of print]
8. Engelfriet P, Hoekstra J, Hoogenveen R, Büchner F, Van Rossum C, et al. (2010) Food and vessels: the importance of a healthy diet to prevent cardiovascular disease. Eur J Cardiov Prev Rehabil 17(1):50-5. doi: 10.1097/HJR.0b013e32832f3a76
9. U.S. Food and Drug Administration (FDA) (2010) Dietary Supplements. Version current 6 March. Available: http://www.fda.gov/AboutFDA/Transparency/ Basics/ucm193949.htm (accessed 28 January 2013).
10. Cicero AFG, Brancaleoni M, Laghi L, Donati F, Mino M (2005) Antihyperlipidaemic effect of a Monascus purpureus brand dietary supplement on a large sample of subjects at low risk for cardiovascular disease: a pilot study. Complem Ther Med; 13:273-278. (Pubitemid 43032955)
11. Cicero AFG, Benvenuti C, ARMoweb study Group (2010) Efficacy of a red yeast rice based nutraceutical in large subgroups of hypercholesterolemic subjects in every day clinical practice. Med J Nutr Metab; 3:239-246.
12. Trimarco B, Benvenuti C, Rozza F, Cimmino CS, Giudice R, et al. (2011) Clinical evidence of efficacy of red yeast rice and berberine in a large controlled study versus diet. Med J Nutrition Metab 4(2):133-9. doi: 10.1007/s12349-010-0043-6
13. Gouni-Berthold I, Berthold HK (2002) Policosanol: clinical pharmacology and therapeutic significance of a new lipid-lowering agent. Am Heart J;143(2):356-65.
14. Chen JT, Wesley R, Shamburek RD, Pucino F, Csako G (2005) Meta-analysis of natural therapies for hyperlipidemia: plant sterols and stanols versus policosanol. Pharmacotherapy; 25 (2):171-183. (Pubitemid 40223479)
15. Dulin MF, Hatcher LF, Sasser HC, Barringer TA (2006) Policosanol is ineffective in the treatment of hypercholesterolemia: a randomized controlled trial. Am J Clin Nutr 84(6):1543-8. (Pubitemid 44912842)
16. Berthold HK, Unverdorben S, Degenhardt R, Bulitta M, Gouni-Berthold I (2006) Effect of Policosanol on Lipid Levels Among Patients With Hypercholesterolemia or Combined Hyperlipidemia. JAMA 295(19):2262-9. (Pubitemid 43736576)
17. Cicero AFG, Derosa G, Parini A, Maffioli P, D'Addato S, et al. (2013) Red yeast rice improves lipid pattern, high-sensitivity C-reactive protein, and vascular remodeling parameters in moderately hypercholesterolemic Italian subjects. Nutr Res 33(8):622-8. doi: 10.1016/j.nutres.2013.05.015. Epub 2013 Jul 12.
18. Yang CW, Mousa SA (2012) The effect of red yeast rice (Monascus purpureus) in dyslipidemia and other disorders. Complement Ther Med 20(6):466-74. doi: 10.1016/j.ctim.2012.07.004. Epub 2012 Aug 17.
19. Kidd P (2011) Astaxanthin, cell membrane nutrient with diverse clinical benefits and anti-aging potential. Altern Med Rev;16(4):355-64.
20. Homocysteine Lowering Trialists' Collaboration (2005) Dose-dependent effects of folic acid on blood concentrations of homocysteine: a meta-analysis of the randomized trials. Am J Clin Nut;82(4):806-12.
21. Hu Y, Ehli EA, Kittelsrud J, Ronan PJ, Munger K, et al. (2012) Lipid-lowering effect of berberine in human subjects and rats. Phytomedicine 19(10):861-7. doi: 10.1016/j.phymed.2012.05.009. Epub 2012 Jun 26.
22. Affuso F, Mercurio V, Ruvolo A, Pirozzi C, Micillo F, et al. (2012) A nutraceutical combination improves insulin sensitivity in patients with metabolic syndrome. World J Cardiol 4(3):77-83. doi: 10.4330/wjc.v4.i3.77.
23. Pisciotta L, Bellocchio A, Bertolini S (2012) 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 11:123. doi: 10.1186/1476-511X-11-123.
24. Izzo R, de Simone G, Giudice R, Chinali M, Trimarco V, et al. (2010) Effects of nutraceuticals on prevalence of metabolic syndrome and on calculated Framingham Risk Score in individuals with dyslipidemia. J Hypertens 28(7):1482-7. doi: 10.1097/HJH.0b013e3283395208.
25. Guardamagna O, Abello F, Baracco V, Stasiowska B, Martino F (2011) The treatment of hypercholesterolemic children: efficacy and safety of a combination of red yeast rice extract and policosanols. Nutr Metab Cardiovasc Dis 21(6):424-9. doi: 10.1016/j.numecd.2009.10.015. Epub 2010 Feb 12.
26. Friedewald WT, Levy RI, Fredrickson DS (1972) Estimation of the concentration of low density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifugation. Clin Chem 18:499-502.
27. Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, et al. (1985) Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia 28:412-9. (Pubitemid 15018832)
28. Harland JI (2012) Food combinations for cholesterol lowering. Nutr Res Rev;25(2):249-66. doi: 10.1017/S0954422412000170.
29. Lee YS, Kim WS, Kim KH, Yoon MJ, Cho HJ, et al. (2006) Berberine, a natural plant product, activates AMP-activated protein kinase with beneficial metabolic effects in diabetic and insulin-resistant states. Diabetes 55(8):2256-6.
30. Xie W, Gu D, Li J, Cui K, Zhang Y (2011) Effects and action mechanisms of berberine and Rhizoma coptidis on gut microbes and obesity in high-fat diet-fed C57BL/6J Mice. PLoS ONE 6(9): e24520. doi: 10.1371/journal.pone.0024520. Epub 2011 Sep 6.
31. Cicero AFG, Rovati L, Stetnikar I (2007) Eulipidemic effects of berberine administered alone or in combination with other natural cholesterol-lowering agents. Arzneimittel-Forschung (Drug Research) 57(1):26-30. (Pubitemid 46212985)
32. Marazzi G, Cacciotti L, Pelliccia F, Iaia L, Volterrani M, et al. (2011) Long-term effects of nutraceuticals (berberine, red yeast rice, policosanol) in elderly hypercholesterolemic patients. Adv Ther 28(12):1105-13. doi: 10.1007/s12325-011-0082-5. Epub 2011 Nov 21.
33. Castelli WP, Garrison RJ, Wilson PW, Abbott RD, Kalousdian S, et al. (1986) Incidence of coronary heart disease and lipoprotein cholesterol levels, The Framingham Study. JAMA 256:2835-8. (Pubitemid 17178361)
34. Ridker PM, Rifai N, Cook NR, Bradwin G, Buring JE (2005) Non-HDL cholesterol, apolipoprotein A-I and B100, standard lipid measures, lipid ratios, and CRP as risk factors for cardiovascular disease in women. JAMA 294:326-33. (Pubitemid 41043776)
35. American Heart Association (2013) Version current February 2013. Available: http://www.heart.org/HEARTORG/Conditions/Cholesterol/ AboutCholesterol/What-Your-Cholesterol-Levels-Mean-UCM-305562-Article.jsp (accessed 22 February 2013).
36. McQueen MJ, Hawken S, Wang X, Ounpuu S, Sniderman A, et al. (2008) Lipids, lipoproteins, and apolipoproteins as risk markers of myocardial infarction in 52 countries (the INTERHEART study): a case-control study. Lancet 372 (9634):224-33. doi: 10.1016/S0140-6736(08)61076-4. (Pubitemid 351978112)
37. Parish S, Peto R, Palmer A, Clarke R, Lewington S, et al. (2009) The joint effects of apolipoprotein B, apolipoprotein A1, LDL cholesterol, and HDL cholesterol on risk: 3510 cases of acute myocardial infarction and 9805 controls. Eur Heart J 30(17):2137-46. doi: 10.1093/eurheartj/ehp221. Epub 2009 Jun 11.
38. Walldius G, Aastveit AH, Jungner I (2006) Stroke mortality and the apoB/apoAI ratio: results of the AMORIS prospective study. J Intern Med 259:259-266.
39. Canetti M, Moreira M, Mas R, Illnait J, Fernandez L, et al. (1995) A two-year study on the efficacy and tolerability of policosanol in patients with type II hyperlipoproteinaemia. Int J Clin Pharmacol Res; 15(4):159-65. (Pubitemid 26037759)
40. Li YG, Zhang F, Wang ZT, Hu ZB (2004) Identification and chemical profiling of monacolins in red yeast rice using high-performance liquid chromatography with photodiode array detector and mass spectrometry. J Pharm Biomed Anal 2004 35(5):1101-12. (Pubitemid 39140277)
41. Wang TH, Lin TF (2007) Monascus rice products. Adv Food Nutr Res; 53:123-59.
42. Lu Z, Kou W, Du B, Wu Y, Zhao S, et al. (2008) Chinese Coronary Secondary Prevention Study Group, Li S. Effect of Xuezhikang, an extract from red yeast Chinese rice, on coronary events in a Chinese population with previous myocardial infarction. Am J Cardiol 101(12):1689-93. doi: 10.1016/j.amjcard. 2008.02.056. Epub 2008 Apr 11. PubMed PMID: 18549841.
43. Kong W, Wei J, Abidi P, Lin M, Inaba S, et al. (2004) Berberine is a novel cholesterol-lowering drug working through a unique mechanism distinct from statins. Nature Medicine 10 (12): 1344-51. doi: 10.1038/nm1135. (Pubitemid 40022716)
44. Sniderman AD, Williams K, Contois JH, Monroe HM, McQueen MJ, et al. (2011) A meta-analysis of low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B as markers of cardiovascular risk. Circ Cardiovasc Qual Outcomes. 2011;4(3):337-45. doi: 10.1161/CIRCOUTCOMES.110. 959247.