Clinical trial NCT01168700 - References

Metabolic Syndrome — Trial of Supplementation With Aged Garlic Extract to Improve Endothelial Function in Patients With Metabolic Syndrome

Citation(s)

•   Accini JL, Sotomayor A, Trujillo F, Barrera JG, Bautista L, López-Jaramillo P
  Colombian study to assess the use of noninvasive determination of endothelium-mediated vasodilatation (CANDEV). Normal values and factors associated. Endothelium. 2001;8(2):157-66.
•   Alberti KG, Zimmet PZ
  Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53.
•   Amagase H, Petesch BL, Matsuura H, Kasuga S, Itakura Y
  Intake of garlic and its bioactive components. J Nutr. 2001 Mar;131(3s):955S-62S. Review.
•   Arenas IA, Xu Y, Lopez-Jaramillo P, Davidge ST
  Angiotensin II-induced MMP-2 release from endothelial cells is mediated by TNF-alpha. Am J Physiol Cell Physiol. 2004 Apr;286(4):C779-84. Epub 2003 Nov 26.
•   Borek C
  Antioxidant health effects of aged garlic extract. J Nutr. 2001 Mar;131(3s):1010S-5S. Review.
•   Celermajer DS, Sorensen KE, Gooch VM, Spiegelhalter DJ, Miller OI, Sullivan ID, Lloyd JK, Deanfield JE
  Non-invasive detection of endothelial dysfunction in children and adults at risk of atherosclerosis. Lancet. 1992 Nov 7;340(8828):1111-5.
•   Chi MS, Koh ET, Stewart TJ
  Effects of garlic on lipid metabolism in rats fed cholesterol or lard. J Nutr. 1982 Feb;112(2):241-8.
•   Ford ES, Giles WH, Dietz WH
  Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA. 2002 Jan 16;287(3):356-9.
•   García RG, Celedón J, Sierra-Laguado J, Alarcón MA, Luengas C, Silva F, Arenas-Mantilla M, López-Jaramillo P
  Raised C-reactive protein and impaired flow-mediated vasodilation precede the development of preeclampsia. Am J Hypertens. 2007 Jan;20(1):98-103.
•   Garcia RG, Perez M, Maas R, Schwedhelm E, Böger RH, López-Jaramillo P
  Plasma concentrations of asymmetric dimethylarginine (ADMA) in metabolic syndrome. Int J Cardiol. 2007 Nov 15;122(2):176-8. Epub 2007 Jan 16.
•   Gebhardt R
  Inhibition of cholesterol biosynthesis by a water-soluble garlic extract in primary cultures of rat hepatocytes. Arzneimittelforschung. 1991 Aug;41(8):800-4.
•   Gebhardt R
  Multiple inhibitory effects of garlic extracts on cholesterol biosynthesis in hepatocytes. Lipids. 1993 Jul;28(7):613-9.
•   Grundy SM, Brewer HB Jr, Cleeman JI, Smith SC Jr, Lenfant C; American Heart Association; National Heart, Lung, and Blood Institute
  Definition of metabolic syndrome: Report of the National Heart, Lung, and Blood Institute/American Heart Association conference on scientific issues related to definition. Circulation. 2004 Jan 27;109(3):433-8. Review.
•   Karlsson C, Lindell K, Ottosson M, Sjöström L, Carlsson B, Carlsson LM
  Human adipose tissue expresses angiotensinogen and enzymes required for its conversion to angiotensin II. J Clin Endocrinol Metab. 1998 Nov;83(11):3925-9.
•   Kerwin JF Jr, Lancaster JR Jr, Feldman PL
  Nitric oxide: a new paradigm for second messengers. J Med Chem. 1995 Oct 27;38(22):4343-62. Review.
•   Kiesewetter H, Jung F, Jung EM, Mroweitz C, Koscielny J, Wenzel E
  Effect of garlic on platelet aggregation in patients with increased risk of juvenile ischaemic attack. Eur J Clin Pharmacol. 1993;45(4):333-6.
•   Lanas F, Avezum A, Bautista LE, Diaz R, Luna M, Islam S, Yusuf S; INTERHEART Investigators in Latin America
  Risk factors for acute myocardial infarction in Latin America: the INTERHEART Latin American study. Circulation. 2007 Mar 6;115(9):1067-74.
•   Lopez AD
  Assessing the burden of mortality from cardiovascular diseases. World Health Stat Q. 1993;46(2):91-6.
•   López-Jaramillo P, Casas JP, Bautista L, Serrano NC, Morillo CA
  An integrated proposal to explain the epidemic of cardiovascular disease in a developing country. From socioeconomic factors to free radicals. Cardiology. 2001;96(1):1-6. Review.
•   López-Jaramillo P, Díaz LA, Pardo A, Parra G, Jaimes H, Chaudhuri G
  Estrogen therapy increases plasma concentrations of nitric oxide metabolites in postmenopausal women but increases flow-mediated vasodilation only in younger women. Fertil Steril. 2004 Dec;82(6):1550-5.
•   López-Jaramillo P, Herrera E, Garcia RG, Camacho PA, Castillo VR
  Inter-relationships between body mass index, C-reactive protein and blood pressure in a Hispanic pediatric population. Am J Hypertens. 2008 May;21(5):527-32. doi: 10.1038/ajh.2007.86. Epub 2008 Mar 6.
•   López-Jaramillo P, Silva SY, Rodríguez-Salamanca N, Duràn A, Mosquera W, Castillo V
  Are nutrition-induced epigenetic changes the link between socioeconomic pathology and cardiovascular diseases? Am J Ther. 2008 Jul-Aug;15(4):362-72. doi: 10.1097/MJT.0b013e318164bf9c.
•   Lundgren M, Svensson M, Lindmark S, Renström F, Ruge T, Eriksson JW
  Fat cell enlargement is an independent marker of insulin resistance and 'hyperleptinaemia'. Diabetologia. 2007 Mar;50(3):625-33. Epub 2007 Jan 10.
•   Macan H, Uykimpang R, Alconcel M, Takasu J, Razon R, Amagase H, Niihara Y
  Aged garlic extract may be safe for patients on warfarin therapy. J Nutr. 2006 Mar;136(3 Suppl):793S-795S.
•   Moncada S, Palmer RM, Higgs EA
  Nitric oxide: physiology, pathophysiology, and pharmacology. Pharmacol Rev. 1991 Jun;43(2):109-42. Review.
•   Palmer RM, Ferrige AG, Moncada S
  Nitric oxide release accounts for the biological activity of endothelium-derived relaxing factor. Nature. 1987 Jun 11-17;327(6122):524-6.
•   Perez M, Casas JP, Cubillos-Garzón LA, Serrano NC, Silva F, Morillo CA, López-Jaramillo P
  Using waist circumference as a screening tool to identify Colombian subjects at cardiovascular risk. Eur J Cardiovasc Prev Rehabil. 2003 Oct;10(5):328-35.
•   Pi-Sunyer FX
  The obesity epidemic: pathophysiology and consequences of obesity. Obes Res. 2002 Dec;10 Suppl 2:97S-104S. Review.
•   Pineda CA
  Síndrome Metabólico: definición, historia, criterios. Colombia Médica. 2008; 39 : 96-106.
•   Reaven GM
  Banting lecture 1988. Role of insulin resistance in human disease. Diabetes. 1988 Dec;37(12):1595-607. Review.
•   Rotter V, Nagaev I, Smith U
  Interleukin-6 (IL-6) induces insulin resistance in 3T3-L1 adipocytes and is, like IL-8 and tumor necrosis factor-alpha, overexpressed in human fat cells from insulin-resistant subjects. J Biol Chem. 2003 Nov 14;278(46):45777-84. Epub 2003 Sep 2.
•   Rueda-Clausen C, Bolivar IC, Calderon J, Fernandez-Alfonso MS, Carreño M, Cachofeiro V, et al
  Abdominal obesity is related with changes in vascular reactivity of human internal mammary artery independently of other cardiovascular risk factors. Atherosclerosis Sup. 2007; 8:11.
•   Sendl A, Schliack M, Löser R, Stanislaus F, Wagner H
  Inhibition of cholesterol synthesis in vitro by extracts and isolated compounds prepared from garlic and wild garlic. Atherosclerosis. 1992 May;94(1):79-85.
•   Shoetan A, Augusti KT, Joseph PK
  Hypolipidemic effects of garlic oil in rats fed ethanol and a high lipid diet. Experientia. 1984 Mar 15;40(3):261-3.
•   Slowing K, Ganado P, Sanz M, Ruiz E, Tejerina T
  Study of garlic extracts and fractions on cholesterol plasma levels and vascular reactivity in cholesterol-fed rats. J Nutr. 2001 Mar;131(3s):994S-9S.
•   Srivastava KC, Tyagi OD
  Effects of a garlic-derived principle (ajoene) on aggregation and arachidonic acid metabolism in human blood platelets. Prostaglandins Leukot Essent Fatty Acids. 1993 Aug;49(2):587-95.
•   Steiner M, Khan AH, Holbert D, Lin RI
  A double-blind crossover study in moderately hypercholesterolemic men that compared the effect of aged garlic extract and placebo administration on blood lipids. Am J Clin Nutr. 1996 Dec;64(6):866-70.
•   Tadi P, Teel RW, Lau B
  Anticandidal and anticarcinogenic potentials of garlic.1990: Int. Clin. Nutr. Rev. 10: 423-429.
•   Teran E, Escudero C, Moya W, Flores M, Vallance P, Lopez-Jaramillo P
  Elevated C-reactive protein and pro-inflammatory cytokines in Andean women with pre-eclampsia. Int J Gynaecol Obstet. 2001 Dec;75(3):243-9.
•   Welch C, Wuarin L, Sidell N
  Antiproliferative effect of the garlic compound S-allyl cysteine on human neuroblastoma cells in vitro. Cancer Lett. 1992 Apr 30;63(3):211-9.
•   Williams MJ, Sutherland WH, McCormick MP, Yeoman DJ, de Jong SA
  Aged garlic extract improves endothelial function in men with coronary artery disease. Phytother Res. 2005 Apr;19(4):314-9.
•   World Health Organization
  Deaths from coronary heart disease. The Atlas of Heart Disease and Stroke 2006; Available at: http://www.who.int/cardiovascular_diseases/en/cvd_atlas_14_deathHD.pdf.
•   World Health Organization
  Global burden of coronary heart disease. The Atlas of Heart Disease and Stroke 2006; Available at: http://www.who.int/cardiovascular_diseases/en/cvd_atlas_13_coronaryHD.pdf
•   Yamasaki T, Li L, Lau B
  Garlic compounds protect vascular endothelial cells from hydrogen peroxide-induced oxidant injury. 1993: Phytother. Res. 8: 408-412.
•   Yeh YY, Yeh SM
  Garlic reduces plasma lipids by inhibiting hepatic cholesterol and triacylglycerol synthesis. Lipids. 1994 Mar;29(3):189-93.
•   Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators
  Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52.
•   Yusuf S, Reddy S, Ounpuu S, Anand S
  Global burden of cardiovascular diseases: part I: general considerations, the epidemiologic transition, risk factors, and impact of urbanization. Circulation. 2001 Nov 27;104(22):2746-53. Review.
•   ZLATKIS A, ZAK B, BOYLE AJ
  A new method for the direct determination of serum cholesterol. J Lab Clin Med. 1953 Mar;41(3):486-92.

A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF THE SUPPLEMENTATION WITH KIOLIC® IN PATIENTS WITH DIAGNOSIS OF METABOLIC SYNDROME TO IMPROVE ENDOTHELIAL FUNCTION AND INFLAMMATORY STATE. "KYMES"

Details for clinical trial NCT01168700