Obesity Clinical Trial
Official title:
Antiplatlet Effects of Standardized Tomato Extract in Hypertensive Subjects at High Estimated Cardiovascular Risk
Verified date | June 2017 |
Source | Poznan University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The reducing the anti-aggregation properties of platelets significantly decreases the risk of myocardial infarction and the total number of cardiovascular events. In patients who have cardiovascular disease, anti-platelet therapy reduces the risk of serious vascular events. Side effects, such as bleeding, are relatively small so the benefits of anti-platelet therapy in secondary prevention exceed the risk of these side effects. According to guidelines for the treatment of arterial hypertension, PTNT 2015, patients with arterial hypertension (HA) that have a 20% or higher risk for cardiovascular events in the next 10 years, should have ASA included in their treatment to reduce this risk. It has been proved that the use of acetylsalicylic acid in secondary prevention reduces the risk of major cardiovascular events, while the benefits of ASA in primary prevention have recently been debated. The benefits of using ASA in primary prevention should always be confronted with the risk of hemorrhagic complications of this therapy According to 2016 European Guidelines on cardiovascular disease (CVD) prevention in clinical practice, anti-platelet therapy is not recommended in individuals who do not suffer from CVD, due to the increased risk of major bleeding. It is important to look for alternative anti-platelet therapy for people with cardiovascular risk factors. Standardized tomato extract (STE) does not cause side effects and may have multiple beneficial effects on total cardiovascular risk, primarily by inhibiting platelet aggregation. Since its discovery in 1999, several studies and human trials with STE have been carried out. During the last 50 years, tomato (Lycopersicon esculentum) has become a highly consumed food. The benefits of inhibiting platelet activity through diet are currently difficult to determine due to the lack of clear and comprehensive scientific data. It is difficult to specify the over activity of the plaques or their proper activity. However, there are data available that indicate the benefits of a diet containing diminishing activity of platelets (Mediterranean diet) and lowering cardiovascular risk.The investigators want to conduct a comparison of the less common STE with clinically recognized ASA. The aim of the study was to compare the anti-platelet effect of STE and ASA in hypertensive patients with high cardiovascular risk.The study highlights that STE may be an alternative, food-based strategy to control the platelets reactivity.
Status | Completed |
Enrollment | 82 |
Est. completion date | June 1, 2017 |
Est. primary completion date | January 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - informed consent - Primary hypertension Exclusion Criteria: - secondary hypertension, - white coat hypertension, - coronary artery disease, - myocardial infarction, - revascularization, - stroke, - TIA, - lower limb atherosclerosis, - congestive heart failure NYHA III-IV, - chronic kidney disease (GFR 30 ml/min), - addiction to alcohol and psychotropic substances, - active cancer, - congenital or acquired haemostatic disorder, - use of ASA, STE, or other antiplatelet agents within the last 14 days. - additional ex-clusion criteria for Group 2 were hypersensitivity to acetylsalicylic acid and ac-tive gastric or duodenal ulcers. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Beata Krasinska |
Antithrombotic Trialists' (ATT) Collaboration, Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaglioni MC, Zanchetti A. Aspirin in the primary and secondary prevention of vascular — View Citation
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Muss — View Citation
Burton-Freeman B, Sesso HD. Whole food versus supplement: comparing the clinical evidence of tomato intake and lycopene supplementation on cardiovascular risk factors. Adv Nutr. 2014 Sep;5(5):457-85. Review. — View Citation
Canene-Adams K, Campbell JK, Zaripheh S, Jeffery EH, Erdman JW Jr. The tomato as a functional food. J Nutr. 2005 May;135(5):1226-30. — View Citation
Dutta-Roy AK, Crosbie L, Gordon MJ. Effects of tomato extract on human platelet aggregation in vitro. Platelets. 2001 Jun;12(4):218-27. — View Citation
F Piepoli M. 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 b — View Citation
Fuentes E, Forero-Doria O, Carrasco G, Maricán A, Santos LS, Alarcón M, Palomo I. Effect of tomato industrial processing on phenolic profile and antiplatelet activity. Molecules. 2013 Sep 17;18(9):11526-36. doi: 10.3390/molecules180911526. — View Citation
Ghavipour M, Saedisomeolia A, Djalali M, Sotoudeh G, Eshraghyan MR, Moghadam AM, Wood LG. Tomato juice consumption reduces systemic inflammation in overweight and obese females. Br J Nutr. 2013 Jun;109(11):2031-5. doi: 10.1017/S0007114512004278. Epub 2012 — View Citation
Hu FB, Rimm EB, Stampfer MJ, Ascherio A, Spiegelman D, Willett WC. Prospective study of major dietary patterns and risk of coronary heart disease in men. Am J Clin Nutr. 2000 Oct;72(4):912-21. — View Citation
Jacques PF, Lyass A, Massaro JM, Vasan RS, D'Agostino RB Sr. Relationship of lycopene intake and consumption of tomato products to incident CVD. Br J Nutr. 2013 Aug 28;110(3):545-51. doi: 10.1017/S0007114512005417. Epub 2013 Jan 15. — View Citation
Navarrete S, Alarcón M, Palomo I. Aqueous Extract of Tomato (Solanum lycopersicum L.) and Ferulic Acid Reduce the Expression of TNF-a and IL-1ß in LPS-Activated Macrophages. Molecules. 2015 Aug 21;20(8):15319-29. doi: 10.3390/molecules200815319. — View Citation
O'Kennedy N, Crosbie L, van Lieshout M, Broom JI, Webb DJ, Duttaroy AK. Effects of antiplatelet components of tomato extract on platelet function in vitro and ex vivo: a time-course cannulation study in healthy humans. Am J Clin Nutr. 2006 Sep;84(3):570-9 — View Citation
O'Kennedy N, Crosbie L, Whelan S, Luther V, Horgan G, Broom JI, Webb DJ, Duttaroy AK. Effects of tomato extract on platelet function: a double-blinded crossover study in healthy humans. Am J Clin Nutr. 2006 Sep;84(3):561-9. — View Citation
O'Kennedy N, Raederstorff D, Duttaroy AK. Fruitflow(®): the first European Food Safety Authority-approved natural cardio-protective functional ingredient. Eur J Nutr. 2017 Mar;56(2):461-482. doi: 10.1007/s00394-016-1265-2. Epub 2016 Jul 7. Review. — View Citation
Schwager J, Richard N, Mussler B, Raederstorff D. Tomato Aqueous Extract Modulates the Inflammatory Profile of Immune Cells and Endothelial Cells. Molecules. 2016 Jan 29;21(2):168. doi: 10.3390/molecules21020168. — View Citation
Tektonidis TG, Åkesson A, Gigante B, Wolk A, Larsson SC. A Mediterranean diet and risk of myocardial infarction, heart failure and stroke: A population-based cohort study. Atherosclerosis. 2015 Nov;243(1):93-8. doi: 10.1016/j.atherosclerosis.2015.08.039. — View Citation
Tektonidis TG, Åkesson A, Gigante B, Wolk A, Larsson SC. Adherence to a Mediterranean diet is associated with reduced risk of heart failure in men. Eur J Heart Fail. 2016 Mar;18(3):253-9. doi: 10.1002/ejhf.481. Epub 2016 Jan 18. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inhibition of platelet function in response to anti-platelet therapy STE and ASA | The platelet inhibition after STE and ASA therapy (VerifyNow Aspirin for ASA and STE Groups and VerifyNow P2Y12 for STE Group only) The platelet reactivity measurements will be performed using the VerifyNow Tests (Accumetrics Inc., USA) method. | 1 month | |
Secondary | The reduction in BP after STE therapy | The reduction in office BP (measured three times in standard conditions) and in 24-hour ABPM parameters | 1 month |
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