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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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Discovered thousands of years ago, coffee is among the most consumed beverages in the world. The relationship between coffee and cardiovascular risk, more specifically coronary artery disease, is controversial. Platelet aggregation and its relationship with coffee is also controversial. The investigators propose this study to evaluate the relationship between coffee and platelet aggregability in patients with coronary artery disease.
30 patients with coronary artery disease (proven by previous coronary angiography) will be selected at the Heart Institute (InCor USP) for the study. Patients will be instructed to abstain from caffeinated beverages during 22 days. After this period, one group will consume caffeinated coffee during 28 days, followed by decaffeinated coffee during more 28 days and another group will start with decaffeinated coffee followed by caffeinated. All participants will receive "Nespresso" coffee maker "Essenza" model. The coffee "Nespresso blend voluto" will be provided (caffeinated and decaffeinated). The patients will have to take four cups of espresso per day (three cups a day for patients aged 65 and over). The investigators will evaluate platelet aggregation by Multiplate® (ASPI, ADP and arachidonic acid) and by optical aggregometry (ADP and arachidonic acid).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeinated coffee | Other | Patients will be instructed to abstain from caffeinated beverages during 22 days. After this period, they will consume caffeinated coffee during 28 days, followed by decaffeinated coffee during more 28 days. |
|
| Decaffeinated coffee | Other | Patients will be instructed to abstain from caffeinated beverages during 22 days. After this period, they will consume decaffeinated coffee during 28 days, followed by caffeinated coffee during more 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coffee | Dietary Supplement | Participants will receive "Nespresso" coffee maker "Essenza" model. The coffee "Nespresso blend voluto" will be provided (caffeinated and decaffeinated). The patients will have to take four cups of espresso per day (three cups a day for patients aged 65 and over). |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet aggregation evaluated by Multiplate® ASPI | Compare the inhibition of platelet aggregation evaluated by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period). | 8 weeks (±1) |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet aggregation evaluated by Multiplate® ADP e Arachidonic acid | Compare the inhibition of platelet aggregation evaluated by Multiplate® ADP and Arachidonic acid after 4 weeks of caffeinated coffee consumption with platelet aggregability after 4 weeks of decaffeinated coffee consumption. | 4 week (±1) |
| Measure | Description | Time Frame |
|---|---|---|
| Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Elderly (≥65 years) and non-elderly | Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Elderly (≥65 years) and non-elderly | 8 weeks (±1) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute (InCor) / University of São Paulo | São Paulo | São Paulo | 05403-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Adriana Farah. Coffee: Emerging Health Effects and Disease Prevention. Coffee Constituints. 2012. John Wiley & Sons, Inc. Published by Blackwell Publishing Ltd. | ||
| 19026304 | Background | Greenberg JA, Chow G, Ziegelstein RC. Caffeinated coffee consumption, cardiovascular disease, and heart valve disease in the elderly (from the Framingham Study). Am J Cardiol. 2008 Dec 1;102(11):1502-8. doi: 10.1016/j.amjcard.2008.07.046. Epub 2008 Sep 11. | |
| 18707777 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003069 | Coffee |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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This is a prospective, open label, controlled study
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|
| Platelet aggregation evaluated by Multiplate® ADP |
Compare the inhibition of platelet aggregation evaluated by Multiplate® ADP after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period). |
| 8 weeks (±1) |
| Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid) 1 | Compare platelet aggregability by optical aggregometry (ADP and arachidonic acid) after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period). | 8 weeks (±1) |
| Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid) | Compare the inhibition of platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid) after 4 weeks of caffeinated coffee consumption with platelet aggregability after 4 weeks of decaffeinated coffee consumption. | 4 weeks (±1) |
| Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Feminine and masculine genders | Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Feminine and masculine genders | 8 weeks (±1) |
| Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Renal dysfunction (Creatinine > 1.8mg/dl) and without renal dysfunction | Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Renal dysfunction (Creatinine > 1.8mg/dl) and without renal dysfunction | 8 weeks (±1) |
| Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Obese (BMI≥30 Kg/m2) and non-obese | Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Obese (BMI≥30 Kg/m2) and non-obese | 8 weeks (±1) |
| Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Glycemia >99mg/dl and no change in fasting glycemia | Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Glycemia >99mg/dl and no change in fasting glycemia | 8 weeks (±1) |
| Compare platelet aggregation by Multiplate® ASPI in the following subgroup: With of Beta-blocker and without | Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: With of Beta-blocker and without | 8 weeks (±1) |
| Compare platelet aggregation by Multiplate® ASPI in the following subgroup: With statin and without | Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: With statin and without | 8 weeks (±1) |
| Delta change of platelet aggregation and Fraction of immature platelets (PFI) | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Fraction of immature platelets (PFI) | 8 weeks (±1) |
| Delta change of platelet aggregation and Small-LDL | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Small-LDL | 8 weeks (±1) |
| Delta change of platelet aggregation and Fasting glycemia | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Fasting glycemia | 8 weeks (±1) |
| Delta change of platelet aggregation and Glycated hemoglobin | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Glycated hemoglobin | 8 weeks (±1) |
| Delta change of platelet aggregation and Lipid profile | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Lipid profile (total cholesterol, HDL [high-density lipoprotein], LDL [low-density lipoprotein], very low-density lipoprotein [VLDL] and triglycerides) | 8 weeks (±1) |
| Delta change of platelet aggregation and Lipoprotein a | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Lipoprotein a - Lp(a) | 8 weeks (±1) |
| Delta change of platelet aggregation and Sirtuins | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Sirtuins | 8 weeks (±1) |
| Delta change of platelet aggregation and Advanced glycation final product (RAGE) receiver | Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Advanced glycation final product (RAGE) receiver | 8 weeks (±1) |
| Background |
| Wu JN, Ho SC, Zhou C, Ling WH, Chen WQ, Wang CL, Chen YM. Coffee consumption and risk of coronary heart diseases: a meta-analysis of 21 prospective cohort studies. Int J Cardiol. 2009 Nov 12;137(3):216-25. doi: 10.1016/j.ijcard.2008.06.051. Epub 2008 Aug 15. |
| 16636169 | Background | Lopez-Garcia E, van Dam RM, Willett WC, Rimm EB, Manson JE, Stampfer MJ, Rexrode KM, Hu FB. Coffee consumption and coronary heart disease in men and women: a prospective cohort study. Circulation. 2006 May 2;113(17):2045-53. doi: 10.1161/CIRCULATIONAHA.105.598664. Epub 2006 Apr 24. |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |