Caffeine Clinical Trial
Official title:
Genetic Determinants of Cardiovascular Response to Coffee Drinking
Verified date | March 2011 |
Source | G. d'Annunzio University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
Cardiovascular and neuropsychologic effects of coffee are still debated. The precise
mechanism underlying the actions of caffeine on the cardiovascular and neuropsychologic
systems is incompletely understood and a considerable variability in the response to coffee
drinking was observed, in part ascribable to a genetic trait.
The aim of the study is to evaluate acute cardiovascular and neuropsychologic effects of
coffee and explore whether such effects are influenced by the genetic asset of caffeine
metabolism (by a polymorphisms of cytochrome P450 1A2), adenosine metabolism (by
polymorphisms of adenosine receptor and adenosine monophosphate deaminase) or catecholamine
receptors (by polymorphisms of adrenergic receptors).
Status | Completed |
Enrollment | 110 |
Est. completion date | September 2010 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Age between 18 and 40 years - Males (to avoid variation due to female hormonal cycle) - No known active ongoing disease (apparent good health) - Non-smokers (to avoid contributory effects of nicotine or other tobacco alkaloids to caffeine effects or tolerance) - Average coffee intake (not less than one cup/day and not greater than three cups/day) Exclusion Criteria: - Treatment with any drug with known activity on the adrenergic system - Hypertension - Therapy with sympathomimetic drugs, theophylline, alpha- or beta-blockers, any antihypertensive therapy - Body mass index (BMI) > 30 kg/m2 (obesity) - BMI < 18.5 kg/m2 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Italy | Institute of Cardiology - Center of Excellence on Aging, G. d'Annunzio University | Chieti |
Lead Sponsor | Collaborator |
---|---|
G. d'Annunzio University | Institute for Scientific Information on Coffee, Italian Istituto Nazionale Ricerche Cardiovascolari |
Italy,
1) Hartley TR, Lovallo WR, Whitsett TL. Cardiovascular effects of caffeine in men and women. Am J Cardiol 2004;93:1022-6. 2) Lopez-Garcia E, van Dam RM, Willett WC, et al. Coffee consumption and coronary heart disease in men and women: a prospective cohort study. Circulation 2006;113:2045-53. 3) Silletta MG, Marfisi R, Levantesi G, et al. Coffee consumption and risk of cardiovascular events after acute myocardial infarction: results from the GISSI (Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico)-Prevenzione trial. Circulation 2007;116:2944-51. 4) Yang A, Palmer AA, de Wit H. Genetics of caffeine consumption and responses to caffeine. Psychopharmacology (Berl) 2010;211:245-57. 5) Cornelis MC, El-Sohemy A, Kabagambe EK, Campos H. Coffee, CYP1A2 genotype, and risk of myocardial infarction. JAMA 2006;295:1135-41. 6) Fredholm BB. Astra Award Lecture. Adenosine, adenosine receptors and the actions of caffeine. Pharmacol Toxicol 1995;76:93-101. 7) Anderson JL, Habashi J, Carlquist JF, et al. A common variant of the AMPD1 gene predicts improved cardiovascular survival in patients with coronary artery disease. J Am Coll Cardiol 2000;36:1248-52. 8) Snapir A, Heinonen P, Tuomainen TP, et al. An insertion/deletion polymorphism in the alpha2B-adrenergic receptor gene is a novel genetic risk factor for acute coronary events. J Am Coll Cardiol 2001;37:1516-22. 9) Bengtsson K, Melander O, Orho-Melander M, et al. Polymorphism in the beta(1)-adrenergic receptor gene and hypertension. Circulation 2001;104:187-90. 10) White HL, Maqbool A, McMahon AD, et al. An evaluation of the beta-1 adrenergic receptor Arg389Gly polymorphism in individuals at risk of coronary events. A WOSCOPS substudy. Eur Heart J 2002;23:1087-92. 11) Brodde OE. Beta-1 and beta-2 adrenoceptor polymorphisms: functional importance, impact on cardiovascular diseases and drug responses. Pharmacol Ther 2008;117:1-29.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in platelet aggregation | Light transmission aggregometry (LTA) induced by ADP and apinephrine. Platelet function analyzer (PFA) by collagen-ADP and collagen-epinephrine cartridges. | From baseline to 30 minutes and 2 hours after coffee or decaffeinated alternatively | No |
Primary | Change in cognitive tasks measures | Low intensity task of focused attention and choice reaction times (Categorical Search Task). More demanding response interference tasks (Letter Flanker Task). Classic interference task (Stroop Test). |
From 30 minutes until 2 hours after coffee or decaffeinated alternatively | No |
Primary | Change in blood pressure | From baseline until 2 hours after coffee or decaffeinated alternatively | No | |
Primary | Change in heart rate | From baseline until 2 hours after coffee or decaffeinated alternatively | No | |
Secondary | Change in plasma caffeine concentration | From baseline to 30 minutes and 2 hours after coffee or decaffeinated alternatively | No | |
Secondary | Change in plasma adrenaline and noradrenaline concentration | From baseline to 30 minutes and 2 hours after coffee or decaffeinated alternatively | No |
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