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CompletedNCT01330680Updated Apr 7, 2011

Genetic Determinants of Cardiovascular Response to Coffee Drinking

An interventional study of Coffee and Decaffeinated coffee in Caffeine, sponsored by G. d'Annunzio University. Completed at 1 site in Italy. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-07.

Sponsored by G. d'Annunzio University · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study summary

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).

Read the detailed description

Coffee is among the most widely consumed beverages worldwide. Despite the relationship between coffee consumption and the incidence of cardiovascular disease has been studied extensively, the effects of this drink on the cardiovascular apparatus and its role as a risk factor for coronary heart disease are still debated. Moreover, the effect of coffee on attention, sleep changes, anxiety and panic disorders was studied but a great variability was observed.

Many of the known or suspected cardiovascular and neuropsychologic effects of coffee have been attributed to caffeine. The main mechanism of action of caffeine is to antagonize adenosine receptors; a secondary effect is the inhibition of phosphodiesterases, with the subsequent accumulation of cyclic adenosine monophosphate and a intensification of the effects of catecholamines.

It is also well known that there is a considerable variability in the cardiovascular and neuropsychologic response to coffee drinking, explaining the inconsistency between different effects observed in the various studies. This variability may have a genetic basis.

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).

02

Conditions studied

  • Caffeine

Keywords

  • coffee
  • caffeine
  • blood pressure
  • nutrigenetics
  • gene polymorphisms
  • Acute Cardiovascular and Neuropsychologic Effects
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In context

Lead sponsor

G. d'Annunzio University is the lead sponsor of 62 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Coffee

    Dietary Supplement: Coffee

  • Active comparator
    Decaffeinated coffee

    Dietary Supplement: Decaffeinated coffee

Interventions

  • Dietary supplementCoffee

    40 mL dose of a decaffeinated preparation spiked with the addition of caffeine, at a dose of 3 mg/kg

  • Dietary supplementDecaffeinated coffee

    40 mL dose of decaffeinated coffee

06

What researchers measure

Primary outcomes

  1. Change in platelet aggregation

    Light transmission aggregometry (LTA) induced by ADP and apinephrine. Platelet function analyzer (PFA) by collagen-ADP and collagen-epinephrine cartridges.

    Time frame: From baseline to 30 minutes and 2 hours after coffee or decaffeinated alternatively

  2. 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).

    Time frame: From 30 minutes until 2 hours after coffee or decaffeinated alternatively

  3. Change in blood pressure

    Time frame: From baseline until 2 hours after coffee or decaffeinated alternatively

  4. Change in heart rate

    Time frame: From baseline until 2 hours after coffee or decaffeinated alternatively

Secondary outcomes

  1. Change in plasma caffeine concentration

    Time frame: From baseline to 30 minutes and 2 hours after coffee or decaffeinated alternatively

  2. Change in plasma adrenaline and noradrenaline concentration

    Time frame: From baseline to 30 minutes and 2 hours after coffee or decaffeinated alternatively

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Study locations

1 site
  • Institute of Cardiology - Center of Excellence on Aging, G. d'Annunzio University
    Chieti, 66100, Italy
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References and documents

Publications

  • 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.
  • Renda G, Zimarino M, Antonucci I, Tatasciore A, Ruggieri B, Bucciarelli T, Prontera T, Stuppia L, De Caterina R. Genetic determinants of blood pressure responses to caffeine drinking. Am J Clin Nutr. 2012 Jan;95(1):241-8. doi: 10.3945/ajcn.111.018267. Epub 2011 Dec 14. PubMed 22170367 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01330680
Lead sponsor
G. d'Annunzio University
Collaborators
Institute for Scientific Information on Coffee, Italian Istituto Nazionale Ricerche Cardiovascolari
First posted
Apr 7, 2011
Start date
Sep 2004
Primary completion
Dec 2006
Completion
Sep 2010
Last update
Apr 7, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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