NCT01330680

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 7, 2011

Completed
Last Updated

April 7, 2011

Status Verified

March 1, 2011

Enrollment Period

2.2 years

First QC Date

March 29, 2011

Last Update Submit

April 6, 2011

Conditions

Caffeine

Keywords

coffeecaffeineblood pressurenutrigeneticsgene polymorphismsAcute Cardiovascular and Neuropsychologic Effects

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • Change in blood pressure

    From baseline until 2 hours after coffee or decaffeinated alternatively

  • Change in heart rate

    From baseline until 2 hours after coffee or decaffeinated alternatively

Secondary Outcomes (2)

  • Change in plasma caffeine concentration

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

  • Change in plasma adrenaline and noradrenaline concentration

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

Study Arms (2)

Coffee

EXPERIMENTAL
Dietary Supplement: Coffee

Decaffeinated coffee

ACTIVE COMPARATOR
Dietary Supplement: Decaffeinated coffee

Interventions

CoffeeDIETARY_SUPPLEMENT

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

Coffee
Decaffeinated coffeeDIETARY_SUPPLEMENT

40 mL dose of decaffeinated coffee

Decaffeinated coffee

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Cardiology - Center of Excellence on Aging, G. d'Annunzio University

Chieti, 66100, Italy

Location

Related Publications (2)

  • 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.

    BACKGROUND

  • 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.

    PMID: 22170367DERIVED

MeSH Terms

Interventions

Coffee

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 29, 2011

First Posted

April 7, 2011

Study Start

September 1, 2004

Primary Completion

December 1, 2006

Study Completion

September 1, 2010

Last Updated

April 7, 2011

Record last verified: 2011-03

Locations

IT(1)