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Completed

NCT Number: NCT01330680

Genetic Determinants of Cardiovascular Response to Coffee Drinking

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).

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Key information

Conditions

Caffeine

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Chieti, 66100, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coffee

Dietary Supplement

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

Decaffeinated coffee

Dietary Supplement

40 mL dose of decaffeinated coffee

Primary outcomes

  1. Change in platelet aggregation

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

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

  2. Change in cognitive tasks measures

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

    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).

  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

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Collaborators

  • Institute for Scientific Information on Coffee
  • Italian Istituto Nazionale Ricerche Cardiovascolari

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2010
First posted
Apr 7, 2011
Registry last updated
Apr 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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