Genetic Determinants of Cardiovascular Response to Coffee Drinking

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2010-09-30

Brief Summary

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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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Detailed Description

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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).

Conditions

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Caffeine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Coffee

Group Type EXPERIMENTAL

Coffee

Intervention Type DIETARY_SUPPLEMENT

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

Decaffeinated coffee

Group Type ACTIVE_COMPARATOR

Decaffeinated coffee

Intervention Type DIETARY_SUPPLEMENT

40 mL dose of decaffeinated coffee

Interventions

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Coffee

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

Intervention Type DIETARY_SUPPLEMENT

Decaffeinated coffee

40 mL dose of decaffeinated coffee

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes