Genetic Determinants of Cardiovascular Response to Coffee Drinking

Not Applicable

Completed

• Conditions: Caffeine
• Interventions: Dietary Supplement: Coffee; Dietary Supplement: Decaffeinated coffee

• Registration Number: NCT01330680
• Lead Sponsor: G. d'Annunzio University

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).

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).

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2006-12
• Study Completion: 2010-09
• Status Verified: 2011-03
• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-04-06
• Last Update Submitted: 2011-04-06
• Study First Posted: 2011-04-07
• Last Update Posted: 2011-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Coffee	Coffee	-
Decaffeinated coffee	Decaffeinated coffee	-

Primary Outcome Measures

Name	Time	Method
Change in platelet aggregation	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.
Change in cognitive tasks measures	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).
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of Cardiology - Center of Excellence on Aging, G. d'Annunzio University; 🇮🇹 Chieti, Italy