Genetic Determinants of Cardiovascular Response to Coffee Drinking

This study has been completed.
Sponsor:
Collaborators:
Institute for Scientific Information on Coffee (ISIC)
Italian Istituto Nazionale Ricerche Cardiovascolari
Information provided by:
G. d'Annunzio University
ClinicalTrials.gov Identifier:
NCT01330680
First received: March 29, 2011
Last updated: April 6, 2011
Last verified: March 2011
  Purpose

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).


Condition Intervention
Caffeine
Dietary Supplement: Coffee
Dietary Supplement: Decaffeinated coffee

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Genetic Determinants of Cardiovascular Response to Coffee Drinking

Resource links provided by NLM:


Further study details as provided by G. d'Annunzio University:

Primary Outcome Measures:
  • Change in platelet aggregation [ Time Frame: From baseline to 30 minutes and 2 hours after coffee or decaffeinated alternatively ] [ Designated as safety issue: No ]
    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 [ Time Frame: From 30 minutes until 2 hours after coffee or decaffeinated alternatively ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline until 2 hours after coffee or decaffeinated alternatively ] [ Designated as safety issue: No ]
  • Change in heart rate [ Time Frame: From baseline until 2 hours after coffee or decaffeinated alternatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in plasma caffeine concentration [ Time Frame: From baseline to 30 minutes and 2 hours after coffee or decaffeinated alternatively ] [ Designated as safety issue: No ]
  • Change in plasma adrenaline and noradrenaline concentration [ Time Frame: From baseline to 30 minutes and 2 hours after coffee or decaffeinated alternatively ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: September 2004
Study Completion Date: September 2010
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coffee Dietary Supplement: Coffee
40 mL dose of a decaffeinated preparation spiked with the addition of caffeine, at a dose of 3 mg/kg
Active Comparator: Decaffeinated coffee Dietary Supplement: Decaffeinated coffee
40 mL dose of decaffeinated coffee

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).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330680

Locations
Italy
Institute of Cardiology - Center of Excellence on Aging, G. d'Annunzio University
Chieti, Italy, 66100
Sponsors and Collaborators
G. d'Annunzio University
Institute for Scientific Information on Coffee (ISIC)
Italian Istituto Nazionale Ricerche Cardiovascolari
  More Information

No publications provided by G. d'Annunzio University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Raffaele De Caterina/MD, PhD, Institute of Cardiology, G. d'Annunzio University of Chieti
ClinicalTrials.gov Identifier: NCT01330680     History of Changes
Other Study ID Numbers: C041003
Study First Received: March 29, 2011
Last Updated: April 6, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by G. d'Annunzio University:
coffee
caffeine
blood pressure
nutrigenetics
gene polymorphisms
Acute Cardiovascular and Neuropsychologic Effects

ClinicalTrials.gov processed this record on July 31, 2014