CaffeineNCT01330680
Genetic Determinants of Cardiovascular Response to Coffee Drinking
A study testing Coffee and Decaffeinated coffee in people with Caffeine, run by G. d'Annunzio University at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Caffeine
- What is being tested?
- Coffee and Decaffeinated coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2004to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Cardiology - Center of Excellence on Aging, G. d'Annunzio University
Chieti, 66100
About this study
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).
Read the 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).
- Conditions
- Caffeine
- Being tested
- Coffee, Decaffeinated coffee
- Keywords
- coffee, caffeine, blood pressure, nutrigenetics, gene polymorphisms, Acute Cardiovascular and Neuropsychologic Effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoffeeDietary supplement
40 mL dose of a decaffeinated preparation spiked with the addition of caffeine, at a dose of 3 mg/kg
Decaffeinated coffeeDietary supplement
40 mL dose of decaffeinated coffee
| Study group | Role | What they receive |
|---|---|---|
| Coffee | Experimental | Not described Receives: Dietary Supplement: Coffee |
| Decaffeinated coffee | Active comparator | Not described Receives: Dietary Supplement: Decaffeinated coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in platelet aggregation
Light transmission aggregometry (LTA) induced by ADP and apinephrine. Platelet function analyzer (PFA) by collagen-ADP and collagen-epinephrine cartridges.
Measured: 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).
Measured: From 30 minutes until 2 hours after coffee or decaffeinated alternatively
Change in blood pressure
Measured: From baseline until 2 hours after coffee or decaffeinated alternatively
Change in heart rate
Measured: From baseline until 2 hours after coffee or decaffeinated alternatively
Secondary outcomes (2)
Change in plasma caffeine concentration
Measured: From baseline to 30 minutes and 2 hours after coffee or decaffeinated alternatively
Change in plasma adrenaline and noradrenaline concentration
Measured: From baseline to 30 minutes and 2 hours after coffee or decaffeinated alternatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startSep 2004
- Primary completionDec 2006
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CaffeineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Scientific Information on Coffee, Italian Istituto Nazionale Ricerche Cardiovascolari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330680
- Sponsor's protocol ID
- C041003
- Status last verified
- Mar 2011
- First submitted
- 29 Mar 2011
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
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.
PubMed 22170367
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Determinants of Cardiovascular Response to Coffee Drinking
- ClinicalTrials.gov ID
- NCT01330680
- Acronym / sponsor ID
- C041003
- Conditions
- Caffeine
- Keywords
- coffee, caffeine, blood pressure, nutrigenetics, gene polymorphisms, Acute Cardiovascular and Neuropsychologic Effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Collaborators
- Institute for Scientific Information on Coffee, Italian Istituto Nazionale Ricerche Cardiovascolari
- Study start
- Sep 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coffee | Experimental | Dietary Supplement: Coffee |
| Decaffeinated coffee | Active comparator | Dietary Supplement: Decaffeinated coffee |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coffee40 mL dose of a decaffeinated preparation spiked with the addition of caffeine, at a dose of 3 mg/kg | Dietary supplement | Coffee |
| Decaffeinated coffee40 mL dose of decaffeinated coffee | Dietary supplement | Decaffeinated coffee |
Primary outcome
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.
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).
Change in blood pressure
Time frame: From baseline until 2 hours after coffee or decaffeinated alternatively
Change in heart rate
Time frame: From baseline until 2 hours after coffee or decaffeinated alternatively
2 secondary outcomes
Change in plasma caffeine concentration
Time frame: From baseline to 30 minutes and 2 hours after coffee or decaffeinated alternatively
Change in plasma adrenaline and noradrenaline concentration
Time frame: From baseline to 30 minutes and 2 hours after coffee or decaffeinated alternatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
- Background1) 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.
- Derived from this study: PubMed 22170367Renda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffee and Decaffeinated coffee in people with Caffeine, run by G. d'Annunzio University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in platelet aggregation (time frame: From baseline to 30 minutes and 2 hours after coffee or decaffeinated alternatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01330680, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2011.