Effects of Espresso on Platelet Aggregability in Patients With Coronary Artery Disease

January 22, 2024 updated by: Jose Carlos Nicolau, University of Sao Paulo

Evaluation of the Effect of Espresso on Platelet Aggregability in Patients With Coronary Artery Disease

Discovered thousands of years ago, coffee is among the most consumed beverages in the world. The relationship between coffee and cardiovascular risk, more specifically coronary artery disease, is controversial. Platelet aggregation and its relationship with coffee is also controversial. The investigators propose this study to evaluate the relationship between coffee and platelet aggregability in patients with coronary artery disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

30 patients with coronary artery disease (proven by previous coronary angiography) will be selected at the Heart Institute (InCor USP) for the study. Patients will be instructed to abstain from caffeinated beverages during 22 days. After this period, one group will consume caffeinated coffee during 28 days, followed by decaffeinated coffee during more 28 days and another group will start with decaffeinated coffee followed by caffeinated. All participants will receive "Nespresso" coffee maker "Essenza" model. The coffee "Nespresso blend voluto" will be provided (caffeinated and decaffeinated). The patients will have to take four cups of espresso per day (three cups a day for patients aged 65 and over). The investigators will evaluate platelet aggregation by Multiplate® (ASPI, ADP and arachidonic acid) and by optical aggregometry (ADP and arachidonic acid).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 05403-000
        • Recruiting
        • Heart Institute (InCor) / University of São Paulo
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 20 to 80 years;
  • Coronary artery disease documented by coronary angiography;
  • Use of aspirin 100mg.

Exclusion Criteria:

  • Serum creatinine dosage > 2.5 mg/dl;
  • Hemoglobin <12 g/% for men and <11 g/% for women;
  • Platelets <100,000 or >400,000/mm3;
  • Leukocytosis >12,000/mm3;
  • Fasting glycemia >126mg/dl;
  • Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) with values above the upper limits of normality;
  • Consumption of more than 30 grams of alcohol per day;
  • Active smoking or ex-smoking for less than 2 years;
  • Use of P2Y12 inhibitor;
  • Ventricular dysfunction (left ventricular ejection fraction <45%).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Caffeinated coffee
Patients will be instructed to abstain from caffeinated beverages during 22 days. After this period, they will consume caffeinated coffee during 28 days, followed by decaffeinated coffee during more 28 days.
Dietary supplement: Coffee
Participants will receive "Nespresso" coffee maker "Essenza" model. The coffee "Nespresso blend voluto" will be provided (caffeinated and decaffeinated). The patients will have to take four cups of espresso per day (three cups a day for patients aged 65 and over).
Other: Decaffeinated coffee
Patients will be instructed to abstain from caffeinated beverages during 22 days. After this period, they will consume decaffeinated coffee during 28 days, followed by caffeinated coffee during more 28 days.
Dietary supplement: Coffee
Participants will receive "Nespresso" coffee maker "Essenza" model. The coffee "Nespresso blend voluto" will be provided (caffeinated and decaffeinated). The patients will have to take four cups of espresso per day (three cups a day for patients aged 65 and over).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet aggregation evaluated by Multiplate® ASPI
Time Frame: 8 weeks (±1)
Compare the inhibition of platelet aggregation evaluated by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period).
8 weeks (±1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet aggregation evaluated by Multiplate® ADP e Arachidonic acid
Time Frame: 4 week (±1)
Compare the inhibition of platelet aggregation evaluated by Multiplate® ADP and Arachidonic acid after 4 weeks of caffeinated coffee consumption with platelet aggregability after 4 weeks of decaffeinated coffee consumption.
4 week (±1)
Platelet aggregation evaluated by Multiplate® ADP
Time Frame: 8 weeks (±1)
Compare the inhibition of platelet aggregation evaluated by Multiplate® ADP after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period).
8 weeks (±1)
Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid) 1
Time Frame: 8 weeks (±1)
Compare platelet aggregability by optical aggregometry (ADP and arachidonic acid) after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period).
8 weeks (±1)
Platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid)
Time Frame: 4 weeks (±1)
Compare the inhibition of platelet aggregation evaluated by optical aggregometry (ADP and arachidonic acid) after 4 weeks of caffeinated coffee consumption with platelet aggregability after 4 weeks of decaffeinated coffee consumption.
4 weeks (±1)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Elderly (≥65 years) and non-elderly
Time Frame: 8 weeks (±1)
Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Elderly (≥65 years) and non-elderly
8 weeks (±1)
Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Feminine and masculine genders
Time Frame: 8 weeks (±1)
Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Feminine and masculine genders
8 weeks (±1)
Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Renal dysfunction (Creatinine > 1.8mg/dl) and without renal dysfunction
Time Frame: 8 weeks (±1)
Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Renal dysfunction (Creatinine > 1.8mg/dl) and without renal dysfunction
8 weeks (±1)
Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Obese (BMI≥30 Kg/m2) and non-obese
Time Frame: 8 weeks (±1)
Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Obese (BMI≥30 Kg/m2) and non-obese
8 weeks (±1)
Compare platelet aggregation by Multiplate® ASPI in the following subgroup: Glycemia >99mg/dl and no change in fasting glycemia
Time Frame: 8 weeks (±1)
Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: Glycemia >99mg/dl and no change in fasting glycemia
8 weeks (±1)
Compare platelet aggregation by Multiplate® ASPI in the following subgroup: With of Beta-blocker and without
Time Frame: 8 weeks (±1)
Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: With of Beta-blocker and without
8 weeks (±1)
Compare platelet aggregation by Multiplate® ASPI in the following subgroup: With statin and without
Time Frame: 8 weeks (±1)
Compare platelet aggregation by Multiplate® ASPI after 8 weeks of espresso consumption in relation to basal platelet aggregability (after coffee withdrawal period) in the following subgroup: With statin and without
8 weeks (±1)
Delta change of platelet aggregation and Fraction of immature platelets (PFI)
Time Frame: 8 weeks (±1)
Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Fraction of immature platelets (PFI)
8 weeks (±1)
Delta change of platelet aggregation and Small-LDL
Time Frame: 8 weeks (±1)
Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Small-LDL
8 weeks (±1)
Delta change of platelet aggregation and Fasting glycemia
Time Frame: 8 weeks (±1)
Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Fasting glycemia
8 weeks (±1)
Delta change of platelet aggregation and Glycated hemoglobin
Time Frame: 8 weeks (±1)
Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Glycated hemoglobin
8 weeks (±1)
Delta change of platelet aggregation and Lipid profile
Time Frame: 8 weeks (±1)
Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Lipid profile (total cholesterol, HDL [high-density lipoprotein], LDL [low-density lipoprotein], very low-density lipoprotein [VLDL] and triglycerides)
8 weeks (±1)
Delta change of platelet aggregation and Lipoprotein a
Time Frame: 8 weeks (±1)
Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Lipoprotein a - Lp(a)
8 weeks (±1)
Delta change of platelet aggregation and Sirtuins
Time Frame: 8 weeks (±1)
Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Sirtuins
8 weeks (±1)
Delta change of platelet aggregation and Advanced glycation final product (RAGE) receiver
Time Frame: 8 weeks (±1)
Correlate the delta change of platelet aggregation of the basal in relation to 8 weeks of coffee use in relation to: Advanced glycation final product (RAGE) receiver
8 weeks (±1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

March 15, 2024

Study Completion (Estimated)

March 15, 2024

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDC 4954/19/173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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