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Influence of Coffee on the Health and on the Heart of Normal, Diabetics e Coronary Artery Disease Patients (Coffee&Heart)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by University of Sao Paulo.
Recruitment status was:  Recruiting
Feculdade de Medicina da Universidade de Sao Paulo - Brasil
Information provided by (Responsible Party):
Luiz Antonio M. Cesar, University of Sao Paulo Identifier:
First received: October 26, 2009
Last updated: January 6, 2014
Last verified: January 2014
Coffee is a worldwide drink, been part of any culture. There are some concerns about effects of coffee on the health. Recently, epidemiological studies have shown benefits of coffee drinking to diabetics and also to prevent diabetes in populations. We aim to understand some effects of coffee and not only caffeine over vascular system, in special coronary artery disease patients, diabetics end normal people.

Coronary Artery Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Study of Coffee and Its Influence on the Heart in Normal People, Those With Coronary Artery Disease and Diabetics.

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Verify the relationship between coffee ingestion and cardiovascular morbidity and mortality [ Time Frame: 10 years of follow-up ]

Secondary Outcome Measures:
  • Relationship between coffee ingestion and cardiovascular risk factors [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
Blood samples.

Estimated Enrollment: 300
Study Start Date: March 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Normal volunteers, with no diagnosed chronic disease.
Coronary artery disease
Group of patients with diagnosed coronary artery disease.
Diabetic patients.

Detailed Description:
Patients will have a wash-out period (21 days) with no coffee or other caffeine-drinks. Then they will be submitted to treadmill test, MAPA, Holter-ECG and vascular reactivity study, biochemical and inflammatory plasma dosages, as basal. Then they will start a period of coffee drinking over 4 weeks; and all exams will be repeated. We will study two types of coffee, arabica and robusta; with two types of toasted beans(regular and soft). Also regular and decaffeinated coffee. A total of 300 (100 normal people, 100 diabetics, 100 coronary disease) individuals will be tested.

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Group of normal patients, group of patients with diagnosed coronary artery disease and group of diabetic patients.

Inclusion Criteria:

Normal Volunteers:

  1. Healthy volunteer.
  2. Age between 20 and 80 years.
  3. No addict to drugs.
  4. Absence of chronicle diseases.
  5. No alcohol abuse.
  6. No smoker.

Coronary artery disease:

  1. Presence of coronary artery disease, by coronary angiography
  2. Stable angina, class 1-3 of CCS.
  3. Age between 20 and 80 years.
  4. Treadmill effort test with ischemia.
  5. No alcohol abuse.
  6. No smoker.


  1. Presence of type II Diabetes on oral treatment.
  2. Age between 20 and 80 years.
  3. Absence of chronicle diseases, except diabetes.
  4. No alcohol abuse.
  5. No smoker.

Exclusion Criteria:

Normal Volunteers:

  1. Any blood test with twice or more the upper limit range.
  2. Presence of enlarged QRS.

Coronary artery disease:

  1. Any blood test with twice or more the upper limit range even with treatment.
  2. Presence of enlarged QRS.
  3. Ventricular dysfunction (EF < 45%).


  1. Blood glucose greater than 160 mg/dL.
  2. Others blood tests with twice or more the upper limit range even with treatment.
  3. Presence of enlarged QRS.
  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 identifier: NCT01003392

Heart Institute (InCor), Univ. of Sao Paulo Medical School Recruiting
Sao Paulo, Brazil, 05403000
Contact: Luiz A Machado Cesar, Phd, MD    551130695387   
Contact: Bruno M Mioto, MD    551130695437   
Sub-Investigator: Bruno M Mioto, MD         
Principal Investigator: Miguel A Moretti, MD, PhD         
Sub-Investigator: Daniela Taratsouchi, nutricionist         
Sub-Investigator: Reynaldo V Amato, MD, PhD         
Sub-Investigator: Vera Lucia Tuda, Nurse         
Sponsors and Collaborators
University of Sao Paulo
Feculdade de Medicina da Universidade de Sao Paulo - Brasil
Study Chair: Luiz A Machado Cesar, PhD, MD. Heart Institute
  More Information

Responsible Party: Luiz Antonio M. Cesar, Professor of Medicine, University of Sao Paulo Identifier: NCT01003392     History of Changes
Other Study ID Numbers: SDC2500/04/120
CAPPesq-879/04 ( Other Identifier: CAPPesq )
Study First Received: October 26, 2009
Last Updated: January 6, 2014

Keywords provided by University of Sao Paulo:
Coronary artery disease
Heart system

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on April 24, 2017