Influence of Coffee on the Health and on the Heart of Normal, Diabetics e Coronary Artery Disease Patients (Coffee&Heart)
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 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.|
- Verify the relationship between coffee ingestion and cardiovascular morbidity and mortality [ Time Frame: 10 years of follow-up ] [ Designated as safety issue: No ]
- Relationship between coffee ingestion and cardiovascular risk factors [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003392
|Heart Institute (InCor), Univ. of Sao Paulo Medical School||Recruiting|
|Sao Paulo, Brazil, 05403000|
|Contact: Luiz A Machado Cesar, Phd, MD 551130695387 firstname.lastname@example.org|
|Contact: Bruno M Mioto, MD 551130695437 email@example.com|
|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|
|Study Chair:||Luiz A Machado Cesar, PhD, MD.||Heart Institute|