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The Impact of Caffeine on Brachial Endothelial Function in Healthy Subjects and in Patients With Ischemic Heart Disease

The Impact of Caffeine on Brachial Endothelial Function in Healthy Subjects & in Patients With Ischemic Heart Disease

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00564824
Enrollment
80
Registered
2007-11-28
Start date
2007-11-30
Completion date
2010-01-31
Last updated
2010-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease

Keywords

coronary disease, atherosclerosis, endothelial function, caffeine, cerebrovascular disease, prevention

Brief summary

Prior work (Chris, M. et al, Clinical Science 2005; 109, 55-60) has demonstrated that drinking a cup of coffee (80-100 mg of caffeine) an hour before endothelium-dependent FMD (flow-mediated dilatation) of the brachial artery, effects endothelial function in healthy adults subjects. This effect might be attributed to caffeine, given that decaffeinated coffee (\<2 mg of caffeine) was not associated with any change in endothelial performance. In the current study we intend to further examine the impact of caffeine on brachial endothelial function among healthy subjects & in patients with proven ischemic heart disease.

Detailed description

Background: Prior work (Chris, M. et al, Clinical Science 2005; 109, 55-60) has demonstrated that drinking a cup of coffee (80-100 mg of caffeine) an hour before endothelium-dependent FMD (flow-mediated dilatation) of the brachial artery, effects endothelial function in healthy adults subjects. This effect might be attributed to caffeine, given that decaffeinated coffee (\<2 mg of caffeine) was not associated with any change in endothelial performance. In the current study we intend to further examine the impact of caffeine on brachial endothelial function among healthy subjects & in patients with proven ischemic heart disease. Aim: To evaluate the impact of 200 mg caffeine tablet intake (equivalent to 2 cups of coffee), compared to placebo on brachial endothelial function in healthy subjects & in patients with proven ischemic heart disease. Methods: 1. Patients will be invited for two endothelial function tests 1 week apart. 2. ECG, heart rate & blood pressure will be recorded at rest prior to each test. 3. Following overnight fasting and discontinuation of all medications for ≥ 12 hours and absence of \> 48 hour caffeine consumption, patients will receive 200 mg of caffeine tablets or placebo, in a double-blind, cross-over study design. An hour later the patient will undergo endothelium-dependent flow-mediated dilation (FMD) and endothelium-independent, nitroglycerin (NTG)-mediated vasodilation will be assessed non-invasively in the brachial artery, using a high resolution (15 MHz) linear array ultrasound. 4. Prior to and after the FMD, blood will be drawn to test caffeine levels, adiponectin, CBC, electrolytes, CRP and lipids.

Interventions

DRUGCaffeine

Caffeine 200 mg tablet

DRUGPlacebo

Placebo pills

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with documented ischemic heart disease * Healthy subjects who are not heavy regular coffee drinkers

Exclusion criteria

* Patients with unstable angina pectoris * Patients with acute or chronic heart failure * Patients with cardiac arrhythmia

Design outcomes

Primary

MeasureTime frame
Flow-mediated dilation (FMD) as surrogate of brachial artery endothelial function1-2 hours post caffeine (or placebo)

Secondary

MeasureTime frame
Markers of inflammation such as hs-CRP, Il6, homocysteine, serum caffeine level1-2 hours post caffeine or placebo

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026