Food-Drug Interactions
Conditions
Keywords
Coffee, Grapefruit Juice, Felodipine, Calcium Channel Blocker, Hemodynamics, CYP3A4
Brief summary
Coffee is a globally popular beverage. More than half of the United States population spends an estimated $ 40 billion on the purchase of coffee each year. Personal consumption habits can vary. For example, the frequency of ingestion ranged from 59% for every day to 8% for less than one day per week consumption in one survey. In the case of occasional consumption, coffee can markedly elevate blood pressure in normotensive and hypertensive individuals. This pressor effect can occur with a caffeine dose of 200 - 250 mg, which can be found 2 - 3 cups of coffee. A major active constituent in coffee is caffeine, which is the most widely used pharmacological substance in the world. Drug therapy plays a major role in the management of hypertension. However, the interaction between coffee or caffeine and blood pressure lowering drugs has been assessed in only three clinical studies that were reported more than three decades ago. We conducted a comprehensive interaction study involving a commonly ingested amount of a particular Colombian coffee and felodipine in healthy middle-aged men and women. Peripheral (brachial) and central (aortic) hemodynamics and caffeine and felodipine pharmacokinetics were evaluated.
Interventions
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy (normal physical exam, blood clinical chemistry) * willingly signs ethics approved informed consent form
Exclusion criteria
* history of cardiac, renal, hepatic or gastrointestinal disease or substance abuse * significant illness within 2 weeks of starting study * history of allergy to felodipine , tablet ingredients or dihydropyridines * routinely taking prescription or OTC drugs or natural health products * received an investigational drug withing the previous 4 weeks * females who are pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure . | Change from Baseline to 8 hours Post Dose | Peripheral (brachial systolic and diastolic blood pressure) and central (aortic systolic blood pressure) measurements were the mean of at least 3 readings after 5 minutes of sitting at rest. The respective instruments used were BpTRU™ Vital Signs Monitor (BpTRU Medical Devices, Coquitlam BC, Canada) and SphygmoCor® CP Pulse Wave Analysis System - Research (AtCor Medical, Inc., Itasca, IL USA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect of coffee on the oral pharmacokinetics of felodipine. | Change from Baseline to 8 hours Post Dose | Area Under Curve (AUC) Time Frame: predose, 1,2,3,4,5,6,7,8 hours post-dose |
Countries
Canada
Outcome results
None listed