Clinical trial NCT04060225: Effects of High Caffeine Content Coffee on Blood Pressure in Young Adults
Official title: Short-term and Intermediate-term Effects of High Volume High Caffeine Content Coffee on Blood Pressure in Young Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: High Blood Pressure
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to help further the understanding of the effects of commercially available high-caffeine containing coffee on blood pressure in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years old
* Male or Female
* No prior diagnosis of hypertension
* No prior chronic disease requiring medical intervention
* Ability to demonstrate correct usage of ambulatory blood pressure monitoring device

Exclusion Criteria:

- Age less than 18 years old

* Prior chronic disease (such as hypertension) requiring medical intervention
* Previously undiagnosed hypertension
* Intolerance or allergy to coffee or caffeine
* Inability to demonstrate correct usage of ambulatory blood pressure monitoring device
* Inability to complete the required abstinence period prior to study interventions
* Known pregnancy
* Use of birth control
* Tobacco use
* Participation in other investigational drug studies at the time of this study
* Medical illness requiring medical or symptomatic management

Primary outcomes:
measure: Mean change ambulatory blood pressure
timeFrame: baseline to 30 minutes
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 1 hour
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 1.5 hour
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 2 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 2.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 3 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 3.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 4 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 4.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 5.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 6 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 6.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 7 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 7.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 8 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 8.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 9 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 9.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 10 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 10.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 11 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 11.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 12 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 12.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 13 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 13.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 14 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 14.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 15 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 15.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 16 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 16.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 17 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 17.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 18 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 18.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 19 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 19.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 20 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 20.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 21 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 21.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 22 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 22.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 23 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 23.5 hours
measure: Mean change ambulatory blood pressure
timeFrame: baseline, 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: URMC Cardiology; 919 Westfall Rd, Building C
state: New York
Study officials:
References: