High Blood PressureNCT04060225
Effects of High Caffeine Content Coffee on Blood Pressure in Young Adults
A study testing Coffee in people with High Blood Pressure, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2019to 19 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
URMC Cardiology; 919 Westfall Rd, Building C
Rochester, New York, 14618
About this study
Official title: Short-term and Intermediate-term Effects of High Volume High Caffeine Content Coffee on Blood Pressure in Young Adults
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.
- Conditions
- High Blood Pressure
- Being tested
- Coffee
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoffeeOther
Starbuck's brand blonde roast coffee, 20 ounces
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Participants will be asked to participate in a single arm study with three phases (washout phase, abstinence phase, and exposure phase). These participants will first be asked to abstain from drinking any caffeinated food or beverages for 72 hours (known as the washout phase). Following the first phase, participants will then wear a blood pressure cuff to collect diastolic and systolic blood pressure for 24 hours (abstinence phase) wherein they will be asked to refrain from caffeinated products. Participants will then drink the coffee intervention and collect blood pressure measurements for 24 hours (exposure phase). Receives: Other: Coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 0-3 hour after drinking the coffee versus 0-3 hours after the end of the washout period.
Measured: baseline to 30 minutes
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 0-3 hour after drinking the coffee versus 0-3 hours after the end of the washout period.
Measured: baseline, 1 hour
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 0-3 hour after drinking the coffee versus 0-3 hours after the end of the washout period.
Measured: baseline, 1.5 hour
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 0-3 hours after drinking the coffee versus 0-3 hours after the end of the washout period.
Measured: baseline, 2 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 0-3 hours after drinking the coffee versus 0-3 hours after the end of the washout period.
Measured: baseline, 2.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 0-3 hour after drinking the coffee versus 0-3 hours after the end of the washout period.
Measured: baseline, 3 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 3-6 hours after drinking the coffee versus 3-6 hours after the end of the washout period.
Measured: baseline, 3.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 3-6 hours after drinking the coffee versus 3-6 hours after the end of the washout period.
Measured: baseline, 4 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 3-6 hours after drinking the coffee versus 3-6 hours after the end of the washout period.
Measured: baseline, 4.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 3-6 hours after drinking the coffee versus 3-6 hours after the end of the washout period.
Measured: baseline, 5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 3-6 hours after drinking the coffee versus 3-6 hours after the end of the washout period.
Measured: baseline, 5.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 3-6 hours after drinking the coffee versus 3-6 hours after the end of the washout period.
Measured: baseline, 6 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 6-9 hours after drinking the coffee versus 6-9 hours after the end of the washout period.
Measured: baseline, 6.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 6-9 hours after drinking the coffee versus 6-9 hours after the end of the washout period.
Measured: baseline, 7 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 6-9 hours after drinking the coffee versus 6-9 hours after the end of the washout period.
Measured: baseline, 7.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 6-9 hours after drinking the coffee versus 6-9 hours after the end of the washout period.
Measured: baseline, 8 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 6-9 hours after drinking the coffee versus 6-9 hours after the end of the washout period.
Measured: baseline, 8.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 6-9 hours after drinking the coffee versus 6-9 hours after the end of the washout period.
Measured: baseline, 9 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 9-12 hours after drinking the coffee versus 9-12 hours after the end of the washout period.
Measured: baseline, 9.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 9-12 hours after drinking the coffee versus 9-12 hours after the end of the washout period.
Measured: baseline, 10 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 9-12 hours after drinking the coffee versus 9-12 hours after the end of the washout period.
Measured: baseline, 10.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 9-12 hours after drinking the coffee versus 9-12 hours after the end of the washout period.
Measured: baseline, 11 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 9-12 hours after drinking the coffee versus 9-12 hours after the end of the washout period.
Measured: baseline, 11.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 9-12 hours after drinking the coffee versus 9-12 hours after the end of the washout period.
Measured: baseline, 12 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 12-15 hours after drinking the coffee versus 12-15 hours after the end of the washout period.
Measured: baseline, 12.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 12-15 hours after drinking the coffee versus 12-15 hours after the end of the washout period.
Measured: baseline, 13 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 12-15 hours after drinking the coffee versus 12-15 hours after the end of the washout period.
Measured: baseline, 13.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 12-15 hours after drinking the coffee versus 12-15 hours after the end of the washout period.
Measured: baseline, 14 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 12-15 hours after drinking the coffee versus 12-15 hours after the end of the washout period.
Measured: baseline, 14.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 12-15 hours after drinking the coffee versus 12-15 hours after the end of the washout period.
Measured: baseline, 15 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 15-18 hours after drinking the coffee versus 15-18 hours after the end of the washout period.
Measured: baseline, 15.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 15-18 hours after drinking the coffee versus 15-18 hours after the end of the washout period.
Measured: baseline, 16 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 15-18 hours after drinking the coffee versus 15-18 hours after the end of the washout period.
Measured: baseline, 16.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 15-18 hours after drinking the coffee versus 15-18 hours after the end of the washout period.
Measured: baseline, 17 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 15-18 hours after drinking the coffee versus 15-18 hours after the end of the washout period.
Measured: baseline, 17.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 15-18 hours after drinking the coffee versus 15-18 hours after the end of the washout period.
Measured: baseline, 18 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 18-21 hours after drinking the coffee versus 18-21 hours after the end of the washout period.
Measured: baseline, 18.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 18-21 hours after drinking the coffee versus 18-21 hours after the end of the washout period.
Measured: baseline, 19 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 18-21 hours after drinking the coffee versus 18-21 hours after the end of the washout period.
Measured: baseline, 19.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 18-21 hours after drinking the coffee versus 18-21 hours after the end of the washout period.
Measured: baseline, 20 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 18-21 hours after drinking the coffee versus 18-21 hours after the end of the washout period.
Measured: baseline, 20.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 18-21 hours after drinking the coffee versus 18-21 hours after the end of the washout period.
Measured: baseline, 21 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 21-24 hours after drinking the coffee versus 21-24 hours after the end of the washout period.
Measured: baseline, 21.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 21-24 hours after drinking the coffee versus 21-24 hours after the end of the washout period.
Measured: baseline, 22 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 21-24 hours after drinking the coffee versus 21-24 hours after the end of the washout period.
Measured: baseline, 22.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 21-24 hours after drinking the coffee versus 21-24 hours after the end of the washout period.
Measured: baseline, 23 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 21-24 hours after drinking the coffee versus 21-24 hours after the end of the washout period.
Measured: baseline, 23.5 hours
Mean change ambulatory blood pressure
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 21-24 hours after drinking the coffee versus 21-24 hours after the end of the washout period.
Measured: baseline, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start2 Dec 2019
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Why it stopped: not possible to enroll during COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Bisognano, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060225
- Sponsor's protocol ID
- 00003172
- Status last verified
- Jan 2021
- First submitted
- 15 Aug 2019
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term and Intermediate-term Effects of High Volume High Caffeine Content Coffee on Blood Pressure in Young Adults
- ClinicalTrials.gov ID
- NCT04060225
- Acronym / sponsor ID
- 00003172
- Conditions
- High Blood Pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not possible to enroll during COVID pandemic
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Other: CoffeeParticipants will be asked to participate in a single arm study with three phases (washout phase, abstinence phase, and exposure phase). These participants will first be asked to abstain from drinking any caffeinated food or beverages for 72 hours (known as the washout phase). Following the first phase, participants will then wear a blood pressure cuff to collect diastolic and systolic blood pressure for 24 hours (abstinence phase) wherein they will be asked to refrain from caffeinated products. Participants will then drink the coffee intervention and collect blood pressure measurements for 24 hours (exposure phase). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoffeeStarbuck's brand blonde roast coffee, 20 ounces | Other | Participants |
Primary outcome
Mean change ambulatory blood pressure
Time frame: baseline to 30 minutes
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 0-3 hour after drinking the coffee versus 0-3 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 1 hour
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 0-3 hour after drinking the coffee versus 0-3 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 1.5 hour
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 0-3 hour after drinking the coffee versus 0-3 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 2 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 0-3 hours after drinking the coffee versus 0-3 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 2.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 0-3 hours after drinking the coffee versus 0-3 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 3 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 0-3 hour after drinking the coffee versus 0-3 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 3.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 3-6 hours after drinking the coffee versus 3-6 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 4 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 3-6 hours after drinking the coffee versus 3-6 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 4.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 3-6 hours after drinking the coffee versus 3-6 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 3-6 hours after drinking the coffee versus 3-6 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 5.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 3-6 hours after drinking the coffee versus 3-6 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 6 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 3-6 hours after drinking the coffee versus 3-6 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 6.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 6-9 hours after drinking the coffee versus 6-9 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 7 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 6-9 hours after drinking the coffee versus 6-9 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 7.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 6-9 hours after drinking the coffee versus 6-9 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 8 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 6-9 hours after drinking the coffee versus 6-9 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 8.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 6-9 hours after drinking the coffee versus 6-9 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 9 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 6-9 hours after drinking the coffee versus 6-9 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 9.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 9-12 hours after drinking the coffee versus 9-12 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 10 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 9-12 hours after drinking the coffee versus 9-12 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 10.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 9-12 hours after drinking the coffee versus 9-12 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 11 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 9-12 hours after drinking the coffee versus 9-12 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 11.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 9-12 hours after drinking the coffee versus 9-12 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 12 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 9-12 hours after drinking the coffee versus 9-12 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 12.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 12-15 hours after drinking the coffee versus 12-15 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 13 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 12-15 hours after drinking the coffee versus 12-15 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 13.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 12-15 hours after drinking the coffee versus 12-15 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 14 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 12-15 hours after drinking the coffee versus 12-15 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 14.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 12-15 hours after drinking the coffee versus 12-15 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 15 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 12-15 hours after drinking the coffee versus 12-15 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 15.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 15-18 hours after drinking the coffee versus 15-18 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 16 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 15-18 hours after drinking the coffee versus 15-18 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 16.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 15-18 hours after drinking the coffee versus 15-18 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 17 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 15-18 hours after drinking the coffee versus 15-18 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 17.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 15-18 hours after drinking the coffee versus 15-18 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 18 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 15-18 hours after drinking the coffee versus 15-18 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 18.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 18-21 hours after drinking the coffee versus 18-21 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 19 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 18-21 hours after drinking the coffee versus 18-21 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 19.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 18-21 hours after drinking the coffee versus 18-21 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 20 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 18-21 hours after drinking the coffee versus 18-21 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 20.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 18-21 hours after drinking the coffee versus 18-21 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 21 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 18-21 hours after drinking the coffee versus 18-21 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 21.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 21-24 hours after drinking the coffee versus 21-24 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 22 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 21-24 hours after drinking the coffee versus 21-24 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 22.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 21-24 hours after drinking the coffee versus 21-24 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 23 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 21-24 hours after drinking the coffee versus 21-24 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 23.5 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 21-24 hours after drinking the coffee versus 21-24 hours after the end of the washout period.
Mean change ambulatory blood pressure
Time frame: baseline, 24 hours
Participants will wear a ambulatory blood pressure cuff for 24 hours with half hourly measurements of systolic and diastolic blood pressure. Mean change will be measured comparing the same participants blood pressure at 21-24 hours after drinking the coffee versus 21-24 hours after the end of the washout period.
Results and safety
The study was stopped early (reason given: not possible to enroll during COVID pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffee in people with High Blood Pressure, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: not possible to enroll during COVID pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change ambulatory blood pressure (time frame: baseline to 30 minutes). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.