Effects of High Caffeine Content Coffee on Blood Pressure in Young Adults
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04060225 |
Recruitment Status :
Terminated
(not possible to enroll during COVID pandemic)
First Posted : August 19, 2019
Last Update Posted : January 14, 2021
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Condition or disease | Intervention/treatment | Phase |
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High Blood Pressure | Other: Coffee | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Short-term and Intermediate-term Effects of High Volume High Caffeine Content Coffee on Blood Pressure in Young Adults |
Actual Study Start Date : | December 2, 2019 |
Actual Primary Completion Date : | December 19, 2019 |
Actual Study Completion Date : | December 19, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Participants
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).
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Other: Coffee
Starbuck's brand blonde roast coffee, 20 ounces |
- 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.

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Ages Eligible for Study: | 18 Years to 30 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060225
United States, New York | |
URMC Cardiology; 919 Westfall Rd, Building C | |
Rochester, New York, United States, 14618 |
Responsible Party: | John Bisognano, Professor, University of Rochester |
ClinicalTrials.gov Identifier: | NCT04060225 |
Other Study ID Numbers: |
00003172 |
First Posted: | August 19, 2019 Key Record Dates |
Last Update Posted: | January 14, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypertension Vascular Diseases Cardiovascular Diseases |