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Effects of High Caffeine Content Coffee on Blood Pressure in Young Adults

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
Sponsor:
Information provided by (Responsible Party):
John Bisognano, University of Rochester

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.

Condition or disease Intervention/treatment Phase
High Blood Pressure Other: Coffee Not Applicable

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

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).
Other: Coffee
Starbuck's brand blonde roast coffee, 20 ounces




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.

  46. 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.

  47. 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.

  48. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

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


Locations
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United States, New York
URMC Cardiology; 919 Westfall Rd, Building C
Rochester, New York, United States, 14618
Sponsors and Collaborators
University of Rochester
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases