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

NCT04060225 | Terminated

• 1 other identifier: 00003172
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

High Blood Pressure

Outcome Measures

Primary Outcomes (48)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  baseline, 24 hours

Study Arms (1)

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).

Other: Coffee

Interventions

Coffee OTHER

Starbuck's brand blonde roast coffee, 20 ounces

Participants

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

URMC Cardiology; 919 Westfall Rd, Building C

Rochester, New York, 14618, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Coffee

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 19, 2019
• Study Start: December 2, 2019
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)