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

Not Applicable

Terminated

• Conditions: High Blood Pressure
• Interventions: Other: Coffee

• Registration Number: NCT04060225
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-19
• Study Start: 2019-12-02
• Primary Completion: 2019-12-19
• Study Completion: 2019-12-19
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants	Coffee	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).

Primary Outcome Measures

Name	Time	Method
Mean change ambulatory blood pressure	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.

Trial Locations

Locations (1)

URMC Cardiology; 919 Westfall Rd, Building C; 🇺🇸 Rochester, New York, United States