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

NCT ID: NCT04060225

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-02
• Study Completion Date: 2019-12-19

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Coffee

Intervention Type: OTHER

Starbuck's brand blonde roast coffee, 20 ounces

Interventions

Coffee

Starbuck's brand blonde roast coffee, 20 ounces

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

John Bisognano

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

URMC Cardiology; 919 Westfall Rd, Building C

Rochester, New York, United States

Countries

United States

Other Identifiers

00003172

Identifier Type: -

Identifier Source: org_study_id