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

University of Rochester

Status: Terminated

Conditions: High Blood Pressure

Treatments: Other: Coffee

Study type: Interventional

Funder types: Other

Identifiers

NCT04060225

00003172

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Participants

Experimental group

Description:

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).

Treatment:

Other: Coffee