ChOcolate COnsumption And Blood Pressure (COCOA-BP): A Wearable Devices Pilot Trial

Boston Scientific Corporation67 enrolled

Overview

The COCOA-BP Trial is designed to assess the impact of 50g daily dark chocolate intake on blood pressure and compare outcome data derived from wearable/digital health devices to data derived from standard methods. Additionally, the usability of the wearable technology will be evaluated.

The COCOA-BP Trial is a prospective, single-center, single-arm, Boston Scientific volunteer trial, designed to assess the impact of 50g daily dark chocolate intake on blood pressure and compare outcome data derived from wearable/digital health devices to data derived from standard methods. Additionally, the usability of the wearable technology will be evaluated.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Health Behavior Blood Pressure

Interventions

Dark ChocolateOTHER

50g dark chocolate consumed for a period of 2 weeks

Wearable devicesDEVICE

Up to three wearable devices will be worn by the subject to measure parameters such as heart rate, blood pressure and number of steps

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is at least 18 years of age * Subject has an iPhone (5 or higher) * Subject is willing to comply with all trial requirements * Subject understands the trial requirements and procedures and provides written informed consent before any trial-specific procedures are performed Exclusion Criteria: * Anyone part of the study execution team cannot be part of the trial * Current smoker or history of smoking in the last 5 years (including E-cigarettes) * Diabetes mellitus including those managed by diet alone * Medically treated hypertension * Diagnosed with persistent or frequent irregular heart beat (e.g. atrial flutter, atrial fibrillation) * Permanent pacemaker or defibrillator implanted * Subject is a women who is pregnant * Known allergy to chocolate or cacao products * Known allergy to skin adhesives

Outcomes

Primary Outcomes

Change in resting systolic blood pressure after daily dark chocolate

Time frame: 14 days after daily consumption of dark chocolate

Secondary Outcomes

Correlation of physical activity (steps) to resting blood pressure and heart rate

Time frame: daily, for four weeks

Comparison of blood pressure derived from wearable digital health devices to data derived from standard methods

Time frame: End of week two and end of week four

Comparison of heart rate derived from wearable digital health devices to data derived from standard methods

Time frame: End of week two and end of week four

Data from ClinicalTrials.gov

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