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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Health Behavior, Blood Pressure

Intervention / Treatment
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* Other: Dark Chocolate
* Device: Wearable devices


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chocolate consumption<br>Subjects will consume 50g of dark chocolate for 2 weeks and have their blood pressure compared before chocolate and after chocolate | Other: Dark Chocolate<br>* 50g dark chocolate consumed for a period of 2 weeks<br>Device: Wearable devices<br>* Up to three wearable devices will be worn by the subject to measure parameters such as heart rate, blood pressure and number of steps<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in resting systolic blood pressure after daily dark chocolate |  | 14 days after daily consumption of dark chocolate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of physical activity (steps) to resting blood pressure and heart rate |  | daily, for four weeks | 
| Comparison of blood pressure derived from wearable digital health devices to data derived from standard methods |  | 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 |  | End of week two and end of week four | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dark Chocolate, Blood Pressure, Wearable Devices, Digital Health