Blood Pressure, Health Behavior
Conditions
Keywords
Dark Chocolate, Blood Pressure, Wearable Devices, Digital Health
Brief summary
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
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.
Interventions
OTHERDark Chocolate
50g dark chocolate consumed for a period of 2 weeks
DEVICEWearable devices
Up to three wearable devices will be worn by the subject to measure parameters such as heart rate, blood pressure and number of steps
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in resting systolic blood pressure after daily dark chocolate | 14 days after daily consumption of dark chocolate |
Secondary
| Measure | 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 |
Outcome results
None listed