ChOcolate COnsumption And Blood Pressure (COCOA-BP): A Wearable Devices Pilot Trial
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Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
67 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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