CompletedNot Applicable

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

67 participantsStarted 2016-09-16

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in resting systolic blood pressure after daily dark chocolate

Timeframe: 14 days after daily consumption of dark chocolate

Trial details

NCT IDNCT02764203

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-09-12

View on ClinicalTrials.gov More Health Behavior trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.