Health BehaviorCOCOA-BPNCT02764203
ChOcolate COnsumption And Blood Pressure (COCOA-BP): A Wearable Devices Pilot Trial
A study testing Dark Chocolate and Wearable devices in people with Health Behavior and Blood Pressure, run by Boston Scientific Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Blood Pressure
- What is being tested?
- Dark Chocolate and Wearable devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 16 Sep 2016to 12 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Subject is a women who is pregnant
- Known allergy to chocolate or cacao products
- Known allergy to skin adhesives
About this study
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.
Read the 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.
- Conditions
- Health Behavior, Blood Pressure
- Being tested
- Dark Chocolate, Wearable devices
- Keywords
- Dark Chocolate, Blood Pressure, Wearable Devices, Digital Health
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Chocolate consumption | Experimental | Subjects will consume 50g of dark chocolate for 2 weeks and have their blood pressure compared before chocolate and after chocolate Receives: Other: Dark Chocolate; Device: Wearable devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting systolic blood pressure after daily dark chocolate
Measured: 14 days after daily consumption of dark chocolate
Secondary outcomes (3)
Correlation of physical activity (steps) to resting blood pressure and heart rate
Measured: daily, for four weeks
Comparison of blood pressure derived from wearable digital health devices to data derived from standard methods
Measured: 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
Measured: End of week two and end of week four
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start16 Sep 2016
- Primary completion12 Sep 2017
- Study completion12 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Christen, MD, PhD, Principal investigator, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764203
- Sponsor's protocol ID
- S2363
- Acronym
- COCOA-BP
- Status last verified
- Oct 2017
- First submitted
- 2 May 2016
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ChOcolate COnsumption And Blood Pressure (COCOA-BP): A Wearable Devices Pilot Trial
- ClinicalTrials.gov ID
- NCT02764203
- Acronym / sponsor ID
- COCOA-BP / S2363
- Conditions
- Health Behavior, Blood Pressure
- Keywords
- Dark Chocolate, Blood Pressure, Wearable Devices, Digital Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2016 (actual)
- Primary completion
- 12 Sep 2017 (actual)
- Study completion
- 12 Sep 2017 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chocolate consumption | Experimental | Other: Dark Chocolate, Device: Wearable devicesSubjects will consume 50g of dark chocolate for 2 weeks and have their blood pressure compared before chocolate and after chocolate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dark Chocolate50g dark chocolate consumed for a period of 2 weeks | Other | Chocolate consumption |
| Wearable devicesUp to three wearable devices will be worn by the subject to measure parameters such as heart rate, blood pressure and number of steps | Device | Chocolate consumption |
Primary outcome
Change in resting systolic blood pressure after daily dark chocolate
Time frame: 14 days after daily consumption of dark chocolate
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Christen, MD, PhD principal investigator
Sponsor GmbH
Questions about this trial
What is this clinical trial studying?
A study testing Dark Chocolate and Wearable devices in people with Health Behavior and Blood Pressure, run by Boston Scientific Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resting systolic blood pressure after daily dark chocolate (time frame: 14 days after daily consumption of dark chocolate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.