ChOcolate COnsumption And Blood Pressure (COCOA-BP): A We... | NCT02764203

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

NCT02764203

Sponsor

Boston Scientific Corporation

Status

Completed

Last Update Posted

Oct 4, 2017Actual

Enrollment

67Actual

Phase

Not Applicable

Conditions

Health Behavior
Blood Pressure

Interventions

Dark Chocolate
Wearable devices

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 16, 2016Actual

Primary Completion Date

Sep 12, 2017Actual

Completion Date

Sep 12, 2017Actual

First Submitted Date

May 2, 2016

First Submission Date that Met QC Criteria

May 5, 2016

First Posted Date

May 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2017

Last Update Posted Date

Oct 4, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chocolate consumption	Experimental	Subjects will consume 50g of dark chocolate for 2 weeks and have their blood pressure compared before chocolate and after chocolate	Other: Dark Chocolate Device: Wearable devices

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dark Chocolate	Other	50g dark chocolate consumed for a period of 2 weeks	Chocolate consumption

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Thomas Christen, MD, PhD	Sponsor GmbH	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D015438	Health Behavior

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D000076251	Wearable Electronic Devices

Ancestor Terms

ID	Term
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided