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

NCT ID: NCT02764203

Last Updated: 2017-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-16

Study Completion Date

2017-09-12

Brief Summary

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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

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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

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Health Behavior Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Chocolate consumption

Subjects will consume 50g of dark chocolate for 2 weeks and have their blood pressure compared before chocolate and after chocolate

Group Type EXPERIMENTAL

Dark Chocolate

Intervention Type OTHER

50g dark chocolate consumed for a period of 2 weeks

Wearable devices

Intervention Type DEVICE

Up to three wearable devices will be worn by the subject to measure parameters such as heart rate, blood pressure and number of steps

Interventions

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Dark Chocolate

50g dark chocolate consumed for a period of 2 weeks

Intervention Type OTHER

Wearable 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Christen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sponsor GmbH

Other Identifiers

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S2363

Identifier Type: -

Identifier Source: org_study_id