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

October 1, 2017 updated by: Boston Scientific Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chocolate consumption
Subjects will consume 50g of dark chocolate for 2 weeks and have their blood pressure compared before chocolate and after chocolate
Other: Dark Chocolate
50g dark chocolate consumed for a period of 2 weeks
Device: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of physical activity (steps) to resting blood pressure and heart rate
Time Frame: daily, for four weeks
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
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
End of week two and end of week four

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Thomas Christen, MD, PhD, Sponsor GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2016

Primary Completion (Actual)

September 12, 2017

Study Completion (Actual)

September 12, 2017

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

October 1, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S2363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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