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

Boston Scientific logo

Boston Scientific

Status

Completed

Conditions

Health Behavior
Blood Pressure

Treatments

Device: Wearable devices
Other: Dark Chocolate

Study type

Interventional

Funder types

Industry

Identifiers

NCT02764203
S2363

Details and patient eligibility

About

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.

Full 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.

Enrollment

67 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

67 participants in 1 patient group

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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