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Completed

NCT Number: NCT02764203

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

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.

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Key information

Conditions

Health Behavior Behavior Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dark Chocolate

Other

50g dark chocolate consumed for a period of 2 weeks

Wearable devices

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

Primary outcomes

  1. Change in resting systolic blood pressure after daily dark chocolate

    Time frame: 14 days after daily consumption of dark chocolate

Secondary outcomes

  1. Correlation of physical activity (steps) to resting blood pressure and heart rate

    Time frame: daily, for four weeks

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: COCOA-BP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 6, 2016
Registry last updated
Oct 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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