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

Blood Pressure Clinical Trial

— COCOA-BP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764203
• Other study ID #: S2363
• Status: Completed
• Phase: N/A
• First received: May 2, 2016
• Last updated: October 1, 2017
• Start date: September 16, 2016
• Est. completion date: September 12, 2017

Study information

• Verified date: October 2017
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 12, 2017
• Est. primary completion date: September 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Health Behavior

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in resting systolic blood pressure after daily dark chocolate		14 days after daily consumption of dark chocolate
Secondary	Correlation of physical activity (steps) to resting blood pressure and heart rate		daily, for four weeks
Secondary	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
Secondary	Comparison of heart rate derived from wearable digital health devices to data derived from standard methods		End of week two and end of week four