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

NCT02764203 | Completed

• 1 other identifier: S2363
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Health Behavior; Blood Pressure

Keywords

Dark Chocolate; Blood Pressure; Wearable Devices; Digital Health

Outcome Measures

Primary Outcomes (1)

• Change in resting systolic blood pressure after daily dark chocolate

  14 days after daily consumption of dark chocolate

Secondary Outcomes (3)

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

  daily, for four weeks

• 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

• 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

Study Arms (1)

Chocolate consumption

EXPERIMENTAL

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

Other: Dark Chocolate; Device: Wearable devices

Interventions

Dark Chocolate OTHER

50g dark chocolate consumed for a period of 2 weeks

Chocolate consumption

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

Chocolate consumption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Health Behavior

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Thomas Christen, MD, PhD

  Sponsor GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 6, 2016
• Study Start: September 16, 2016
• Primary Completion: September 12, 2017
• Study Completion: September 12, 2017
• Last Updated: October 4, 2017

Record last verified: 2017-10