Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT02764203
Status:
COMPLETED
Last Update Posted:
2017-10-04
First Post:
2016-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ChOcolate COnsumption And Blood Pressure (COCOA-BP): A Wearable Devices Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076251', 'term': 'Wearable Electronic Devices'}], 'ancestors': [{'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-01', 'studyFirstSubmitDate': '2016-05-02', 'studyFirstSubmitQcDate': '2016-05-05', 'lastUpdatePostDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in resting systolic blood pressure after daily dark chocolate', 'timeFrame': '14 days after daily consumption of dark chocolate'}], 'secondaryOutcomes': [{'measure': 'Correlation of physical activity (steps) to resting blood pressure and heart rate', 'timeFrame': 'daily, for four weeks'}, {'measure': 'Comparison of blood pressure derived from wearable digital health devices to data derived from standard methods', 'timeFrame': 'End of week two and end of week four'}, {'measure': 'Comparison of heart rate derived from wearable digital health devices to data derived from standard methods', 'timeFrame': 'End of week two and end of week four'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dark Chocolate', 'Blood Pressure', 'Wearable Devices', 'Digital Health'], 'conditions': ['Health Behavior', 'Blood Pressure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is at least 18 years of age\n* Subject has an iPhone (5 or higher)\n* Subject is willing to comply with all trial requirements\n* Subject understands the trial requirements and procedures and provides written informed consent before any trial-specific procedures are performed\n\nExclusion Criteria:\n\n* Anyone part of the study execution team cannot be part of the trial\n* Current smoker or history of smoking in the last 5 years (including E-cigarettes)\n* Diabetes mellitus including those managed by diet alone\n* Medically treated hypertension\n* Diagnosed with persistent or frequent irregular heart beat (e.g. atrial flutter, atrial fibrillation)\n* Permanent pacemaker or defibrillator implanted\n* Subject is a women who is pregnant\n* Known allergy to chocolate or cacao products\n* Known allergy to skin adhesives'}, 'identificationModule': {'nctId': 'NCT02764203', 'acronym': 'COCOA-BP', 'briefTitle': 'ChOcolate COnsumption And Blood Pressure (COCOA-BP): A Wearable Devices Pilot Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'ChOcolate COnsumption And Blood Pressure (COCOA-BP): A Wearable Devices Pilot Trial', 'orgStudyIdInfo': {'id': 'S2363'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chocolate consumption', 'description': 'Subjects will consume 50g of dark chocolate for 2 weeks and have their blood pressure compared before chocolate and after chocolate', 'interventionNames': ['Other: Dark Chocolate', 'Device: Wearable devices']}], 'interventions': [{'name': 'Dark Chocolate', 'type': 'OTHER', 'description': '50g dark chocolate consumed for a period of 2 weeks', 'armGroupLabels': ['Chocolate consumption']}, {'name': 'Wearable devices', 'type': 'DEVICE', 'description': 'Up to three wearable devices will be worn by the subject to measure parameters such as heart rate, blood pressure and number of steps', 'armGroupLabels': ['Chocolate consumption']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Thomas Christen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sponsor GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}