Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2025-12-25 @ 4:18 PM
Study NCT ID:
NCT01507259
Status:
COMPLETED
Last Update Posted:
2012-07-27
First Post:
2012-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chocolate's Effect on the Cerebral Vasculature
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069956', 'term': 'Chocolate'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-26', 'studyFirstSubmitDate': '2012-01-06', 'studyFirstSubmitQcDate': '2012-01-09', 'lastUpdatePostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-10', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Determine effect on cerebral vasculature'], 'conditions': ['Cerebral Vasculature']}, 'descriptionModule': {'briefSummary': 'The popularity of chocolate can largely be attributed to its mood elevating properties, research shows that it contains antioxidants that also provide physical health benefits. Dark chocolate, in particular, contains high levels of an antioxidant called epicatechin, which is known to cause changes in blood vessels by relaxing them and increasing blood flow.\n\nLittle is know about the immediate effects of chocolate consumption, or the differences between milk and dark chocolate with regards to these effects. The project will investigate the effect of a single bar of dark or milk chocolate upon blood flow to the brain, using simple ultrasound tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No regular medication including vitamins/antioxidants\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Inability to perform breath-hold test\n* Any known cardiovascular disease, diabetes, throid disease, high blood pressure, hyperlipidaemia or pregnancy'}, 'identificationModule': {'nctId': 'NCT01507259', 'briefTitle': "Chocolate's Effect on the Cerebral Vasculature", 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Glasgow and Clyde'}, 'officialTitle': 'A Randomised Trial of Effect of Chocolate Upon Cerebrovascular Reactivity in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'GN11MT497'}}, 'armsInterventionsModule': {'armGroups': [{'label': '100 g containing 70% or 34% cocoa', 'description': 'Healthy controls', 'interventionNames': ['Other: cocoa']}], 'interventions': [{'name': 'cocoa', 'type': 'OTHER', 'description': '70% versus 34%', 'armGroupLabels': ['100 g containing 70% or 34% cocoa']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G11 6NT', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Western Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Glasgow', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Sponsor's representative", 'investigatorFullName': 'Steven Burke', 'investigatorAffiliation': 'NHS Greater Glasgow and Clyde'}}}}