Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT01344551
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2011-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Cocoa Flavanols on Human Cognitive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009410', 'term': 'Nerve Degeneration'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-20', 'studyFirstSubmitDate': '2011-04-27', 'studyFirstSubmitQcDate': '2011-04-28', 'lastUpdatePostDateStruct': {'date': '2013-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Executive function - attention', 'timeFrame': 'change from baseline to 2 hours'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'change from baseline to 2 hours'}, {'measure': 'Plasma flavanols', 'timeFrame': 'change from baseline to 2 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neural Degeneration']}, 'descriptionModule': {'briefSummary': 'To determine the acute and chronic effects of cocoa derived flavonoids on cognitive function in healthy older adults.', 'detailedDescription': 'This is a randomised controlled double blind cross over study investigating the acute effects of high flavanol (495mg) compared to low flavanol (23mg)cocoa drink on cognitive function in a healthy older adult population (n=60). The primary outcome measure of this study is to determine the effects of the flavanol intervention on cognitive measures of executive function and attention and the secondary measures of blood pressure and to determine whether any observed effects are paralleled by plasma flavanol levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 62 - 75 years\n* A signed consent form\n\nExclusion Criteria:\n\n* Blood pressure \\> 160/90 mmHg\n* Haemoglobin (anaemia marker) \\< 125 g/l\n* Gamma GT (liver enzymes) \\> 80 IU/l\n* Had suffered a myocardial infarction or stroke in the previous 12 months\n* Suffers from any gastrointestinal/stomach disorder\n* Suffers from any blood-clotting disorder\n* On medication for hypertension\n* Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)\n* Depression or major mental illness\n* Any dietary restrictions or on a weight reducing diet\n* Drinking more than 21 units per week\n* On any medication affecting blood clotting\n* Smoking\n* Vegans'}, 'identificationModule': {'nctId': 'NCT01344551', 'briefTitle': 'Effects of Cocoa Flavanols on Human Cognitive Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Reading'}, 'orgStudyIdInfo': {'id': 'UReading-2011-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Flavanol', 'description': 'High Flavanol cocoa drink containing 495mg cocoa', 'interventionNames': ['Dietary Supplement: Cocoa Drink']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low Flavanol', 'description': 'Low Flavanol cocoa drink (23mg)', 'interventionNames': ['Dietary Supplement: Cocoa Drink']}], 'interventions': [{'name': 'Cocoa Drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High Flavanol (495mg) Low Flavanol (23mg) Matched for macro and micro nutrients', 'armGroupLabels': ['High Flavanol', 'Low Flavanol']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RG2 9AR', 'city': 'Reading', 'state': 'Berkshire', 'country': 'United Kingdom', 'facility': 'University of Reading', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'overallOfficials': [{'name': 'Jeremy Spencer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Reading'}, {'name': 'Laurie Butler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Reading'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Reading', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nutritional Medicine', 'investigatorFullName': 'Jeremy Paul Edward Spencer', 'investigatorAffiliation': 'University of Reading'}}}}