Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-29 @ 7:07 AM
Study NCT ID:
NCT01308892
Status:
COMPLETED
Last Update Posted:
2011-06-17
First Post:
2011-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Health Effects of Flavanol Rich Chocolate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-16', 'studyFirstSubmitDate': '2011-02-15', 'studyFirstSubmitQcDate': '2011-03-03', 'lastUpdatePostDateStruct': {'date': '2011-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '0, 4wk'}, {'measure': 'FMD', 'timeFrame': '0, 4wk'}, {'measure': 'PWA', 'timeFrame': '0, 4wk'}], 'secondaryOutcomes': [{'measure': 'leukocyte count and activation', 'timeFrame': '0, 4wk'}, {'measure': 'PBMC gene expression', 'timeFrame': '0, 4wk'}, {'measure': 'Markers of inflammation and ED', 'timeFrame': '0, 4wk'}, {'measure': 'Blood pressure', 'timeFrame': '0 and 2h', 'description': 'acute study part'}, {'measure': 'FMD', 'timeFrame': '0 and 2hrs', 'description': 'acute study part'}, {'measure': 'PWA', 'timeFrame': '0 and 2 hrs', 'description': 'acute study part'}, {'measure': 'Leukocyte count and activation', 'timeFrame': '0 and 2 hrs', 'description': 'acute study part'}, {'measure': 'PBMC gene expression', 'timeFrame': '0 and 2 hrs', 'description': 'acute study part'}, {'measure': 'markers of inflammation and ED', 'timeFrame': '0 and 2hrs', 'description': 'acute study part'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'In the CHOC study the investigators will examine the effect of chocolate flavanols on vascular function, inflammation, oxidative stress and markers of endothelial function. The effects of both acute consumption and prolonged consumption will be studied. The secondary objectives are to investigate if daily intake of chocolate flavanols for 4 weeks will improve the response to a high fat/high energy challenge.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* 45-70 years old\n* BMI between 25 and 32 kg/m2\n\nExclusion Criteria:\n\n* Urine glucose concentrations outside normal ranges (\\> 0,25 g/l)\n* Fasting blood glucose \\< 7.0 mmol/L)\n* Systolic Bp \\> 160 mmHg or diastolic Bp \\> 100 mmHg\n* Blood Hb values below 8.4 mmol/L\n* Allergic to cow milk, dairy products or chocolate\n* Vegetarian\n* Tobacco smoker\n* Diagnosed with any long-term medical condition (e.g., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease, renal failure)'}, 'identificationModule': {'nctId': 'NCT01308892', 'acronym': 'CHOC', 'briefTitle': 'Cardiovascular Health Effects of Flavanol Rich Chocolate', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'Cardiovascular Health Effects of Flavanol Rich Chocolate', 'orgStudyIdInfo': {'id': 'NL33506.081.10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High flavaonol chocolate', 'interventionNames': ['Dietary Supplement: High flavanol chocolate', 'Dietary Supplement: High fat challenge']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low flavanol chocolate', 'interventionNames': ['Dietary Supplement: Low flavanol chocolate', 'Dietary Supplement: High fat challenge']}], 'interventions': [{'name': 'High flavanol chocolate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'chocolate high in flavanols', 'armGroupLabels': ['High flavaonol chocolate']}, {'name': 'Low flavanol chocolate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'chocolate low in flavanols', 'armGroupLabels': ['Low flavanol chocolate']}, {'name': 'High fat challenge', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Milkshake with 95g fat', 'armGroupLabels': ['High flavaonol chocolate', 'Low flavanol chocolate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6703HD', 'city': 'Wageningen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Wageningen universiteit division of human', 'geoPoint': {'lat': 51.97, 'lon': 5.66667}}], 'overallOfficials': [{'name': 'Michael Müller, Prof.Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Chair Department of human nutrition NMG group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Top Institute Food and Nutrition', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Wageningen universiteit department of human nutrition', 'oldOrganization': 'Wageningen University'}}}}