Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 6:04 AM
Study NCT ID:
NCT01681394
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
2012-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression
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']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-02', 'studyFirstSubmitDate': '2012-09-05', 'studyFirstSubmitQcDate': '2012-09-06', 'lastUpdatePostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gene expression changes in PBMCs (using a microarray)', 'timeFrame': '0-6 hours'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '0-2-3-6 hours'}, {'measure': 'Endothelial function (assessed by ischemic reactive hyperemia)', 'timeFrame': '0-2-3-6 hours'}, {'measure': 'Plasma levels of procyanidins metabolites', 'timeFrame': '0-6 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiovascular Function', 'Gene Expression']}, 'descriptionModule': {'briefSummary': 'It has been evidenced that chocolate and cocoa consumption increase vasodilation and reduce blood pressure. However, the mechanisms implicated in these effects have not been elucidated yet. The purpose of this study is to evaluate changes in gene expression induced by the administration of a polyphenol-rich cocoa extract in peripheral blood mononuclear cells (PBMC) in humans.', 'detailedDescription': 'This is a prospective, randomized, controlled, double-blind and cross-over study. The intervention will consist in the administration of 250g of chocolate cream with or without the extract after 12 hours fasting. Blood samples will be taken at point 0, 2, 3 and 6 hours after the administration. At each time point, blood pressure and endothelial function (with a non-invasive method) will be measured.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.Healthy males between the ages of 20 and 39 who do not meet any of the exclusion criteria.\n\nExclusion Criteria:\n\n1. Body mass index (BMI) lower than 18 or greater than 27 Kg/m2\n2. Smokers\n3. Regular medication\n4. Consumption of medication during the last week\n5. Following a weight-loss diet\n6. Vegetarians\n7. Abnormal glucose levels\n8. Diabetes\n9. Cardiovascular disease\n10. Gastrointestinal disease\n11. Anemia\n12. Allergy'}, 'identificationModule': {'nctId': 'NCT01681394', 'briefTitle': 'Effect of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression', 'organization': {'class': 'OTHER', 'fullName': 'Technological Centre of Nutrition and Health, Spain'}, 'officialTitle': 'Effect of the Administration of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression in Humans', 'orgStudyIdInfo': {'id': 'PBMCS-CTNS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Product 1', 'description': '250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)', 'interventionNames': ['Dietary Supplement: Polyphenol-rich cocoa extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control product', 'description': '250 g of chocolate cream', 'interventionNames': ['Dietary Supplement: Chocolate cream']}], 'interventions': [{'name': 'Polyphenol-rich cocoa extract', 'type': 'DIETARY_SUPPLEMENT', 'description': '250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)', 'armGroupLabels': ['Product 1']}, {'name': 'Chocolate cream', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Control product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43204', 'city': 'Reus', 'state': 'Tarragona', 'country': 'Spain', 'facility': 'Technological Center of Nutrition and Health (CTNS)', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}], 'overallOfficials': [{'name': 'Rosa Solà, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Rovira i Virgili'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technological Centre of Nutrition and Health, Spain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}