Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-27 @ 10:19 AM
Study NCT ID:
NCT01781559
Status:
COMPLETED
Last Update Posted:
2013-12-12
First Post:
2013-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioefficacy of Phenolic Acids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C017616', 'term': 'phenolic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-11', 'studyFirstSubmitDate': '2013-01-28', 'studyFirstSubmitQcDate': '2013-01-30', 'lastUpdatePostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment', 'timeFrame': 'After 1 hour'}], 'secondaryOutcomes': [{'measure': 'Change from predose in blood pressure at 0.5h', 'timeFrame': 'After 30 min'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'The objective is to demonstrate the effect of phenolic acids on endothelial function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, Men and women\n* Subjects with endothelial dysfunction defined as a basal brachial artery flow-mediated dilatation (FMD) measurement between 3% and 8% at screening\n\nExclusion Criteria:\n\n* Any food allergy\n* Abnormal blood pressure defined as follow: systolic \\<100 or \\>160 mmHg and diastolic \\<50 or \\>100mmHg\n* Pregnancy or lactating women\n* Regular consumption of cholesterol-lowering or antihypertensive medication\n* Smokers\n* Inability to restrain from caffeine/tea and alcohol for 12hrs prior to study visits (intake1 day before screening measurements (and 1 day before each visit)\n* Not restrain the intake of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study.\n* Excessive alcohol intake defined as \\> 280 g per week for men and \\>210g per week for women'}, 'identificationModule': {'nctId': 'NCT01781559', 'briefTitle': 'Bioefficacy of Phenolic Acids', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Effect of Phenolic Acids on the Human Vasculature', 'orgStudyIdInfo': {'id': '11.35.NRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'phenolic acid + maltodextrin', 'description': 'phenolic acid + maltodextrin;', 'interventionNames': ['Dietary Supplement: phenolic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Maltodextrin', 'description': 'Maltodextrin', 'interventionNames': ['Dietary Supplement: phenolic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'flavanol + maltodextrin', 'description': 'flavanol + maltodextrin', 'interventionNames': ['Dietary Supplement: phenolic acid']}], 'interventions': [{'name': 'phenolic acid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'phenolic acid', 'armGroupLabels': ['Maltodextrin', 'flavanol + maltodextrin', 'phenolic acid + maltodextrin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Perth', 'country': 'Australia', 'facility': 'School of Medicine and Pharmacology - University of WA', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Kevin Croft, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Medicine and Pharmacology - University of WA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}