Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-01-19 @ 4:01 PM
Study NCT ID:
NCT02728466
Status:
COMPLETED
Last Update Posted:
2016-06-22
First Post:
2016-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cocoa Procyanidins on Vascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D044945', 'term': 'Proanthocyanidins'}], 'ancestors': [{'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013634', 'term': 'Tannins'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-21', 'studyFirstSubmitDate': '2016-03-09', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pulse wave velocity', 'timeFrame': 'Baseline and 1 month', 'description': 'Measured by SphygmoCor on baseline 2 hours postconsumption and on 1 month.'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline and 1 month', 'description': 'automatical measurements on baseline 2 hours postconsumption and on 1 month'}, {'measure': 'high density lipoproteins (HDL)', 'timeFrame': 'Baseline and 1 month', 'description': 'measured on baseline and after 1 month'}, {'measure': 'low density lipoproteins (LDL)', 'timeFrame': 'Baseline and 1 month', 'description': 'measured on baseline and after 1 month'}, {'measure': 'cholesterol', 'timeFrame': 'Baseline and 1 month', 'description': 'measured on baseline and after 1 month'}, {'measure': 'triglyceride', 'timeFrame': 'Baseline and 1 month', 'description': 'measured on baseline and after 1 month'}], 'primaryOutcomes': [{'measure': 'Change form Baseline Endothelial function at 1 month', 'timeFrame': 'Baseline and 1 month', 'description': 'Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption on baseline and on 1 month'}], 'secondaryOutcomes': [{'measure': 'Plasma flavanol metabolites', 'timeFrame': 'Baseline and 1 month', 'description': 'Measured by high performance liquid chromotography (HPLC) at 2 hours and on 1 month postconsumption'}, {'measure': 'Urinary flavanol metabolites', 'timeFrame': 'Baseline and 1 month', 'description': 'Measured up to 24 hours post consumption on day 1 and 1 month after consumption'}, {'measure': 'Urinary valerolactone metabolites', 'timeFrame': 'Baseline and 1 month', 'description': 'Measured up to 24 hours post consumption on day 1 and 1 month after consumption'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['flavanols', 'cocoa procyanidins', 'vascular function', 'endothelial function'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '30358831', 'type': 'DERIVED', 'citation': 'Rodriguez-Mateos A, Weber T, Skene SS, Ottaviani JI, Crozier A, Kelm M, Schroeter H, Heiss C. Assessing the respective contributions of dietary flavanol monomers and procyanidins in mediating cardiovascular effects in humans: randomized, controlled, double-masked intervention trial. Am J Clin Nutr. 2018 Dec 1;108(6):1229-1237. doi: 10.1093/ajcn/nqy229.'}]}, 'descriptionModule': {'briefSummary': 'There is a question regarding the role of higher flavanol oligomers (procyanidins) and of intestinal flavanol metabolites i.e. valerolactones, in the context of flavanol intake-related vascular effects. Only flavanol monomers, and to a certain degree dimers, are absorbed in the small intestine and enter circulation. Higher oligomers (procyanidins) are not absorbed and are catabolized by the colonic microflora. The catabolites enter the circulation. Phenolic acids and valerolactones represent a significant proportion of these catabolites, reaching peak concentrations in the order of 6-10 h post ingestion. The vascular effects of these colonic microbiome-derived flavanol derivatives have not been studied so far. The purpose of the study is to determine the timecourse of endothelial function along with flavanol catabolites \\& metabolites during acute, sustained, and acute on sustained ingestion of procyanidins as compared to previously used flavanol interventions, and flavanol free control.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male subjects (no clinical signs or symptoms of cardiovascular disease)\n* \\>18 years, \\<35 years\n\nExclusion Criteria:\n\n* cardiovascular disease\n* acute inflammation\n* cardiac arrhythmia\n* renal failure\n* heart failure (NYHA II-IV)\n* diabetes mellitus\n* C-reactive protein \\> 1 mg/dl\n* malignant disease'}, 'identificationModule': {'nctId': 'NCT02728466', 'briefTitle': 'Effects of Cocoa Procyanidins on Vascular Function', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Investigation on the Effects of Cocoa Procyanidins on Vascular Function in Healthy Individuals', 'orgStudyIdInfo': {'id': 'Cocoa procyanidins'}, 'secondaryIdInfos': [{'id': '12-018', 'type': 'OTHER', 'domain': 'CTSU'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Flavanol and procyanidin supplement', 'description': 'Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers)', 'interventionNames': ['Dietary Supplement: Flavanol and procyanidin supplement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Procyanidin-containing supplement', 'description': 'Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)', 'interventionNames': ['Dietary Supplement: Procyanidin-containing supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Flavanols and procyanidins deprived supplement', 'description': 'Control supplement deprived of flavanols and procyanidins Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement', 'interventionNames': ['Dietary Supplement: control supplement deprived of flavanols and procyanidins']}], 'interventions': [{'name': 'Flavanol and procyanidin supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers)', 'armGroupLabels': ['Flavanol and procyanidin supplement']}, {'name': 'Procyanidin-containing supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)', 'armGroupLabels': ['Procyanidin-containing supplement']}, {'name': 'control supplement deprived of flavanols and procyanidins', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo comparator: flavanol and procyanidin deprived supplement Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement', 'armGroupLabels': ['Flavanols and procyanidins deprived supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Christian Heiß, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf'}, {'name': 'Malte Kelm, Prof. MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division of Cardiology, Pulmonary Diseases, Vascular Medicine', 'investigatorFullName': 'Klinik für Kardiologie, Pneumologie und Angiologie', 'investigatorAffiliation': 'Heinrich-Heine University, Duesseldorf'}}}}