Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-03-05 @ 11:18 PM
Study NCT ID:
NCT01799005
Status:
COMPLETED
Last Update Posted:
2015-02-03
First Post:
2013-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FLAVIOLA Health Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-01', 'studyFirstSubmitDate': '2013-02-24', 'studyFirstSubmitQcDate': '2013-02-24', 'lastUpdatePostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Flavanol metabolites', 'timeFrame': 'day 0 [baseline], and day 30 each 0 and 2h'}, {'measure': 'Microparticles', 'timeFrame': 'Time points: day 0 [baseline], and day 30 each 0 and 2h.'}, {'measure': 'Dietary pattern', 'timeFrame': 'Time points: day 0 [baseline] and day 30'}, {'measure': 'Vascular stiffness', 'timeFrame': 'Time points: day 0 [baseline], and day 30 each 0 and 2h.'}, {'measure': 'Microvascular function', 'timeFrame': 'Time points: day 0 [baseline], and day 30 each 0 and 2h.'}], 'primaryOutcomes': [{'measure': 'Endothelial function', 'timeFrame': 'Time points: day 0 [baseline], and day 30 each 0 and 2h.'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Time points: day 0 [baseline], and day 30 each 0 and 2h.'}, {'measure': 'Glucose', 'timeFrame': 'Time points: day 0 [baseline], and day 30 each 0 and 2h.'}, {'measure': 'Plasma lipids', 'timeFrame': 'Time points: day 0 [baseline], and day 30 each 0 and 2h.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['flavanols', 'diet', 'endothelial function', 'blood pressure', 'FLAVIOLA'], 'conditions': ['Vascular Health']}, 'referencesModule': {'references': [{'pmid': '26348767', 'type': 'DERIVED', 'citation': 'Sansone R, Rodriguez-Mateos A, Heuel J, Falk D, Schuler D, Wagstaff R, Kuhnle GG, Spencer JP, Schroeter H, Merx MW, Kelm M, Heiss C; Flaviola Consortium, European Union 7th Framework Program. Cocoa flavanol intake improves endothelial function and Framingham Risk Score in healthy men and women: a randomised, controlled, double-masked trial: the Flaviola Health Study. Br J Nutr. 2015 Oct 28;114(8):1246-55. doi: 10.1017/S0007114515002822. Epub 2015 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'Atherosclerosis progressively occurs with increasing age in the general population. So far most dietary intervention studies with flavanols were performed over short time frames and in small groups of young healthy and older patients with manifest cardiovascular disease, respectively. Vascular health is defined as absence of vascular disease and the presence of optimal parameters that determine the development and progression of arteriosclerosis (endothelial function, blood pressure, plasma lipids, and glucose). It is not clear whether flavanols can improve parameters of vascular health, most importantly endothelial function, when given repetitively to healthy middle aged and which factors affect the efficacy of flavanol interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male, age 35-60 years, healthy\n* female, age 35-60 years, healthy\n\nExclusion Criteria:\n\n* diabetes mellitus, acute inflammation, arrhythmia, active malignancy, terminal renal failure, signs, symptoms or medication indicative of manifest cardiovascular disease (CAD, PAD, CVD)'}, 'identificationModule': {'nctId': 'NCT01799005', 'acronym': 'FHS', 'briefTitle': 'FLAVIOLA Health Study', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Impact of Dietary Flavanols on Vascular Health in a General Population of Healthy Middle-aged Europeans: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'FHS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'flavanol rich intervention', 'description': 'Ingestion of 410mg flavanols twice a day for 30 days', 'interventionNames': ['Dietary Supplement: Flavanol (410 mg)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'flavanol free intervention', 'description': 'Ingestion of a macro and micro nutrients matched flavanol free drink', 'interventionNames': ['Dietary Supplement: Control (no flavanols)']}], 'interventions': [{'name': 'Flavanol (410 mg)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Ingestion of intervention drink containing 410 mg flavanols twice a day for 30 days'], 'armGroupLabels': ['flavanol rich intervention']}, {'name': 'Control (no flavanols)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Ingestion of a macro- and micronutrient matched control drink that is free of flavanols twice per day'], 'armGroupLabels': ['flavanol free intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Division of Cardiology, Pulmonology and Vascular Medicine', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Christian Heiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Cardiology, Pulmonology and Vascular Medicine'}, {'name': 'Malte Kelm, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Cardiology, Pulmonology and Vascular Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. Christian Heiss', 'investigatorFullName': 'Klinik für Kardiologie, Pneumologie und Angiologie', 'investigatorAffiliation': 'Heinrich-Heine University, Duesseldorf'}}}}