Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01412320
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
2011-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cocoa Flavanols in Renal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069956', 'term': 'Chocolate'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-12', 'studyFirstSubmitDate': '2011-08-05', 'studyFirstSubmitQcDate': '2011-08-08', 'lastUpdatePostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of flavanols on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.', 'timeFrame': '30 days', 'description': 'To study the effect of flavanols on flow mediated dilation of the brachial artery after 5 minutes of forearm ischemia and reperfusion in patients with ESRD'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['End Stage Renal Disease', 'Endothelial Dysfunction']}, 'referencesModule': {'references': [{'pmid': '18510961', 'type': 'BACKGROUND', 'citation': 'Balzer J, Rassaf T, Heiss C, Kleinbongard P, Lauer T, Merx M, Heussen N, Gross HB, Keen CL, Schroeter H, Kelm M. Sustained benefits in vascular function through flavanol-containing cocoa in medicated diabetic patients a double-masked, randomized, controlled trial. J Am Coll Cardiol. 2008 Jun 3;51(22):2141-9. doi: 10.1016/j.jacc.2008.01.059.'}, {'pmid': '37916745', 'type': 'DERIVED', 'citation': 'Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.'}, {'pmid': '26485680', 'type': 'DERIVED', 'citation': 'Luedike P, Rammos C, Pohl J, Heisler M, Totzeck M, Kleophas W, Hetzel GR, Kelm M, Hendgen-Cotta U, Rassaf T. Filtration of Macrophage Migration Inhibitory Factor (MIF) in Patients with End Stage Renal Disease Undergoing Hemodialysis. PLoS One. 2015 Oct 20;10(10):e0140215. doi: 10.1371/journal.pone.0140215. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'Purpose of the study is to characterize the potential acute and long-term improvement of dietary flavanols on vascular function in patients with end-stage renal disease (ESRD).\n\nPatients will twice daily receive either a flavanol-poor or a flavanol-rich drink. In a double blind, placebo-controlled crossover study the safety, efficacy and acute beneficial effects of flavanol ingestion will be assessed in 10 patients with ESRD. In a 30 day long-term, double blind, placebo-controlled parallel study the chronic effects of dietary flavanols on vascular function in 52 patients with ESRD will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* end stage renal disease\n* \\>18 years\n* chronic intermittent hemodialysis\n\nExclusion Criteria:\n\n* acute Infection\n* acute renal failure\n* heart failure (NYHA IV)\n* pregnancy\n* anuria'}, 'identificationModule': {'nctId': 'NCT01412320', 'briefTitle': 'Cocoa Flavanols in Renal Disease', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'The Impact of Dietary Flavanols on Cardiovascular Dysfunction in End-stage Renal Disease', 'orgStudyIdInfo': {'id': 'ESRD_2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flavanol rich cocoa', 'interventionNames': ['Other: Cocoa']}, {'type': 'EXPERIMENTAL', 'label': 'Flavanol poor', 'interventionNames': ['Other: Cocoa']}], 'interventions': [{'name': 'Cocoa', 'type': 'OTHER', 'description': 'dissolved in water twice daily', 'armGroupLabels': ['Flavanol rich cocoa']}, {'name': 'Cocoa', 'type': 'OTHER', 'description': 'dissolved in water twice daily', 'armGroupLabels': ['Flavanol poor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Heinrich-Heine-University', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinik für Kardiologie, Pneumologie und Angiologie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Christos Rammos, MD Clinic for Cardiology, Pneumology and Angiology', 'investigatorFullName': 'Klinik für Kardiologie, Pneumologie und Angiologie', 'investigatorAffiliation': 'Heinrich-Heine University, Duesseldorf'}}}}