Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 4:54 AM
Study NCT ID:
NCT00914251
Status:
UNKNOWN
Last Update Posted:
2009-06-17
First Post:
2009-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular Effects of Hesperidin in Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006569', 'term': 'Hesperidin'}], 'ancestors': [{'id': 'D044950', 'term': 'Flavanones'}, {'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': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-06-16', 'studyFirstSubmitDate': '2009-06-03', 'studyFirstSubmitQcDate': '2009-06-03', 'lastUpdatePostDateStruct': {'date': '2009-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of oral supplementation of hesperidin', 'timeFrame': '3 weeks'}], 'secondaryOutcomes': [{'measure': 'Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.', 'timeFrame': '3 weeks'}]}, 'conditionsModule': {'keywords': ['endothelial', 'metabolic syndrome', 'hesperidin'], 'conditions': ['Endothelial Dysfunction', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '19064532', 'type': 'BACKGROUND', 'citation': 'Muniyappa R, Hall G, Kolodziej TL, Karne RJ, Crandon SK, Quon MJ. Cocoa consumption for 2 wk enhances insulin-mediated vasodilatation without improving blood pressure or insulin resistance in essential hypertension. Am J Clin Nutr. 2008 Dec;88(6):1685-96. doi: 10.3945/ajcn.2008.26457.'}, {'pmid': '17724029', 'type': 'BACKGROUND', 'citation': "Collins QF, Liu HY, Pi J, Liu Z, Quon MJ, Cao W. Epigallocatechin-3-gallate (EGCG), a green tea polyphenol, suppresses hepatic gluconeogenesis through 5'-AMP-activated protein kinase. J Biol Chem. 2007 Oct 12;282(41):30143-9. doi: 10.1074/jbc.M702390200. Epub 2007 Aug 27."}, {'pmid': '21346065', 'type': 'DERIVED', 'citation': 'Rizza S, Muniyappa R, Iantorno M, Kim JA, Chen H, Pullikotil P, Senese N, Tesauro M, Lauro D, Cardillo C, Quon MJ. Citrus polyphenol hesperidin stimulates production of nitric oxide in endothelial cells while improving endothelial function and reducing inflammatory markers in patients with metabolic syndrome. J Clin Endocrinol Metab. 2011 May;96(5):E782-92. doi: 10.1210/jc.2010-2879. Epub 2011 Feb 23.'}]}, 'descriptionModule': {'briefSummary': 'It has been suggested that cardiovascular risk factors either independently or in cluster (metabolic syndrome) increase the risk of both type 2 diabetes (DM2) and cardiovascular diseases (CVD). Consumption of citrus fruits is linked to reduced cardiovascular morbidity and mortality. Hesperidin is a flavanone abundant in citrus fruit with putative vasodilator actions in vitro. While molecular mechanisms of vascular actions of hesperidin begin to be explored, no data on in vivo vascular effect of this flavanone has been ever acquired.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metabolic Syndrome (ATPIII criteria)\n* BMI \\<35\n* Age 20-55\n\nExclusion Criteria:\n\n* History of cancer.\n* History of cardiovascular diseases.\n* Any other acute or chronic illness which requires administration of steroids or other drugs able to interfere with glucose or lipid metabolism.'}, 'identificationModule': {'nctId': 'NCT00914251', 'briefTitle': 'Vascular Effects of Hesperidin in Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Rome Tor Vergata'}, 'officialTitle': 'Positive Vascular Effect of Hesperidin in Subjects Affected by Metabolic Syndrome', 'orgStudyIdInfo': {'id': '073/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hesperidin, 500 mg per day', 'description': '500 mg daily of oral Hesperidin for 3 weeks', 'interventionNames': ['Drug: Hesperidin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Hesperidin', 'type': 'DRUG', 'description': 'Administration of oral Hesperidin, 500 mg/daily', 'armGroupLabels': ['Hesperidin, 500 mg per day']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administration of oral Placebo, 500 mg/daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00133', 'city': 'Rome', 'state': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Rizza, MD', 'role': 'CONTACT', 'email': 'rizza@med.uniroma2.it'}, {'name': 'Stefano Rizza, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Manfredi Tesauro, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Davide Lauro, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Rome Tor Vergata', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rome Tor Vergata', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Stefano Rizza', 'oldOrganization': 'Medicine Internal Department'}}}}