Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-03-11 @ 3:41 AM
Study NCT ID:
NCT02205567
Status:
COMPLETED
Last Update Posted:
2015-08-06
First Post:
2014-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bergamot and Cardio-Metabolic Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum and plasma samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-05', 'studyFirstSubmitDate': '2014-07-29', 'studyFirstSubmitQcDate': '2014-07-30', 'lastUpdatePostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in plasma lipids', 'timeFrame': 'baseline and 6 months', 'description': 'We will measure at baseline and after 6 months the following plasma lipids concentrations: total cholesterol, triglycerides, LDL-cholesterol and HDL-cholesterol.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in atherogenic lipoproteins, carotid intima-media thickness (IMT) and liver steatosis', 'timeFrame': 'baseline and 6 months', 'description': 'We will measure at baseline and after 6 months carotid IMT by color doppler ultrasound, atherogenic lipoproteins by electrophoresis and liver steatosis by abdominal ultrasound.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'Bergamot-derived products have shown significant effects on plasma lipids. We aim in the present study to evaluate the effect of bergamot on several cardio-metabolic risk markers.', 'detailedDescription': 'The research hypothesis is to assess whether bergamot reduces plasma lipids (total cholesterol, triglycerides, low-density lipoprotein (LDL)-cholesterol and high-density lipoprotein (HDL)-cholesterol), atherogenic lipoproteins, carotid intima-media thickness (IMT) and liver steatosis in patients with dyslipidemia.\n\nThe primary objective is to assess whether bergamot reduces plasma lipids and atherogenic lipoproteins in patients with dyslipidemia.\n\nPrimary endpoint: Reduction in plasma lipids and atherogenic lipoproteins. The secondary objective is to assess whether bergamot reduces carotid intima-media thickness (IMT) and liver steatosis in patients with dyslipidemia.\n\nSecondary endpoint: Reduction in IMT and and liver steatosis.\n\nClinical diagnostic tools will include the measurement of:\n\n1. cIMT, that will be assessed by B-mode real-time ultrasound using a single sonographer (Medison SonoAce Pico, with a probe of 7.5-10.0 MHz) in a standardized manner with fixed angles of insonation;\n2. liver steatosis, that will be assessed by by abdominal ultrasound.\n\nBiochemical analyses will include the analysis of:\n\n1. Routine testing of plasma lipids;\n2. Atherogenic lipoproteins, e.g. the analysis of 11 distinct lipoproteins including very-low-density lipoprotein (VLDL), 3 intermediate density lipoprotein (IDL) subclasses and 7 low density lipoprotein (LDL) subclasses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult subjects with dyslipidemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elevated LDL-cholesterolemia\n\nExclusion Criteria:\n\n* severe hepatic or renal diseases'}, 'identificationModule': {'nctId': 'NCT02205567', 'briefTitle': 'Bergamot and Cardio-Metabolic Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'University of Palermo'}, 'officialTitle': 'The Effect of Bergamot on Plasma Lipids, Lipoproteins and Carotid Intima-media Thickness', 'orgStudyIdInfo': {'id': 'BMT14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 2', 'description': '1000 mg/day of Bergamot-derived product', 'interventionNames': ['Dietary Supplement: Bergamot-derived product']}, {'label': 'Group 1', 'description': '500 mg/day of Bergamot-derived product', 'interventionNames': ['Dietary Supplement: Bergamot-derived product']}], 'interventions': [{'name': 'Bergamot-derived product', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Group 1: 500mg/day Group 2: 1000mg/day', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90127', 'city': 'Palermo', 'state': 'PA', 'country': 'Italy', 'facility': 'University Hospital of Palermo', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}], 'overallOfficials': [{'name': 'Giuseppe Montalto, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Palermo, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Palermo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Manfredi Rizzo', 'investigatorAffiliation': 'University of Palermo'}}}}