Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-01-03 @ 2:51 AM
Study NCT ID:
NCT01968369
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2013-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Tomato Sauce on Endothelial Dysfunction Induced by a High Fat Meal in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2013-10-16', 'studyFirstSubmitQcDate': '2013-10-23', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'plasma level of lycopene and other substances contained in tomatoes.', 'timeFrame': 'change 2 and 3.5 hour after a high fat meal'}, {'measure': 'glucose and lipid', 'timeFrame': 'change 2 and 3.5 hour after a high fat meal', 'description': 'glucose and lipid variation'}], 'primaryOutcomes': [{'measure': 'Flow Mediated Dilatation (FMD)', 'timeFrame': 'change in FMD 2 and 3.5 hour after a high fat meal', 'description': 'Endothelial function as measured non-invasively by ultrasound (LogiQ P5 pro, GE Healthcare) using the "Flow Mediated Dilatation" (FMD) technique with the aid of a dedicated hardware (Multimedia Video Engine II (MVE2) DSP Lab., Pisa CNR, Italy).'}], 'secondaryOutcomes': [{'measure': 'Arterial stiffness measured as Stiffness Index (SI), Carotid distensibility (CD)', 'timeFrame': 'change in SI and CD 2 and 3.5 hour after a high fat meal', 'description': 'systemic and local arterial stiffness measured by digital photoplethysmography (PulseTracePT1000 - MicroMedical Ltd) and by carotid ultrasound (LogiQ P5 pro, GE Healthcare) with the aid of a dedicated hardware (Multimedia Video Engine II (MVE2) DSP Lab., Pisa CNR, Italy).'}, {'measure': 'inflammatory cytokines', 'timeFrame': 'chnage in inflammatory cytokines 2 and 3.5 hour after a high fat meal'}, {'measure': 'blood pressure', 'timeFrame': 'change in blood pressure 2 and 3.5 hour after a high fat mealeal', 'description': 'office blood pressure measured by a semiautomatic oscillometric device (TM-2501, A\\&D instruments Ltd)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['flow mediated vasodilatation', 'tomato', 'arterial stiffness', 'lycopene'], 'conditions': ['Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'Several epidemiological and intervention studies suggest that a high dietary intake of tomatoes is associated with lower risk of cardiovascular disease (CVD), while, low intake is associated with an increased incidence of CVD. This beneficial effects have been attributed especially to lycopene, an antioxidant present in high concentration within tomatoes but other substances could be of importance.\n\nEndothelial dysfunction is an early marker of atherosclerosis leading to CVD. The aim of the present study is therefore to investigate whether consumption of tomato products ameliorates peripheral endothelial function, triggered by a high fat meal, in human volunteers in a randomised, crossover dietary intervention study.\n\nStudy design:\n\nInvestigators are randomising healthy men (N=14-28) to consume a high fat meal either with or without tomato sauce (80 gr) in a cross-over design with a 7 days wash-out period. During the week before the study all the subjects will be maintained in a low fibers diet and only subjects randomized to tomatoes will receive a daily dose of 80 mg of tomato sauce (80 gr for 7 days= total load 560 mg).\n\nWe hypothesize that tomato sauce can improve the deleterious effects of a high fat meal on vascular function.', 'detailedDescription': 'Several epidemiological and intervention studies suggest that a high dietary intake of tomatoes is associated with lower risk of cardiovascular disease (CVD), while, low intake is associated with an increased incidence of CVD. This beneficial effects have been attributed especially to lycopene, an antioxidant present in high concentration within tomatoes but other substances could be of importance.\n\nEndothelial dysfunction is an early marker of atherosclerosis leading to CVD. The aim of the present study is therefore to investigate whether consumption of tomato products ameliorates peripheral endothelial function, triggered by a high fat meal, in human volunteers in a randomised, crossover dietary intervention study.\n\nStudy design:\n\nInvestigators are randomising healthy men (N=14-28) to consume a high fat meal either with or without tomato sauce (80 gr) in a cross-over design with a 7 days wash-out period. During the week before the study all the subjects will be maintained in a low fibers diet and only subjects randomized to tomatoes will receive a daily dose of 80 mg of tomato sauce (80 gr for 7 days= total load 560 mg).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men,\n* without overt risk factors for CVD (see exclusion criteria);\n* age range 28 ±10 years;\n* BMI between 19-27 Kg/m2\n\nExclusion Criteria:\n\n* Previous cardiovascular events, kidney failure (serum creatinine ≥1,5 mg/dl), arterial blood pressure ≥140/90mmHg or diagnosed hypertension; chronic inflammatory or neoplastic diseases, diabetes mellitus or impaired fasting glucose (glucose ≥110 mg/dL), hypercholesterolemia (total cholesterol ≥240 mg/dl or anti-lipemic medication use), current smoking, antihypertensive medications; use of antioxidant drugs or NSAIDs or COXIBs; food allergy to tomato or other components of the high fat diet.'}, 'identificationModule': {'nctId': 'NCT01968369', 'acronym': 'VRPM', 'briefTitle': 'Effects of Tomato Sauce on Endothelial Dysfunction Induced by a High Fat Meal in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Universita di Verona'}, 'officialTitle': 'Effects of Tomato Sauce on Endothelial Dysfunction Induced by a High Fat Meal in Healthy Subjects', 'orgStudyIdInfo': {'id': 'VRPM_Tomato_and_endothelium'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tomato sauce (+/- high fat meal)', 'description': '80 gr for 7 days= total load 560 mg (+/- high fat meal)', 'interventionNames': ['Dietary Supplement: tomato sauce']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'diet without tomato (+/- high fat meal)', 'description': 'diet without tomato (+/- high fat meal)', 'interventionNames': ['Dietary Supplement: tomato sauce']}], 'interventions': [{'name': 'tomato sauce', 'type': 'DIETARY_SUPPLEMENT', 'description': 'We are randomising healthy men (N=14-28) to consume a high fat meal either with or without tomato sauce (80 gr) in a cross-over design with a 7 days wash-out period. During the week before the study, all the subjects will be maintained in a low fibers diet and only subjects randomized to tomatoes will receive a daily dose of 80 mg of tomato sauce (80 gr for 7 days= total load 560 mg).', 'armGroupLabels': ['diet without tomato (+/- high fat meal)', 'tomato sauce (+/- high fat meal)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37134', 'city': 'Verona', 'country': 'Italy', 'facility': 'University of Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'overallOfficials': [{'name': 'Cristiano Fava, M.D.; PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universita di Verona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universita di Verona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Cristiano Fava', 'investigatorAffiliation': 'Universita di Verona'}}}}