Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-01-10 @ 5:32 PM
Study NCT ID:
NCT00966550
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2009-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Tomato Products and Disease Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bburton@iit.edu', 'phone': '312-567-5307', 'title': 'Dr. Britt Burton-Freeman', 'organization': 'Illinois Institute of Technology'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Acute study; Chronic effect should be investigated.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tomato', 'description': 'High fat tomato test meal\n\nTomato products: High fat tomato test meal', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-tomato', 'description': 'Non-tomato high fat test meal\n\nNon-tomato test meal: High fat non-tomato test meal', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'IL-6 Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tomato', 'description': 'High fat tomato test meal\n\nTomato products: High fat tomato test meal'}, {'id': 'OG001', 'title': 'Non-tomato', 'description': 'Non-tomato high fat test meal\n\nNon-tomato test meal: High fat non-tomato test meal'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 hour postprandial study', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was per-protocol (tomato vs Non-tomato) and no imputations were given for any missing values; missing values treated as a missing.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tomato First Then Non-tomato', 'description': 'Tomato :High fat meal with tomato'}, {'id': 'FG001', 'title': 'Non-tomato First Then Tomato', 'description': 'Non-tomato :High fat meal with non-tomato'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tomato First Then Non-tomato', 'description': 'tomato High fat test meal\n\nTomato products: tomato with High fat test meal'}, {'id': 'BG001', 'title': 'Non-tomato First Then Tomato', 'description': 'Non-tomato high fat test meal\n\nNon-tomato test meal: non-tomato with High fat test meal'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.9', 'spread': '5', 'groupId': 'BG000'}, {'value': '28.7', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '27', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of twenty five subjects completed the crossover study (n = 12 females, n = 13 males).'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-03', 'studyFirstSubmitDate': '2009-08-26', 'resultsFirstSubmitDate': '2014-08-20', 'studyFirstSubmitQcDate': '2009-08-26', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-10-13', 'studyFirstPostDateStruct': {'date': '2009-08-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IL-6 Concentrations', 'timeFrame': '6 hour postprandial study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tomato', 'Nutrition'], 'conditions': ['Inflammation']}, 'referencesModule': {'references': [{'pmid': '22331646', 'type': 'RESULT', 'citation': 'Burton-Freeman B, Talbot J, Park E, Krishnankutty S, Edirisinghe I. Protective activity of processed tomato products on postprandial oxidation and inflammation: a clinical trial in healthy weight men and women. Mol Nutr Food Res. 2012 Apr;56(4):622-31. doi: 10.1002/mnfr.201100649. Epub 2012 Feb 14.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this research study is to test whether certain compounds in tomatoes will help reduce factors in the subject's blood associated with disease risk. The investigators want to know if the tomato-associated compounds will lower or improve the status of these factors, like cholesterol and inflammation. In this research study, the subject will be asked to consume high fat test meals on two separate occasions. The investigators want to see how the subject's body responds to a standard high fat meal, one meal with tomato products and one meal without tomato products. The investigators will measure the subject's blood throughout the study period to determine if consumption of tomato products reduces factors in their blood associated with disease risk.", 'detailedDescription': "This study will take three weeks at most, and require one initial screening visit lasting approximately 45 minutes and two study visits each lasting approximately 6 - 8 hours. The investigators are looking for healthy, non-smoking male and female volunteers between the ages of 18 - 65, with no medical history of diabetics, heart, lung, kidney, stomach, or liver disease.\n\nThe initial screening visit will determine subject' eligibility through height, weight and waist circumference measurements, blood glucose (finger prick) test and a fasting screening blood draw. There will be no compensation for the screening visit, other than transportation costs.\n\nIf subject qualify, subject will continue to the two study visits. Each visit will require subject to have blood drawn several times during subject' study visit (total amount of blood equal to approximately 1 ½ tablespoons). To make this process more tolerable, a registered nurse will place a catheter (similar to what happens when you give blood) into subject's vein for ease in drawing blood. After the catheter placement and the first blood draw, subject will be asked to eat the test meal (tomato or non-tomato meal) and then subject will continue to have blood taken at specific time points for the next 6 hours. The investigators will also do an ultrasound on subject's arm to measure blood flow both before eating and midway through the 6 - hour study visit. The investigators will ask that subject not consume tomatoes or tomato products during the course of the study and record all food and beverages consumed on certain days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female\n* Between ages of 18-65\n* BMI between 19 and 24 and hsCRP \\< 1mg/L\n* BMI between 25 and 35 and hsCRP \\> 2.5mg/L\n* No clinical evidence of cardiovascular, respiratory, renal, GI or hepatic disease\n\nExclusion Criteria:\n\n* Pregnant and/or lactating\n* allergies or intolerances to foods consumed in the study\n* fasting blood glucose \\> 110mg/dL\n* taking OTC antioxidant supplements, prescription meds that may interfere with study endpoints\n* unusual dietary habits\n* actively trying to lose or gain weight\n* addicted to drugs or alcohol\n* medically documented psychiatric or neurological disturbances\n* smoker (past smoker allowed if cessation \\> 2 years)'}, 'identificationModule': {'nctId': 'NCT00966550', 'acronym': 'TOM', 'briefTitle': 'A Study of Tomato Products and Disease Risk', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clinical Nutrition Research Center, Illinois Institute of Technology'}, 'officialTitle': 'Tomato Products and Postprandial Oxidation and Inflammation: a Clinical Trial in Healthy Weight Men and Women', 'orgStudyIdInfo': {'id': 'TOM 2009-071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tomato', 'description': 'Tomato with high carb/fat meal', 'interventionNames': ['Other: Tomato']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-Tomato', 'description': 'Non-tomato with high carb/fat meal', 'interventionNames': ['Other: Non-tomato']}], 'interventions': [{'name': 'Tomato', 'type': 'OTHER', 'otherNames': ['Active Comparator'], 'description': 'Tomato with high carb/fat meal', 'armGroupLabels': ['Tomato']}, {'name': 'Non-tomato', 'type': 'OTHER', 'otherNames': ['Placebo Comparator'], 'description': 'Non-tomato with high carb/fat meal', 'armGroupLabels': ['Non-Tomato']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Clinical Nutrition Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Britt Burton-Freeman, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Nutrition Research Center, Illinois Institute of Technology'}, {'name': 'Indika Edirisinghe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Nutrition Research Center, Illinois Institute of Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Nutrition Research Center, Illinois Institute of Technology', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Tomato Products Wellness Council', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}