Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 4:09 PM
Study NCT ID:
NCT01948661
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2013-01-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma
Sponsor:
Organization:
Raw JSON
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Ospedali Galliera'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental Arm', 'description': 'Mirtoselect ® 500 mg tablet, 1000 mg (two oral tablets) per day, and Meriva ®, 500 mg tablet, 1000 mg (two oral tablets) per day for 28 days', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'Placebo A (Mirtoselect® 0 g) + Placebo B (Meriva® 0 gr) /die', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 2, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Beta Catenin Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'Mirtoselect ® 500 mg tablet, 1000 mg (two oral tablets) per day, and Meriva ®, 500 mg tablet, 1000 mg (two oral tablets) per day for 28 days'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Placebo A (Mirtoselect® 0 g) + Placebo B (Meriva® 0 gr) /die'}], 'classes': [{'title': 'Pre-treatment: Normal tissue', 'categories': [{'measurements': [{'value': '100', 'spread': '0', 'groupId': 'OG000'}, {'value': '100', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pre-treatment: Dysplasia', 'categories': [{'measurements': [{'value': '100', 'spread': '0', 'groupId': 'OG000'}, {'value': '100', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment: Normal tissue', 'categories': [{'measurements': [{'value': '100', 'spread': '0', 'groupId': 'OG000'}, {'value': '100', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment: Dysplasia', 'categories': [{'measurements': [{'value': '100', 'spread': '0', 'groupId': 'OG000'}, {'value': '100', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'description': 'Change of immunohistochemical expression of beta-catenin in normal and adenomatous colonic tissue', 'unitOfMeasure': 'percentage of positive cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Beta-catenin expression according to the treatment arms and the time points in normal tissue and dysplasia'}, {'type': 'SECONDARY', 'title': 'Change in Biomarkes Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm', 'description': 'Mirtoselect ® 500 mg tablet, 1000 mg (two oral tablets) per day, and Meriva ®, 500 mg tablet, 1000 mg (two oral tablets) per day for 28 days'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Placebo A (Mirtoselect® 0 g) + Placebo B (Meriva® 0 gr) /die'}], 'classes': [{'title': 'NFKβ Pre-treatment: Normal tissue', 'categories': [{'measurements': [{'value': '36.7', 'spread': '21.3', 'groupId': 'OG000'}, {'value': '52.7', 'spread': '20.9', 'groupId': 'OG001'}]}]}, {'title': 'NFKβ Post-treatment: Normal tissue', 'categories': [{'measurements': [{'value': '42.3', 'spread': '31.7', 'groupId': 'OG000'}, {'value': '50.7', 'spread': '26.7', 'groupId': 'OG001'}]}]}, {'title': 'NFKβ Pre-treatment: Dysplasia', 'categories': [{'measurements': [{'value': '69.7', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '74.3', 'spread': '15', 'groupId': 'OG001'}]}]}, {'title': 'NFKβ Post-treatment: Dysplasia', 'categories': [{'measurements': [{'value': '74.3', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '81.4', 'spread': '13.5', 'groupId': 'OG001'}]}]}, {'title': 'Ki-67 Pre-treatment: Normal tissue', 'categories': [{'measurements': [{'value': '19.4', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '21.2', 'spread': '11.4', 'groupId': 'OG001'}]}]}, {'title': 'Ki-67 Post-treatment: Normal tissue', 'categories': [{'measurements': [{'value': '16.1', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '15.9', 'spread': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'Ki-67 Pre-treatment: Dysplasia', 'categories': [{'measurements': [{'value': '44.9', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '42.9', 'spread': '19.5', 'groupId': 'OG001'}]}]}, {'title': 'Ki-67 Post-treatment: Dysplasia', 'categories': [{'measurements': [{'value': '58.0', 'spread': '26.0', 'groupId': 'OG000'}, {'value': '58.2', 'spread': '23.6', 'groupId': 'OG001'}]}]}, {'title': 'P53 Pre-treatment: Normal tissue', 'categories': [{'measurements': [{'value': '8.7', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'P53 Post-treatment: Normal tissue', 'categories': [{'measurements': [{'value': '3.9', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'P53 Pre-treatment: Dysplasia', 'categories': [{'measurements': [{'value': '50.0', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '20.5', 'groupId': 'OG001'}]}]}, {'title': 'P53 Post-treatment: Dysplasia', 'categories': [{'measurements': [{'value': '60.3', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '51.8', 'spread': '24.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4 weeks', 'description': 'Change in immunohistochemical expression of Nuclear Factor-Kβ (NFKβ), Ki-67 Labeling Index, and P53 in normal tissue and displasia', 'unitOfMeasure': 'percentage of positive cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Tissue biomarker expression according to the treatment arms and the timepoints in normal tissue and dysplasia'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: Anthocyanins+Phospholipidic Curcumin', 'description': 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randomized'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Arm', 'description': 'Mirtoselect ® 500 mg tablet, 1000 mg (two oral tablets) per day, and Meriva ®, 500 mg tablet, 1000 mg (two oral tablets) per day for 28 days'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'Placebo A (Mirtoselect® 0 g) + Placebo B (Meriva® 0 gr) /die'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.8', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '67.9', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '69.3', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Level of Education', 'classes': [{'categories': [{'title': 'Primary-middle', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'High university', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoker', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Former', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcholol Habits', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Current/Former', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline BMI', 'classes': [{'categories': [{'title': '<25 kg/m^2', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': '≥25 kg/m^2', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Family history of colorectal cancer', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline histological type', 'classes': [{'categories': [{'title': 'Tubular', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Villous', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Dysplasia grade', 'classes': [{'categories': [{'title': 'Low-grade', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'High-grade', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '# of comorbidity', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'number of comorbidities', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': '# of concomitant medications', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '4', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'number of concomitant medications', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-01', 'size': 1039217, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-10T06:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2013-01-18', 'resultsFirstSubmitDate': '2024-02-07', 'studyFirstSubmitQcDate': '2013-09-19', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-10', 'studyFirstPostDateStruct': {'date': '2013-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Beta Catenin Expression', 'timeFrame': 'baseline and 4 weeks', 'description': 'Change of immunohistochemical expression of beta-catenin in normal and adenomatous colonic tissue'}], 'secondaryOutcomes': [{'measure': 'Change in Biomarkes Expression', 'timeFrame': 'baseline and 4 weeks', 'description': 'Change in immunohistochemical expression of Nuclear Factor-Kβ (NFKβ), Ki-67 Labeling Index, and P53 in normal tissue and displasia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colorectal Adenoma', 'Risk Reduction']}, 'descriptionModule': {'briefSummary': 'It has been shown that curcumin and cyanidin-3-glucoside (C3G) have anticancer effects. In this clinical trial we compare the affect of their combination vs placebo in a four weeks intervention before endoscopic polypectomy.', 'detailedDescription': 'Colonic adenomatous polyps are pre cancer lesions and are used as intermediate markers for testing agents with potential cancer prevention.\n\nMeriva© is a bioavailable form of curcumin, a polyphenolic compound obtained from turmeric (Curcuma longa L.) endowed with anti-inflammatory, antioxidant and antitumor effects. In vivo data indicate that curcumin formulated with phosphatidylcholine furnishes higher blood levels of parent agent than natural curcumin.\n\nMirtoselect©, an anthocyanin mixture from bilberry containing isolated cyanidin-3-glucoside (C3G), the most abundant anthocyanin in diet, prevents intestinal adenoma formation in the Apc(Min) mouse model.\n\nThe investigators hypothesize that the combination of both agents will decrease the expression of proteins involved in colon tumorigenesis relative to placebo.\n\nThe change of biomarker expression between pre-treatment biopsy and post-treatment endoscopic resection in the target adenoma and the normal rectal mucosa will be the response measures.\n\nThe primary response measure is the change of immunohistochemical (IHC) expression of β-catenin in adenomatous tissue and normal rectal mucosa. Secondary response measures are the changes of IHC Nuclear Factor-Kβ (NFKβ), cell proliferation by Ki-67 Labeling Index and apoptosis by P53 in adenomatous and adjacent normal mucosa.\n\nThe study design is a phase II, randomized, double blind, placebo controlled, window of opportunity trial of the combination of Mirtoselect 1 gr/day+Meriva 1 gr/day or placebo. Subjects with histological confirmation of colorectal adenomatous polyps \\>1 cm not suitable to immediate complete removal will be enrolled in a 4-week intervention trial before endoscopic polypectomy.\n\nThe demonstration of a biological activity of the two agent combination may provide the rationale for a phase III trial aimed at reducing the risk of colon cancer in high risk subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Subjects with colorectal adenomatous polyps greater than 1 cm in maximum diameter not suitable to immediate complete removal;\n* Normal renal and hepatic function;\n* WHO Performance status=0;\n\nExclusion Criteria:\n\n* Presence of hyperplastic polyps and/or flat adenomas;\n* Subjects with pre-existing colorectal cancer;\n* Presence of carcinomatous tissue in adenoma;'}, 'identificationModule': {'nctId': 'NCT01948661', 'acronym': 'MIRACOL', 'briefTitle': 'Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma', 'organization': {'class': 'OTHER', 'fullName': 'Ente Ospedaliero Ospedali Galliera'}, 'officialTitle': 'Randomized Window of Opportunity Trial of Anthocyanin Extract and Phospholipid Curcumin in Subjects With Colorectal Adenoma', 'orgStudyIdInfo': {'id': 'GAL 02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anthocyanins+Phospholipidic Curcumin', 'description': 'Mirtoselect ® 500 mg tablet, 1000 mg (two oral tablets) per day and Meriva ®, 500 mg tablet, 1000 mg (two oral tablets) per day for 28 days', 'interventionNames': ['Dietary Supplement: Mirtoselect® + Meriva®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placeboA + placeboB', 'description': 'placeboA + placeboB per day for four weeks', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Mirtoselect® + Meriva®', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Anthocyanins+Phospholipidic Curcumin']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['placeboA + placeboB']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chiavari', 'country': 'Italy', 'facility': '"Gastroenterologia d\'urgenza ed Endoscopia digestiva" Ospedale di Lavagna ASL 4 Chiavarese', 'geoPoint': {'lat': 44.31771, 'lon': 9.32241}}, {'city': 'Genoa', 'country': 'Italy', 'facility': 'S.S. Gastroenterologia Ospedale Villa Scassi, ASL3 Genovese', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '16128', 'city': 'Genova', 'country': 'Italy', 'facility': 'Medical Oncology Ente Ospedaliero Ospedali Galliera', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Divisione di Prevenzione e Genetica Oncologica, IEO', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Andrea DeCensi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Oncology Ente Ospedaliero Ospedali Galliera'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ente Ospedaliero Ospedali Galliera', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione Umberto Veronesi', 'class': 'OTHER'}, {'name': 'Indena S.p.A', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Oncology Director', 'investigatorFullName': 'Andrea DeCensi', 'investigatorAffiliation': 'Ente Ospedaliero Ospedali Galliera'}}}}