Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-04-23 @ 8:19 PM
Study NCT ID:
NCT02473302
Status:
COMPLETED
Last Update Posted:
2015-06-16
First Post:
2015-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C501309', 'term': 'ATF7IP protein, human'}, {'id': 'D024505', 'term': 'Tocopherols'}], 'ancestors': [{'id': 'D014810', 'term': 'Vitamin E'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-12', 'studyFirstSubmitDate': '2015-06-12', 'studyFirstSubmitQcDate': '2015-06-12', 'lastUpdatePostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fecal marker', 'timeFrame': '12 weeks', 'description': 'TBARS Fecal for red meat pane and NOCs Fecal for ham'}], 'secondaryOutcomes': [{'measure': 'NOC', 'timeFrame': '12 weeks', 'description': 'Fecal marker for red meat pane'}, {'measure': 'cytotoxic activity of fecal water', 'timeFrame': '12 weeks', 'description': 'Fecal marker for red meat pane'}, {'measure': 'DHN-MA', 'timeFrame': '12 weeks', 'description': 'urinary marker for red meat pane'}, {'measure': 'TBARs', 'timeFrame': '12 weeks', 'description': 'Fecal marker for ham'}, {'measure': 'cytotoxic activity of fecal water', 'timeFrame': '12 weeks', 'description': 'Fecal marker for ham'}, {'measure': 'DHN-MA', 'timeFrame': '12 weeks', 'description': 'urinary marker for ham'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Colorectal Cancer is, in non-smokers for both sex, first cause of cancers mortality in Western country.\n\nThe main risk factors associated with colorectal cancer depend of lifestyle, and processed meat and red meat could be involved in carcinogenesis by cytotoxic and genotoxic compound linked to lipid peroxidation and nitrosation.\n\nThe aim of this study is to study the impact of the daily consumption of beef, processed or not, on lipid peroxidation induced heme iron ; and to study the impact of the daily consumption of ham, processed or not, on the nitrosilation induced heme iron.', 'detailedDescription': '24 healthy volunteers will be randomized and will start the study. The study will last 12 weeks for each subject. The first week will be a week of adaptation (or run-in period) to the diet which they will have to follow for the duration of study. During this period, they will collect 3 samples of stools and urine. Then subjects will alternate 4 days of diet either with ham, or with ham and pomegranate extract, or with ham enriched with vitamin E or sirloin steak, marinated sirloin steak or marinated cooked sirloin steak. At least, 3 days will separate every period (wash-out) of nutritional intervention. Urines and stools will be collected last 3 days of every interventional period and also last day of every wash out period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male\n* Body mass index 20 \\<= BMI \\<= 30 kg/m2\n* Affiliated to French National Health Insurance\n* Subject giving his written informed consent\n* Subject considered as normal after clinical examination and medical questionnaire\n\nExclusion Criteria:\n\n* Previous medical and/or surgery judged by the investigator as incompatible with this study\n* Previous familial of colon, ovarian or breast cancer\n* Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments\n* Dislike ham or red meat\n* Heavy consumer of alcohol\n* Practising intensive physical exercise (\\> 5 hours)\n* Being under someone's supervision\n* Refusal to be registered on the National Volunteers Data file\n* Dietary habits unreliable to controlled food intake\n* Being in exclusion on the National Volunteers Data file"}, 'identificationModule': {'nctId': 'NCT02473302', 'briefTitle': 'Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing', 'organization': {'class': 'OTHER', 'fullName': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement"}, 'officialTitle': 'Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing', 'orgStudyIdInfo': {'id': 'Securiviande'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'ham', 'description': '160g per day during 4 days', 'interventionNames': ['Other: ham']}, {'type': 'EXPERIMENTAL', 'label': 'ham + pomegranate extract', 'description': '160g per day during 4 days', 'interventionNames': ['Other: ham + pomegranate extract']}, {'type': 'EXPERIMENTAL', 'label': 'ham + tocopherol', 'description': '160g per day during 4 days', 'interventionNames': ['Other: ham + tocopherol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'rare sirloin steak', 'description': '110g per day during 4 days', 'interventionNames': ['Other: rare sirloin steak']}, {'type': 'EXPERIMENTAL', 'label': 'marinated rare sirloin steak', 'description': '110g per day during 4 days', 'interventionNames': ['Other: marinated rare sirloin steak']}, {'type': 'EXPERIMENTAL', 'label': 'marinated cooked sirloin steak', 'description': '110g per day during 4 days', 'interventionNames': ['Other: marinated cooked sirloin steak']}], 'interventions': [{'name': 'ham', 'type': 'OTHER', 'description': '160g per day during 4 days', 'armGroupLabels': ['ham']}, {'name': 'ham + pomegranate extract', 'type': 'OTHER', 'description': '160g per day during 4 days', 'armGroupLabels': ['ham + pomegranate extract']}, {'name': 'ham + tocopherol', 'type': 'OTHER', 'description': '160g per day during 4 days', 'armGroupLabels': ['ham + tocopherol']}, {'name': 'rare sirloin steak', 'type': 'OTHER', 'description': '110g per day during 4 days', 'armGroupLabels': ['rare sirloin steak']}, {'name': 'marinated rare sirloin steak', 'type': 'OTHER', 'description': '110g per day during 4 days', 'armGroupLabels': ['marinated rare sirloin steak']}, {'name': 'marinated cooked sirloin steak', 'type': 'OTHER', 'description': '110g per day during 4 days', 'armGroupLabels': ['marinated cooked sirloin steak']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63009', 'city': 'Clermont-Ferrand', 'state': 'Auvergne', 'country': 'France', 'facility': 'CRNH Auvergne', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Fabrice PIERRE, Phd', 'role': 'STUDY_CHAIR', 'affiliation': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement"}, {'name': 'Noel CANO, Md, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement", 'class': 'OTHER'}, 'collaborators': [{'name': "Centre de Recherche en Nutrition Humaine d'Auvergne", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical research assistant', 'investigatorFullName': 'Adeline BLOT', 'investigatorAffiliation': 'University Hospital, Clermont-Ferrand'}}}}