Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-02-22 @ 5:24 PM
Study NCT ID:
NCT00953602
Status:
UNKNOWN
Last Update Posted:
2009-08-25
First Post:
2009-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Time Metabolic Changes Induced by Genetically Modified Potatoes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-08-24', 'studyFirstSubmitDate': '2009-08-05', 'studyFirstSubmitQcDate': '2009-08-05', 'lastUpdatePostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glucose metabolism', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glucose Metabolism', 'Hormonal Changes', 'Satiety']}, 'descriptionModule': {'briefSummary': 'In this study the effects of genetically modified potatoes on the human metabolism will be observed. Healthy volunteers receive for one week muffins, produced with starch from a genetically modified potato or with a normal available starch, in a randomized trial.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male volunteers\n\nExclusion Criteria:\n\n* acute oder severe chronic diseases'}, 'identificationModule': {'nctId': 'NCT00953602', 'briefTitle': 'Long Time Metabolic Changes Induced by Genetically Modified Potatoes', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'orgStudyIdInfo': {'id': 'EA4/011/09'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Genetically modified potato', 'type': 'OTHER', 'description': 'Genetically modified potato'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12200', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Joachim Spranger, MD', 'role': 'CONTACT', 'email': 'joachim.spranger@charite.de', 'phone': '0049308445', 'phoneExt': '2114'}], 'facility': 'Charité, Dpt. of Endocrinology, Diabetes and Nutrition', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Jaochim Spranger, MD', 'role': 'CONTACT', 'email': 'joachim.spranger@charite.de', 'phone': '0049308445', 'phoneExt': '2114'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor J. Spranger', 'oldOrganization': 'Charite University, Berlin, Germany'}}}}