Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-01 @ 5:35 PM
Study NCT ID:
NCT00953966
Status:
UNKNOWN
Last Update Posted:
2009-08-25
First Post:
2009-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-06'}, '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': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose metabolism', 'timeFrame': '2 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glucose Metabolism', 'Endocrine Metabolism', 'Satiety']}, 'descriptionModule': {'briefSummary': 'Starches from genetically modified potatoes, which differed in terms of amylose, amylopectin and phosphate content, were tested in a human randomized controlled trial.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy males\n\nExclusion Criteria:\n\n* no acute oder severe chronic diseases'}, 'identificationModule': {'nctId': 'NCT00953966', 'briefTitle': 'Metabolic Changes Induced by Genetically Modified Potatoes', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'orgStudyIdInfo': {'id': 'EA4/069/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Starch 1', 'description': 'Starch 1', 'interventionNames': ['Other: Genetically modified potatoes']}, {'type': 'OTHER', 'label': 'Starch 2', 'description': 'Starch 2', 'interventionNames': ['Other: Genetically modified potatoes']}, {'type': 'OTHER', 'label': 'Starch 3', 'description': 'Starch 3', 'interventionNames': ['Other: Genetically modified potatoes']}, {'type': 'OTHER', 'label': 'Starch 4', 'description': 'Starch 4', 'interventionNames': ['Other: Genetically modified potatoes']}, {'type': 'OTHER', 'label': 'Starch 5', 'description': 'Starch 5', 'interventionNames': ['Other: Genetically modified potatoes']}, {'type': 'OTHER', 'label': 'Starch 6', 'description': 'Starch 6', 'interventionNames': ['Other: Genetically modified potatoes']}, {'type': 'OTHER', 'label': 'Starch 7', 'description': 'Starch 7', 'interventionNames': ['Other: Genetically modified potatoes']}], 'interventions': [{'name': 'Genetically modified potatoes', 'type': 'OTHER', 'description': 'Starch from genetically modified potatoes', 'armGroupLabels': ['Starch 1', 'Starch 2', 'Starch 3', 'Starch 4', 'Starch 5', 'Starch 6', 'Starch 7']}]}, '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, Dept. of Endocrinology, Diabetes and Nutrition', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Joachim 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'}}}}