Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-01 @ 3:08 PM
Study NCT ID:
NCT02629705
Status:
COMPLETED
Last Update Posted:
2018-10-18
First Post:
2015-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Carrageenan's Effect on Insulin Resistance in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002351', 'term': 'Carrageenan'}], 'ancestors': [{'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-17', 'studyFirstSubmitDate': '2015-12-04', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intestinal permeability', 'timeFrame': '2 weeks'}, {'measure': 'Intestinal microbiome constitution', 'timeFrame': '2 weeks'}, {'measure': 'Markers of systemic inflammation including lymphocyte activation, cytokines and adipokines', 'timeFrame': '2 weeks'}], 'primaryOutcomes': [{'measure': 'Insulin sensitivity assessed by oral glucose tolerance test (OGTT): Matsuda index', 'timeFrame': '2 weeks'}, {'measure': 'Insulin sensitivity assessed by hyperinsulinemic clamp: M-value', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Endogenous glucose production measured by tracer-method', 'timeFrame': '2 weeks'}, {'measure': 'Cerebral insulin sensitivity measured by MRI', 'timeFrame': '2 weeks'}, {'measure': 'Intrahepatic triglyceride content', 'timeFrame': '2 weeks'}, {'measure': 'Glycemia during OGTT', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '39593091', 'type': 'DERIVED', 'citation': 'Wagner R, Buettner J, Heni M, Fritsche L, Kullmann S, Wagmuller M, Peter A, Preissl H, Machann J, Jumpertz von Schwartzenberg R, Birkenfeld AL, Pape UF, van Hall G, Plomgaard P, Haring HU, Fritsche A, Thompson KN, Klein R, Stefan N. Carrageenan and insulin resistance in humans: a randomised double-blind cross-over trial. BMC Med. 2024 Nov 26;22(1):558. doi: 10.1186/s12916-024-03771-8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the ingestion of the common food additive carrageenan contributes to insulin resistance and thus to the pathogenesis of type 2 diabetes in humans.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body mass index (BMI) 18.5 - 29.9 kg/m²\n\nExclusion Criteria:\n\n* any chronic illness\n* any ongoing medication\n* known infections\n* known liver disease\n* known renal insufficiency\n* alcohol consumption over 30 g/d\n* shift work'}, 'identificationModule': {'nctId': 'NCT02629705', 'briefTitle': "Study of Carrageenan's Effect on Insulin Resistance in Humans", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Investigation of the Effect of Carrageenan as Food Additive on Insulin Resistance in Humans', 'orgStudyIdInfo': {'id': 'CGN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A', 'description': '1. Placebo intervention\n2. Assessment block (3 days)\n3. Washout-phase of 21-35 days\n4. Carrageenan intervention\n5. Assessment block (3 days)', 'interventionNames': ['Dietary Supplement: Carrageenan', 'Dietary Supplement: Placebo']}, {'type': 'OTHER', 'label': 'Group B', 'description': '1. Carrageenan intervention\n2. Assessment block (3 days)\n3. Washout-phase of 21-35 days\n4. Placebo intervention\n5. Assessment block (3 days)', 'interventionNames': ['Dietary Supplement: Carrageenan', 'Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Carrageenan', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['E407'], 'description': 'Carrageenan 250 mg bid supplemented to a standard food', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo (Mannitol/Aerosil) bid supplemented to a standard food', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'University Hospital Tübingen, Department of Internal Medicine', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Robert Wagner, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tübingen, Department of Internal Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}