Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-04 @ 8:07 PM
Study NCT ID:
NCT02459535
Status:
COMPLETED
Last Update Posted:
2020-06-24
First Post:
2015-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, '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': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-23', 'studyFirstSubmitDate': '2015-03-23', 'studyFirstSubmitQcDate': '2015-06-01', 'lastUpdatePostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in GIP release', 'timeFrame': '120 mins', 'description': 'comparison between all seven interventions'}, {'measure': 'change in GLP-1 release', 'timeFrame': '120 mins', 'description': 'comparison between all seven interventions'}, {'measure': 'change in GLP-2 release', 'timeFrame': '120 mins', 'description': 'comparison between all seven interventions'}, {'measure': 'change in PYY release', 'timeFrame': '120 mins', 'description': 'comparison between all seven interventions'}, {'measure': 'change in insulin release', 'timeFrame': '120 mins', 'description': 'comparison between all seven interventions'}, {'measure': 'change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin secretion', 'timeFrame': '120 mins', 'description': 'comparison between all seven interventions'}, {'measure': 'change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin sensitivity', 'timeFrame': '120 mins', 'description': 'comparison between all seven interventions'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['incretin release'], 'conditions': ['Pre-diabetes', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.\n\nRecent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.\n\nHowever, it is unclear, if these findings are valid for all kinds of AS, as they are chemically different. Furthermore, data on human subjects are sparse and controversial.\n\nThe investigators will therefore conduct 7 consecutive single oral stimulations with glucose or AS alone or a combination. Three different AS will be tested.', 'detailedDescription': 'Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.\n\nRecent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.\n\nHowever, it is unclear, if these findings are valid for all kinds of AS, as they are chemically different. Up to now, no single study has ever compared metabolic responses to different AS in the same subjects. Furthermore, data on human subjects are sparse and controversial. This is partially explained by different methodical approaches such as intragastral/intraduodenal application of AS, rather than conventional oral consumption.\n\nThe investigators will therefore conduct 7 consecutive single oral stimulations with glucose or AS alone or a combination. Three different AS will be tested: saccharin, aspartame and sucralose.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy\n\nExclusion Criteria:\n\n* metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease'}, 'identificationModule': {'nctId': 'NCT02459535', 'acronym': 'ILIAS-1', 'briefTitle': 'Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1', 'organization': {'class': 'OTHER', 'fullName': 'German Institute of Human Nutrition'}, 'officialTitle': 'Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1', 'orgStudyIdInfo': {'id': 'ILIAS-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Glucose only', 'description': 'oral ingestion of 54 g Glucose in 300 ml water at t=0 in fasted state; blood samples over 120 mins', 'interventionNames': ['Other: oral stimulation glucose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glucose + Saccharin', 'description': 'oral ingestion of 54 g Glucose + 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins', 'interventionNames': ['Other: oral stimulation glucose', 'Other: oral stimulation saccharin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saccharin only', 'description': 'oral ingestion of 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins', 'interventionNames': ['Other: oral stimulation saccharin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glucose + Aspartame', 'description': 'oral ingestion of 54 g Glucose 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins', 'interventionNames': ['Other: oral stimulation glucose', 'Other: oral stimulation aspartame']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aspartame only', 'description': 'oral ingestion of 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins', 'interventionNames': ['Other: oral stimulation aspartame']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glucose + Sucralose', 'description': 'oral ingestion of 54 g Glucose + 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins', 'interventionNames': ['Other: oral stimulation glucose', 'Other: oral stimulation sucralose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sucralose only', 'description': 'oral ingestion of 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins', 'interventionNames': ['Other: oral stimulation sucralose']}], 'interventions': [{'name': 'oral stimulation glucose', 'type': 'OTHER', 'description': 'oral stimulation with glucose, AS or glucose+AS in fasted state, blood samples from fasted state up to 120 min post-ingestion', 'armGroupLabels': ['Glucose + Aspartame', 'Glucose + Saccharin', 'Glucose + Sucralose', 'Glucose only']}, {'name': 'oral stimulation saccharin', 'type': 'OTHER', 'armGroupLabels': ['Glucose + Saccharin', 'Saccharin only']}, {'name': 'oral stimulation aspartame', 'type': 'OTHER', 'armGroupLabels': ['Aspartame only', 'Glucose + Aspartame']}, {'name': 'oral stimulation sucralose', 'type': 'OTHER', 'armGroupLabels': ['Glucose + Sucralose', 'Sucralose only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14458', 'city': 'Bergholz-Rehbrücke', 'state': 'Brandenburg', 'country': 'Germany', 'facility': 'German Institut for Human Nutrition; Department for Clinical Nutrition', 'geoPoint': {'lat': 52.34719, 'lon': 13.10532}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Institute of Human Nutrition', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Clinical Nutrition', 'investigatorFullName': 'Prof. Dr. med. Andreas F. H. Pfeiffer', 'investigatorAffiliation': 'German Institute of Human Nutrition'}}}}