Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-03-05 @ 3:31 AM
Study NCT ID:
NCT04019457
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2019-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cereals and Intestinal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019446', 'term': 'Endotoxemia'}], 'ancestors': [{'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014115', 'term': 'Toxemia'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-27', 'studyFirstSubmitDate': '2019-07-10', 'studyFirstSubmitQcDate': '2019-07-10', 'lastUpdatePostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in parameters of intestinal barrier function', 'timeFrame': '1 week', 'description': 'Changes in endotoxin plasma levels'}], 'secondaryOutcomes': [{'measure': 'Changes in blood lipid levels', 'timeFrame': '1 week', 'description': 'Changes in triglyceride levels (mg/dl), changes in cholesterol levels (mg/dl)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endotoxemia', 'Diet, Healthy']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to determine the effect of dietary fiber on intestinal function in healthy subjects.', 'detailedDescription': 'In the intervention study normal weight participants will receive defined amounts of different cereal flakes for several days. Before and after intervention parameters of intestinal function will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\<25 kg/m2\n* daily alcohol consumption \\<20g (men) or \\<10g (women)\n\nExclusion Criteria:\n\n* food allergies or intolerances\n* instable body weight\n* BMI \\<18,5 kg/m2 or \\>25 kg/m2\n* bariatric surgery within the last 5 years\n* intake of antibiotics within the last month or during the study\n* daily alcohol consumption \\>20g (men) or \\>10g (women)\n* pregnancy and/or lactation period\n* viral or bacterial infection during the last three weeks\n* increased inflammatory markers of unknown reason\n* chronic or acute disease of gastrointestinal tract'}, 'identificationModule': {'nctId': 'NCT04019457', 'briefTitle': 'Cereals and Intestinal Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Vienna'}, 'officialTitle': 'Cereals and Intestinal Function: Investigations in Healthy Participants', 'orgStudyIdInfo': {'id': 'UVienna19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dietary fiber 1', 'description': 'Participants receive cereal flakes 1 to include it in their normal diet.', 'interventionNames': ['Other: Dietary intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Dietary fiber 2', 'description': 'Participants receive cereal flakes 2 to include it in their normal diet.', 'interventionNames': ['Other: Dietary intervention']}], 'interventions': [{'name': 'Dietary intervention', 'type': 'OTHER', 'description': 'Dietary intervention: Participants receive dietary fibers for a defined number of days.', 'armGroupLabels': ['Dietary fiber 1', 'Dietary fiber 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prof. Dr. Ina Bergheim', 'investigatorAffiliation': 'University of Vienna'}}}}