Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT03352050
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2017-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mushroom Effects on Satiety and Gut Health Markers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2017-06-21', 'studyFirstSubmitQcDate': '2017-11-21', 'lastUpdatePostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'satiety', 'timeFrame': 'Baseline', 'description': 'Measure satiety subjectively after consumption of breakfast with mushrooms'}], 'secondaryOutcomes': [{'measure': 'Gut health', 'timeFrame': '10 days', 'description': 'Measure stool weight and gut microbiota after consumption of mushrooms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diet Modification']}, 'descriptionModule': {'briefSummary': 'The Investigator will compare the effect of mushrooms to ground beef in an intervention study and measure satiety markers and gut health markers', 'detailedDescription': 'Subjects will consume their habitual diet and the investigators will compare the acute effect of mushroom consumption on satiety and food intake. Additionally, subjects will consume mushrooms for 10 days and the investigators will measure gut health markers, including short chain fatty acids, microbiota, and fecal weight.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Willing to consume mushrooms or ground beef for 10 days\n\nExclusion Criteria:\n\n* Disease (chronic)\n* Smoking,'}, 'identificationModule': {'nctId': 'NCT03352050', 'briefTitle': 'Mushroom Effects on Satiety and Gut Health Markers', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Mushroom Effects on Satiety and Gut Health Markers', 'orgStudyIdInfo': {'id': '1512M81224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ground beef', 'description': 'ground beef instead of mushrooms', 'interventionNames': ['Other: ground beef']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mushroom', 'description': '2 servings of mushrooms', 'interventionNames': ['Dietary Supplement: mushroom']}], 'interventions': [{'name': 'mushroom', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Mushroom']}, {'name': 'ground beef', 'type': 'OTHER', 'armGroupLabels': ['ground beef']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55108', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Department of Food Science and Nutrition', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Joanne Slavin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}