Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT03407794
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2018-01-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women
Sponsor:
Organization:
Raw JSON
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There were few subjects in each group.'}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'description': 'All study participants were healthy and no serious adverse events were expected.', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fermented Vegetable', 'description': 'Participants randomized into the fermented vegetable group will receive 1/2 cup per day of fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nFermented vegetable: The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Non-fermented Vegetable', 'description': 'Participants randomized into the non-fermented vegetable group will receive 1/2 cup per day of non-fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nNon-fermented vegetable: The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 9, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 20, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 17, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'C-reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.'}, {'id': 'OG001', 'title': 'Fermented Vegetable', 'description': 'Participants randomized into the fermented vegetable group will receive 1/2 cup per day of fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nFermented vegetable: The 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[{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.'}, {'id': 'OG001', 'title': 'Fermented Vegetable', 'description': 'Participants randomized into the fermented vegetable group will receive 1/2 cup per day of fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nFermented vegetable: The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks'}, {'id': 'OG002', 'title': 'Non-fermented Vegetable', 'description': 'Participants randomized into the non-fermented vegetable group will receive 1/2 cup per day of non-fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nNon-fermented vegetable: The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.14', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '3.5'}, {'value': '3.34', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.7'}, {'value': '3.38', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '3.58'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'The Shannon Index is a measure of diversity of microbial species that takes into account both abundance (the number of species present) and evenness (how close the numbers for each species are). The Shannon index can be calculated using the following equation: H= -∑(i=1)\\^s pi ln(pi). A value of zero for H indicates that a community has only one species. The higher the value of H, the higher the diversity of species in a particular community.', 'unitOfMeasure': 'Shannon index', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.'}, {'id': 'OG001', 'title': 'Fermented Vegetable', 'description': 'Participants randomized into the fermented vegetable group will receive 1/2 cup per day of fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nFermented vegetable: The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks'}, {'id': 'OG002', 'title': 'Non-fermented Vegetable', 'description': 'Participants randomized into the non-fermented vegetable group will receive 1/2 cup per day of non-fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nNon-fermented vegetable: The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '28'}, {'value': '23.3', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '28'}, {'value': '26.7', 'groupId': 'OG002', 'lowerLimit': '22.5', 'upperLimit': '27.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Measured using a multifrequency bioimpedance scale', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Fat Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.'}, {'id': 'OG001', 'title': 'Fermented Vegetable', 'description': 'Participants randomized into the fermented vegetable group will receive 1/2 cup per day of fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nFermented vegetable: The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks'}, {'id': 'OG002', 'title': 'Non-fermented Vegetable', 'description': 'Participants randomized into the non-fermented vegetable group will receive 1/2 cup per day of non-fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nNon-fermented vegetable: The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '35.5'}, {'value': '31.4', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '41'}, {'value': '36.8', 'groupId': 'OG002', 'lowerLimit': '34.8', 'upperLimit': '39.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Measured using a multifrequency bioimpedance scale', 'unitOfMeasure': '% body fat', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.'}, {'id': 'OG001', 'title': 'Fermented Vegetable', 'description': 'Participants randomized into the fermented vegetable group will receive 1/2 cup per day of fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nFermented vegetable: The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks'}, {'id': 'OG002', 'title': 'Non-fermented Vegetable', 'description': 'Participants randomized into the non-fermented vegetable group will receive 1/2 cup per day of non-fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nNon-fermented vegetable: The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '111'}, {'value': '121', 'groupId': 'OG001', 'lowerLimit': '108', 'upperLimit': '122'}, {'value': '107', 'groupId': 'OG002', 'lowerLimit': '104', 'upperLimit': '121'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Measured using an electronic blood pressure cuff', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lipopolysaccharide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.'}, {'id': 'OG001', 'title': 'Fermented Vegetable', 'description': 'Participants randomized into the fermented vegetable group will receive 1/2 cup per day of fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nFermented vegetable: The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks'}, {'id': 'OG002', 'title': 'Non-fermented Vegetable', 'description': 'Participants randomized into the non-fermented vegetable group will receive 1/2 cup per day of non-fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nNon-fermented vegetable: The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '14.9'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '10.5', 'upperLimit': '16.5'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '11', 'upperLimit': '15.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 weeks', 'description': 'Marker of inflammation in serum', 'unitOfMeasure': 'micrograms/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.'}, {'id': 'FG001', 'title': 'Fermented Vegetable', 'description': 'Participants randomized into the fermented vegetable group will receive 1/2 cup per day of fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nFermented vegetable: The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks'}, {'id': 'FG002', 'title': 'Non-fermented Vegetable', 'description': 'Participants randomized into the non-fermented vegetable group will receive 1/2 cup per day of non-fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nNon-fermented vegetable: The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.'}, {'id': 'BG001', 'title': 'Fermented Vegetable', 'description': 'Participants randomized into the fermented vegetable group will receive 1/2 cup per day of fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nFermented vegetable: The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks'}, {'id': 'BG002', 'title': 'Non-fermented Vegetable', 'description': 'Participants randomized into the non-fermented vegetable group will receive 1/2 cup per day of non-fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.\n\nNon-fermented vegetable: The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '50'}, {'value': '37', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '63'}, {'value': '44', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '69'}, {'value': '37', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education: Some college, College degree, Graduate degree', 'classes': [{'categories': [{'title': 'Some College', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'College Degree', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Graduate Degree', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-05', 'size': 272844, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-27T09:25', 'hasProtocol': True}, {'date': '2019-07-05', 'size': 201988, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-09-27T16:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study investigators will be blinded to the treatment conditions and the outcome assessors will only have access to study ID numbers when conducting the lab analyses.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized parallel-arm trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-28', 'studyFirstSubmitDate': '2018-01-16', 'resultsFirstSubmitDate': '2021-04-27', 'studyFirstSubmitQcDate': '2018-01-16', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-28', 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C-reactive Protein', 'timeFrame': '6 weeks', 'description': 'Marker of systemic inflammation: serum CRP'}, {'measure': 'Shannon Index', 'timeFrame': '6 weeks', 'description': 'The Shannon Index is a measure of diversity of microbial species that takes into account both abundance (the number of species present) and evenness (how close the numbers for each species are). The Shannon index can be calculated using the following equation: H= -∑(i=1)\\^s pi ln(pi). A value of zero for H indicates that a community has only one species. The higher the value of H, the higher the diversity of species in a particular community.'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': '6 weeks', 'description': 'Measured using a multifrequency bioimpedance scale'}, {'measure': 'Body Fat Percentage', 'timeFrame': '6 weeks', 'description': 'Measured using a multifrequency bioimpedance scale'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': '6 weeks', 'description': 'Measured using an electronic blood pressure cuff'}, {'measure': 'Lipopolysaccharide', 'timeFrame': '6 weeks', 'description': 'Marker of inflammation in serum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammation', "Women's Health", 'Gastrointestinal Microbiome']}, 'referencesModule': {'references': [{'pmid': '21745625', 'type': 'BACKGROUND', 'citation': 'Kim EK, An SY, Lee MS, Kim TH, Lee HK, Hwang WS, Choe SJ, Kim TY, Han SJ, Kim HJ, Kim DJ, Lee KW. Fermented kimchi reduces body weight and improves metabolic parameters in overweight and obese patients. Nutr Res. 2011 Jun;31(6):436-43. doi: 10.1016/j.nutres.2011.05.011.'}, {'pmid': '25688926', 'type': 'BACKGROUND', 'citation': 'Han K, Bose S, Wang JH, Kim BS, Kim MJ, Kim EJ, Kim H. Contrasting effects of fresh and fermented kimchi consumption on gut microbiota composition and gene expression related to metabolic syndrome in obese Korean women. Mol Nutr Food Res. 2015 May;59(5):1004-8. doi: 10.1002/mnfr.201400780. Epub 2015 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'This proposal will examine whether daily consumption of fermented vegetables for 6 weeks can impact the gut microflora and markers of inflammation of women between the ages of 18-70 years.', 'detailedDescription': 'Interested participants will be invited to an orientation where study procedures will be explained in detail. Once the consent form is signed participants will schedule a visit to provide blood, urine and stool samples at the beginning of the intervention at which point they will be randomized into one of three groups: a fermented vegetable group (1/2 cup per day for 6 weeks), a non-fermented vegetable group (1/2 cup per day for 6 weeks) and a control group (usual diet). Both vegetable groups will receive weekly deliveries of the vegetables to be consumed. Following 6 weeks, participants will provide blood, urine and stool samples one more time. Participants will also fill out questionnaires related to dietary intake, demographics, physical activity, prescription medication use and gastrointestinal function. Compliance will be monitored weekly via a gastrointestinal function log where participants will be asked to enter whether they consumed or not the vegetable provided each day, as well as any side effects of consumption.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Participant eligibility is based on self-representation of gender identity', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI: 18.5-40 kg/m2\n* Non-smoker\n* No previous diagnosis of cancer\n* No thyroid disease\n* No diabetes\n* Willing to consume 1/2 cup of vegetables daily for 6 weeks\n* No use of psychotic or depression medication\n* No medication to lose weight\n* Not on a weight loss diet\n* No use of antibiotics over the past 3 months\n* No consumption of fermented vegetables on a regular basis\n* No history of autoimmune disease, including gastrointestinal disease\n\nExclusion Criteria:\n\n* BMI \\<18.5 or \\>40 kg/m2\n* Smoker\n* Taking medications that affect appetite or body weight\n* Uncontrolled Hypertension\n* Diabetes\n* Not willing to consume 1/2 cup of vegetables daily for 6 weeks\n* Willing to show up at two appointments\n* Following a fad diet\n* Using antibiotics frequently\n* Diagnosed with autoimmune disease, like psoriasis, rheumatoid arthritis, thyroid disease, colitis\n* Regular consumption of fermented vegetables'}, 'identificationModule': {'nctId': 'NCT03407794', 'briefTitle': 'Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women', 'organization': {'class': 'OTHER', 'fullName': 'University of North Florida'}, 'officialTitle': 'Effects of Fermented Vegetables on Markers of Inflammation and Composition of the Intestinal Microflora in Overweight and Obese Women', 'orgStudyIdInfo': {'id': '10334264-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.'}, {'type': 'EXPERIMENTAL', 'label': 'Fermented vegetable', 'description': 'Participants randomized into the fermented vegetable group will receive 1/2 cup per day of fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.', 'interventionNames': ['Other: Fermented vegetable']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-fermented vegetable', 'description': 'Participants randomized into the non-fermented vegetable group will receive 1/2 cup per day of non-fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.', 'interventionNames': ['Other: Non-fermented vegetable']}], 'interventions': [{'name': 'Fermented vegetable', 'type': 'OTHER', 'description': 'The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks', 'armGroupLabels': ['Fermented vegetable']}, {'name': 'Non-fermented vegetable', 'type': 'OTHER', 'description': 'The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks', 'armGroupLabels': ['Non-fermented vegetable']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of North Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan at the moment.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Arkansas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Andrea Arikawa', 'investigatorAffiliation': 'University of North Florida'}}}}