Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT03314194
Status:
COMPLETED
Last Update Posted:
2021-07-16
First Post:
2017-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plant Based Diet, Ethnicity, and the Gut Microbiome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pre Post Design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-15', 'studyFirstSubmitDate': '2017-08-28', 'studyFirstSubmitQcDate': '2017-10-13', 'lastUpdatePostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbial Community Profile', 'timeFrame': '4 days', 'description': 'A microbial community profile will be generated for each individual using high-throughput Illumina sequencing of the 16S rDNA microbial gene sequence. This community profile of each subjects microbiome will be assessed from a minimum of 10,000 sequences per individual at multiple timepoints. The profile will be used to quantify how inter-individual variation of the microbiome varies across ethnicities.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diet Modification', 'Microbial Colonization']}, 'referencesModule': {'references': [{'pmid': '35998206', 'type': 'DERIVED', 'citation': 'Li J, George Markowitz RH, Brooks AW, Mallott EK, Leigh BA, Olszewski T, Zare H, Bagheri M, Smith HM, Friese KA, Habibi I, Lawrence WM, Rost CL, Ledeczi A, Eeds AM, Ferguson JF, Silver HJ, Bordenstein SR. Individuality and ethnicity eclipse a short-term dietary intervention in shaping microbiomes and viromes. PLoS Biol. 2022 Aug 23;20(8):e3001758. doi: 10.1371/journal.pbio.3001758. eCollection 2022 Aug.'}]}, 'descriptionModule': {'briefSummary': 'Samples will be collected to determine human genetic variation, fecal and oral microbial communities, and metabolome products. Several evolutionary and ecological diversity metrics will be distilled to test: a) if microbiome variation within each ethnicity is less than that between ethnicities; b) if microbiome variation is finely structured according to genetic relatedness; and c) if dietary variation impacts human genome x microbiome associations.', 'detailedDescription': 'To characterize the human gut microbiome under highly controlled dietary intake in healthy normal weight adult participants who differ by ethnicity: White non-Hispanic and Black non-Hispanic adults. Samples will be collected to determine human genetic variation, fecal and oral microbial communities, and metabolome products. Several evolutionary and ecological diversity metrics will be distilled to test: a) if microbiome variation within each ethnicity is less than that between ethnicities; b) if microbiome variation is finely structured according to genetic relatedness; and c) if dietary variation impacts human genome x microbiome associations.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Age 18-40\n* BMI 18.5-24.9\n* Caucasian or African American\n\nExclusion Criteria:\n\n* Not weight stable\n* Using Medications\n* Using Dietary Supplements\n* Chronic Disease\n* Tobacco Use\n* Drug Use\n* Pregnant or Lactating\n* Diet Restrictions\n* Vegetarian or Vegan'}, 'identificationModule': {'nctId': 'NCT03314194', 'briefTitle': 'Plant Based Diet, Ethnicity, and the Gut Microbiome', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Plant Based Diet, Ethnicity, and the Gut Microbiome', 'orgStudyIdInfo': {'id': '171170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Plant Based Diet Group', 'description': 'Study aims for two cohorts of 20 females each, being tested over 6 days in two conditions: habitual diet versus plant based diet.', 'interventionNames': ['Other: Plant Based Diet']}], 'interventions': [{'name': 'Plant Based Diet', 'type': 'OTHER', 'description': 'Plant Based Diet for 4 Days Compared to Habitual Diet', 'armGroupLabels': ['Plant Based Diet Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Heidi J Silver, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No Plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seth Bordenstein', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate Professor of Medicine', 'investigatorFullName': 'Heidi J. Silver', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}