Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-01 @ 7:00 AM
Study NCT ID:
NCT06381232
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collection and Analyses of Physiological, Physical, and Molecular Data From a Diverse Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2028-07-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2024-04-18', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Molecular Determinants of Health and Disease', 'timeFrame': '10 years', 'description': 'We measure thousands of transcript levels in multiple clinical samples. The primary outcome measures are changes in quantitative gene expression, microbial or human, as a result of transitioning from a healthy state to a disease.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['General Health', 'Wellness']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to collect and analyze physiological, physical, and molecular data from a diverse population to increase our understanding of how such parameters are associated with health and disease.', 'detailedDescription': 'The analyses conducted by Viome will include, but are not limited to: genetic, transcriptomic, metabolomic, physiological, and physical. The samples collected from participants may include any of these: stool, blood, saliva, cheek swab, vaginal, breast milk/colostrum, nasal swabs or washes, and urine.\n\nStudy participants will collect the clinical samples and ship them to Viome labs or CROs (Contract Research Organizations), where they will be analyzed.\n\nThe objective of the study is to establish which foods correspond with increased wellness, and which foods correspond to decreased wellness.\n\nThe study hypothesis is that by monitoring the patterns of food intake and lifestyle parameters, in conjunction with non-invasive sample testing, personalized diet and lifestyle recommendations can be elucidated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with specific phenotypes of interest and matched healthy controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anyone that resides in the US at the time of enrollment.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06381232', 'briefTitle': 'Collection and Analyses of Physiological, Physical, and Molecular Data From a Diverse Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viome'}, 'officialTitle': 'Collection and Analyses of Physiological, Physical, and Molecular Data From a Diverse Population', 'orgStudyIdInfo': {'id': 'VIOME-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Control', 'interventionNames': ['Other: No Intervention']}, {'label': 'Cases (Various Phenotypes)', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'This is an observational study, there are no interventions.', 'armGroupLabels': ['Cases (Various Phenotypes)', 'Healthy Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98011', 'city': 'Bothell', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Momchilo Vuyisich', 'role': 'CONTACT', 'email': 'studies@viome.com', 'phone': '425-300-6933'}], 'facility': 'Viome Life Sciences', 'geoPoint': {'lat': 47.76232, 'lon': -122.2054}}], 'centralContacts': [{'name': 'Momchilo Vuyisich, PhD', 'role': 'CONTACT', 'email': 'studies@viome.com', 'phone': '(425) 300-6933'}], 'overallOfficials': [{'name': 'Momchilo Vuyisich, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Viome'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Viome', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}