Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 10:01 PM
Study NCT ID:
NCT05256251
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2021-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Westlake Longevity Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2031-11-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2022-02-21', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical frailty', 'timeFrame': '36 months', 'description': "Physical frailty will be evaluated by using Fried's criteria."}, {'measure': 'Gut microbiome', 'timeFrame': '36 months', 'description': 'Fecal microbiome will be analyzed by 16S/ITS rRNA gene sequencing and metagenome sequencing. Furthermore, fecal microbiota will be cultured, picked and identified.'}], 'secondaryOutcomes': [{'measure': 'Cognitive function', 'timeFrame': '36 months', 'description': 'Cognitive function will be evaluated by using Mini-Mental State Examination (MMSE).'}, {'measure': 'Blood biochemical parameters', 'timeFrame': '36 months', 'description': 'Blood biochemical parameters (e.g., glucose and lipids) will be analyzed by an automated biochemical analyzer.'}, {'measure': 'Metabolomics profiling', 'timeFrame': '36 months', 'description': 'Blood and fecal metabolomics will be analyzed by LC-MS/MS.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gut microbiome', 'Aging'], 'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'The Westlake Longevity Cohort (We-Longevity) is a prospective cohort study among centenarians, nonagenarians and senior citizens living in Lishui, China. The primary aim of this cohort is to characterize the multi-omics molecular characteristics of healthy longevity and their dynamic trajectories. The second aim is to culture the gut microbiota of these elderly people through culturomics. The third aim of We-Longevity is to investigate the association of dietary and lifestyle with the multi-omics molecular characteristics of healthy longevity, and to facilitate the development of personalized nutritional/lifestyle recommendation for the public.', 'detailedDescription': "Aging is a major risk factor for most fatal diseases, such as Alzheimer's disease, type 2 diabetes, cardiovascular disease, and cancer. Global population aging is becoming increasingly serious, and this trend is mainly driving the annual increase in the prevalence of aging-related diseases. Healthy longevity is influenced by a variety of factors, such as diet structure, lifestyle, ecological environment, gut microbiome, and genetics. At present, research on healthy longevity is mainly focused on Drosophila, nematodes, and mouse models, but few studies have targeted longevity populations. Centenarians and nonagenarians are the best populations to study healthy longevity. However, the multi-omics molecular characteristics and regulatory mechanisms of healthy longevity in humans are still unclear. Therefore, the We-Longevity design includes centenarians, nonagenarians, and senior citizens. We will determine the fecal/serum metabolome, culturable gut microbiome characteristics, gut microbiome, serum proteome, and genome, together with diet, lifestyle, and disease information."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the participants should be Chinese residents, regardless of the ethics.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants live in Lishui, China.\n* Participants intend to remain in Lishui for ≥3 years.\n\nExclusion Criteria:\n\n* Participants with infectious diseases.'}, 'identificationModule': {'nctId': 'NCT05256251', 'acronym': 'We-Longevity', 'briefTitle': 'Westlake Longevity Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Westlake University'}, 'officialTitle': 'Westlake Longevity Cohort', 'orgStudyIdInfo': {'id': '20211015ZJS001'}}, 'contactsLocationsModule': {'locations': [{'zip': '323000', 'city': 'Lishui', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junhui Zhang, PhD', 'role': 'CONTACT', 'email': 'zhangjunhui@westlake.edu.cn', 'phone': '86-0571-86915303'}, {'name': 'Xinyu Wang, bachelor', 'role': 'CONTACT', 'email': 'wangxinyu30@westlake.edu.cn', 'phone': '86-0571-86915303'}, {'name': 'Ju-Sheng Zheng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lishui Yikang Hospital', 'geoPoint': {'lat': 28.46042, 'lon': 119.91029}}], 'centralContacts': [{'name': 'Ju-Sheng Zheng, PhD', 'role': 'CONTACT', 'email': 'zhengjusheng@westlake.edu.cn', 'phone': '86-0571-86915303'}, {'name': 'Junhui Zhang, PhD', 'role': 'CONTACT', 'email': 'zhangjunhui@westlake.edu.cn', 'phone': '86-0571-86915303'}], 'overallOfficials': [{'name': 'Ju-Sheng Zheng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Westlake University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Westlake University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}