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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05256251
Other study ID # 20211015ZJS001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 15, 2021
Est. completion date November 14, 2031

Study information

Verified date November 2023
Source Westlake University
Contact Ju-Sheng Zheng, PhD
Phone 86-0571-86915303
Email zhengjusheng@westlake.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The Westlake Longevity Cohort (We-Longevity) is a prospective cohort study among centenarians, nonagenarians, senior citizens and their family members up to three generations 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. Another 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.


Description:

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 are influenced by a variety of factors, such as diet structure, lifestyle, ecological environment, gut microbiome and genetics. At present, the researches on healthy longevity are mainly focused on Drosophila, nematodes and mouse models, and few studies on longevity population. Centenarians and nonagenarians are the best objects to study healthy longevity. However, the multi-omics molecular characteristics and regulatory mechanism of healthy longevity in human are still unclear. There, the present We-Longevity design includes 200 centenarians, 600 nonagenarians, 400 senior citizens. We will determine the fecal/serum metabolome, gut microbiome serum proteome and genome, together with diet, lifestyle and disease information.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date November 14, 2031
Est. primary completion date November 14, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Participants aged 50 years or order. - Participants live in Lishui, China. - Participants intend to remain in Lishui for =3 years. Exclusion Criteria: - Participants with cancer, serious medical disorders or infectious diseases.

Study Design


Locations

Country Name City State
China Lishui City People's Hospital Lishui Zhejiang

Sponsors (2)

Lead Sponsor Collaborator
Westlake University The Sixth Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary aging Physical frailty will be evaluated by using Fried's criteria. 36 months
Primary Gut microbiota Fecal microbiome will be analyzed by 16S rRNA gene sequencing and metagenome sequencing. 36 months
Primary Metabolomics of serum and gut microbiome Metabolomics of serum and gut microbiome will be analyzed by liquid chromatograph-mass spectrometer (LC/MS). 36 months
Primary Proteomic profiling of serum Proteomic characterization of serum will be analyzed by liquid chromatograph-mass spectrometer (LC/MS). 36 months
Primary Genome Genomic characterization will be analyzed by Illumina ASA-750K arrays. 36 months
Secondary Cognitive function Cognitive function will be evaluated by using Mini-Mental State Examination (MMSE). 36 months
Secondary Blood glucose examination of blood samples Blood glucose will be analyzed by automatic biochemical analyser. 36 months
Secondary Blood blood lipids examination of blood samples Blood blood lipids (HDL, LDL, TC and TG) will be analyzed by automatic biochemical analyser. 36 months
Secondary Serum cytokines examination of blood samples Serum cytokines (IFN?, IL10, IL12p70, IL13, IL1ß, IL2, IL4, IL6, IL8 and TNFa) will be analyzed by electrochemiluminescence immunoassay. 36 months
Secondary Serum neurotranszmitters examination of blood samples Serum neurotranszmitters (dopamine, choline, acetyl choline, tyramine, tryptamine, 5-hydroxyindoleacetic acid, phenylpyruvic acid, 3,4-dihydroxyphenylacetic acid and 3-hydroxyo-aminobenzoic acid) will be analyzed by liquid chromatograph-mass spectrometer (LC/MS). 36 months
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