Aging Clinical Trial
— EVIA-NLOfficial title:
Early Variations in Immune Aging
NCT number | NCT06295354 |
Other study ID # | 2024-17062 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | December 2028 |
Background: Despite an increase in lifespan over the last decades, our healthspan lags behind. In our aging population, it is pressing that we prevent age-related morbidities and associated burden on the health care system. Instead of investigating aging in already aged populations, the currently proposed study aims to elucidate the process of immune aging in relation to biological aging, demographic and lifestyle factors in young and midlife adults, and to identify early biomarkers and pathways associated with fast versus slow immune aging and aging endotypes. Study design: A single-center, observational prospective cohort study in the Netherlands. Participants from priorly established cohorts will be invited to join the EVIA-study. We will obtain demographic and basic clinical data and biological samples (blood and stool) at baseline and after three years, with a short, yearly online questionnaire in between.
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | December 2028 |
Est. primary completion date | December 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility | Inclusion Criteria: - Aged between 20 and 60 years; - Able to communicate orally in Dutch or English; - Able to give informed consent. Exclusion Criteria: - Any systemic disease or condition, or the use of systemic medication, with the exception of the following: - Cardiovascular disease and related medication - Metabolic syndrome, including diabetes, hypertension, and hyperuricemia - Pregnancy at inclusion (will be recorded during study); - Acute illness or fever <1 month before inclusion; - Received vaccines or antibiotics 3 months before inclusion; - Participation in an intervention trial; - Legally incapacitated or unwilling to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunological function | As comprised by cytokine porudction capacity, immunophenotyping, circulating inflammatory markers and metabolomics | At baseline and after 3 years | |
Primary | Immunological Aging Score | As scored by immune population aging scores, an inflammatory aging score (unpiblished work) and a transcriptomics aging score (idem) | At baseline and after 3 years | |
Primary | Biological Aging Score | As scored by epigenetic aging (scored by means of DNA methylation), organ aging (Oh et al) and lipidomic aging scores (unpublished) | At baseline and after 3 years | |
Primary | Metagenomics | From stool microbiome | At baseline and after 3 years | |
Primary | Genetics and epigenetics | SNPs, telomere attrition, accessible loci | At baseline and after 3 years | |
Primary | Clinical events | Hospital admissions and new medical diagnoses | Between baseline and the 3-year timepoint |
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