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Clinical Trials/NCT06295354
NCT06295354
Terminated
Not Applicable

Early Variations in Immune Aging

Radboud University Medical Center1 site in 1 country1,000 target enrollmentOctober 7, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
Radboud University Medical Center
Enrollment
1000
Locations
1
Primary Endpoint
Metagenomics
Status
Terminated
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 7, 2024
End Date
March 18, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Metagenomics

Time Frame: At baseline and after 3 years

From stool microbiome

Clinical events

Time Frame: Between baseline and the 3-year timepoint

Hospital admissions and new medical diagnoses

Immunological function

Time Frame: At baseline and after 3 years

As comprised by cytokine porudction capacity, immunophenotyping, circulating inflammatory markers and metabolomics

Immunological Aging Score

Time Frame: At baseline and after 3 years

As scored by immune population aging scores, an inflammatory aging score (unpiblished work) and a transcriptomics aging score (idem)

Biological Aging Score

Time Frame: At baseline and after 3 years

As scored by epigenetic aging (scored by means of DNA methylation), organ aging (Oh et al) and lipidomic aging scores (unpublished)

Genetics and epigenetics

Time Frame: At baseline and after 3 years

SNPs, telomere attrition, accessible loci

Study Sites (1)

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