Early Variations in Immune Aging (EVIA-NL)

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.

Study Overview

• Status: Terminated
• Conditions: Aging; Aging Well; Immuno Aging
• Intervention / Treatment: Other: No intervention, we just study 'aging'

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6525GA
    • Radboud University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants for each age group will be recruited via invitation. Former participants from the HFGP cohorts will be invited only if they had originally given permission to be approached for future studies. In case insufficient inclusions result from previous cohorts, we will proceed to recruit new healthy volunteers from the Nijmegen region. In that case, we will promote the study via local newspaper(s), social media, and flyers (will be added to the CMO file should this arise). This way, the recruitment is performed as an open invitation, and any willing participants may reach out to the research team via email or telephone.

This is an observational study to explore natural aging. Participants are not subjected to any intervention.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
20-30 years old; The target population consists of 1000 participants, equally distributed over different age groups (20-30, 30-40, 40-50, and 50-60 years old) and sex. Main exclusion criteria are any systemic condition or medication apart from cardiometabolic disorders, pregnancy at inclusion or recent vaccinations. Individuals will be compared over time, and age groups will be compared over time and per time point. None of the age groups will get an intervention, the goal is to observationally study them.	Other: No intervention, we just study 'aging'; No intervention, we just study 'aging'
3-40 years old; The target population consists of 1000 participants, equally distributed over different age groups (20-30, 30-40, 40-50, and 50-60 years old) and sex. Main exclusion criteria are any systemic condition or medication apart from cardiometabolic disorders, pregnancy at inclusion or recent vaccinations. Individuals will be compared over time, and age groups will be compared over time and per time point. None of the age groups will get an intervention, the goal is to observationally study them.	Other: No intervention, we just study 'aging'; No intervention, we just study 'aging'
40-50 years old; The target population consists of 1000 participants, equally distributed over different age groups (20-30, 30-40, 40-50, and 50-60 years old) and sex. Main exclusion criteria are any systemic condition or medication apart from cardiometabolic disorders, pregnancy at inclusion or recent vaccinations. Individuals will be compared over time, and age groups will be compared over time and per time point. None of the age groups will get an intervention, the goal is to observationally study them.	Other: No intervention, we just study 'aging'; No intervention, we just study 'aging'
50-60 years old; The target population consists of 1000 participants, equally distributed over different age groups (20-30, 30-40, 40-50, and 50-60 years old) and sex. Main exclusion criteria are any systemic condition or medication apart from cardiometabolic disorders, pregnancy at inclusion or recent vaccinations. Individuals will be compared over time, and age groups will be compared over time and per time point. None of the age groups will get an intervention, the goal is to observationally study them.	Other: No intervention, we just study 'aging'; No intervention, we just study 'aging'

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunological function	As comprised by cytokine porudction capacity, immunophenotyping, circulating inflammatory markers and metabolomics	At baseline and after 3 years
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
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
Metagenomics	From stool microbiome	At baseline and after 3 years
Genetics and epigenetics	SNPs, telomere attrition, accessible loci	At baseline and after 3 years
Clinical events	Hospital admissions and new medical diagnoses	Between baseline and the 3-year timepoint

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Actual): January 27, 2025
• Study Completion (Actual): March 18, 2025

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-17062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No