Early Variations in Immune Aging

Terminated

• Conditions: Aging Well; Aging; Immuno Aging
• Interventions: Other: No intervention, we just study 'aging'

• Registration Number: NCT06295354
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-06
• Status Verified: 2024-10
• Study Start: 2024-10-07
• Primary Completion: 2025-01-27
• Study Completion: 2025-03-18
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3-40 years old	No intervention, we just study 'aging'	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.
40-50 years old	No intervention, we just study 'aging'	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.
20-30 years old	No intervention, we just study 'aging'	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.
50-60 years old	No intervention, we just study 'aging'	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Radboud university medical center; 🇳🇱 Nijmegen, Netherlands