Clinical trial NCT06295354: Early Variations in Immune Aging
Official title: Early Variations in Immune Aging
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aging
Aging Well
Immuno Aging
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Immunological function
timeFrame: At baseline and after 3 years
measure: Immunological Aging Score
timeFrame: At baseline and after 3 years
measure: Biological Aging Score
timeFrame: At baseline and after 3 years
measure: Metagenomics
timeFrame: At baseline and after 3 years
measure: Genetics and epigenetics
timeFrame: At baseline and after 3 years
measure: Clinical events
timeFrame: Between baseline and the 3-year timepoint
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
Study officials:
References: