Early Variations in Immune Aging

NCT06295354 | Terminated

• 1 other identifier: 2024-17062
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Aging Well; Immuno Aging

Outcome Measures

Primary Outcomes (6)

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As scored by epigenetic aging (scored by means of DNA methylation), organ aging (Oh et al) and lipidomic aging scores (unpublished)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

Study Arms (4)

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'

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'

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'

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'

Interventions

No intervention, we just study 'aging' OTHER

No intervention, we just study 'aging'

20-30 years old; 3-40 years old; 40-50 years old; 50-60 years old

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Aged between 20 and 60 years;
• Able to communicate orally in Dutch or English;
• Able to give informed consent.

You may not qualify if:

• 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
• Participation in an intervention trial;
• Legally incapacitated or unwilling to provide informed consent.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical center

Nijmegen, 6525GA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Stool samples * Blood samples (isolated cell populations, RNA and DNA)

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 6, 2024
• Study Start: October 7, 2024
• Primary Completion: January 27, 2025
• Study Completion: March 18, 2025
• Last Updated: May 1, 2025

Record last verified: 2024-10

Locations

NL (1)