AgingEVIA-NLNCT06295354
Early Variations in Immune Aging
An observational study of Aging and Aging Well, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Aging Well, Immuno Aging
- Type of treatment
- Vaccines
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Oct 2024to 18 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Aged between 20 and 60 years;
- Able to communicate orally in Dutch or English;
- Able to give informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- No intervention, we just study 'aging'
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, we just study 'aging'Other
No intervention, we just study 'aging'
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: No intervention, we just study 'aging' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological function
As comprised by cytokine porudction capacity, immunophenotyping, circulating inflammatory markers and metabolomics
Measured: 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)
Measured: 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)
Measured: At baseline and after 3 years
Metagenomics
From stool microbiome
Measured: At baseline and after 3 years
Genetics and epigenetics
SNPs, telomere attrition, accessible loci
Measured: At baseline and after 3 years
Clinical events
Hospital admissions and new medical diagnoses
Measured: Between baseline and the 3-year timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start7 Oct 2024
- Primary completion27 Jan 2025
- Study completion18 Mar 2025
Why it stopped: Low participant number.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295354
- Sponsor's protocol ID
- 2024-17062
- Acronym
- EVIA-NL
- Status last verified
- Oct 2024
- First submitted
- 26 Feb 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Variations in Immune Aging
- ClinicalTrials.gov ID
- NCT06295354
- Acronym / sponsor ID
- EVIA-NL / 2024-17062
- Conditions
- Aging, Aging Well, Immuno Aging
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low participant number.
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 20-30 years old | – | Other: 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. |
| 3-40 years old | – | Other: 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 | – | Other: 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 | – | Other: 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Aged between 20 and 60 years;
- Able to communicate orally in Dutch or English;
- Able to give informed consent.
Key exclusion criteria (8 listed)
- Any systemic disease or condition, or the use of systemic medication, with the exception of the following:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, we just study 'aging'No intervention, we just study 'aging' | Other | 20-30 years old, 3-40 years old, 40-50 years old, 50-60 years old |
Primary outcome
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)
Metagenomics
Time frame: At baseline and after 3 years
From stool microbiome
Genetics and epigenetics
Time frame: At baseline and after 3 years
SNPs, telomere attrition, accessible loci
Clinical events
Time frame: Between baseline and the 3-year timepoint
Hospital admissions and new medical diagnoses
Results and safety
The study was stopped early (reason given: Low participant number.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Aging Well, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low participant number.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological function (time frame: At baseline and after 3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.