Early Variations in Immune Aging

Aging Clinical Trial

— EVIA-NL  

Official title:

Early Variations in Immune Aging

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06295354
• Other study ID #: 2024-17062
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: December 2028

Study information

• Verified date: February 2024
• Source: Radboud University Medical Center
• Contact: Elisabeth Dulfer, MD
• Phone: (024) 361 66 36
• Email: evia.aig[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Aging Well

Intervention

Other:
• No intervention, we just study 'aging'
No intervention, we just study 'aging'

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Outcome

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