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临床试验/NCT06295354
NCT06295354终止不适用

Early Variations in Immune Aging

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1,000
试验地点
1
主要终点
Metagenomics

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Metagenomics

时间窗: At baseline and after 3 years

From stool microbiome

Clinical events

时间窗: Between baseline and the 3-year timepoint

Hospital admissions and new medical diagnoses

Immunological function

时间窗: At baseline and after 3 years

As comprised by cytokine porudction capacity, immunophenotyping, circulating inflammatory markers and metabolomics

Immunological Aging Score

时间窗: 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

时间窗: 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)

Genetics and epigenetics

时间窗: At baseline and after 3 years

SNPs, telomere attrition, accessible loci

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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