NCT07169721

Brief Summary

The goal of this observational study is to evaluate the influence of circadian rhythms on the determination of an individual's immune age. The biomarker IMMAX was calculated for 50 participants aged 20-69 at 8 a.m., 1 p.m. and 6 p.m. on the same day.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2024

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 5, 2025

Last Update Submit

September 11, 2025

Conditions

Healthy SubjectsImmune Cells (Mucosal and Systemic)

Keywords

immune age

Outcome Measures

Primary Outcomes (1)

  • Changes in the Immune Age Index Immune Age Index (IMMAX) from morning to midday and evening

    To determine the Immune Age Index, 100 µl blood is collected and immunostained with antibodies. The immune cells are then analyzed using flow cytometry. IMMAX values range from 0 to 1 with higher values indicating a higher immune age.

    From 8 a.m. until 6 p.m. on the same day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects who are willing to visit the study centre in Dortmund three times a day.

You may qualify if:

  • aged \> 18 years
  • knowledge of German or English sufficient to provide verbal explanations and obtain written consent

You may not qualify if:

  • exercise on the assessment day
  • acute infection
  • vaccination within the last 4 weeks
  • autoimmune disease
  • cancer
  • drugs that may influence immune cell counts
  • participation in other interventional studies during study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leibniz Research Centre for Working and Environment and Human Factors

Dortmund, 44139, Germany

Location

Related Publications (2)

  • Brode P, Claus M, Gajewski PD, Getzmann S, Wascher E, Watzl C. From Immunosenescence to Aging Types-Establishing Reference Intervals for Immune Age Biomarkers by Centile Estimation. Int J Mol Sci. 2023 Aug 24;24(17):13186. doi: 10.3390/ijms241713186.

    PMID: 37685992BACKGROUND

  • Brode P, Claus M, Gajewski PD, Getzmann S, Golka K, Hengstler JG, Wascher E, Watzl C. Calibrating a Comprehensive Immune Age Metric to Analyze the Cross Sectional Age-Related Decline in Cardiorespiratory Fitness. Biology (Basel). 2022 Oct 27;11(11):1576. doi: 10.3390/biology11111576.

    PMID: 36358277BACKGROUND

Study Design

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

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 12, 2025

Study Start

December 1, 2023

Primary Completion

March 28, 2024

Study Completion

April 22, 2024

Last Updated

September 17, 2025

Record last verified: 2025-09

Locations

DE(1)