Healthy SubjectsCIRCA-IMMAXNCT07169721
CIRCAdian Rhythm of the IMMune Age IndeX (IMMAX)
An observational study of Healthy Subjects and Immune Cells (Mucosal and Systemic), run by Leibniz Research Centre for Working Environment and Human Factors at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Immune Cells (Mucosal and Systemic)
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2023to 22 Apr 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects who are willing to visit the study centre in Dortmund three times a day.
Who may be able to join
- aged > 18 years
- knowledge of German or English sufficient to provide verbal explanations and obtain written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Leibniz Research Centre for Working and Environment and Human Factors
Dortmund, 44139
About this study
Official title: CIRCAdian Rhythm of the IMMune Age IndeX (CIRCA-IMMAX) - Influence of Circadian Rhythm on the Determination of an Immune Age Metric
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.
- Keywords
- immune age
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 8 a.m. until 6 p.m. on the same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Dec 2023
- Primary completion28 Mar 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leibniz Research Centre for Working Environment and Human Factors
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169721
- Sponsor's protocol ID
- Ethics committee approval: 243
- Acronym
- CIRCA-IMMAX
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37685992Brode 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.
PubMed 36358277
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIRCAdian Rhythm of the IMMune Age IndeX (CIRCA-IMMAX) - Influence of Circadian Rhythm on the Determination of an Immune Age Metric
- ClinicalTrials.gov ID
- NCT07169721
- Acronym / sponsor ID
- CIRCA-IMMAX / Ethics committee approval: 243
- Keywords
- immune age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Leibniz Research Centre for Working Environment and Human FactorsUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 12 Sep 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who are willing to visit the study centre in Dortmund three times a day.
Key inclusion criteria (2 listed)
- aged > 18 years
- knowledge of German or English sufficient to provide verbal explanations and obtain written consent
Key exclusion criteria (7 listed)
- exercise on the assessment day
- acute infection
- vaccination within the last 4 weeks
- autoimmune disease
- cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in the Immune Age Index Immune Age Index (IMMAX) from morning to midday and evening
Time frame: From 8 a.m. until 6 p.m. on the same day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Background: PubMed 37685992Brode 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.
- Background: PubMed 36358277Brode 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.
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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 Healthy Subjects and Immune Cells (Mucosal and Systemic), run by Leibniz Research Centre for Working Environment and Human Factors at 1 site in Germany.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 17 Sep 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in the Immune Age Index Immune Age Index (IMMAX) from morning to midday and evening (time frame: From 8 a.m. until 6 p.m. on the same day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07169721, which also lists 2 linked publications.
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 17 Sep 2025.