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AzTrials

Mitochondrial FunctionFMAPNCT06498791

Functional Mitochondrial Analysis PBMCs

An observational study of Mitochondrial Function, run by VASCage GmbH at 1 site in Austria.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The primary goal of this prospective, exploratory, longitudinal, single-centre, cohort study is to assess the stability of the mitochondrial flux in PBMCs over long-term cryopreservation. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Mitochondrial Function
What is being tested?
Venipuncture and Questionnaire
How many people
20 participants
Where
1 siteAustria
Study dates
21 Jan 2025to May 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The source population for this study comprises adults (older than 18 years of age) with an equal distribution of male and female. Overall, 20 individuals will be included in the study (10 male, 10 female).

Who may be able to join

  • Aged between 18-85
  • Willingness and ability to consent

Who cannot join

  • Regular (e.g. daily, weekly or similar) intake of medication or nutritional supplements except oral and spiral contraceptives
  • Autoimmune diseases or immune alterations
  • Diseases in the context of haematopoiesis, haemophilia, hematophobia
  • Diagnosed mild or major neurocognitive disorder
  • Depressive episodes in the last two years
  • Chronic infectious diseases
Show all 9Show fewer
  • Neurostimulators or drug pump
  • Involved in competitive sports (over the past two years)
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University Innsbruck - Department of Neurology

    Innsbruck, Tyrol, 6020

Other trials in Austria

About this study

Official title: Functional Mitochondrial Analysis of Peripheral Blood Mononuclear Cells (PBMCs) - a Pilot Study

The primary goal of this prospective, exploratory, longitudinal, single-centre, cohort study is to assess the stability of the mitochondrial flux in PBMCs over long-term cryopreservation.

Secondary goals of this study are:

  • to identify changes in the mitochondrial respiratory flux in different metabolic states of cryopreserved PBMCs during long-term cryopreservation.
  • to assess variability between mitochondrial respiration from PBMCs isolated from same volunteers at different times, seasons or from different arms.
Read the detailed description

The analysis of mitochondrial function can also be referred to as a bioenergetic snapshot. Mitochondria are dynamic metabolic organelles that adapt to various physiological demands, reflecting an individual's lifestyle and exposure to environmental factors, medications, and toxins. Numerous studies have shown that mitochondrial respiration declines with age and correlates with many age-related diseases. This raises the question of how mitochondria influence cells in a clinical context.

For this purpose, 20 participants are recruited and comprehensively characterized in terms of their demographic information and clinical profiles. Additionally, physical examinations are conducted, and participants are surveyed about their lifestyles through questionnaires. Over a 12-month period, blood samples are collected at intervals of three months, resulting in a total of five study visits. For the analysis of mitochondrial oxygen consumption, peripheral blood mononuclear cells (PBMCs) are preferably used, as they provide a minimally invasive and easily accessible insight into mitochondrial function and overall metabolic status and are isolated from the collected blood samples.

To enable the application of mitochondrial diagnostics in research for early disease detection and therapeutic development, additional information is needed regarding the stability of mitochondrial respiration in cryopreserved PBMCs using high-resolution respirometry (HRR) with O2k technology. The goal of this study is to assess how the duration of cryopreservation affects mitochondrial bioenergetics compared to freshly isolated PBMCs.

The study also considers a variety of parameters that could potentially influence the stability of mitochondrial respiration. These factors include non-fasting blood collection, discrepancies between the right and left arm, and seasonal effects. To what extent the intraindividual variability in these parameters affects the mitochondrial respiration is yet to be fully understood.

Furthermore, the longitudinal study design allows the tracking of mitochondrial activity and stability over time, providing a better understanding of the central processes of cellular respiration.

Thus, the planned study promises to yield significant insights into mitochondrial respiration and cellular bioenergetics in a clinical context.

Being tested
Venipuncture, Questionnaire
Keywords
Mitochondrial respiration, PBMC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenipunctureOther

    Blood drawing

  • QuestionnaireOther

    Completion of the questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stability of mitochondrial respiratory flux (O2 flux) in cryopreserved PBMCs

    Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis

    Measured: 1 week and every 8 weeks after cryopreservation

  2. Stability of O2 concentration in cryopreserved PBMCs

    Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis

    Measured: 1 week and every 8 weeks after cryopreservation

  3. Assessment of mitochondrial respiratory flux (O2 flux) in fresh PBMCs compared to cryopreserved PBMCs

    Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis

    Measured: Baseline visit, 3, 6, 9, 12 months visit

  4. Assessment of O2 concentration in fresh PBMCs compared to cryopreserved PBMCs

    Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis

    Measured: Baseline visit, 3, 6, 9, 12 months visit

Secondary outcomes (20)

  1. Assessment of O2 flux in fresh and cryopreserved PBMCs in fasted vs non-fasted sampling conditions

    Assessement of mitochondrial bioenergetic snapshot in fresh and cryopreserved PBMCs at two different collection time points (fasted and non-fasted)

    Measured: 6 months visit

  2. Assessment of O2 flux in fresh and cryopreserved PBMCs at different seasonal collection time points

    Assessement of mitochondrial bioenergetic snapshot in fresh and cryopreserved PBMCs in different seasons

    Measured: Baseline visit, 3, 6, 9, 12 months visit

  3. Assessment of O2 flux in fresh and cryopreserved PBMCs at different venipuncture sites

    Assessement of mitochondrial bioenergetic snapshot in fresh and cryopreserved PBMCs collected from left and right arm

    Measured: 3 months visit

  4. Assessment of blood count and differential blood count I

    Analysis of complete blood count (e.g. erythrocyte concentration (mg/dL))

    Measured: Baseline visit, 3, 6, 9, 12 months visit

  5. Assessment of blood count and differential blood count II

    Analysis of complete blood count (e.g. haemoglobin concentration (g/dL))

    Measured: Baseline visit, 3, 6, 9, 12 months visit

  6. Concentration of Creatinine and Urea

    Creatinine (mg/dL), Urea (mg/dL)

    Measured: Baseline visit, 3, 6, 9, 12 months visit

  7. Concentration of Creatine Kinase

    Creatine Kinase (U/L)

    Measured: Baseline, 6, 12 months visit

  8. Concentration of Glucose

    Glucose (mg/dL, mmol/L)

    Measured: Baseline visit, 3, 6, 9, 12 months visit

  9. Concentration of HbA1c

    HbA1c (%)

    Measured: Baseline, 6, 12 months visit

  10. Concentration of Sodium, Potassium, Chloride and Calcium

    Sodium (mmol/L), potassium (mmol/L), chloride (mmol/L), calcium (mmol/L)

    Measured: Baseline, 6, 12 months visit

  11. Concentration of GOT and GPT

    Glutamic-oxaloacetic transaminase (GOT, U/L), glutamic-pyruvic transaminase (GPT, U/L), gamma-glutamyl-transpeptidase (gamma-GT, U/L), lactate dehydrogenase (LDH, U/L)

    Measured: Baseline, 6, 12 months visit

  12. Concentration of triglyceride and cholesterol

    Triglyceride (mmol/L), cholesterol (all, mmol/L )

    Measured: Baseline, 6, 12 months visit

  13. Concentration of LDL-cholesterol and HDL-cholesterol

    LDL-cholesterol (mg/dL), HDL-cholesterol (mg/dL)

    Measured: Baseline, 6, 12 months visit

  14. Concentration of Lipoprotein a

    Lipoprotein a (mg/dL)

    Measured: Baseline visit

  15. Assessment of Sedimentation rate

    Sedimentation rate (mm/h)

    Measured: Baseline, 12 months visit

  16. Concentration of C-reactive protein

    CRP sensitive (mg/L)

    Measured: Baseline visit, 3, 6, 9, 12 months visit

  17. Concentration of Interleukin-6

    Interleukin-6 (pg/ml)

    Measured: Baseline, 6, 12 months visit

  18. Concentration of Thyroid-stimulating hormone

    TSH (mU/mL)

    Measured: Baseline, 12 months visit

  19. Concentration of Iric acid

    Uric acid (mg/dL)

    Measured: Baseline, 12 months visit

  20. Concentration of Ferritin

    Ferritin (ng/mL, μg/L)

    Measured: Baseline, 12 months visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2024
  2. Study start21 Jan 2025
  3. Primary completionJan 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06498791
Sponsor's protocol ID
C_2_A.7-0039_009
Acronym
FMAP
Status last verified
Mar 2025
First submitted
18 Jun 2024
Last updated
6 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Mitochondrial Function, run by VASCage GmbH at 1 site in Austria.

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 9 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 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 Austria. 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?

This study is still under way. Results are not available in the source record yet.

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?

Stability of mitochondrial respiratory flux (O2 flux) in cryopreserved PBMCs (time frame: 1 week and every 8 weeks after cryopreservation). The study lists 4 primary outcomes in all. 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 NCT06498791.

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 6 Mar 2025.

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