NCT06498791

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

June 18, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

January 21, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

12 months

First QC Date

June 18, 2024

Last Update Submit

March 3, 2025

Conditions

Mitochondrial Function

Keywords

Mitochondrial respirationPBMC

Outcome Measures

Primary Outcomes (4)

  • Stability of mitochondrial respiratory flux (O2 flux) in cryopreserved PBMCs

    Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis

    1 week and every 8 weeks after cryopreservation

  • Stability of O2 concentration in cryopreserved PBMCs

    Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis

    1 week and every 8 weeks after cryopreservation

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

    Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis

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

  • Assessment of O2 concentration in fresh PBMCs compared to cryopreserved PBMCs

    Mitochondrial respiratory flux is assessed by High Resolution Respirometry analysis

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

Secondary Outcomes (20)

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

    6 months visit

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

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

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

    3 months visit

  • Assessment of blood count and differential blood count I

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

  • Assessment of blood count and differential blood count II

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

  • +15 more secondary outcomes

Other Outcomes (11)

  • Demographic data I

    Baseline visit

  • Demographic data II

    Baseline visit

  • Demographic data III

    Baseline visit

  • +8 more other outcomes

Interventions

VenipunctureOTHER

Blood drawing

QuestionnaireOTHER

Completion of the questionnaire

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

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

You may not qualify if:

  • 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
  • Neurostimulators or drug pump
  • Involved in competitive sports (over the past two years)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Innsbruck - Department of Neurology

Innsbruck, Tyrol, 6020, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Interventions

PhlebotomySurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Michael Knoflach, AssozProf Dr

    Medical University of Innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 18, 2024

First Posted

July 12, 2024

Study Start

January 21, 2025

Primary Completion

January 1, 2026

Study Completion

May 1, 2026

Last Updated

March 6, 2025

Record last verified: 2025-03

Locations

AU(1)