Functional Mitochondrial Analysis PBMCs

NCT06498791 | Active Not Recruiting

• 1 other identifier: C_2_A.7-0039_009
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitochondrial Function

Keywords

Mitochondrial respiration; PBMC

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

Other Outcomes (11)

• Demographic data I

  Baseline visit

• Demographic data II

  Baseline visit

• Demographic data III

  Baseline visit

Interventions

Venipuncture OTHER

Blood drawing

Questionnaire OTHER

Completion of the questionnaire

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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

Sponsors & Collaborators

• VASCage GmbH: lead
• Oroboros Instruments: collaborator

Study Sites (1)

Medical University Innsbruck - Department of Neurology

Innsbruck, Tyrol, 6020, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Interventions

Phlebotomy; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment 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)