Ischemic PreconditioningNCT05412888
Effect of CoQ10 on the Endocrine Function of Skeletal Muscle
A study testing CoQ10 supplementation, Ischemic preconditioning training and IPC training combined with CoQ10 supplementation in people with Ischemic Preconditioning and Coenzyme Q Deficiency, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Recent studies have also shown that repeated episodes of ischemia, followed by reperfusion (IPC), can contribute to the development of adaptive changes not only in the area of the heart muscle, but also in the structure of the skeletal muscles. In the project, several research questions will be evaluated e.g. Read more about this study
- Who is it for?
- Ages 21 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ischemic Preconditioning, Coenzyme Q Deficiency, Exercise Training
- What is being tested?
- CoQ10 supplementation, Ischemic preconditioning training and IPC training combined with CoQ10 supplementation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2023to 30 Sep 2026
- Phase
- Interventional
- 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 21 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- not taking medication during the study,
- good health (no concomitant injuries),
- negative history of cardiovascular disorders, autonomic nervous system, mental disorders, cerebrospinal injuries and other diseases that may directly affect the results obtained.
Who cannot join
- Lack of consent to participate in the research project or negative result of medical examinations.
Trial locations and contacts
1 site in 1 country.
Jedrzej Antosiewicz contact
Poland1 site
Jedrzej Antosiewicz
Gdansk, Pomeranian Voivodeship, 80-210
Jedrzej Antosiewicz, Ph.D., 0048 513046412, jant@gumed.edu.pl
Jedrzej Antosiewicz, jant@gumed.edu.pl
About this study
Official title: The Effect of Ischemic Preconditioning and Physical Exercise on the Endocrine Function of Skeletal Muscle - the Effect of CoQ10 Supplementation. In Vivo and in Vitro Studies.
Recent studies have also shown that repeated episodes of ischemia, followed by reperfusion (IPC), can contribute to the development of adaptive changes not only in the area of the heart muscle, but also in the structure of the skeletal muscles.
In the project, several research questions will be evaluated e.g. what is the relationship between oxidative stress parameters, uric acid concentration and nitric oxide degradation products in groups of people undergoing two-week training in ischemic training, or what is the relationship between the expression of genes associated with muscle cell growth (e.g. myostatin gene) and the effect of ischemia preconditioning training etc.
Read the detailed description
Both in sport and medicine, methods are constantly sought that can significantly contribute to improving the ability of tissues to perform their functions and protecting them from effort-induced damage.
In a wide range of interests, especially in people treated for ischemic changes of cardiovascular diseases, are protocols of tissue preconditioning by transient ischemia which significantly contribute to the increase in blood flow in tissue structure.
Recent studies have also shown that repeated episodes of ischemia, followed by reperfusion (IPC), can contribute to the development of adaptive changes not only in the area of the heart muscle, but also in the structure of the skeletal muscles. There is still a lack of detailed research on genetic conditions related to adaptive changes in this area of interest.
In the project, the following research questions were posed:
- What is the relationship between oxidative stress parameters, uric acid concentration and nitric oxide degradation products in groups of people undergoing two-week training in IPC training, or 2 weeks of CoQ10 supplementation in the light of non-training and non-supplementation?
- What is the relationship between two weeks of lower limb ischemia preconditioning training, or CoQ10 supplementation, and the expression of genes associated with the stress response (HSF-1, NF-kB, TNF dependent glass)?
- What is the relationship between the expression of genes associated with muscle cell growth (e.g. myostatin gene) and the effect of preconditioning training by ischemia?
- What is the relationship between the expression of genes associated with intracellular metabolism and the effect of CoQ10 supplementation?
- What is the relationship between the expression of genes encoding enzymes of energy pathways (e.g. GAPDH, LDH) and IPC training or CoQ10 supplementation in the study group?
- How does IPC training or CoQ10 supplementation affect the expression of genes responsible for membrane transport, and the Hedgehog pathway in muscle cells (including Gli1)?
- How does IPC training affect the expression of transcription factors: Hif-1-alpha (hypoxia-induced factor) and NF-kB and selected genes dependent on their activity?
HYPOTHESIS The level of gene expression associated with oxidative stress, muscle fiber development, angiogenesis, muscle cell energy, and membrane transport will change under the influence of the use of preconditioning training by deficiency or CoQ10 supplementation
- Being tested
- CoQ10 supplementation, Ischemic preconditioning training, IPC training combined with CoQ10 supplementation, Sham IPC combined with placebo
- Keywords
- skeletal muscle, myokines, ischemia, inflammation
- Medical subject headings
- Coenzyme Q10 Deficiency, Ischemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoQ10 supplementationDietary supplement
Young men training endurance running will be supplemented with CoQ10
Ischemic preconditioning trainingProcedure or surgery
Young men training endurance running will undergo IPC training
IPC training combined with CoQ10 supplementationDietary supplement
Young men training endurance running will undergo IPC training combined with CoQ10 supplementation
Sham IPC combined with placeboDietary supplement
Young men training endurance running will undergo sham IPC training combined with placebo supplementation
| Study group | Role | What they receive |
|---|---|---|
| Supplemented population 300mg | Placebo comparator | Supplemented population 300mg/24h CoQ10 - 25 participants Receives: Dietary Supplement: CoQ10 supplementation |
| Training and IPC preconditioning | Experimental | Group subjected to training and preconditioning by ischemia (IPC training) - 25 participants, Receives: Procedure: Ischemic preconditioning training |
| Control group (placebo) | Placebo comparator | Control group to CoQ10 supplementation (placebo)- 25 participants Receives: Dietary Supplement: Sham IPC combined with placebo |
| IPC control group | Sham comparator | IPC control group - 25 participants Receives: Dietary Supplement: IPC training combined with CoQ10 supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of IPC on physical performance
IPC training will be combined with endurance exercise and VO2max and serum Lactate will be measured
Measured: 8 weeks
The effects of CoQ10 supplementation on physical performance
CoQ10 supplementation combined with endurance training will be evaluated for endurance improvement in young men. VO2max, myokines, genes associated with the stress response will be measured
Measured: 8 weeks
The effects of CoQ10 supplementation and IPC on physical performance
CoQ10 supplementation combined with IPC and endurance training will be evaluated for endurance improvement in young men. VO2max, myokines, genes associated with the stress response, ulic acid will be measured
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Mar 2023 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic PreconditioningStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412888
- Sponsor's protocol ID
- MUGdansk CoQ10
- Status last verified
- Jan 2023
- First submitted
- 25 May 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brzezinska P, Kochanowicz A, Borkowska A, Kochanowicz M, Antosiewicz J, Mieszkowski J, Stankiewicz B. Ischemic preconditioning modulates the acute post-exercise inflammatory, angiogenic, and neurotrophic response in endurance runners. Sci Rep. 2026 Jun 9. doi: 10.1038/s41598-026-52742-x. Online ahead of print.
PubMed 42265179
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ischemic Preconditioning and Physical Exercise on the Endocrine Function of Skeletal Muscle - the Effect of CoQ10 Supplementation. In Vivo and in Vitro Studies.
- ClinicalTrials.gov ID
- NCT05412888
- Acronym / sponsor ID
- MUGdansk CoQ10
- Keywords
- skeletal muscle, myokines, ischemia, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 9 Jun 2022 (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.
Recent studies have also shown that repeated episodes of ischemia, followed by reperfusion (IPC), can contribute to the development of adaptive changes not only in the area of the heart muscle, but also in the structure of the skeletal muscles.
In the project, several research questions will be evaluated e.g. what is the relationship between oxidative stress parameters, uric acid concentration and nitric oxide degradation products in groups of people undergoing two-week training in ischemic training, or what is the relationship between the expression of genes associated with muscle cell growth (e.g. myostatin gene) and the effect of ischemia preconditioning training etc.
Detailed description
Both in sport and medicine, methods are constantly sought that can significantly contribute to improving the ability of tissues to perform their functions and protecting them from effort-induced damage.
In a wide range of interests, especially in people treated for ischemic changes of cardiovascular diseases, are protocols of tissue preconditioning by transient ischemia which significantly contribute to the increase in blood flow in tissue structure.
Recent studies have also shown that repeated episodes of ischemia, followed by reperfusion (IPC), can contribute to the development of adaptive changes not only in the area of the heart muscle, but also in the structure of the skeletal muscles. There is still a lack of detailed research on genetic conditions related to adaptive changes in this area of interest.
In the project, the following research questions were posed:
- What is the relationship between oxidative stress parameters, uric acid concentration and nitric oxide degradation products in groups of people undergoing two-week training in IPC training, or 2 weeks of CoQ10 supplementation in the light of non-training and non-supplementation?
- What is the relationship between two weeks of lower limb ischemia preconditioning training, or CoQ10 supplementation, and the expression of genes associated with the stress response (HSF-1, NF-kB, TNF dependent glass)?
- What is the relationship between the expression of genes associated with muscle cell growth (e.g. myostatin gene) and the effect of preconditioning training by ischemia?
- What is the relationship between the expression of genes associated with intracellular metabolism and the effect of CoQ10 supplementation?
- What is the relationship between the expression of genes encoding enzymes of energy pathways (e.g. GAPDH, LDH) and IPC training or CoQ10 supplementation in the study group?
- How does IPC training or CoQ10 supplementation affect the expression of genes responsible for membrane transport, and the Hedgehog pathway in muscle cells (including Gli1)?
- How does IPC training affect the expression of transcription factors: Hif-1-alpha (hypoxia-induced factor) and NF-kB and selected genes dependent on their activity?
HYPOTHESIS The level of gene expression associated with oxidative stress, muscle fiber development, angiogenesis, muscle cell energy, and membrane transport will change under the influence of the use of preconditioning training by deficiency or CoQ10 supplementation
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supplemented population 300mg | Placebo comparator | Dietary Supplement: CoQ10 supplementationSupplemented population 300mg/24h CoQ10 - 25 participants |
| Training and IPC preconditioning | Experimental | Procedure: Ischemic preconditioning trainingGroup subjected to training and preconditioning by ischemia (IPC training) - 25 participants, |
| Control group (placebo) | Placebo comparator | Dietary Supplement: Sham IPC combined with placeboControl group to CoQ10 supplementation (placebo)- 25 participants |
| IPC control group | Sham comparator | Dietary Supplement: IPC training combined with CoQ10 supplementationIPC control group - 25 participants |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- not taking medication during the study,
- good health (no concomitant injuries),
- negative history of cardiovascular disorders, autonomic nervous system, mental disorders, cerebrospinal injuries and other diseases that may directly affect the results obtained.
Key exclusion criteria (1 listed)
- Lack of consent to participate in the research project or negative result of medical examinations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoQ10 supplementationYoung men training endurance running will be supplemented with CoQ10 | Dietary supplement | Supplemented population 300mg |
| Ischemic preconditioning trainingYoung men training endurance running will undergo IPC training | Procedure or surgery | Training and IPC preconditioning |
| IPC training combined with CoQ10 supplementationYoung men training endurance running will undergo IPC training combined with CoQ10 supplementation | Dietary supplement | IPC control group |
| Sham IPC combined with placeboYoung men training endurance running will undergo sham IPC training combined with placebo supplementation | Dietary supplement | Control group (placebo) |
Primary outcome
The effects of IPC on physical performance
Time frame: 8 weeks
IPC training will be combined with endurance exercise and VO2max and serum Lactate will be measured
The effects of CoQ10 supplementation on physical performance
Time frame: 8 weeks
CoQ10 supplementation combined with endurance training will be evaluated for endurance improvement in young men. VO2max, myokines, genes associated with the stress response will be measured
The effects of CoQ10 supplementation and IPC on physical performance
Time frame: 8 weeks
CoQ10 supplementation combined with IPC and endurance training will be evaluated for endurance improvement in young men. VO2max, myokines, genes associated with the stress response, ulic acid will be measured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 42265179Brzezinska P, Kochanowicz A, Borkowska A, Kochanowicz M, Antosiewicz J, Mieszkowski J, Stankiewicz B. Ischemic preconditioning modulates the acute post-exercise inflammatory, angiogenic, and neurotrophic response in endurance runners. Sci Rep. 2026 Jun 9. doi: 10.1038/s41598-026-52742-x. Online ahead of print.
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Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
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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.
Jedrzej Antosiewicz contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoQ10 supplementation, Ischemic preconditioning training and IPC training combined with CoQ10 supplementation in people with Ischemic Preconditioning and Coenzyme Q Deficiency, run by Medical University of Gdansk at 1 site in Poland.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Jan 2023. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jedrzej Antosiewicz (0048 513046412, jant@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of IPC on physical performance (time frame: 8 weeks). The study lists 3 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 NCT05412888, which also lists 1 linked publication.
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 4 Jan 2023.