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Not yet recruiting NCT05412888

Effect of CoQ10 on the Endocrine Function of Skeletal Muscle

No phase Interventional Ischemic Preconditioning Coenzyme Q Deficiency Exercise Training

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CoQ10 supplementation, Ischemic preconditioning training, IPC training combined with CoQ10 supplementation, Sham IPC combined with placebo.
Who it may be relevant to
Registry conditions: Ischemic Preconditioning, Coenzyme Q Deficiency, Exercise Training. Basic parameters: 21 years — 29 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Overview

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:

1. 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? 2. 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)? 3. 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? 4. What is the relationship between the expression of genes associated with intracellular metabolism and the effect of CoQ10 supplementation? 5. 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? 6. 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)? 7. 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

Interventions

  • Dietary supplement CoQ10 supplementation
    Young men training endurance running will be supplemented with CoQ10
  • Procedure Ischemic preconditioning training
    Young men training endurance running will undergo IPC training
  • Dietary supplement IPC training combined with CoQ10 supplementation
    Young men training endurance running will undergo IPC training combined with CoQ10 supplementation
  • Dietary supplement Sham IPC combined with placebo
    Young men training endurance running will undergo sham IPC training combined with placebo supplementation

Primary outcome measures

  • The effects of IPC on physical performance [Time frame: 8 weeks]
  • The effects of CoQ10 supplementation on physical performance [Time frame: 8 weeks]
  • The effects of CoQ10 supplementation and IPC on physical performance [Time frame: 8 weeks]

Eligibility criteria

Inclusion Criteria: - gender (males only),

  • 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.

Exclusion criteria

Lack of consent to participate in the research project or negative result of medical examinations.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

Poland · 1 center
  • Jedrzej Antosiewicz — Gdansk

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. PMID 42265179

Identifiers

NCT: NCT05412888 · MUGdansk CoQ10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗