Clinical trial NCT05412888: Effect of CoQ10 on the Endocrine Function of Skeletal Muscle
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ischemic Preconditioning
Coenzyme Q Deficiency
Exercise Training
Keywords: skeletal muscle
myokines
ischemia
inflammation
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 100
Sex: MALE
Minimum age (years): 21
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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

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.

Primary outcomes:
measure: The effects of IPC on physical performance
timeFrame: 8 weeks
measure: The effects of CoQ10 supplementation on physical performance
timeFrame: 8 weeks
measure: The effects of CoQ10 supplementation and IPC on physical performance
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Jedrzej Antosiewicz
state: Pomorskie
Study officials:
References: