Effect of CoQ10 on the Endocrine Function of Skeletal Muscle

Exercise Training Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05412888
• Other study ID #: MUGdansk CoQ10
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: January 2023
• Source: Medical University of Gdansk
• Contact: Jedrzej Antosiewicz
• Phone: 0048 513046412
• Email: jant[@]gumed.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 30, 2026
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise Training
• Ischemic Preconditioning

Intervention

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
• Sham IPC combined with placebo
Young men training endurance running will undergo sham IPC training combined with placebo supplementation

Locations

Country	Name	City	State
Poland	Jedrzej Antosiewicz	Gdansk	Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effects of IPC on physical performance	IPC training will be combined with endurance exercise and VO2max and serum Lactate will be measured	8 weeks
Primary	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	8 weeks
Primary	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	8 weeks