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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05412888
Other study ID # MUGdansk CoQ10
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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