Effect of CoQ10 on the Endocrine Function of Skeletal Muscle

NCT ID: NCT05412888

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-09-30

Brief Summary

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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

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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

Conditions

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Ischemic Preconditioning Coenzyme Q Deficiency Exercise Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Supplemented population 300mg

Supplemented population 300mg/24h CoQ10 - 25 participants

Group Type PLACEBO_COMPARATOR

CoQ10 supplementation

Intervention Type DIETARY_SUPPLEMENT

Young men training endurance running will be supplemented with CoQ10

Training and IPC preconditioning

Group subjected to training and preconditioning by ischemia (IPC training) - 25 participants,

Group Type EXPERIMENTAL

Ischemic preconditioning training

Intervention Type PROCEDURE

Young men training endurance running will undergo IPC training

Control group (placebo)

Control group to CoQ10 supplementation (placebo)- 25 participants

Group Type PLACEBO_COMPARATOR

Sham IPC combined with placebo

Intervention Type DIETARY_SUPPLEMENT

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

IPC control group

IPC control group - 25 participants

Group Type SHAM_COMPARATOR

IPC training combined with CoQ10 supplementation

Intervention Type DIETARY_SUPPLEMENT

Young men training endurance running will undergo IPC training combined with CoQ10 supplementation

Interventions

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CoQ10 supplementation

Young men training endurance running will be supplemented with CoQ10

Intervention Type DIETARY_SUPPLEMENT

Ischemic preconditioning training

Young men training endurance running will undergo IPC training

Intervention Type PROCEDURE

IPC training combined with CoQ10 supplementation

Young men training endurance running will undergo IPC training combined with CoQ10 supplementation

Intervention Type DIETARY_SUPPLEMENT

Sham IPC combined with placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

29 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jedrzej Antosiewicz

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Countries

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Poland

Central Contacts

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Jedrzej Antosiewicz

Role: CONTACT

0048 513046412

Jedrzej Antosiewicz

Role: CONTACT

Facility Contacts

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Jedrzej Antosiewicz, Ph.D.

Role: primary

0048 513046412

Jedrzej Antosiewicz

Role: backup

Other Identifiers

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MUGdansk CoQ10

Identifier Type: -

Identifier Source: org_study_id

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