Effect of CoQ10 on the Endocrine Function of Skeletal Muscle

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Exercise Training; Ischemic Preconditioning; Coenzyme Q Deficiency
• Intervention / Treatment: Dietary supplement: CoQ10 supplementation; Procedure: Ischemic preconditioning training; Dietary supplement: Sham IPC combined with placebo; Dietary supplement: IPC training combined with CoQ10 supplementation

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jedrzej Antosiewicz; Phone Number: 0048 513046412; Email: jant@gumed.edu.pl
• Study Contact Backup: Name: Jedrzej Antosiewicz; Email: jant@gumed.edu.pl

Study Locations

• Poland
  • Pomorskie
    • Gdańsk, Pomorskie, Poland, 80-210
      • Jedrzej Antosiewicz
      • Contact: Jedrzej Antosiewicz; Email: jant@gumed.edu.pl
      • Contact: Jedrzej Antosiewicz, Ph.D.; Phone Number: 0048 513046412; Email: jant@gumed.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 29 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Supplemented population 300mg; Supplemented population 300mg/24h CoQ10 - 25 participants	Dietary supplement: CoQ10 supplementation; Young men training endurance running will be supplemented with CoQ10
Experimental: Training and IPC preconditioning; Group subjected to training and preconditioning by ischemia (IPC training) - 25 participants,	Procedure: Ischemic preconditioning training; Young men training endurance running will undergo IPC training
Placebo Comparator: Control group (placebo); Control group to CoQ10 supplementation (placebo)- 25 participants	Dietary supplement: Sham IPC combined with placebo; Young men training endurance running will undergo sham IPC training combined with placebo supplementation
Sham Comparator: IPC control group; IPC control group - 25 participants	Dietary supplement: IPC training combined with CoQ10 supplementation; Young men training endurance running will undergo IPC training combined with CoQ10 supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Medical University of Gdansk

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): September 30, 2026

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 2, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: inflammation; ischemia; skeletal muscle; myokines
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: MUGdansk CoQ10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No