NCT05412888

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Mar 2023Sep 2026

First Submitted

Initial submission to the registry

May 25, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

May 25, 2022

Last Update Submit

January 2, 2023

Conditions

Keywords

skeletal musclemyokinesischemiainflammation

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (4)

Supplemented population 300mg

PLACEBO COMPARATOR

Supplemented population 300mg/24h CoQ10 - 25 participants

Dietary Supplement: CoQ10 supplementation

Training and IPC preconditioning

EXPERIMENTAL

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

Procedure: Ischemic preconditioning training

Control group (placebo)

PLACEBO COMPARATOR

Control group to CoQ10 supplementation (placebo)- 25 participants

Dietary Supplement: Sham IPC combined with placebo

IPC control group

SHAM COMPARATOR

IPC control group - 25 participants

Dietary Supplement: IPC training combined with CoQ10 supplementation

Interventions

CoQ10 supplementationDIETARY_SUPPLEMENT

Young men training endurance running will be supplemented with CoQ10

Supplemented population 300mg

Young men training endurance running will undergo IPC training

Training and IPC preconditioning

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

IPC control group

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

Control group (placebo)

Eligibility Criteria

Age21 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Lack of consent to participate in the research project or negative result of medical examinations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jedrzej Antosiewicz

Gdansk, Pomeranian Voivodeship, 80-210, Poland

Location

MeSH Terms

Conditions

Coenzyme Q10 DeficiencyIschemiaInflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jedrzej Antosiewicz

CONTACT

Jedrzej Antosiewicz

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

June 9, 2022

Study Start

March 1, 2023

Primary Completion

July 31, 2023

Study Completion (Estimated)

September 30, 2026

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations