Effects of Coenzyme Q10 Supplementation on Oxidative Stress, Antioxidant Capacity, Inflammatory Responses, Fatigue Elimination, and Exercise Performance in Athletes

March 19, 2020 updated by: LJ Hwu, Chung Shan Medical University

Effects of Coenzyme Q10 Supplementation on Oxidative Stress, Antioxidant Capacity, Inflammatory Responses, Fatigue Elimination, and Exercise Performance in Athletes From Different Sports: Cross-sectional, Interventional, and Follow-up Studies

The aims of the study are 1) to compare the differences in plasma coenzyme Q10, oxidative stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and exercise performances in athletes (i.e., soccer, and taekwondo players) and healthy non-athletes; 2) to investigate the relationship between plasma coenzyme Q10, oxidative stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and exercise performances; 3) to explore the influence on plasma coenzyme Q10, oxidative stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and exercise performances after 12 weeks of coenzyme Q10 intervention (150 mg/day and 300 mg/day).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The long-term high-amount and -intensity exercise training could cause oxidative damage, muscle impairment, inflammation and exercise fatigue to athletes easily. Such above conditions will affect the exercise performances and health of athletes. The aims of the study are 1) to compare the differences in plasma coenzyme Q10, oxidative stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and exercise performances in athletes (i.e., soccer, and taekwondo players) and healthy non-athletes; 2) to investigate the relationship between plasma coenzyme Q10, oxidative stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and exercise performances; 3) to explore the influence on plasma coenzyme Q10, oxidative stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and exercise performances after 12 weeks of coenzyme Q10 intervention (150 mg/day and 300 mg/day). Eventually, these results of this study can provide the information for the known to improve the oxidative stress, anti-oxidation and inflammation internal to the bodies of athletes for various competitions. As a consequence, the athletic performances can be further enhanced.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Athletes (soccer and taekwondo players)

Exclusion Criteria:

  • Antioxidant vitamins users
  • Statins or Aspirin therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Placebo
Other: Placebo
Placebo (dextrin)
Experimental: Q10-150
coenzyme Q10 150 mg/d.
Dietary supplement: Coenzyme Q10
150 mg or 300 mg
Experimental: Q10-300
coenzyme Q10 300 mg/d.
Dietary supplement: Coenzyme Q10
150 mg or 300 mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
malondialdehyde (MDA)
Time Frame: 12 weeks
MDA (micromol/L) will measure by thiobarbituric acid reacting substance.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Antioxidant capacity
Time Frame: 12 weeks
Total antioxidant capacity (TAC) was measured by a Trolox equivalent antioxidant capacity assay in serum and erythrocytes.
12 weeks
high sensitivity C-reactive protein (hs-CRP)
Time Frame: 12 weeks
hs-CRP will measure by immunoturbidimetry.
12 weeks
creatine kinase (CK)
Time Frame: 12 weeks
serum CK will measure by enzymatic method.
12 weeks
Lactate dehydrogenase (LDH)
Time Frame: 12 weeks
serum LDH will measure by enzymatic method.
12 weeks
one-repetition maximum (1-RM)
Time Frame: 12 weeks
1RM measurements will report in kilograms for data analysis.
12 weeks
Glucose
Time Frame: 12 weeks
mmol/L
12 weeks
HbA1C
Time Frame: 12 weeks
HbA1C will measure by an automated glycated hemoglobin analyzer
12 weeks
Insulin
Time Frame: 12 weeks
insulin will measure by an automated chemistry analyzer
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MOST106-2410-H-030-065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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