- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03321110
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
43
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: Placebo
|
Placebo (dextrin)
|
Experimental: Q10-150
coenzyme Q10 150 mg/d.
|
150 mg or 300 mg
|
Experimental: Q10-300
coenzyme Q10 300 mg/d.
|
150 mg or 300 mg
|
What is the study measuring?
Primary Outcome Measures
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
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
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)
December 1, 2017
Primary Completion (Actual)
July 31, 2019
Study Completion (Actual)
July 31, 2019
Study Registration Dates
First Submitted
October 13, 2017
First Submitted That Met QC Criteria
October 22, 2017
First Posted (Actual)
October 25, 2017
Study Record Updates
Last Update Posted (Actual)
March 23, 2020
Last Update Submitted That Met QC Criteria
March 19, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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