Effects of Coenzyme Q10 Supplementation on Oxidative Stress, Antioxidant Capacity, Inflammatory Responses, Fatigue Elimination, and Exercise Performance in Athletes
Primary Purpose
Athlete
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo
Coenzyme Q10
Sponsored by
About this trial
This is an interventional basic science trial for Athlete
Eligibility Criteria
Inclusion Criteria:
- Athletes (soccer and taekwondo players)
Exclusion Criteria:
- Antioxidant vitamins users
- Statins or Aspirin therapy.
Sites / Locations
- Chung Shan Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Placebo
Q10-150
Q10-300
Arm Description
Placebo
coenzyme Q10 150 mg/d.
coenzyme Q10 300 mg/d.
Outcomes
Primary Outcome Measures
malondialdehyde (MDA)
MDA (micromol/L) will measure by thiobarbituric acid reacting substance.
Secondary Outcome Measures
Antioxidant capacity
Total antioxidant capacity (TAC) was measured by a Trolox equivalent antioxidant capacity assay in serum and erythrocytes.
high sensitivity C-reactive protein (hs-CRP)
hs-CRP will measure by immunoturbidimetry.
creatine kinase (CK)
serum CK will measure by enzymatic method.
Lactate dehydrogenase (LDH)
serum LDH will measure by enzymatic method.
one-repetition maximum (1-RM)
1RM measurements will report in kilograms for data analysis.
Glucose
mmol/L
HbA1C
HbA1C will measure by an automated glycated hemoglobin analyzer
Insulin
insulin will measure by an automated chemistry analyzer
Full Information
NCT ID
NCT03321110
First Posted
October 13, 2017
Last Updated
March 19, 2020
Sponsor
Chung Shan Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03321110
Brief Title
Effects of Coenzyme Q10 Supplementation on Oxidative Stress, Antioxidant Capacity, Inflammatory Responses, Fatigue Elimination, and Exercise Performance in Athletes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Athlete
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
placebo-control
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo
Arm Title
Q10-150
Arm Type
Experimental
Arm Description
coenzyme Q10 150 mg/d.
Arm Title
Q10-300
Arm Type
Experimental
Arm Description
coenzyme Q10 300 mg/d.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo (dextrin)
Intervention Type
Dietary Supplement
Intervention Name(s)
Coenzyme Q10
Intervention Description
150 mg or 300 mg
Primary Outcome Measure Information:
Title
malondialdehyde (MDA)
Description
MDA (micromol/L) will measure by thiobarbituric acid reacting substance.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Antioxidant capacity
Description
Total antioxidant capacity (TAC) was measured by a Trolox equivalent antioxidant capacity assay in serum and erythrocytes.
Time Frame
12 weeks
Title
high sensitivity C-reactive protein (hs-CRP)
Description
hs-CRP will measure by immunoturbidimetry.
Time Frame
12 weeks
Title
creatine kinase (CK)
Description
serum CK will measure by enzymatic method.
Time Frame
12 weeks
Title
Lactate dehydrogenase (LDH)
Description
serum LDH will measure by enzymatic method.
Time Frame
12 weeks
Title
one-repetition maximum (1-RM)
Description
1RM measurements will report in kilograms for data analysis.
Time Frame
12 weeks
Title
Glucose
Description
mmol/L
Time Frame
12 weeks
Title
HbA1C
Description
HbA1C will measure by an automated glycated hemoglobin analyzer
Time Frame
12 weeks
Title
Insulin
Description
insulin will measure by an automated chemistry analyzer
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Athletes (soccer and taekwondo players)
Exclusion Criteria:
Antioxidant vitamins users
Statins or Aspirin therapy.
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Coenzyme Q10 Supplementation on Oxidative Stress, Antioxidant Capacity, Inflammatory Responses, Fatigue Elimination, and Exercise Performance in Athletes
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