AthleteNCT03321110
Effects of Coenzyme Q10 Supplementation on Oxidative Stress, Antioxidant Capacity, Inflammatory Responses, Fatigue Elimination, and Exercise Performance in Athletes
A study testing Coenzyme Q10 in people with Athlete, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Athlete
- What is being tested?
- Coenzyme Q10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Athletes (soccer and taekwondo players)
Who cannot join
- Antioxidant vitamins users
- Statins or Aspirin therapy.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Athlete
- Being tested
- Placebo, Coenzyme Q10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo (dextrin)
Coenzyme Q10Dietary supplement
150 mg or 300 mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Placebo Receives: Other: Placebo |
| Q10-150 | Experimental | coenzyme Q10 150 mg/d. Receives: Dietary Supplement: Coenzyme Q10 |
| Q10-300 | Experimental | coenzyme Q10 300 mg/d. Receives: Dietary Supplement: Coenzyme Q10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
malondialdehyde (MDA)
MDA (micromol/L) will measure by thiobarbituric acid reacting substance.
Measured: 12 weeks
Secondary outcomes (8)
Antioxidant capacity
Total antioxidant capacity (TAC) was measured by a Trolox equivalent antioxidant capacity assay in serum and erythrocytes.
Measured: 12 weeks
high sensitivity C-reactive protein (hs-CRP)
hs-CRP will measure by immunoturbidimetry.
Measured: 12 weeks
creatine kinase (CK)
serum CK will measure by enzymatic method.
Measured: 12 weeks
Lactate dehydrogenase (LDH)
serum LDH will measure by enzymatic method.
Measured: 12 weeks
one-repetition maximum (1-RM)
1RM measurements will report in kilograms for data analysis.
Measured: 12 weeks
Glucose
mmol/L
Measured: 12 weeks
HbA1C
HbA1C will measure by an automated glycated hemoglobin analyzer
Measured: 12 weeks
Insulin
insulin will measure by an automated chemistry analyzer
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 Dec 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthleteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo-control
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LJ Hwu, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321110
- Sponsor's protocol ID
- MOST106-2410-H-030-065
- Status last verified
- Mar 2020
- First submitted
- 13 Oct 2017
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03321110
- Acronym / sponsor ID
- MOST106-2410-H-030-065
- Conditions
- Athlete
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- placebo-control
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Other: PlaceboPlacebo |
| Q10-150 | Experimental | Dietary Supplement: Coenzyme Q10coenzyme Q10 150 mg/d. |
| Q10-300 | Experimental | Dietary Supplement: Coenzyme Q10coenzyme Q10 300 mg/d. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Athletes (soccer and taekwondo players)
Key exclusion criteria (2 listed)
- Antioxidant vitamins users
- Statins or Aspirin therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo (dextrin) | Other | Placebo |
| Coenzyme Q10150 mg or 300 mg | Dietary supplement | Q10-150, Q10-300 |
Primary outcome
malondialdehyde (MDA)
Time frame: 12 weeks
MDA (micromol/L) will measure by thiobarbituric acid reacting substance.
8 secondary outcomes
Antioxidant capacity
Time frame: 12 weeks
high sensitivity C-reactive protein (hs-CRP)
Time frame: 12 weeks
creatine kinase (CK)
Time frame: 12 weeks
Lactate dehydrogenase (LDH)
Time frame: 12 weeks
one-repetition maximum (1-RM)
Time frame: 12 weeks
Glucose
Time frame: 12 weeks
HbA1C
Time frame: 12 weeks
Insulin
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 in people with Athlete, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
malondialdehyde (MDA) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.