Oxidative StressPhase 2/3NCT01940627
Influence of a Short Term Supplementation With Ubiquinol on Diverse Aspects Related to the Physical Activity
A Phase 2/3 study testing Ubiquinol in people with Oxidative Stress and Inflammation, run by Universidad de Granada at 1 site in Spain.
Trial summary
The General Aim of this study is to verify if a short term supplementation can modulate diverse aspects related to the physical regular high intensity activity. To get this general aim and following the criteria established by the EFSA Guides, this general aim will be divided in specific or concrete aims, and will be… Read more about this study
- Who is it for?
- Ages 31 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Inflammation, Muscle Injury
- What is being tested?
- Ubiquinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2013to Sep 2013
- Phase
- Phase 2/3
- 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 31 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Masculine Sex (Note: we don not consider the feminine sex due to the scarce number in the fire Department of Granada which is lower enough than the masculine)
- Age between 31-45 years.
- Not to train or to practice habitually another physical sports activity different from the habitual one of their activities. They are subject physically active but not top athletes.
- Maximum oxygen consumption between 35 and 65 mL/kg min-1.
- Body Fat Percentage <15 % .
- To give informed consent.
- To be able of carry their maximum body weight.
Who cannot join
- Injuries before the study.
- Some cardiovascular pathology or respiratory during the study.
- Use of immunosuppressants or nephrotoxic drugs.
- Use of protein and / or antioxidant supplements.
- Some absolute or relative contraindication in the medical routine recognition.
- -Any of the criteria needed for the incorporation that are not fulfilled totally.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of a Short Term Supplementation With Ubiquinol on Diverse Aspects Related to the Physical Activity (Muscle Function, Oxidative Stress and Inflammatory Signaling)
The General Aim of this study is to verify if a short term supplementation can modulate diverse aspects related to the physical regular high intensity activity. To get this general aim and following the criteria established by the EFSA Guides, this general aim will be divided in specific or concrete aims, and will be studied by its specific analytical.
First Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short term (2 weeks) study can influence the physical performance, resitance , muscle function and weakening: maintenance of normal muscle function, maintenance of endurance performance, increase in endurance performance/capacity, reduction in the rated perceived exertion/effort during exercise, increase in physical performance and maintenance of muscle mass and piscological variables that the sportsman suffers before and after the high intensity exercise.
Read more
Second Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short term (2 weeks) study can influence the biochemical and haematological parameters in sportsman.
Third Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short term (2 weeks) study can influence the oxidative stress asociated to a high intensity exercise.
Fourth Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short term (2 weeks) study can influence the inflammatory signaling, the activity of diverse pro - and anti-inflammatory citokines associated to high intensity exercise.
Read the detailed description
3.1.- SUBJECTS This is a randomized, controled, double blind trial. The experimental subjects that will take part in this study are Spanish Fire Department. We will try to get a total sample of 100 subjects on each study to constitute two groups of 50 subjects, one experimental group will receive ubiquinol capsules (200 mg/day during 2 weeks) and a control group receiving placebo during the same period of time. Likewise, a nutritional survey will be realized, with follow-up of 72h, to assure that the all the subjects consume similar diets and these will not interfere with the study. They will be informed about the characteristics of the study and we will get informed consent form them.
Following the EFSA Guides, the subjects might be considered to be a healthy population in general and inside this category, they are a specific group of physically active subjects, there would be included the normal population and / or amateur sportsman.
- Conditions
- Oxidative Stress, Inflammation, Muscle Injury
- Being tested
- Ubiquinol, Control
- Keywords
- Ubiquinol, exercise
- Medical subject headings
- Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UbiquinolDietary supplement
Also called reduced Coenzyme Q10
Ubiquinol 200mg/day (two capsules of 100 mg (Breakfast and lunch)) for 14 days
ControlDietary supplement
Also called Capsules without ubiquinol
placebo capsules (two capsules (Breakfast and lunch)) for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Ubiquinol | Experimental | Firemen consuming 200 mg ubiquinol/day during two weeks Receives: Dietary Supplement: Ubiquinol |
| Control | Placebo comparator | Firemen consuming placebo capsules during two weeks Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood and urine samples
Oxidative stress and Inflammatory signaling and Muscle Function
Measured: May-June 2013 (1 month)
Secondary outcomes (1)
physiological measures
physical performance, resitance , muscle function and weakening
Measured: May-June 2013 (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julio J. Ochoa, Universidad de Granada
- Investigators
- Julio J Ochoa, Ph.D., Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940627
- Sponsor's protocol ID
- 3795-00
- Other IDs
- 3795-00
- Status last verified
- Sep 2013
- First submitted
- 3 Sep 2013
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Short Term Supplementation With Ubiquinol on Diverse Aspects Related to the Physical Activity (Muscle Function, Oxidative Stress and Inflammatory Signaling)
- ClinicalTrials.gov ID
- NCT01940627
- Acronym / sponsor ID
- 3795-00
- Conditions
- Oxidative Stress, Inflammation, Muscle Injury
- Keywords
- Ubiquinol, exercise
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 12 Sep 2013 (estimated)
- 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 General Aim of this study is to verify if a short term supplementation can modulate diverse aspects related to the physical regular high intensity activity. To get this general aim and following the criteria established by the EFSA Guides, this general aim will be divided in specific or concrete aims, and will be studied by its specific analytical.
First Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short term (2 weeks) study can influence the physical performance, resitance , muscle function and weakening: maintenance of normal muscle function, maintenance of endurance performance, increase in endurance performance/capacity, reduction in the rated perceived exertion/effort during exercise, increase in physical performance and maintenance of muscle mass and piscological variables that the sportsman suffers before and after the high intensity exercise.
Second Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short term (2 weeks) study can influence the biochemical and haematological parameters in sportsman.
Third Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short term (2 weeks) study can influence the oxidative stress asociated to a high intensity exercise.
Fourth Specific Aim: To study how the supplementation with 200 mg of ubiquinol in a short term (2 weeks) study can influence the inflammatory signaling, the activity of diverse pro - and anti-inflammatory citokines associated to high intensity exercise.
Detailed description
3.1.- SUBJECTS This is a randomized, controled, double blind trial. The experimental subjects that will take part in this study are Spanish Fire Department. We will try to get a total sample of 100 subjects on each study to constitute two groups of 50 subjects, one experimental group will receive ubiquinol capsules (200 mg/day during 2 weeks) and a control group receiving placebo during the same period of time. Likewise, a nutritional survey will be realized, with follow-up of 72h, to assure that the all the subjects consume similar diets and these will not interfere with the study. They will be informed about the characteristics of the study and we will get informed consent form them.
Following the EFSA Guides, the subjects might be considered to be a healthy population in general and inside this category, they are a specific group of physically active subjects, there would be included the normal population and / or amateur sportsman.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ubiquinol | Experimental | Dietary Supplement: UbiquinolFiremen consuming 200 mg ubiquinol/day during two weeks |
| Control | Placebo comparator | Dietary Supplement: ControlFiremen consuming placebo capsules during two weeks |
Who may qualify
- Ages
- 31 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Masculine Sex (Note: we don not consider the feminine sex due to the scarce number in the fire Department of Granada which is lower enough than the masculine)
- Age between 31-45 years.
- Not to train or to practice habitually another physical sports activity different from the habitual one of their activities. They are subject physically active but not top athletes.
- Maximum oxygen consumption between 35 and 65 mL/kg min-1.
- Body Fat Percentage <15 % .
Key exclusion criteria (6 listed)
- Injuries before the study.
- Some cardiovascular pathology or respiratory during the study.
- Use of immunosuppressants or nephrotoxic drugs.
- Use of protein and / or antioxidant supplements.
- Some absolute or relative contraindication in the medical routine recognition.
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 |
|---|---|---|
| UbiquinolAlso: reduced Coenzyme Q10Ubiquinol 200mg/day (two capsules of 100 mg (Breakfast and lunch)) for 14 days | Dietary supplement | Ubiquinol |
| ControlAlso: Capsules without ubiquinolplacebo capsules (two capsules (Breakfast and lunch)) for 14 days | Dietary supplement | Control |
Primary outcome
Blood and urine samples
Time frame: May-June 2013 (1 month)
Oxidative stress and Inflammatory signaling and Muscle Function
1 secondary outcome
physiological measures
Time frame: May-June 2013 (1 month)
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 12 Sep 2013.
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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.
Julio J Ochoa, Ph.D. principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ubiquinol in people with Oxidative Stress and Inflammation, run by Universidad de Granada at 1 site in Spain.
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 7 inclusion and 6 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 12 Sep 2013. 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 Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Blood and urine samples (time frame: May-June 2013 (1 month)). 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 12 Sep 2013.