Coenzyme Q10Phase 1CoQ10SportNCT03893864
Bioavailability and Impact of Coenzyme Q10 in Stressing Exercise in Senescence Athletes
A Phase 1 study testing Administration of a product with Fitosomed Ubiquinone, Coenzyme Q10 level in muscle biopsies and Coenzyme Q10 level in plasma, blood cells, urine cells in people with Coenzyme Q10 and Oxidative Stress, run by Centre d'Alt Rendiment at 1 site in Spain.
Trial summary
It is proposed to establish a group of subjects composed of 10 healthy individuals of> 50 years and <65, physically active, without metabolic or inflammatory pathology. All of them will undergo a health examination and the physical condition and the absence of contraindication of the sports practice will be… Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coenzyme Q10, Oxidative Stress, Aging
- What is being tested?
- Administration of a product with Fitosomed Ubiquinone, Coenzyme Q10 level in muscle biopsies and Coenzyme Q10 level in plasma, blood cells, urine cells
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2018to 28 Feb 2019
- Phase
- Phase 1
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Athletes over 50 active at this time
- Runners
- Without medical treatment
- Without acute or chronic inflmatory disease
- No recent infectious processes
- No muscle or joint injuries in the last 6 months
- Stable training during the evaluation period
- Without taking supplementation
Who cannot join
- Injuried, sickness, during the study
- Lack of compromise
- Inflamatory process
- Abandon the training by any reason
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centre D'Alt Rendiment, Sant Cugat
Sant Cugat Del Vallés, Barcelona, 08174
About this study
Official title: Bioavailability and Impact of the Administration of Coenzyme Q10, on Mitochondrial Function Associated With Exercise Under Stress Conditions in Physically Active Individuals of Senescence Age
It is proposed to establish a group of subjects composed of 10 healthy individuals of> 50 years and <65, physically active, without metabolic or inflammatory pathology. All of them will undergo a health examination and the physical condition and the absence of contraindication of the sports practice will be characterized through a monitored effort test. Each subject will take a capsule of coenzyme Q10® INDENA for 30 days. The dose to be administered is 100 mg/d of CoQ10 a with food (noon). The state of physical condition and the biochemical and biological variables that reflect oxidative stress and mitochondrial functioning before and after the intervention will be measured.
Read the detailed description
The purpose of the study is in the first time determine the variation of the levels of coenzyme Q10 in different tissues, plasma, urinary epithelium, muscle, mononuclear cells, before and after the administration during one month of 100 mg of phytosomal ubiquinone (INDENA). Secondly, it is intended to determine the antioxidant functionality of the administered ubiquinone, evaluating its effect on the oxidative pattern that occurs after an exercise of moderate intensity, but performed in a stressful environment, a climatic chamber where the temperature is 35ºC and there is 55% humidity. To this end, the collaboration of 12 healthy volunteers, and 10 control subjects, over 50 and under 65, active runners with experience, without active inflammatory pathology, without prescribed medical treatment and with the commitment not to take any nutritional supplementation. There is also a compromise by athletes on maintaining the diet and training as it is at the time of the first evaluation The subjects sign an informed consent to carry out the study and they are shown the acceptance of the Ethics Committee approved by the General Directorate of Sports of the Generalitat of Catalonia. Basal blood samples are taken, the sample is taken from the first urine in the morning and a muscle biopsy is performed on the vastus lateralis of the m. quadricipitalis. On a second day, a progressive, maximum effort test is carried out in order to characterize the level of physical condition and determine the working regimes in the climatic chamber. They are re-scheduled for a third day for that purpose. On that day blood is drawn to obtain the Total Antioxidant Capacity of the blood and they are exposed to the temperature and humidity and are asked to run on the treadmill for 5 minutes at each of the speeds corresponding to 70, 75 and 80% of the maximum speed reached in the first test. At the end a lactate sample is taken. This period of 15 minutes is repeated 3 times. When finished, at the 30th minute, a new blood sample is taken to assess the TAC postexercise/exposition.
The stress test and blood extractions, urine collection and muscle biopsy are repeated after one month of taking the phytosomed Ubiquinone.
There is a control group of 10 subjects who follow absolutely the same path, but do not take any supplementation (Ubiquinone) and do not have a muscle biopsy.
- Conditions
- Coenzyme Q10, Oxidative Stress, Aging
- Being tested
- Administration of a product with Fitosomed Ubiquinone, Coenzyme Q10 level in muscle biopsies, Coenzyme Q10 level in plasma, blood cells, urine cells, Total antioxidant capacity after strenous exercise
- Keywords
- Coenzyme Q10, Ubiquinone, Ubiquinol, Oxidative pattern, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of a product with Fitosomed UbiquinoneDietary supplement
Also called Coenzyme Q10, UbiQuisome
Healthy runner athletes, > 50 years old, without any chronic illness, without any other nutritional supplementation or drug intervention, took 100 mg/d of fitosomed Ubiquinone with lunch, daily, during one month, maintaining their usual training sessions.
Coenzyme Q10 level in muscle biopsiesProcedure or surgery
Also called Muscle Biopsy
Determination of the muscle Ubiquinone concentration, the metabolic and structure characteristics of the muscle before and after one month of supplementation
Coenzyme Q10 level in plasma, blood cells, urine cellsDiagnostic test
Determination of Ubiquinone concentration in different tissues before and after one month of supplementation or not
Total antioxidant capacity after strenous exerciseDiagnostic test
Also called TAC after exercise
Determination of the Total Antioxidant Capacity after strenous exercise in the Climate Chamber
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (CoQ10) | Experimental | Runner athletes > 50 years old, took 100 mg/d of fitosomed Ubiquinone with lunch, daily, during one month, maintaining their usual training sessions Receives: Dietary Supplement: Administration of a product with Fitosomed Ubiquinone; Procedure: Coenzyme Q10 level in muscle biopsies; Diagnostic Test: Coenzyme Q10 level in plasma, blood cells, urine cells; Diagnostic Test: Total antioxidant capacity after strenous exercise |
| Control Group | Active comparator | Runner athletes > 50 years old with the same characteristics as the Experimental arm, served as control group, maintaining the training sessions Both groups were evaluated before and after the month of intervention or no intervention. Receives: Diagnostic Test: Coenzyme Q10 level in plasma, blood cells, urine cells; Diagnostic Test: Total antioxidant capacity after strenous exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the concentration of CoQ10 on different tissues after supplementation for a month
Evaluate the change in the concentration of CoQ10 on plasma, muscle, monouclear cells and urinary epithelium, by specific analysis of every sample tissue at the Pathology Dept and the Methabolopathies Dept of the Pediatric Hospital of Sant Joan de Deu
Measured: 6 months
Secondary outcomes (2)
Effect of the CoQ10 supplementation on the oxidative response to stressing exercise under heat and humidity
Determination of the inflammatory response before and after stressing exercise at the climate chamber at 35ºC and 55% humidity. The procedure is by the analysis of the venous blood extracted previous the exercise stress and 30 minutes after the period of work
Measured: 3 months
Effect of the CoQ10 supplementation on the inflammatory response to stressing exercise under heat and humidity
Determination of the Total antioxidant capacity before and after stressing exercise at the climate chamber at 35ºC and 55% humidity. The procedure is by the analysis of the venous blood extracted previous the exercise stress and 30 minutes after the period of work
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Mar 2018
- Primary completion30 May 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coenzyme Q10Studies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional study of 22 subjects, 12 under supplemental intervention and 10 as control subjects. Both groups are similar subjects with same characteristics and condition. The interventional group will receive a supplementaction of CoQ10 (100 mg) during one month, the Control group nothing.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Alt Rendiment
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sant Joan de Deu, University of Barcelona, Indena S.p.A
- Responsible party
- Sponsor
- Investigators
- Rafael Artuch, MD, PhD, Study chair, Hospital Sant Joan de Deu, Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893864
- Sponsor's protocol ID
- CAR-2018 CoQ10
- Acronym
- CoQ10Sport
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Impact of the Administration of Coenzyme Q10, on Mitochondrial Function Associated With Exercise Under Stress Conditions in Physically Active Individuals of Senescence Age
- ClinicalTrials.gov ID
- NCT03893864
- Acronym / sponsor ID
- CoQ10Sport / CAR-2018 CoQ10
- Conditions
- Coenzyme Q10, Oxidative Stress, Aging
- Keywords
- Coenzyme Q10, Ubiquinone, Ubiquinol, Oxidative pattern, Exercise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre d'Alt RendimentUniversity, hospital or other
- Collaborators
- Hospital Sant Joan de Deu, University of Barcelona, Indena S.p.A
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 28 Mar 2019 (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.
It is proposed to establish a group of subjects composed of 10 healthy individuals of> 50 years and <65, physically active, without metabolic or inflammatory pathology. All of them will undergo a health examination and the physical condition and the absence of contraindication of the sports practice will be characterized through a monitored effort test. Each subject will take a capsule of coenzyme Q10® INDENA for 30 days. The dose to be administered is 100 mg/d of CoQ10 a with food (noon). The state of physical condition and the biochemical and biological variables that reflect oxidative stress and mitochondrial functioning before and after the intervention will be measured.
Detailed description
The purpose of the study is in the first time determine the variation of the levels of coenzyme Q10 in different tissues, plasma, urinary epithelium, muscle, mononuclear cells, before and after the administration during one month of 100 mg of phytosomal ubiquinone (INDENA). Secondly, it is intended to determine the antioxidant functionality of the administered ubiquinone, evaluating its effect on the oxidative pattern that occurs after an exercise of moderate intensity, but performed in a stressful environment, a climatic chamber where the temperature is 35ºC and there is 55% humidity. To this end, the collaboration of 12 healthy volunteers, and 10 control subjects, over 50 and under 65, active runners with experience, without active inflammatory pathology, without prescribed medical treatment and with the commitment not to take any nutritional supplementation. There is also a compromise by athletes on maintaining the diet and training as it is at the time of the first evaluation The subjects sign an informed consent to carry out the study and they are shown the acceptance of the Ethics Committee approved by the General Directorate of Sports of the Generalitat of Catalonia. Basal blood samples are taken, the sample is taken from the first urine in the morning and a muscle biopsy is performed on the vastus lateralis of the m. quadricipitalis. On a second day, a progressive, maximum effort test is carried out in order to characterize the level of physical condition and determine the working regimes in the climatic chamber. They are re-scheduled for a third day for that purpose. On that day blood is drawn to obtain the Total Antioxidant Capacity of the blood and they are exposed to the temperature and humidity and are asked to run on the treadmill for 5 minutes at each of the speeds corresponding to 70, 75 and 80% of the maximum speed reached in the first test. At the end a lactate sample is taken. This period of 15 minutes is repeated 3 times. When finished, at the 30th minute, a new blood sample is taken to assess the TAC postexercise/exposition.
The stress test and blood extractions, urine collection and muscle biopsy are repeated after one month of taking the phytosomed Ubiquinone.
There is a control group of 10 subjects who follow absolutely the same path, but do not take any supplementation (Ubiquinone) and do not have a muscle biopsy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional study of 22 subjects, 12 under supplemental intervention and 10 as control subjects. Both groups are similar subjects with same characteristics and condition. The interventional group will receive a supplementaction of CoQ10 (100 mg) during one month, the Control group nothing.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (CoQ10) | Experimental | Dietary Supplement: Administration of a product with Fitosomed Ubiquinone, Procedure: Coenzyme Q10 level in muscle biopsies, Diagnostic Test: Coenzyme Q10 level in plasma, blood cells, urine cells, Diagnostic Test: Total antioxidant capacity after strenous exerciseRunner athletes > 50 years old, took 100 mg/d of fitosomed Ubiquinone with lunch, daily, during one month, maintaining their usual training sessions |
| Control Group | Active comparator | Diagnostic Test: Coenzyme Q10 level in plasma, blood cells, urine cells, Diagnostic Test: Total antioxidant capacity after strenous exerciseRunner athletes > 50 years old with the same characteristics as the Experimental arm, served as control group, maintaining the training sessions Both groups were evaluated before and after the month of intervention or no intervention. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Athletes over 50 active at this time
- Runners
- Without medical treatment
- Without acute or chronic inflmatory disease
- No recent infectious processes
Key exclusion criteria (4 listed)
- Injuried, sickness, during the study
- Lack of compromise
- Inflamatory process
- Abandon the training by any reason
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 |
|---|---|---|
| Administration of a product with Fitosomed UbiquinoneAlso: Coenzyme Q10, UbiQuisomeHealthy runner athletes, > 50 years old, without any chronic illness, without any other nutritional supplementation or drug intervention, took 100 mg/d of fitosomed Ubiquinone with lunch, daily, during one month, maintaining their usual training sessions. | Dietary supplement | Intervention Group (CoQ10) |
| Coenzyme Q10 level in muscle biopsiesAlso: Muscle BiopsyDetermination of the muscle Ubiquinone concentration, the metabolic and structure characteristics of the muscle before and after one month of supplementation | Procedure or surgery | Intervention Group (CoQ10) |
| Coenzyme Q10 level in plasma, blood cells, urine cellsDetermination of Ubiquinone concentration in different tissues before and after one month of supplementation or not | Diagnostic test | Control Group, Intervention Group (CoQ10) |
| Total antioxidant capacity after strenous exerciseAlso: TAC after exerciseDetermination of the Total Antioxidant Capacity after strenous exercise in the Climate Chamber | Diagnostic test | Control Group, Intervention Group (CoQ10) |
Primary outcome
Change in the concentration of CoQ10 on different tissues after supplementation for a month
Time frame: 6 months
Evaluate the change in the concentration of CoQ10 on plasma, muscle, monouclear cells and urinary epithelium, by specific analysis of every sample tissue at the Pathology Dept and the Methabolopathies Dept of the Pediatric Hospital of Sant Joan de Deu
2 secondary outcomes
Effect of the CoQ10 supplementation on the oxidative response to stressing exercise under heat and humidity
Time frame: 3 months
Effect of the CoQ10 supplementation on the inflammatory response to stressing exercise under heat and humidity
Time frame: 3 months
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 28 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Coenzyme Q10
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Metabolic Effects of an Ophiocordyceps Sinensis- and CoQ10-Based Formulation in Mild-to-Moderate Hypercholesterolemia
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Not yet recruitingPhase 1/2
COQ10 and Vitamin E for Off-Target Radiation Toxicity
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The Effects of Quercefit® and Ubiqsome™ in Mitigating Inflammation and Promoting Metabolic Health
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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.
Rafael Artuch, MD, PhD study chair
Hospital Sant Joan de Deu, Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Administration of a product with Fitosomed Ubiquinone, Coenzyme Q10 level in muscle biopsies and Coenzyme Q10 level in plasma, blood cells, urine cells in people with Coenzyme Q10 and Oxidative Stress, run by Centre d'Alt Rendiment 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 8 inclusion and 4 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 28 Mar 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in the concentration of CoQ10 on different tissues after supplementation for a month (time frame: 6 months). 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 28 Mar 2019.