- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01940627
Influence of a Short Term Supplementation With Ubiquinol on Diverse Aspects Related to the Physical Activity
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
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Granada, Spain, 18071
- Faculty of Sport Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ubiquinol
Firemen consuming 200 mg ubiquinol/day during two weeks
|
Ubiquinol 200mg/day (two capsules of 100 mg (Breakfast and lunch)) for 14 days
Other Names:
|
Placebo Comparator: Control
Firemen consuming placebo capsules during two weeks
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placebo capsules (two capsules (Breakfast and lunch)) for 14 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood and urine samples
Time Frame: May-June 2013 (1 month)
|
Oxidative stress and Inflammatory signaling and Muscle Function
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May-June 2013 (1 month)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
physiological measures
Time Frame: May-June 2013 (1 month)
|
physical performance, resitance , muscle function and weakening
|
May-June 2013 (1 month)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julio J Ochoa, Ph.D., Universidad de Granada
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3795-00 (Other Identifier: KANEKA corporation)
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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