Influence of a Short Term Supplementation With Ubiquinol on Diverse Aspects Related to the Physical Activity
Condition: Oxidative Stress; Inflammation; Muscle Injury
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 2/Phase 3

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 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.
    

Intervention name(s): Ubiquinol; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ubiquinol 200mg/day (two capsules of 100 mg (Breakfast and lunch)) for 14 days; placebo capsules (two capsules (Breakfast and lunch)) for 14 days
Other intervention name(s): reduced Coenzyme Q10; Capsules without ubiquinol
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Ubiquinol, exercise