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NCT Number: NCT01940627

Influence of a Short Term Supplementation With Ubiquinol on Diverse Aspects Related to the Physical Activity

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.

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Key information

Conditions

Oxidative Stress Behavior Inflammation Motor Activity Muscle Injury Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

31 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Sport Sciences

Granada, 18071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ubiquinol

Dietary Supplement

Ubiquinol 200mg/day (two capsules of 100 mg (Breakfast and lunch)) for 14 days

Other names: reduced Coenzyme Q10

Control

Dietary Supplement

placebo capsules (two capsules (Breakfast and lunch)) for 14 days

Other names: Capsules without ubiquinol

Primary outcomes

  1. Blood and urine samples

    Time frame: May-June 2013 (1 month)

    Oxidative stress and Inflammatory signaling and Muscle Function

Secondary outcomes

  1. physiological measures

    Time frame: May-June 2013 (1 month)

    physical performance, resitance , muscle function and weakening

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

Influence of a Short Term Supplementation With Ubiquinol on Diverse Aspects Related to the Physical Activity (Muscle Function, Oxidative Stress and Inflammatory Signaling)

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 12, 2013
Registry last updated
Sep 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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