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

Primary Purpose

Oxidative Stress, Inflammation, Muscle Injury

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Ubiquinol
Control
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oxidative Stress focused on measuring Ubiquinol, exercise

Eligibility Criteria

31 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Sport Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ubiquinol

Control

Arm Description

Firemen consuming 200 mg ubiquinol/day during two weeks

Firemen consuming placebo capsules during two weeks

Outcomes

Primary Outcome Measures

Blood and urine samples
Oxidative stress and Inflammatory signaling and Muscle Function

Secondary Outcome Measures

physiological measures
physical performance, resitance , muscle function and weakening

Full Information

First Posted
September 3, 2013
Last Updated
September 11, 2013
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT01940627
Brief Title
Influence of a Short Term Supplementation With Ubiquinol on Diverse Aspects Related to the Physical Activity
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Inflammation, Muscle Injury
Keywords
Ubiquinol, exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ubiquinol
Arm Type
Experimental
Arm Description
Firemen consuming 200 mg ubiquinol/day during two weeks
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Firemen consuming placebo capsules during two weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Ubiquinol
Other Intervention Name(s)
reduced Coenzyme Q10
Intervention Description
Ubiquinol 200mg/day (two capsules of 100 mg (Breakfast and lunch)) for 14 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Other Intervention Name(s)
Capsules without ubiquinol
Intervention Description
placebo capsules (two capsules (Breakfast and lunch)) for 14 days
Primary Outcome Measure Information:
Title
Blood and urine samples
Description
Oxidative stress and Inflammatory signaling and Muscle Function
Time Frame
May-June 2013 (1 month)
Secondary Outcome Measure Information:
Title
physiological measures
Description
physical performance, resitance , muscle function and weakening
Time Frame
May-June 2013 (1 month)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio J Ochoa, Ph.D.
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Sport Sciences
City
Granada
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

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

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