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

NCT ID: NCT01940627

Last Updated: 2013-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-09-30

Brief Summary

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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

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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.

Conditions

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Oxidative Stress Inflammation Muscle Injury

Keywords

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Ubiquinol, exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ubiquinol

Firemen consuming 200 mg ubiquinol/day during two weeks

Group Type EXPERIMENTAL

Ubiquinol

Intervention Type DIETARY_SUPPLEMENT

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

Control

Firemen consuming placebo capsules during two weeks

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Ubiquinol

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

Intervention Type DIETARY_SUPPLEMENT

Control

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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reduced Coenzyme Q10 Capsules without ubiquinol

Eligibility Criteria

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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.
Minimum Eligible Age

31 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Julio J. Ochoa

Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julio J Ochoa, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

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Faculty of Sport Sciences

Granada, Granada, Spain

Site Status

Countries

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Spain

Other Identifiers

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3795-00

Identifier Type: OTHER

Identifier Source: secondary_id

3795-00

Identifier Type: -

Identifier Source: org_study_id