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

Inflammation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940627
• Other study ID #: 3795-00
• Secondary ID: 3795-00
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 3, 2013
• Last updated: September 11, 2013
• Start date: April 2013
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 31 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Inflammation
• Muscle Injury
• Oxidative Stress

Intervention

Dietary Supplement:
• Ubiquinol
Ubiquinol 200mg/day (two capsules of 100 mg (Breakfast and lunch)) for 14 days
• Control
placebo capsules (two capsules (Breakfast and lunch)) for 14 days

Locations

Country	Name	City	State
Spain	Faculty of Sport Sciences	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood and urine samples	Oxidative stress and Inflammatory signaling and Muscle Function	May-June 2013 (1 month)	No
Secondary	physiological measures	physical performance, resitance , muscle function and weakening	May-June 2013 (1 month)	No