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

NCT01940627 | Completed Phase 2 DMC

• 1 other identifier: 3795-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress; Inflammation; Muscle Injury

Keywords

Ubiquinol, exercise

Outcome Measures

Primary Outcomes (1)

• Blood and urine samples

  Oxidative stress and Inflammatory signaling and Muscle Function

  May-June 2013 (1 month)

Secondary Outcomes (1)

• physiological measures

  May-June 2013 (1 month)

Study Arms (2)

Ubiquinol

EXPERIMENTAL

Firemen consuming 200 mg ubiquinol/day during two weeks

Dietary Supplement: Ubiquinol

Control

PLACEBO COMPARATOR

Firemen consuming placebo capsules during two weeks

Dietary Supplement: Control

Interventions

Ubiquinol DIETARY_SUPPLEMENT

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

Also known as: reduced Coenzyme Q10

Ubiquinol

Control DIETARY_SUPPLEMENT

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

Also known as: Capsules without ubiquinol

Control

Eligibility Criteria

• Age: 31 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Sport Sciences

Granada, Granada, 18071, Spain

Location

MeSH Terms

Conditions

Inflammation; Motor Activity

Interventions

ubiquinol; ubiquinol-10

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Julio J Ochoa, Ph.D.

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 12, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 12, 2013

Record last verified: 2013-09

Locations

ES (1)