Bioavailability and Impact of Coenzyme Q10 in Stressing Exercise in Senescence Athletes

NCT ID: NCT03893864

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-02-28

Brief Summary

It is proposed to establish a group of subjects composed of 10 healthy individuals of> 50 years and <65, physically active, without metabolic or inflammatory pathology. All of them will undergo a health examination and the physical condition and the absence of contraindication of the sports practice will be characterized through a monitored effort test. Each subject will take a capsule of coenzyme Q10® INDENA for 30 days. The dose to be administered is 100 mg/d of CoQ10 a with food (noon). The state of physical condition and the biochemical and biological variables that reflect oxidative stress and mitochondrial functioning before and after the intervention will be measured.

Detailed Description

The purpose of the study is in the first time determine the variation of the levels of coenzyme Q10 in different tissues, plasma, urinary epithelium, muscle, mononuclear cells, before and after the administration during one month of 100 mg of phytosomal ubiquinone (INDENA). Secondly, it is intended to determine the antioxidant functionality of the administered ubiquinone, evaluating its effect on the oxidative pattern that occurs after an exercise of moderate intensity, but performed in a stressful environment, a climatic chamber where the temperature is 35ºC and there is 55% humidity. To this end, the collaboration of 12 healthy volunteers, and 10 control subjects, over 50 and under 65, active runners with experience, without active inflammatory pathology, without prescribed medical treatment and with the commitment not to take any nutritional supplementation. There is also a compromise by athletes on maintaining the diet and training as it is at the time of the first evaluation The subjects sign an informed consent to carry out the study and they are shown the acceptance of the Ethics Committee approved by the General Directorate of Sports of the Generalitat of Catalonia. Basal blood samples are taken, the sample is taken from the first urine in the morning and a muscle biopsy is performed on the vastus lateralis of the m. quadricipitalis. On a second day, a progressive, maximum effort test is carried out in order to characterize the level of physical condition and determine the working regimes in the climatic chamber. They are re-scheduled for a third day for that purpose. On that day blood is drawn to obtain the Total Antioxidant Capacity of the blood and they are exposed to the temperature and humidity and are asked to run on the treadmill for 5 minutes at each of the speeds corresponding to 70, 75 and 80% of the maximum speed reached in the first test. At the end a lactate sample is taken. This period of 15 minutes is repeated 3 times. When finished, at the 30th minute, a new blood sample is taken to assess the TAC postexercise/exposition.

The stress test and blood extractions, urine collection and muscle biopsy are repeated after one month of taking the phytosomed Ubiquinone.

There is a control group of 10 subjects who follow absolutely the same path, but do not take any supplementation (Ubiquinone) and do not have a muscle biopsy.

Conditions

Coenzyme Q10; Oxidative Stress; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group (CoQ10)

Runner athletes \> 50 years old, took 100 mg/d of fitosomed Ubiquinone with lunch, daily, during one month, maintaining their usual training sessions

Group Type: EXPERIMENTAL

Administration of a product with Fitosomed Ubiquinone

Intervention Type: DIETARY_SUPPLEMENT

Healthy runner athletes, \> 50 years old, without any chronic illness, without any other nutritional supplementation or drug intervention, took 100 mg/d of fitosomed Ubiquinone with lunch, daily, during one month, maintaining their usual training sessions.

Coenzyme Q10 level in muscle biopsies

Intervention Type: PROCEDURE

Determination of the muscle Ubiquinone concentration, the metabolic and structure characteristics of the muscle before and after one month of supplementation

Coenzyme Q10 level in plasma, blood cells, urine cells

Intervention Type: DIAGNOSTIC_TEST

Determination of Ubiquinone concentration in different tissues before and after one month of supplementation or not

Total antioxidant capacity after strenous exercise

Intervention Type: DIAGNOSTIC_TEST

Determination of the Total Antioxidant Capacity after strenous exercise in the Climate Chamber

Control Group

Runner athletes \> 50 years old with the same characteristics as the Experimental arm, served as control group, maintaining the training sessions Both groups were evaluated before and after the month of intervention or no intervention.

Group Type: ACTIVE_COMPARATOR

Coenzyme Q10 level in plasma, blood cells, urine cells

Intervention Type: DIAGNOSTIC_TEST

Determination of Ubiquinone concentration in different tissues before and after one month of supplementation or not

Total antioxidant capacity after strenous exercise

Intervention Type: DIAGNOSTIC_TEST

Determination of the Total Antioxidant Capacity after strenous exercise in the Climate Chamber

Interventions

Administration of a product with Fitosomed Ubiquinone

Healthy runner athletes, \> 50 years old, without any chronic illness, without any other nutritional supplementation or drug intervention, took 100 mg/d of fitosomed Ubiquinone with lunch, daily, during one month, maintaining their usual training sessions.

Intervention Type: DIETARY_SUPPLEMENT

Coenzyme Q10 level in muscle biopsies

Determination of the muscle Ubiquinone concentration, the metabolic and structure characteristics of the muscle before and after one month of supplementation

Intervention Type: PROCEDURE

Coenzyme Q10 level in plasma, blood cells, urine cells

Determination of Ubiquinone concentration in different tissues before and after one month of supplementation or not

Intervention Type: DIAGNOSTIC_TEST

Total antioxidant capacity after strenous exercise

Determination of the Total Antioxidant Capacity after strenous exercise in the Climate Chamber

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Coenzyme Q10; UbiQuisome; Muscle Biopsy; TAC after exercise

Eligibility Criteria

Inclusion Criteria

• Athletes over 50 active at this time
• Runners
• Without medical treatment
• Without acute or chronic inflmatory disease
• No recent infectious processes
• No muscle or joint injuries in the last 6 months
• Stable training during the evaluation period
• Without taking supplementation

Exclusion Criteria

• Injuried, sickness, during the study
• Lack of compromise
• Inflamatory process
• Abandon the training by any reason

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Sant Joan de Deu

OTHER

Sponsor Role: collaborator

University of Barcelona

OTHER

Sponsor Role: collaborator

Indena S.p.A

INDUSTRY

Sponsor Role: collaborator

Centre d'Alt Rendiment

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rafael Artuch, MD, PhD

Role: STUDY_CHAIR

Hospital Sant Joan de Deu, Barcelona

Locations

Centre D'Alt Rendiment, Sant Cugat

Sant Cugat Del Vallés, Barcelona, Spain

Countries

Spain

Other Identifiers

CAR-2018 CoQ10

Identifier Type: -

Identifier Source: org_study_id