Bioavailability and Impact of Coenzyme Q10 in Stressing Exercise in Senescence Athletes (CoQ10Sport)

Bioavailability and Impact of the Administration of Coenzyme Q10, on Mitochondrial Function Associated With Exercise Under Stress Conditions in Physically Active Individuals of Senescence Age

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.

Study Overview

• Status: Completed
• Conditions: Aging; Oxidative Stress; Coenzyme Q10
• Intervention / Treatment: Dietary supplement: Administration of a product with Fitosomed Ubiquinone; Procedure: Coenzyme Q10 level in muscle biopsies; Diagnostic test: Coenzyme Q10 level in plasma, blood cells, urine cells; Diagnostic test: Total antioxidant capacity after strenous exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sant Cugat Del Vallés, Barcelona, Spain, 08174
      • Centre D'Alt Rendiment, Sant Cugat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: 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.; Other Names: Coenzyme Q10; UbiQuisome; Procedure: 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; Other Names: Muscle Biopsy; Diagnostic test: 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; Diagnostic test: Total antioxidant capacity after strenous exercise; Determination of the Total Antioxidant Capacity after strenous exercise in the Climate Chamber; Other Names: TAC after exercise
Active Comparator: 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.	Diagnostic test: 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; Diagnostic test: Total antioxidant capacity after strenous exercise; Determination of the Total Antioxidant Capacity after strenous exercise in the Climate Chamber; Other Names: TAC after exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the concentration of CoQ10 on different tissues after supplementation for a month	Evaluate the change in the concentration of CoQ10 on plasma, muscle, monouclear cells and urinary epithelium, by specific analysis of every sample tissue at the Pathology Dept and the Methabolopathies Dept of the Pediatric Hospital of Sant Joan de Deu	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of the CoQ10 supplementation on the oxidative response to stressing exercise under heat and humidity	Determination of the inflammatory response before and after stressing exercise at the climate chamber at 35ºC and 55% humidity. The procedure is by the analysis of the venous blood extracted previous the exercise stress and 30 minutes after the period of work	3 months
Effect of the CoQ10 supplementation on the inflammatory response to stressing exercise under heat and humidity	Determination of the Total antioxidant capacity before and after stressing exercise at the climate chamber at 35ºC and 55% humidity. The procedure is by the analysis of the venous blood extracted previous the exercise stress and 30 minutes after the period of work	3 months

Collaborators and Investigators

• Sponsor: Centre d'Alt Rendiment
• Collaborators: University of Barcelona; Indena S.p.A; Hospital Sant Joan de Deu
• Investigators: Study Chair: Rafael Artuch, MD, PhD, Hospital Sant Joan de Deu, Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Coenzyme Q10; Ubiquinol; Ubiquinone; Oxidative pattern
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: CAR-2018 CoQ10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No