Clinical trial NCT03893864: Bioavailability and Impact of Coenzyme Q10 in Stressing Exercise in Senescence Athletes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coenzyme Q10
Oxidative Stress
Aging
Keywords: Coenzyme Q10
Ubiquinone
Ubiquinol
Oxidative pattern
Exercise
Lead sponsor: Centre d'Alt Rendiment
Sponsor class: OTHER
Collaborators: name: Hospital Sant Joan de Deu
name: University of Barcelona
name: Indena S.p.A
First posted: 2019-03-28
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional study of 22 subjects, 12 under supplemental intervention and 10 as control subjects. Both groups are similar subjects with same characteristics and condition. The interventional group will receive a supplementaction of CoQ10 (100 mg) during one month, the Control group nothing.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in the concentration of CoQ10 on different tissues after supplementation for a month
timeFrame: 6 months
Secondary outcomes:
measure: Effect of the CoQ10 supplementation on the oxidative response to stressing exercise under heat and humidity
timeFrame: 3 months
measure: Effect of the CoQ10 supplementation on the inflammatory response to stressing exercise under heat and humidity
timeFrame: 3 months
Other outcomes:
Locations:
city: Sant Cugat Del Vallés
country: Spain
facility: Centre D'Alt Rendiment, Sant Cugat
state: Barcelona
Study officials:
affiliation: Hospital Sant Joan de Deu, Barcelona
name: Rafael Artuch, MD, PhD
role: STUDY_CHAIR
References: