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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03893864
Study type Interventional
Source Centre d'Alt Rendiment
Contact
Status Completed
Phase Phase 1
Start date March 1, 2018
Completion date February 28, 2019

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