Oxidative Stress
Conditions
Brief summary
Determine the efficacy of the investigational product versus placebo in reducing stress oxidative during the performance of a physical exercise of a certain intensity and duration.
Detailed description
The effectiveness of a probiotic for oxidative stress after eight weeks of the product to study will be checked. the sample will be formed by cyclists that will submit to a baseline exercise and after the product is taken.
Interventions
DIETARY_SUPPLEMENTLactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG)
six weeks of consumption
DIETARY_SUPPLEMENTLactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG)
six weeks of consumption
DIETARY_SUPPLEMENTmaltodextrin and sucrose (PLACEBO)
six weeks of consumption
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: between 18 and 45 years * Sex: male, of Caucasian race, selected from the general population. * Subjects that perform aerobic physical exercise between 2 and 4 times a week. * Volunteers capable of understanding the clinical study, willing to grant consent informed in writing and to comply with the procedures and requirements of the study
Exclusion criteria
* Subjects with a history of any chronic disease. * History of bronchial asthma or chronic obstructive pulmonary disease, disease Reactive airways such as bronchial asthma, a history of bronchial asthma or severe chronic obstructive pulmonary disease. * Sinus bradycardia, second or third degree of atrioventricular block, insufficiency manifest cardiac or cardiogenic shock. * History of allergic hypersensitivity or poor tolerance to any component of the products under study. * Participation in another clinical trial in the three months prior to the study Lack of will or inability to comply with clinical trial procedures. * Subjects diagnosed and / or under treatment for arterial hypertension. * Smoking subjects (\> 10 cigarettes a day). * Subjects with body mass index greater than 35 Kg / m2 (BMI\> 30). * Subjects with a history of drug, alcohol or other substance abuse or other factors that limit their ability to cooperate during the study. * Subjects whose condition does not make them eligible for the study according to the researcher's criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative damage to lipids | Oxidative lipid damage will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. | It will be measured by isoprostanes in urine 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative damage to DNA | Oxidative damage to DNA will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. | Analysis of 8-oxo 2'-deoxyguanosine in 24-hour urine. |
| Oxidative damage to proteins. | Oxidative damage to protein will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. | Analysis of serum carbonyl groups |
| Oxidative damage to lipids | Oxidative damage to lipids will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. | analysis of malondialdehyde in plasma |
| Blood analysis | Blood analysis will be measured by the ELISA test on two different occasions. The measurements will be made at the beginning and at six weeks of consumption of the product. | serum carbonyls. It is measured in nmol / mg proteins |
Countries
Spain
Outcome results
None listed