Status:
COMPLETED
The Antioxidant Efficacy of a Product Probiotic in Research
Lead Sponsor:
Universidad Católica San Antonio de Murcia
Conditions:
Oxidative Stress
Eligibility:
MALE
18-45 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2019
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03798821
Start Date
January 8 2018
End Date
January 4 2019
Last Update
January 10 2019
Active Locations (1)
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1
Catholic University of Murcia
Murcia, Spain, 30107