The Antioxidant Efficacy of a Product Probiotic in Research

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nutritional Clinical Trial to Evaluate the Antioxidant Efficacy of a Product Probiotic in Research

Conditions
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Oxidative Stress

Intervention / Treatment
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* Dietary Supplement: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG)
* Dietary Supplement: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG)
* Dietary Supplement: maltodextrin and sucrose (PLACEBO)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>One capsule a day will be consumed. At breakfast for the six weeks. | Dietary Supplement: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG)<br>* six weeks of consumption<br>Dietary Supplement: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG)<br>* six weeks of consumption<br>|
| Placebo Comparator: Comparator<br>One capsule a day will be consumed. At breakfast for the six weeks. | Dietary Supplement: maltodextrin and sucrose (PLACEBO)<br>* six weeks of consumption<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative damage to lipids | It will be measured by isoprostanes in urine 24 hours. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative damage to DNA | Analysis of 8-oxo 2'-deoxyguanosine in 24-hour urine. | 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. | 
| Oxidative damage to proteins. | Analysis of serum carbonyl groups | 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. | 
| Oxidative damage to lipids | analysis of malondialdehyde in plasma | 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. | 
| Blood analysis | serum carbonyls. It is measured in nmol / mg proteins | 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. | 
| Blood analysis | Malondialdehyde in plasma | 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. | 
| Blood analysis | Oxidized LDL. | 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. | 
| Blood analysis | Antioxidant capacity. | 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. | 
| Blood analysis | glutathione metabolism. It is measured in nmol / mg proteins | 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. |