The Antioxidant Efficacy of a Product Probiotic in Research

Not Applicable

Completed

• Conditions: Oxidative Stress
• Interventions: Dietary Supplement: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG); Dietary Supplement: maltodextrin and sucrose (PLACEBO); Dietary Supplement: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG)

• Registration Number: NCT03798821
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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.

Study Timeline

• Study Start: 2018-01-08
• Study First Submitted: 2018-03-15
• Primary Completion: 2018-07-30
• Status Verified: 2019-01
• Study Completion: 2019-01-04
• Study First Submitted QC: 2019-01-07
• Last Update Submitted: 2019-01-07
• Study First Posted: 2019-01-10
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG)	One capsule a day will be consumed. At breakfast for the six weeks.
Experimental	Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG)	One capsule a day will be consumed. At breakfast for the six weeks.
Comparator	maltodextrin and sucrose (PLACEBO)	One capsule a day will be consumed. At breakfast for the six weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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
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.	glutathione metabolism. It is measured in nmol / mg proteins

Trial Locations

Locations (1)

Catholic University of Murcia; 🇪🇸 Murcia, Spain