The Antioxidant Efficacy of a Product Probiotic in Research

Oxidative Stress Clinical Trial

— BIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798821
• Other study ID #: UCAM-CFE-0003
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: January 4, 2019

Study information

• Verified date: January 2019
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 4, 2019
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Dietary Supplement:
• Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG)
six weeks of consumption
• Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG)
six weeks of consumption
• maltodextrin and sucrose (PLACEBO)
six weeks of consumption

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.