Clinical trial NCT03798821: The Antioxidant Efficacy of a Product Probiotic in Research
Official title: Nutritional Clinical Trial to Evaluate the Antioxidant Efficacy of a Product Probiotic in Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oxidative damage to lipids
timeFrame: 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 outcomes:
measure: Oxidative damage to DNA
timeFrame: 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.
measure: Oxidative damage to proteins.
timeFrame: 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.
measure: Oxidative damage to lipids
timeFrame: 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.
measure: Blood analysis
timeFrame: 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.
measure: Blood analysis
timeFrame: 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.
measure: Blood analysis
timeFrame: 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.
measure: Blood analysis
timeFrame: 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.
measure: Blood analysis
timeFrame: 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.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References:
citation: Sanchez Macarro M, Avila-Gandia V, Perez-Pinero S, Canovas F, Garcia-Munoz AM, Abellan-Ruiz MS, Victoria-Montesinos D, Luque-Rubia AJ, Climent E, Genoves S, Ramon D, Chenoll E, Lopez-Roman FJ. Antioxidant Effect of a Probiotic Product on a Model of Oxidative Stress Induced by High-Intensity and Duration Physical Exercise. Antioxidants (Basel). 2021 Feb 22;10(2):323. doi: 10.3390/antiox10020323.