The Antioxidant Efficacy of a Product Probiotic in Research (BIO)

Universidad Católica San Antonio de Murcia

Status: Completed

Conditions: Oxidative Stress

Treatments: Dietary Supplement: maltodextrin and sucrose (PLACEBO); Dietary Supplement: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG); Dietary Supplement: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG)

Study type: Interventional

Funder types: Other

Identifiers

NCT03798821

UCAM-CFE-0003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

45 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

One capsule a day will be consumed. At breakfast for the six weeks.

Treatment:

Dietary Supplement: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG)

Dietary Supplement: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG)

Comparator

Placebo Comparator group

Description:

One capsule a day will be consumed. At breakfast for the six weeks.

Treatment:

Dietary Supplement: maltodextrin and sucrose (PLACEBO)