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Completed

NCT Number: NCT03798821

The Antioxidant Efficacy of a Product Probiotic in Research

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG)

Dietary Supplement

six weeks of consumption

Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG)

Dietary Supplement

six weeks of consumption

maltodextrin and sucrose (PLACEBO)

Dietary Supplement

six weeks of consumption

Primary outcomes

  1. Oxidative damage to lipids

    Time frame: 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 outcomes

  1. Oxidative damage to DNA

    Time frame: 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.

  2. Oxidative damage to proteins.

    Time frame: 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

  3. Oxidative damage to lipids

    Time frame: 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

  4. Blood analysis

    Time frame: 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.

    serum carbonyls. It is measured in nmol / mg proteins

  5. Blood analysis

    Time frame: 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.

    Malondialdehyde in plasma

  6. Blood analysis

    Time frame: 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.

    Oxidized LDL.

  7. Blood analysis

    Time frame: 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.

    Antioxidant capacity.

  8. Blood analysis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

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

Acronym: BIO

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 10, 2019
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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