<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03798821</url>
  </required_header>
  <id_info>
    <org_study_id>UCAM-CFE-0003</org_study_id>
    <nct_id>NCT03798821</nct_id>
  </id_info>
  <brief_title>The Antioxidant Efficacy of a Product Probiotic in Research</brief_title>
  <acronym>BIO</acronym>
  <official_title>Nutritional Clinical Trial to Evaluate the Antioxidant Efficacy of a Product Probiotic in Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Católica San Antonio de Murcia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Determine the efficacy of the investigational product versus placebo in reducing stress&#xD;
      oxidative during the performance of a physical exercise of a certain intensity and duration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The effectiveness of a probiotic for oxidative stress after eight weeks of the product to&#xD;
      study will be checked. the sample will be formed by cyclists that will submit to a baseline&#xD;
      exercise and after the product is taken.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2018</start_date>
  <completion_date type="Actual">January 4, 2019</completion_date>
  <primary_completion_date type="Actual">July 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxidative damage to lipids</measure>
    <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.</time_frame>
    <description>It will be measured by isoprostanes in urine 24 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxidative damage to DNA</measure>
    <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.</time_frame>
    <description>Analysis of 8-oxo 2'-deoxyguanosine in 24-hour urine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative damage to proteins.</measure>
    <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.</time_frame>
    <description>Analysis of serum carbonyl groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative damage to lipids</measure>
    <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.</time_frame>
    <description>analysis of malondialdehyde in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood analysis</measure>
    <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.</time_frame>
    <description>serum carbonyls. It is measured in nmol / mg proteins</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood analysis</measure>
    <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.</time_frame>
    <description>Malondialdehyde in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood analysis</measure>
    <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.</time_frame>
    <description>Oxidized LDL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood analysis</measure>
    <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.</time_frame>
    <description>Antioxidant capacity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood analysis</measure>
    <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.</time_frame>
    <description>glutathione metabolism. It is measured in nmol / mg proteins</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Oxidative Stress</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One capsule a day will be consumed. At breakfast for the six weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One capsule a day will be consumed. At breakfast for the six weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG)</intervention_name>
    <description>six weeks of consumption</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG)</intervention_name>
    <description>six weeks of consumption</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>maltodextrin and sucrose (PLACEBO)</intervention_name>
    <description>six weeks of consumption</description>
    <arm_group_label>Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: between 18 and 45 years&#xD;
&#xD;
          -  Sex: male, of Caucasian race, selected from the general population.&#xD;
&#xD;
          -  Subjects that perform aerobic physical exercise between 2 and 4 times a week.&#xD;
&#xD;
          -  Volunteers capable of understanding the clinical study, willing to grant consent&#xD;
             informed in writing and to comply with the procedures and requirements of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history of any chronic disease.&#xD;
&#xD;
          -  History of bronchial asthma or chronic obstructive pulmonary disease, disease Reactive&#xD;
             airways such as bronchial asthma, a history of bronchial asthma or severe chronic&#xD;
             obstructive pulmonary disease.&#xD;
&#xD;
          -  Sinus bradycardia, second or third degree of atrioventricular block, insufficiency&#xD;
             manifest cardiac or cardiogenic shock.&#xD;
&#xD;
          -  History of allergic hypersensitivity or poor tolerance to any component of the&#xD;
             products under study.&#xD;
&#xD;
          -  Participation in another clinical trial in the three months prior to the study Lack of&#xD;
             will or inability to comply with clinical trial procedures.&#xD;
&#xD;
          -  Subjects diagnosed and / or under treatment for arterial hypertension.&#xD;
&#xD;
          -  Smoking subjects (&gt; 10 cigarettes a day).&#xD;
&#xD;
          -  Subjects with body mass index greater than 35 Kg / m2 (BMI&gt; 30).&#xD;
&#xD;
          -  Subjects with a history of drug, alcohol or other substance abuse or other factors&#xD;
             that limit their ability to cooperate during the study.&#xD;
&#xD;
          -  Subjects whose condition does not make them eligible for the study according to the&#xD;
             researcher's criteria.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Catholic University of Murcia</name>
      <address>
        <city>Murcia</city>
        <zip>30107</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>March 15, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Católica San Antonio de Murcia</investigator_affiliation>
    <investigator_full_name>Francisco Javier López Román</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sulfalene</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03798821
org study id: UCAM-CFE-0003
nct id: NCT03798821
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: 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.
description: It will be measured by isoprostanes in urine 24 hours.
measure: 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.
description: Analysis of 8-oxo 2'-deoxyguanosine in 24-hour urine.
measure: 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.
description: Analysis of serum carbonyl groups
measure: 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.
description: analysis of malondialdehyde in plasma
measure: 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.
description: serum carbonyls. It is measured in nmol / mg proteins
measure: 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.
description: Malondialdehyde in plasma
measure: 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.
description: Oxidized LDL.
measure: 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.
description: Antioxidant capacity.
measure: 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.
description: glutathione metabolism. It is measured in nmol / mg proteins
arm group label: Experimental
arm group type: Experimental
description: One capsule a day will be consumed. At breakfast for the six weeks.
arm group label: Comparator
arm group type: Placebo Comparator
description: One capsule a day will be consumed. At breakfast for the six weeks.
intervention type: Dietary Supplement
intervention name: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG)
description: six weeks of consumption
arm group label: Experimental
intervention type: Dietary Supplement
intervention name: Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG)
description: six weeks of consumption
arm group label: Experimental
intervention type: Dietary Supplement
intervention name: maltodextrin and sucrose (PLACEBO)
description: six weeks of consumption
arm group label: Comparator
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Católica San Antonio de Murcia
investigator full name: Francisco Javier López Román
investigator title: Principal Investigator
mesh term: Sulfalene
sharing ipd: Undecided