<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/NCT02230345</url>
  </required_header>
  <id_info>
    <org_study_id>392/13</org_study_id>
    <nct_id>NCT02230345</nct_id>
  </id_info>
  <brief_title>Effects of a Probiotics on the Health of Normal Young Males</brief_title>
  <acronym>FFF</acronym>
  <official_title>Study of the Effects of a Probiotic Yoghourt on the Metabolic Health of Normal Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agroscope Liebefeld-Posieux Research Station ALP</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire Vaudois</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The important role played by the GI tract microflora on the metabolic health of an individual&#xD;
      are increasingly recognized. In this respect, the initial studies of Metchinkoff that&#xD;
      suggested a role of fermented food (specifically yoghourts ) to modulate the gut microflora&#xD;
      have evolved into the concept of &quot;probiotics&quot;. Probiotics are living microorganisms that&#xD;
      bring a benefit to the host when administered in sufficient quantity (WHO/FAO, 2001).&#xD;
&#xD;
      Here the investigators will study, in normal young male volunteers, the potential to modulate&#xD;
      post-prandial metabolic and inflammatory responses by the administration of a yoghourt&#xD;
      containing the probiotic Lactobacillus rhamnosus (LGG).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, double-blind and cross-over study designed to evaluate the&#xD;
      potential of a probiotic (Lactobacillus rhamnosus) to modulate the post prandial metabolic&#xD;
      and inflammatory response of normale healthy individuals.&#xD;
&#xD;
      After a wash out period during which volunteers will have to follow a diet devoid of all milk&#xD;
      or milk-derived products, they will receive, in random order, either a daily dose of the&#xD;
      probiotic, or a daily dose of acidified milk (control) for a total of three consecutive&#xD;
      weeks. At the end of each of these period, they will be submitted to a day of investigation,&#xD;
      during which their metabolic and inflammatory profile will be studied following the ingestion&#xD;
      of a standard test meal. The potential for the probiotic to modulate the metabolic and&#xD;
      inflammatory parameters will be evaluated.&#xD;
&#xD;
      The test meal will provide 1004Kcal under the form of 45.4g proteins (17%), 69g total fatty&#xD;
      acids (62%), and 52.6g glucids (21%) as previously published (Schwander et al, J Nut 2014).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Metabolomic analyses</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of metabolomic changes in blood during the 6 hours after meal ingestion, in presence of yogurt or placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of glucose during the 6 hours after meal ingestion, in presence of yogurt or placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of insulin during the 6 hours after meal ingestion, in presence of yogurt or placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucagon like polypeptide-1</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of GLP-1 during the 6 hours after meal ingestion, in presence of yogurt or placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastric inhibitory polypeptide</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of GIP during the 6 hours after meal ingestion, in presence of yogurt or placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of total cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-cholesterol</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of LDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-cholesterol</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of HDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non esterified fatty acids</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of NEFAs during the 6 hours after meal ingestion, in presence of yogurt or placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of triglycerides during the 6 hours after meal ingestion, in presence of yogurt or placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukin-6</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of IL-6 will be measured in blood of volunteers after the administration of yogurt or placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemokine CCK2</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of CCK2 will be measured in blood of volunteers after the administration of yogurt or placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemokine CCK5</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of CCK5 will be measured in blood of volunteers after the administration of yogurt or placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tunour necrosis factor alpha</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of TNF-a will be measured in blood of volunteers after the administration of yogurt or placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipo-poly-saccharide</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of LPS will be measured in blood of volunteers after the administration of yogurt or placebo</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Transcriptomic analyses</measure>
    <time_frame>6 hours</time_frame>
    <description>Kinetics of gene expression in white blood cells during the 6 hours after meal ingestion, in presence of yogurt or placebo</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Inflammation</condition>
  <condition>Dyslipidemia</condition>
  <arm_group>
    <arm_group_label>Probiotic yogurt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily administration, during two weeks, of two probiotic yogurts (200 mL each)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acidified milk</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Daily administration, over two consecutive weeks, of an isocaloric dose (compared to probiotics) of unfermented acidified milk</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic yogurt</intervention_name>
    <description>Probiotic yogurt (fermented milk with Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus- YoFlex FD-DVS YC-X11 Fr, with the addition of Lactobacillus rhamnosus GG (LGG)- Culture Collection, University of Göteborg, Sweden CCUG 34291).</description>
    <arm_group_label>Probiotic yogurt</arm_group_label>
    <other_name>LGG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Acidified milk</intervention_name>
    <description>Milk will consist in an isocaloric supplement (compared to probiotic yogurt) of unfermented milk</description>
    <arm_group_label>Acidified milk</arm_group_label>
    <other_name>Milk</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal male with normal BMI (18.5-25 kg/m2)&#xD;
&#xD;
          -  non smoker&#xD;
&#xD;
          -  stable physical activity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Food intolerance (ceoliac disease, lactose intolerance, food allergies)&#xD;
&#xD;
          -  Particular regimen (vegetarian...)&#xD;
&#xD;
          -  Chronic disease (any)&#xD;
&#xD;
          -  Elevated blood pressure&#xD;
&#xD;
          -  Regular drug treatment&#xD;
&#xD;
          -  Antibiotics treatement in the preceding six months&#xD;
&#xD;
          -  &gt;4 hrs/week of physical activity&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francois P Pralong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Vaudois</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical research center, Lausanne University hospital</name>
      <address>
        <city>Lausanne</city>
        <state>Vaud</state>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>August 20, 2015</last_update_submitted>
  <last_update_submitted_qc>August 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
    <investigator_full_name>Francois Pralong</investigator_full_name>
    <investigator_title>Full professor and Head, Service of Endocrinology, Diabetology and Metabolism</investigator_title>
  </responsible_party>
  <keyword>Probiotic</keyword>
  <keyword>Yoghourt</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Metabolomics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslipidemias</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <!-- 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/NCT02230345
org study id: 392/13
nct id: NCT02230345
lead sponsor: 
collaborator: 
has dmc: No
The important role played by the GI tract microflora on the metabolic health of an individual
      are increasingly recognized. In this respect, the initial studies of Metchinkoff that
      suggested a role of fermented food (specifically yoghourts ) to modulate the gut microflora
      have evolved into the concept of "probiotics". Probiotics are living microorganisms that
      bring a benefit to the host when administered in sufficient quantity (WHO/FAO, 2001).

      Here the investigators will study, in normal young male volunteers, the potential to modulate
      post-prandial metabolic and inflammatory responses by the administration of a yoghourt
      containing the probiotic Lactobacillus rhamnosus (LGG).
This is a prospective, randomized, double-blind and cross-over study designed to evaluate the
      potential of a probiotic (Lactobacillus rhamnosus) to modulate the post prandial metabolic
      and inflammatory response of normale healthy individuals.

      After a wash out period during which volunteers will have to follow a diet devoid of all milk
      or milk-derived products, they will receive, in random order, either a daily dose of the
      probiotic, or a daily dose of acidified milk (control) for a total of three consecutive
      weeks. At the end of each of these period, they will be submitted to a day of investigation,
      during which their metabolic and inflammatory profile will be studied following the ingestion
      of a standard test meal. The potential for the probiotic to modulate the metabolic and
      inflammatory parameters will be evaluated.

      The test meal will provide 1004Kcal under the form of 45.4g proteins (17%), 69g total fatty
      acids (62%), and 52.6g glucids (21%) as previously published (Schwander et al, J Nut 2014).
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Metabolomic analyses
time frame: 6 hours
description: Kinetics of metabolomic changes in blood during the 6 hours after meal ingestion, in presence of yogurt or placebo
measure: Glucose
time frame: 6 hours
description: Kinetics of glucose during the 6 hours after meal ingestion, in presence of yogurt or placebo
measure: Insulin
time frame: 6 hours
description: Kinetics of insulin during the 6 hours after meal ingestion, in presence of yogurt or placebo
measure: Glucagon like polypeptide-1
time frame: 6 hours
description: Kinetics of GLP-1 during the 6 hours after meal ingestion, in presence of yogurt or placebo
measure: Gastric inhibitory polypeptide
time frame: 6 hours
description: Kinetics of GIP during the 6 hours after meal ingestion, in presence of yogurt or placebo
measure: Total cholesterol
time frame: 6 hours
description: Kinetics of total cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
measure: LDL-cholesterol
time frame: 6 hours
description: Kinetics of LDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
measure: HDL-cholesterol
time frame: 6 hours
description: Kinetics of HDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
measure: Non esterified fatty acids
time frame: 6 hours
description: Kinetics of NEFAs during the 6 hours after meal ingestion, in presence of yogurt or placebo
measure: Triglycerides
time frame: 6 hours
description: Kinetics of triglycerides during the 6 hours after meal ingestion, in presence of yogurt or placebo
measure: Interleukin-6
time frame: 6 hours
description: Kinetics of IL-6 will be measured in blood of volunteers after the administration of yogurt or placebo
measure: Chemokine CCK2
time frame: 6 hours
description: Kinetics of CCK2 will be measured in blood of volunteers after the administration of yogurt or placebo
measure: Chemokine CCK5
time frame: 6 hours
description: Kinetics of CCK5 will be measured in blood of volunteers after the administration of yogurt or placebo
measure: Tunour necrosis factor alpha
time frame: 6 hours
description: Kinetics of TNF-a will be measured in blood of volunteers after the administration of yogurt or placebo
measure: Lipo-poly-saccharide
time frame: 6 hours
description: Kinetics of LPS will be measured in blood of volunteers after the administration of yogurt or placebo
measure: Transcriptomic analyses
time frame: 6 hours
description: Kinetics of gene expression in white blood cells during the 6 hours after meal ingestion, in presence of yogurt or placebo
arm group label: Probiotic yogurt
arm group type: Experimental
description: Daily administration, during two weeks, of two probiotic yogurts (200 mL each)
arm group label: Acidified milk
arm group type: Active Comparator
description: Daily administration, over two consecutive weeks, of an isocaloric dose (compared to probiotics) of unfermented acidified milk
intervention type: Dietary Supplement
intervention name: Probiotic yogurt
description: Probiotic yogurt (fermented milk with Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus- YoFlex FD-DVS YC-X11 Fr, with the addition of Lactobacillus rhamnosus GG (LGG)- Culture Collection, University of Göteborg, Sweden CCUG 34291).
arm group label: Probiotic yogurt
other name: LGG
intervention type: Dietary Supplement
intervention name: Acidified milk
description: Milk will consist in an isocaloric supplement (compared to probiotic yogurt) of unfermented milk
arm group label: Acidified milk
other name: Milk
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Francois P Pralong, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Vaudois
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire Vaudois
investigator full name: Francois Pralong
investigator title: Full professor and Head, Service of Endocrinology, Diabetology and Metabolism
mesh term: Dyslipidemias
mesh term: Inflammation