<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/NCT02228746</url>
  </required_header>
  <id_info>
    <org_study_id>2012-A01610--43</org_study_id>
    <nct_id>NCT02228746</nct_id>
  </id_info>
  <brief_title>Effect of the Alpha-galacto-oligasaccharides on Weight Loss in Overweight or Moderately Obeses Adults : A Randomized Controlled Double Blinded Trial Versus Placebo</brief_title>
  <official_title>Effect of the Alpha-galacto-oligasaccharides on Weight Loss in Overweight or Moderately Obeses Adults : A Randomized Controlled Double Blinded Trial Versus Placebo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Olygose</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute of Cardiometabolism and Nutrition, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Olygose</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical intervention on overweight or moderately obeses adults. The objective of this trial&#xD;
      is to demonstrate the superior eficacy of Alphagos to placebo on weight loss during a&#xD;
      low-calorie diet of 12 weeks. The superiority is judged on body weight. Change in&#xD;
      cardiometabolic risk factors through the intervention have been evaluated as secondary&#xD;
      endpoints&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body weight (kg) between day 0 and week 12</measure>
    <time_frame>Day 0, Day 7, Month 1, Month 2, Month 3</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feeding behaviour</measure>
    <time_frame>Between day 0 and week 12</time_frame>
    <description>Changes in feeding behaviour will be studied by :&#xD;
visual analogue scales rating for hunger, satiety, fullness, desire to eat, prospective consumption during preload-test meal paradigm (standardized breakfast and lunch test)&#xD;
level of circulating peptides involved in the regulation of controlling food intake during a kinetic after a standardized breakfast (samples 30, 60, 120, 180 and 240 min after the start of standardized breakfast)&#xD;
food intake during the lunch test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lean body mass</measure>
    <time_frame>Between day 0 and week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Day 0, day 7, Month1, Month 2, Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip circumference</measure>
    <time_frame>Day 0, Day 7, Month 1, Month 2, Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist to hip circumference ratio</measure>
    <time_frame>Between Day 0 and week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Fat</measure>
    <time_frame>Day 7, Month 3</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>between Day 0 and week 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>arterial systolic and diastolic pressures</measure>
    <time_frame>between day 0 and week 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Morphological, inflammatory and metabolic characteristics of adipose tissue sampled from the abdominal region</measure>
    <time_frame>between day 0 and week 12</time_frame>
    <description>Adipocyte size and diameter, secretion profile of subcutaneous adipose tissue, gene expression profile of adipose tissue, lipolytic response and energy metabolism</description>
  </other_outcome>
  <other_outcome>
    <measure>Components of the intestinal commensal microbiota</measure>
    <time_frame>between day 0 and week 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Lipid Profile</measure>
    <time_frame>Day 0, Week 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Markers of systemic inflammation</measure>
    <time_frame>Day 0, Week 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Glycemic profile</measure>
    <time_frame>Day 0, Week 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Circulating adipokines</measure>
    <time_frame>Day 0, Week 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Hemostatic factors associated with cardiovascular risks</measure>
    <time_frame>Day 0, Week 12</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Randomized Versus Placebo</condition>
  <condition>Controlled</condition>
  <condition>Double Blind</condition>
  <arm_group>
    <arm_group_label>Alpha-galacto-oliosaccharides</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Alpha-galacto-oligosaccharides</intervention_name>
    <description>6g of alpha-galacto-oligosaccharides in a 100 mL flavored drink</description>
    <arm_group_label>Alpha-galacto-oliosaccharides</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index &gt; or equal 25 and &lt; 35&#xD;
&#xD;
          -  Use of effective contraception in women of childbearing age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women (positive pregnancy test) or breastfeeding&#xD;
&#xD;
          -  Anti-hypertensive or cholesterol treatment&#xD;
&#xD;
          -  HIV infection or HCV&#xD;
&#xD;
          -  Hepatic and/or severe renal failure&#xD;
&#xD;
          -  Heart attack within 6 months prior the selection&#xD;
&#xD;
          -  Heart failure known&#xD;
&#xD;
          -  Inflammatory disease known&#xD;
&#xD;
          -  Cancer or have had cancer within 3 years prior to the study except for basal cell skin&#xD;
             cancers&#xD;
&#xD;
          -  Diabetes defined by blood glucose greater than or equal to 1.26 g/L&#xD;
&#xD;
          -  Gastrointestinal disease known&#xD;
&#xD;
          -  Bariatric surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre d'Investigation Clinique Paris-Est/ Bâtiment Antonin Gosset Hôpital de la Pitié Salpêtrière- 56 Boulevard Vincent Auriol</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>April 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Weight Loss</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/NCT02228746
org study id: 2012-A01610--43
nct id: NCT02228746
lead sponsor: 
collaborator: 
has dmc: Yes
Clinical intervention on overweight or moderately obeses adults. The objective of this trial
      is to demonstrate the superior eficacy of Alphagos to placebo on weight loss during a
      low-calorie diet of 12 weeks. The superiority is judged on body weight. Change in
      cardiometabolic risk factors through the intervention have been evaluated as secondary
      endpoints
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Body weight (kg) between day 0 and week 12
time frame: Day 0, Day 7, Month 1, Month 2, Month 3
measure: Feeding behaviour
time frame: Between day 0 and week 12
description: Changes in feeding behaviour will be studied by :
visual analogue scales rating for hunger, satiety, fullness, desire to eat, prospective consumption during preload-test meal paradigm (standardized breakfast and lunch test)
level of circulating peptides involved in the regulation of controlling food intake during a kinetic after a standardized breakfast (samples 30, 60, 120, 180 and 240 min after the start of standardized breakfast)
food intake during the lunch test
measure: Lean body mass
time frame: Between day 0 and week 12
measure: Waist circumference
time frame: Day 0, day 7, Month1, Month 2, Month 3
measure: Hip circumference
time frame: Day 0, Day 7, Month 1, Month 2, Month 3
measure: Waist to hip circumference ratio
time frame: Between Day 0 and week 12
measure: Body Fat
time frame: Day 7, Month 3
measure: Body Mass Index (BMI)
time frame: between Day 0 and week 12
measure: arterial systolic and diastolic pressures
time frame: between day 0 and week 12
measure: Morphological, inflammatory and metabolic characteristics of adipose tissue sampled from the abdominal region
time frame: between day 0 and week 12
description: Adipocyte size and diameter, secretion profile of subcutaneous adipose tissue, gene expression profile of adipose tissue, lipolytic response and energy metabolism
measure: Components of the intestinal commensal microbiota
time frame: between day 0 and week 12
measure: Lipid Profile
time frame: Day 0, Week 12
measure: Markers of systemic inflammation
time frame: Day 0, Week 12
measure: Glycemic profile
time frame: Day 0, Week 12
measure: Circulating adipokines
time frame: Day 0, Week 12
measure: Hemostatic factors associated with cardiovascular risks
time frame: Day 0, Week 12
arm group label: Alpha-galacto-oliosaccharides
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Alpha-galacto-oligosaccharides
description: 6g of alpha-galacto-oligosaccharides in a 100 mL flavored drink
arm group label: Alpha-galacto-oliosaccharides
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Overweight
mesh term: Weight Loss