<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/NCT01673152</url>
  </required_header>
  <id_info>
    <org_study_id>RG 4/2011</org_study_id>
    <nct_id>NCT01673152</nct_id>
  </id_info>
  <brief_title>The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children</brief_title>
  <official_title>The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children: a Randomized, Double Blind, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nutricia Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to assess the effect of oligofructose administration for 12 weeks on&#xD;
      Body Mass Index (BMI) of overweight and obese children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of childhood overweight and obesity is reaching epidemic proportions. There&#xD;
      have been no effective methods for preventing or treating obesity in childhood so far&#xD;
      prompting interest in new interventions. One potential option for obesity prevention is the&#xD;
      use of the prebiotic oligofructose. Data from research on rodents shows that a high-fat diet&#xD;
      enriched with oligofructose causes a decrease in energy intake, less weight gain and a lower&#xD;
      level of triglycerides . A similar effect has been observed in healthy adults. Available&#xD;
      evidence suggests that the addition of oligofructose to the diets of overweight or obese&#xD;
      adults may increase satiety and thus reduce energy intake. Currently, there are no data on&#xD;
      the effect of oligofructose in overweight and obese children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BMI z-score difference</measure>
    <time_frame>after 12 weeks of the intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI z-score difference</measure>
    <time_frame>after 24 weeks of the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of weight reduction</measure>
    <time_frame>after 12 weeks of the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in total body fat measured by Dual-Energy X-ray Absorptiometry (DEXA)</measure>
    <time_frame>after 12 weeks of the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of children with BMI-for-age &gt; 85percentile</measure>
    <time_frame>after 12 and 24 weeks of the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean BMI z-score</measure>
    <time_frame>after 12 and 24 weeks of the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported energy intake (3-day diet record)</measure>
    <time_frame>after 12 weeks of the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of the children with abnormal fasting glucose</measure>
    <time_frame>after 12 weeks of the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of the children with dyslipidemias</measure>
    <time_frame>after 12 weeks of the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of the children with hypertension</measure>
    <time_frame>after 12 weeks of the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects</measure>
    <time_frame>during intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Maltodextrin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Oligofructose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Orafti P95, Beneo-Orafti, Belgium,</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Oligofructose</intervention_name>
    <description>Dosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks</description>
    <arm_group_label>Oligofructose</arm_group_label>
    <other_name>Orafti P95, Beneo-Orafti, Belgium</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Maltodextrin</intervention_name>
    <description>Dosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks</description>
    <arm_group_label>Maltodextrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 7 to 18 years&#xD;
&#xD;
          -  BMI &gt; 85 percentile&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Overweight / obesity secondary to genetic syndromes and/or endocrine diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samodzielny Publiczny Dziecięcy Szpital Kliniczny</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>June 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>January 15, 2014</last_update_submitted>
  <last_update_submitted_qc>January 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Hanna Szajewska</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Overweight</keyword>
  <keyword>Satiety</keyword>
  <keyword>Oligofructose</keyword>
  <keyword>Prebiotic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Body Weight</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/NCT01673152
org study id: RG 4/2011
nct id: NCT01673152
lead sponsor: 
collaborator: 
has dmc: Yes
This study is designed to assess the effect of oligofructose administration for 12 weeks on
      Body Mass Index (BMI) of overweight and obese children.
The prevalence of childhood overweight and obesity is reaching epidemic proportions. There
      have been no effective methods for preventing or treating obesity in childhood so far
      prompting interest in new interventions. One potential option for obesity prevention is the
      use of the prebiotic oligofructose. Data from research on rodents shows that a high-fat diet
      enriched with oligofructose causes a decrease in energy intake, less weight gain and a lower
      level of triglycerides . A similar effect has been observed in healthy adults. Available
      evidence suggests that the addition of oligofructose to the diets of overweight or obese
      adults may increase satiety and thus reduce energy intake. Currently, there are no data on
      the effect of oligofructose in overweight and obese children.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: BMI z-score difference
time frame: after 12 weeks of the intervention
measure: BMI z-score difference
time frame: after 24 weeks of the intervention
measure: Percentage of weight reduction
time frame: after 12 weeks of the intervention
measure: Difference in total body fat measured by Dual-Energy X-ray Absorptiometry (DEXA)
time frame: after 12 weeks of the intervention
measure: Percentage of children with BMI-for-age > 85percentile
time frame: after 12 and 24 weeks of the intervention
measure: Mean BMI z-score
time frame: after 12 and 24 weeks of the intervention
measure: Self-reported energy intake (3-day diet record)
time frame: after 12 weeks of the intervention
measure: Percentage of the children with abnormal fasting glucose
time frame: after 12 weeks of the intervention
measure: Percentage of the children with dyslipidemias
time frame: after 12 weeks of the intervention
measure: Percentage of the children with hypertension
time frame: after 12 weeks of the intervention
measure: Adverse effects
time frame: during intervention
arm group label: Maltodextrin
arm group type: Placebo Comparator
arm group label: Oligofructose
arm group type: Experimental
description: Orafti P95, Beneo-Orafti, Belgium,
intervention type: Dietary Supplement
intervention name: Oligofructose
description: Dosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks
arm group label: Oligofructose
other name: Orafti P95, Beneo-Orafti, Belgium
intervention type: Dietary Supplement
intervention name: Maltodextrin
description: Dosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks
arm group label: Maltodextrin
criteria: 
gender: All
minimum age: 7 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Hanna Szajewska
investigator title: Professor
mesh term: Overweight
mesh term: Body Weight