<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/NCT01686919</url>
  </required_header>
  <id_info>
    <org_study_id>2012/966</org_study_id>
    <nct_id>NCT01686919</nct_id>
  </id_info>
  <brief_title>Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity</brief_title>
  <official_title>Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sykehuset Innlandet HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Innlandet Hospital in Gjøvik is a center for patients suffering from morbid obesity in&#xD;
      Hedmark og Oppland, Norway. Patients with either BMI &gt; 40 kg/m2 or with BMI &gt; 35 kg/m2 and&#xD;
      complications who opt for &quot;gastric bypass&quot; surgery, go through a standard program including a&#xD;
      thorough clinical examination and information on the operation, followed by a learning and&#xD;
      coping program that consists of standard dietary advise for weight loss and includes weekly&#xD;
      visits during 8 weeks.&#xD;
&#xD;
      This research project concerns a subgroup in the patient population described above: morbidly&#xD;
      obese patients with irritable bowel syndrome (IBS). In this group it will be investigated how&#xD;
      an 8 week preoperative milk-free diet affects digestive functions and weight loss. It is&#xD;
      known that milk may cause stomach complaints and may make it more difficult to loose weight.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">December 2014</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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>weight loss</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptoms</measure>
    <time_frame>8 weeks</time_frame>
    <description>Gastrointestinal symptom rating scale (GSRS-IBS) in validated Norwegian translation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IgG antigen against milk</measure>
    <time_frame>8 weeks</time_frame>
    <description>analysed at BMLab, Sandvika</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Obesity, Morbid</condition>
  <arm_group>
    <arm_group_label>milk-free</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>morbidly obese patients with irritable bowel syndrome (IBS) eligible for gastric bypass surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>milk-free</intervention_name>
    <description>milk-free diet during 8 preoperative weeks</description>
    <arm_group_label>milk-free</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  morbid obesity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no consent&#xD;
&#xD;
          -  contraindications to surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Per Farup, MD prof</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <removed_countries>
    <country>Norway</country>
  </removed_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>January 20, 2015</last_update_submitted>
  <last_update_submitted_qc>January 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastric bypass</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Diet</keyword>
  <keyword>Milk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Morbid</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/NCT01686919
org study id: 2012/966
nct id: NCT01686919
lead sponsor: 
collaborator: 
has dmc: No
Innlandet Hospital in Gjøvik is a center for patients suffering from morbid obesity in
      Hedmark og Oppland, Norway. Patients with either BMI > 40 kg/m2 or with BMI > 35 kg/m2 and
      complications who opt for "gastric bypass" surgery, go through a standard program including a
      thorough clinical examination and information on the operation, followed by a learning and
      coping program that consists of standard dietary advise for weight loss and includes weekly
      visits during 8 weeks.

      This research project concerns a subgroup in the patient population described above: morbidly
      obese patients with irritable bowel syndrome (IBS). In this group it will be investigated how
      an 8 week preoperative milk-free diet affects digestive functions and weight loss. It is
      known that milk may cause stomach complaints and may make it more difficult to loose weight.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: weight loss
time frame: 8 weeks
measure: Gastrointestinal symptoms
time frame: 8 weeks
description: Gastrointestinal symptom rating scale (GSRS-IBS) in validated Norwegian translation
measure: IgG antigen against milk
time frame: 8 weeks
description: analysed at BMLab, Sandvika
arm group label: milk-free
arm group type: Experimental
description: morbidly obese patients with irritable bowel syndrome (IBS) eligible for gastric bypass surgery
intervention type: Dietary Supplement
intervention name: milk-free
description: milk-free diet during 8 preoperative weeks
arm group label: milk-free
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Per Farup, MD prof
role: Study Director
affiliation: Norwegian University of Science and Technology
country: Norway
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
mesh term: Obesity
mesh term: Obesity, Morbid