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Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity

Primary Purpose

Obesity, Morbid

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
milk-free
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring Gastric bypass, Questionnaires, Diet, Milk

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • morbid obesity

Exclusion Criteria:

  • no consent
  • contraindications to surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    milk-free

    Arm Description

    morbidly obese patients with irritable bowel syndrome (IBS) eligible for gastric bypass surgery

    Outcomes

    Primary Outcome Measures

    weight loss

    Secondary Outcome Measures

    Gastrointestinal symptoms
    Gastrointestinal symptom rating scale (GSRS-IBS) in validated Norwegian translation
    IgG antigen against milk
    analysed at BMLab, Sandvika

    Full Information

    First Posted
    September 13, 2012
    Last Updated
    January 20, 2015
    Sponsor
    Norwegian University of Science and Technology
    Collaborators
    Sykehuset Innlandet HF
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01686919
    Brief Title
    Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity
    Official Title
    Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    December 2012 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Norwegian University of Science and Technology
    Collaborators
    Sykehuset Innlandet HF

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Morbid
    Keywords
    Gastric bypass, Questionnaires, Diet, Milk

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    milk-free
    Arm Type
    Experimental
    Arm Description
    morbidly obese patients with irritable bowel syndrome (IBS) eligible for gastric bypass surgery
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    milk-free
    Intervention Description
    milk-free diet during 8 preoperative weeks
    Primary Outcome Measure Information:
    Title
    weight loss
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Gastrointestinal symptoms
    Description
    Gastrointestinal symptom rating scale (GSRS-IBS) in validated Norwegian translation
    Time Frame
    8 weeks
    Title
    IgG antigen against milk
    Description
    analysed at BMLab, Sandvika
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: morbid obesity Exclusion Criteria: no consent contraindications to surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Per Farup, MD prof
    Organizational Affiliation
    Norwegian University of Science and Technology
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity

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