Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01686919
Recruitment Status : Withdrawn
First Posted : September 18, 2012
Last Update Posted : January 21, 2015
Sponsor:
Collaborator:
Sykehuset Innlandet HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE September 13, 2012
First Posted Date  ICMJE September 18, 2012
Last Update Posted Date January 21, 2015
Study Start Date  ICMJE December 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2012)
weight loss [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01686919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2012)
  • Gastrointestinal symptoms [ Time Frame: 8 weeks ]
    Gastrointestinal symptom rating scale (GSRS-IBS) in validated Norwegian translation
  • IgG antigen against milk [ Time Frame: 8 weeks ]
    analysed at BMLab, Sandvika
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity
Official Title  ICMJE Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity, Morbid
Intervention  ICMJE Dietary Supplement: milk-free
milk-free diet during 8 preoperative weeks
Study Arms  ICMJE Experimental: milk-free
morbidly obese patients with irritable bowel syndrome (IBS) eligible for gastric bypass surgery
Intervention: Dietary Supplement: milk-free
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 20, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2012)
120
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • morbid obesity

Exclusion Criteria:

  • no consent
  • contraindications to surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Norway
 
Administrative Information
NCT Number  ICMJE NCT01686919
Other Study ID Numbers  ICMJE 2012/966
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE Sykehuset Innlandet HF
Investigators  ICMJE
Study Director: Per Farup, MD prof Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP