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Recruitment Status : Withdrawn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

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.


Condition or disease Intervention/treatment Phase
Obesity, Morbid Dietary Supplement: milk-free Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity
Study Start Date : December 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arm Intervention/treatment
Experimental: milk-free
morbidly obese patients with irritable bowel syndrome (IBS) eligible for gastric bypass surgery
Dietary Supplement: milk-free
milk-free diet during 8 preoperative weeks



Primary Outcome Measures :
  1. weight loss [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Gastrointestinal symptoms [ Time Frame: 8 weeks ]
    Gastrointestinal symptom rating scale (GSRS-IBS) in validated Norwegian translation

  2. IgG antigen against milk [ Time Frame: 8 weeks ]
    analysed at BMLab, Sandvika



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • morbid obesity

Exclusion Criteria:

  • no consent
  • contraindications to surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686919


Sponsors and Collaborators
Norwegian University of Science and Technology
Sykehuset Innlandet HF
Investigators
Study Director: Per Farup, MD prof Norwegian University of Science and Technology

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01686919     History of Changes
Other Study ID Numbers: 2012/966
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by Norwegian University of Science and Technology:
Gastric bypass
Questionnaires
Diet
Milk

Additional relevant MeSH terms:
Obesity
Irritable Bowel Syndrome
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases