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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Norwegian University of Science and Technology

Current Primary Outcome: weight loss [ Time Frame: 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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: Same as current

Information By: Norwegian University of Science and Technology

Dates:
Date Received: September 13, 2012
Date Started: December 2012
Date Completion:
Last Updated: January 20, 2015
Last Verified: January 2015