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

This study is currently recruiting participants.
Verified April 2013 by Norwegian University of Science and Technology
Sponsor:
Collaborator:
Sykehuset Innlandet HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01686919
First received: September 13, 2012
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Obesity, Morbid
 Dietary Supplement: milk-free

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • weight loss [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gastrointestinal symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Gastrointestinal symptom rating scale (GSRS-IBS) in validated Norwegian translation

  • IgG antigen against milk [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    analysed at BMLab, Sandvika


Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • morbid obesity

Exclusion Criteria:

  • no consent
  • contraindications to surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686919

Contacts
Contact: Per Farup, MD prof 004794818603 per.farup@sykehuset-innlandet.no

Locations
Norway
Sykehuset Innlandet HF Recruiting
Gjøvik, Norway
Contact: Ola Dahl, MD PhD     004762333020     olaedahl@gmail.com    
Sub-Investigator: Hestad Hestad, MD PhD            
Sub-Investigator: Jan O Aaseth, MD            
Sub-Investigator: Solveig Ligaarden            
Principal Investigator: Ola Dahl, MD PhD            
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
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01686919     History of Changes
Other Study ID Numbers: 2012/966
Study First Received: September 13, 2012
Last Updated: April 23, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on May 23, 2013