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

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01686919
• Other study ID #: 2012/966
• Status: Withdrawn
• Phase: N/A
• First received: September 13, 2012
• Last updated: January 20, 2015
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• morbid obesity

Exclusion Criteria:

• no consent

• contraindications to surgery

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Obesity
• Obesity, Morbid

Intervention

Dietary Supplement:
• milk-free
milk-free diet during 8 preoperative weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Sykehuset Innlandet HF

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss		8 weeks	No
Secondary	Gastrointestinal symptoms	Gastrointestinal symptom rating scale (GSRS-IBS) in validated Norwegian translation	8 weeks	No
Secondary	IgG antigen against milk	analysed at BMLab, Sandvika	8 weeks	No