Effect of Milk-free Diet on Weight and Irritable Bowel Sy... | NCT01686919

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

NCT01686919

Sponsor

Norwegian University of Science and Technology

Status

Withdrawn

Last Update Posted

Jan 21, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Obesity, Morbid

Interventions

milk-free

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Sep 13, 2012

First Submission Date that Met QC Criteria

Sep 13, 2012

First Posted Date

Sep 18, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2015

Last Update Posted Date

Jan 21, 2015Estimated

Name	Class
Sykehuset Innlandet HF	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
milk-free	Experimental	morbidly obese patients with irritable bowel syndrome (IBS) eligible for gastric bypass surgery	Dietary Supplement: milk-free

Interventions

Name	Type	Description	Arm Group Labels	Other Names
milk-free	Dietary Supplement	milk-free diet during 8 preoperative weeks	milk-free

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
weight loss		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Gastrointestinal symptoms	Gastrointestinal symptom rating scale (GSRS-IBS) in validated Norwegian translation	8 weeks
IgG antigen against milk	analysed at BMLab, Sandvika

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

morbid obesity

Exclusion Criteria:

no consent
contraindications to surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Per Farup, MD prof	Norwegian University of Science and Technology	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided