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Effect of Diet on Gulf War Illness

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low FODMAP Diet
High FODMAP Diet
Sponsored by
Ashok Tuteja
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Gulf War Illness, Diet, IBS, FODMAP

Eligibility Criteria

25 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Gulf War Veterans
  • Men and women age 25-90 years
  • Gulf War Illness: Veterans will have Rome III criteria for IBS and two or more of the non-intestinal symptom groups (chronic-once a week or more often-fatigue, insomnia, joint pains, general stiffness, and headache, neurological an mood, respirator and skin symptoms)
  • Symptoms of > 6 months duration
  • No significant findings on physical examination, complete blood count and clinical chemistry panel
  • Normal gross appearance of the colonic mucosa (small colon polyps not an exclusion criteria)
  • Veterans with psychological disorders will not be excluded but will be identified for sub-group analysis.

Exclusion Criteria:

  • Current evidence of any lower gastrointestinal disorder such as celiac disease or inflammatory bowel disease
  • Clinically significant chronic disease: HIV, cardiac, pulmonary, hepatic or renal dysfunction
  • Presence of Giardia antigen, and Clostridium difficile toxin in stool
  • Current history of drug or alcohol abuse
  • Investigator perception of patient's inability to comply with study protocol
  • Recent change in gastrointestinal medications
  • Subject is currently participating in another research protocol. These subjects will be allowed to enroll after a washout period of one month.

Sites / Locations

  • George E Wahlen VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low FODMAP (modified healthy) Diet

High FODMAP (typical healthy) Diet

Arm Description

Low FODMAP diet for 3 weeks. Veterans will be provided a diet containing foods low in FODMAP.

High FODMAP diet for 3 weeks. Veterans will be provided a typically healthy diet following US Dietary Guidelines, containing foods high in FODMAPs

Outcomes

Primary Outcome Measures

Change in self-reported global Bowel Symptom Score
Change in bowel symptom score after 3 weeks of treatment with a Low FODMAP diet or High FODMAP diet.

Secondary Outcome Measures

Change in self-reported Irritable Bowel Syndrome Quality of Life (IBS-QOL) score
Change in IBS-QOL score after 3 weeks of treatment with a Low FODMAP diet or High FODMAP diet.

Full Information

First Posted
August 24, 2016
Last Updated
January 30, 2018
Sponsor
Ashok Tuteja
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT02881944
Brief Title
Effect of Diet on Gulf War Illness
Official Title
Effect of Diet on Gulf War Illness
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ashok Tuteja
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Fermentable Oligo-, Di and Mono-saccharides And Polyols (FODMAPs) are carbohydrates that are poorly digested in intestines. The undigested carbohydrates are fermented in the colon by gut bacteria. Fermentation of these carbohydrates can lead to diarrhea, gas and distension of the colon. Low FODMAP diet effect may be mediated by changing the gut bacteria and/or by production of chemicals that influence Veteran's intestines which then result in reduced disease symptoms. The goal of this study is to compare a low FODMAP (modified healthy) diet to a high FODMAP (typical healthy) diet for effect on Veterans with IBS and symptoms of Gulf War illness.
Detailed Description
Study Design This will be a prospective, blinded randomized clinical trial with two parallel groups. There will be 1-week screening period, 3-week diet treatment and, follow-up one month later while Veterans choose their own diet. Veterans who were deployed and served in Operation Desert Storm and Desert Shield will be recruited to participate. The two study diets to be provided to the Veterans and compared are: Low FODMAP (modified healthy) diet: High FODMAP (typical healthy) diet: The FODMAP content of this diet will be higher than low FODMAP diet. All questionnaires will be answered and measurements performed at baseline, end of treatment and at follow-up visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Gulf War Illness, Diet, IBS, FODMAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low FODMAP (modified healthy) Diet
Arm Type
Experimental
Arm Description
Low FODMAP diet for 3 weeks. Veterans will be provided a diet containing foods low in FODMAP.
Arm Title
High FODMAP (typical healthy) Diet
Arm Type
Experimental
Arm Description
High FODMAP diet for 3 weeks. Veterans will be provided a typically healthy diet following US Dietary Guidelines, containing foods high in FODMAPs
Intervention Type
Behavioral
Intervention Name(s)
Low FODMAP Diet
Intervention Description
Diet low in foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols
Intervention Type
Behavioral
Intervention Name(s)
High FODMAP Diet
Intervention Description
Typical diet of foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols
Primary Outcome Measure Information:
Title
Change in self-reported global Bowel Symptom Score
Description
Change in bowel symptom score after 3 weeks of treatment with a Low FODMAP diet or High FODMAP diet.
Time Frame
Baseline and 3 Weeks
Secondary Outcome Measure Information:
Title
Change in self-reported Irritable Bowel Syndrome Quality of Life (IBS-QOL) score
Description
Change in IBS-QOL score after 3 weeks of treatment with a Low FODMAP diet or High FODMAP diet.
Time Frame
Baseline and 3 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gulf War Veterans Men and women age 25-90 years Gulf War Illness: Veterans will have Rome III criteria for IBS and two or more of the non-intestinal symptom groups (chronic-once a week or more often-fatigue, insomnia, joint pains, general stiffness, and headache, neurological an mood, respirator and skin symptoms) Symptoms of > 6 months duration No significant findings on physical examination, complete blood count and clinical chemistry panel Normal gross appearance of the colonic mucosa (small colon polyps not an exclusion criteria) Veterans with psychological disorders will not be excluded but will be identified for sub-group analysis. Exclusion Criteria: Current evidence of any lower gastrointestinal disorder such as celiac disease or inflammatory bowel disease Clinically significant chronic disease: HIV, cardiac, pulmonary, hepatic or renal dysfunction Presence of Giardia antigen, and Clostridium difficile toxin in stool Current history of drug or alcohol abuse Investigator perception of patient's inability to comply with study protocol Recent change in gastrointestinal medications Subject is currently participating in another research protocol. These subjects will be allowed to enroll after a washout period of one month.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaya Vijayan, MBBS
Phone
801-582-1565
Ext
4019
Email
jaya.vijayan@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashok K Tuteja, M.D.
Organizational Affiliation
George E. Wahlen VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
George E Wahlen VA Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashok K Tuteja, MD, MPH
Phone
801-582-1565
Ext
4019
Email
ashok.tuteja@va.gov
First Name & Middle Initial & Last Name & Degree
Jaya Vijayan
Phone
801-581-7802
Email
jaya.vijayan@hsc.utah.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Diet on Gulf War Illness

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