Effect of Diet on Gulf War Illness

January 30, 2018 updated by: Ashok Tuteja

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low FODMAP (modified healthy) Diet
Low FODMAP diet for 3 weeks. Veterans will be provided a diet containing foods low in FODMAP.
Behavioral: Low FODMAP Diet
Diet low in foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols
Experimental: High FODMAP (typical healthy) Diet
High FODMAP diet for 3 weeks. Veterans will be provided a typically healthy diet following US Dietary Guidelines, containing foods high in FODMAPs
Behavioral: High FODMAP Diet
Typical diet of foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported global Bowel Symptom Score
Time Frame: Baseline and 3 Weeks
Change in bowel symptom score after 3 weeks of treatment with a Low FODMAP diet or High FODMAP diet.
Baseline and 3 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported Irritable Bowel Syndrome Quality of Life (IBS-QOL) score
Time Frame: Baseline and 3 Weeks
Change in IBS-QOL score after 3 weeks of treatment with a Low FODMAP diet or High FODMAP diet.
Baseline and 3 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ashok Tuteja

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Ashok K Tuteja, M.D., George E. Wahlen VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00087668

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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