- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02881944
Effect of Diet on Gulf War Illness
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
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jaya Vijayan, MBBS
- Phone Number: 4019 801-582-1565
- Email: jaya.vijayan@va.gov
Study Locations
-
-
Utah
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Salt Lake City, Utah, United States, 84132
- Recruiting
- George E Wahlen VA Medical Center
-
Contact:
- Ashok K Tuteja, MD, MPH
- Phone Number: 4019 801-582-1565
- Email: ashok.tuteja@va.gov
-
Contact:
- Jaya Vijayan
- Phone Number: 801-581-7802
- Email: jaya.vijayan@hsc.utah.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Ashok K Tuteja, M.D., George E. Wahlen VA Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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