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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low FODMAP (modified healthy) Diet | Experimental | Low FODMAP diet for 3 weeks. Veterans will be provided a diet containing foods low in FODMAP. |
|
| High FODMAP (typical healthy) Diet | Experimental | High FODMAP diet for 3 weeks. Veterans will be provided a typically healthy diet following US Dietary Guidelines, containing foods high in FODMAPs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low FODMAP Diet | Behavioral | Diet low in foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 3 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 3 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaya Vijayan, MBBS | Contact | 801-582-1565 | 4019 | jaya.vijayan@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Ashok K Tuteja, M.D. | George E. Wahlen VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George E Wahlen VA Medical Center | Recruiting | Salt Lake City | Utah | 84132 | United States |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000092622 | FODMAP Diet |
| ID | Term |
|---|---|
| D000092724 | Elimination Diets |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
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| High FODMAP Diet | Behavioral | Typical diet of foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols |
|
| D004066 | Digestive System Diseases |
| D010829 | Physiological Phenomena |