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| Name | Class |
|---|---|
| University of Arizona | OTHER |
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Objective: Randomized, double blind, placebo-controlled, crossover, clinical trial to examine the effects of the food additive glutamate (in the form of MSG) on IBS and fibromyalgia.
Setting and Subjects: The Fibromyalgia Research Database at OHSU will be utilized to identify and recruit fibromyalgia patients who also have IBS to OHSU study centers.
Intervention: Approximately 60 male and female subjects aged 18-75 will be placed on a 1-month glutamate-free elimination diet. Those that respond positively to the diet (we are estimating 30-40 subjects), will then be randomized to receive either a citrus drink containing 5 grams of MSG; or placebo (the citrus drink alone)on three consecutive days one week apart.
The investigators are hypothesizing that those who react positively to the elimination diet will have symptom occurrence statistically more frequently when given the glutamate challenge, than when given placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - Glutamate challenge | Active Comparator | Glutamate challenge: After the one month glutamate free diet, subjects will receive 5 grams of glutamate for three days on one week and placebo for three days on the next week. Arm 1 is the 5 grams of glutamate which will be given in a mixed juice. |
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| 2- Placebo | Placebo Comparator | Glutamate challenge: After the one month glutamate free diet, subjects will receive 5 grams of glutamate for three days on one week and placebo for three days on the next week. Arm 2 is the placebo arm, which will be juice with nothing added. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutamate additive-free diet | Other | All subjects will follow a diet for one month where all foods containing the additive glutamate have been removed. At the end of the one month diet, subjects who have responded positively to the diet will go onto the challenge arms of the study, where they will be randomized to receive placebo (mixed juice alone) for three days on one week, and 5 grams of glutamate in the mixed juice for three days on the other week. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the number of patients who have a positive response to a one month glutamate free diet, as measured by the Perception of Global Impression of Change (PGIC) scores | 4 weeks | |
| To assess whether symptoms return with MSG challenge statistically more frequently than with placebo as measured by symptom scores. | 6 weeks, 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement on Irritable Bowel Syndrome-Quality of Life (IBS-QOL) questionnaire | 4 weeks, 7 weeks | |
| Improvement in day-to-day functioning based on the Revised Fibromyalgia Impact Questionnaire | 4 weeks, 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Taren, PhD | University of Arizona | Study Chair |
| Kathleen F Holton, MPH, PhDc | University of Arizona and Oregon Health & Science Univ. | Principal Investigator |
| Kimberly D Jones, PhD | Oregon Health and Science University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97238 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22766026 | Result | Holton KF, Taren DL, Thomson CA, Bennett RM, Jones KD. The effect of dietary glutamate on fibromyalgia and irritable bowel symptoms. Clin Exp Rheumatol. 2012 Nov-Dec;30(6 Suppl 74):10-7. Epub 2012 Dec 14. |
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| Placebo diet | Other | Juice with nothing added. |
|
| A reduction in pain based on two visual analog scales, one for gut pain, and another for musculo-skeletal pain | 4 weeks, 7 weeks |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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