An interventional study of Low-glutamate diet in Gulf War Syndrome, sponsored by American University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-01-12.
Sponsored by American University · Not applicable, Interventional, and Treatment
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Among 41 studies in Persian Gulf Syndrome with a site in United States — 9 open to participants now, 9 under way, 1 of them phase 3. Persian Gulf Syndrome · United States.
Among the 41 studies in Persian Gulf Syndrome with a site in United States, this one is the 18th largest by enrollment of the 31 interventional ones that give a count, is one of 2 that started in 2017, is one of 15 with no phase, and was the 24th registered.
41 studies on the registry are indexed under Persian Gulf Syndrome; 9 are open to participants now.
Browse Persian Gulf Syndrome studies →9 of the 41 studies in Persian Gulf Syndrome with a site in United States are open now. Recruiting first, the newest first:
Emory University · Sites in United States
Ages 40–80
Baylor College of Medicine · Sites in United States
Ages 50–70
VA Office of Research and Development · Sites in United States
Ages 50–85
University of California, San Diego · Sites in United States
Ages 50+
Baylor College of Medicine · Sites in United States
Ages 18–64
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 8 Persian Gulf Syndrome studies recruiting now, 2 set no upper age limit and 4 stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 8 · Phase 3 5
First in 1999; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 40 is below the median of 54 across 30 interventional studies indexed under Persian Gulf Syndrome.
Median enrollment 53 across the 31 interventional studies, 50 across the 7 observational. Of the 27 that completed or were terminated, 10 (37%) have results posted.
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1 of 41 have an industry lead sponsor. The 10 most frequent:
American University is the lead sponsor of 20 studies on the registry; 4 are open to participants now.
American University has 2 studies filed under Persian Gulf Syndrome — fewer than ten, so there is no comparison to draw.
3 of the studies in Persian Gulf Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05355272Baylor College of MedicineGrowth Hormone Replacement in Veterans With GWI and AGHD (GWIT) | 2026-12 |
| NCT05820893VA Office of Research and DevelopmentResistant Potato Starch to Alleviate GWI | 2027-06-30 |
| NCT07266571University of Alabama at BirminghamPycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness | 2027-11-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 41 studies in Persian Gulf Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The objective of the proposed research is to examine whether dietary exposure to food additives containing glutamate may be contributing to symptoms in Gulf War Illness (GWI). The rationale for proposed study comes from data in the fibromyalgia field which suggests that reducing the consumption of dietary glutamate can reduce over-excitation in the nervous system, leading to symptom improvement. In prior research, a low-glutamate diet (restricting food additive consumption) was tested in fibromyalgia patients. After one-month on the diet, 84% of patients had >30% of their symptoms go away (with 11 symptoms remitting on average), and 8 subjects had complete remission of all symptoms. Subjects then had a significant return of symptoms upon challenge with monosodium glutamate (MSG) as compared to placebo. Since there is almost complete symptom overlap between fibromyalgia and GWI, it is of utmost importance to test this diet as a low-cost treatment option in GWI patients.
The findings from this research will ultimately be applicable to all GWI patients and potentially to other veterans with a similar symptom profile as well. The ultimate impact of this research could be quite profound, as it has the potential to impact all of the symptoms of GWI, as opposed to being a proposed treatment for only one of the symptoms. This dietary treatment has been shown to dramatically affect symptoms like fatigue, cognitive dysfunction, and pain; and thus, has the potential to dramatically improve quality of life for these individuals. Potential benefits of the treatment are great, and risks are minimal, as the treatment involves shifting the diet to a healthier, whole-food approach.
First, the study will confirm or negate the idea that abnormal glutamate signaling in the nervous system could be causing symptoms in GWI. Second, if found to be successful, then this will provide a low-cost, easy-to-implement treatment option for the many veterans suffering from this multi-symptom illness. Third, this research could lead to future studies to identify potential causes of this abnormal neurotransmission, to help prevent future illness onset.
Objective/ Hypothesis: The objective of this clinical trial is to test the effectiveness of a low-glutamate diet in GWI patients, as a way to mediate symptom occurrence by reducing excess glutamatergic neurotransmission.
Specific Aims:
Aim 1- Determine if GWI is a glutamate neurotoxicity disorder, by testing whether reduced exposure to dietary glutamate can modulate symptoms. Hypothesis: Dietary glutamate restriction will significantly reduce GWI symptoms, including fatigue, cognitive dysfunction, pain, problems sleeping, headache/migraine, and diarrhea; as measured by symptom questionnaire, dolorimetery, computerized cognitive testing, EEG and fMRI memory testing. Additionally, brain glutamate levels will be reduced after one month on the diet, as measured by magnetic resonance spectroscopy (MRS).
Aim 2- Confirm that altered dietary glutamate exposure was the cause of symptom improvement.
Hypothesis: Challenge with MSG, as compared to placebo, in a randomized, double-blind, placebo-controlled crossover challenge, will significantly increase the occurrence of symptoms, cause increased pain sensitivity as measured by dolorimetry, increased excitatory neurotransmission as measured by EEG, and a worsening of cognitive function as measured by computerized cognitive testing.
Study Design: 40 subjects will be recruited from around the US . After phone screening, eligible individuals will travel to Washington DC for their first visit, where subjects will undergo baseline testing, including assessment of symptoms, cognition, brain glutamate levels and working memory testing using fMRI. For phase 1, subjects will be randomized to a low-glutamate diet (n=20) or a waitlisted group (n=20 as controls), and symptom occurrence will be compared after one month. Waitlisted participants will follow the low-glutamate diet over the following month. At the end of phase 1, subjects will return to DC, will undergo post-diet assessment of symptoms (same as baseline), and then will move onto Phase 2 of the study, a randomized, double-blind, placebo-controlled crossover challenge, to test whether symptoms recur upon challenge with MSG and not with placebo. Subjects will be randomized as to which contingency (MSG or placebo) is received first, and will receive MSG for 3 consecutive days on one of the weeks and placebo for 3 consecutive days on the other week. Symptoms, EEG and cognition will be assessed on day 3 of challenges each week. All subjects will still be following the low-glutamate diet during the challenge period, so their only exposure to glutamate will be from the week they receive the MSG.
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Exclusion Criteria:
5 g of placebo (sugar and salt) will be administered in veggie capsules
Other: Low-glutamate diet
5 grams of MSG will be administered in veggie capsules
Other: Low-glutamate diet
The dietary intervention consists of a one-month low-glutamate diet, followed by a randomized crossover challenge with MSG and placebo to measure return of symptoms.
Symptom Score Change
The number and type of symptoms will be assessed with a symptom score measure
Time frame: Baseline, 1 month, 5th week, 6th week
Cognitive Function
A computerized cognitive battery will measure cognitive function
Time frame: Baseline, 1 month, 5th week, 6th week
Change in EEG
Electroencephalography will be used to measure brain excitation
Time frame: Baseline, 1 month, 5th week, 6th week
Change in Brain Glutamate Levels
Brain glutamate levels will be measured using magnetic resonsnance psectroscopy
Time frame: Baseline, 1-month
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Jul 2020, 31 months.
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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American University