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NCT03342482 · ClinicalTrials.gov registry record · NA
Glutamate Neuro-Excitotoxicity in GWI
A NA study, sponsored by American University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT03342482 is a NA study that has completed, run by American University. The registered enrollment target is 40 participants.
The verdict
NCT03342482, a NA study, has completed, sponsored by American University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
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 ill
Interventions
- OTHER Low-glutamate diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-11-14 |
| Est. Completion | 2020-08-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03342482
The ClinicalTrials.gov registry entry for NCT03342482 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is American University, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Low-glutamate diet is the first listed.
NCT03342482 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03342482 about?
NCT03342482 is a clinical study titled "Glutamate Neuro-Excitotoxicity in GWI". 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 d...
What is the current status of trial NCT03342482?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2017-11-14. Estimated completion is 2020-08-31.
What interventions are being tested in trial NCT03342482?
The interventions under investigation include: Low-glutamate diet (OTHER).
Who is sponsoring clinical trial NCT03342482?
This trial is sponsored by American University, which has 16 total clinical trials registered on ClinicalTrials.gov.
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