NCT05675878 Confirmation of Diet as a Treatment for Gulf War Illness
| NCT ID | NCT05675878 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | American University |
| Condition | Gulf War Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 160 participants in total. It began in 2023-03-01 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical trial aims to confirm previous findings from a smaller study which demonstrated significant improvements in all symptoms among veterans with Gulf War Illness after one month on the dietary intervention. The main objectives of this study are: 1) to confirm previous findings of treatment response to the diet in a larger and more diverse group; 2) to examine how changes in the nervous system may be the reason for improvement; and 3) to identify markers which change in the blood after one month on the diet. Participants will have baseline measures collected and then will be randomized into the intervention or wait-listed control group, which they will follow for one month before being reassessed.
Eligibility Criteria
Inclusion Criteria: * Males and Females of all races and ethnicities who are ≤75 yrs of age * Served in the 1990-1991 Persian Gulf War * Fulfill both Center for Disease Control (CDC) and Kansas definitions of Gulf War Illness * Stable medication regimen for ≥1 month and willing to keep medications and supplements stable throughout study participation Exclusion Criteria: * Recent substance use disorder (past year) * Unwilling to stop using alcohol, tobacco (including vaping) and/or marijuana; or unwilling to change diet * Diagnosed seizure disorder or severe asthma requiring past hospitalization * Currently taking medication which affects glutamatergic or GABAergic neurotransmission (but can work with their physician to wean off of these medications prior to participating)
Contact & Investigator
Kathleen F Holton, PhD, MPH
PRINCIPAL INVESTIGATOR
American University
Frequently Asked Questions
Who can join the NCT05675878 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 75 Years, studying Gulf War Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05675878 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 160 participants.
Is NCT05675878 currently recruiting?
Yes, NCT05675878 is actively recruiting participants. Contact the research team at htaheri@american.edu for enrollment information.
Where is the NCT05675878 trial being conducted?
This trial is being conducted at Washington D.C., United States, Fort Lauderdale, United States, Boston, United States.
Who is sponsoring the NCT05675878 clinical trial?
NCT05675878 is sponsored by American University. The principal investigator is Kathleen F Holton, PhD, MPH at American University. The trial plans to enroll 160 participants.