Confirmation of Diet as a Treatment for Gulf War Illness

StatusCompleted
PhasePhase 2/3
Started

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Record History

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  1. Phase changed: Phase 3 → Phase 2/3 Show 6 more changesShow less
    • Trial status changed: Unknown → Completed
    • Final enrollment: 111 participants (planned 160)
    • Primary completion date changed from estimate of Aug 31, 2025 to Dec 31, 2025
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 10 of 10 entries
    • Site details revised at 3 of 3 sites
  2. Changed Registry marked status Unknown; last known: Recruiting
  3. Trial status: Recruiting to Unknownv4
  4. Site contacts updated at 1 of 3 sitesv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Jan 10, 2023 to Mar 1, 2023
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05675878
Lead Sponsor American University
Collaborators: Boston University, Massachusetts General Hospital, Georgetown University, Nova Southeastern University
Conditions
(from sponsor)		 Gulf War Syndrome, Gulf War Illness
Related terms Persian Gulf Syndrome
Enrollment 111 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov