Confirmation of Diet as a Treatment for Gulf War Illness

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
American University
Study ID
NCT05675878
Phase
PHASE3
Status
Recruiting
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Conditions

  • Gulf War Illness
  • Gulf War Syndrome

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dietary Intervention — BEHAVIORAL
    This is a whole food, nutrient-dense diet that aims to remove exposure to specific food additives thought to have negative neurological effects, while also optimizing micronutrient intake.

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
Jul 2024
Primary completion
Aug 31, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dietary Intervention Group
    Subjects will undergo a 2-hour in-depth training via Zoom on how to follow the diet and will receive a binder with helpful information. They will be give the weekend to prepare and then will start the diet the following Monday, and will continue following it for 4 weeks before being reassessed in the lab.
  • No Intervention: Waitlisted Control Group
    The waitlisted control group will follow their usual diet for one month and then will be reassessed (as a comparator group) before being trained on the dietary intervention which they will then follow for the next month.

Primary Outcome Measure

Total Symptom Score [ Time Frame: 1-month ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
American UniversityWashington D.C.District of Columbia20016
Houra Taheri, PhD
[email protected]
Kathleen F Holton, PhD, MPH (PRINCIPAL_INVESTIGATOR)
Nova Southeastern UniversityFort LauderdaleFlorida33314
Oleksandra Shchebet
[email protected]
954-262-2896
Amanpreet Cheema, PhD (PRINCIPAL_INVESTIGATOR)
Boston UniversityBostonMassachusetts02118
Dylan Keating
[email protected]
617-358-2230
Camryn Isemann
[email protected]
617-358-1717
Kimberly Sullivan, PhD (PRINCIPAL_INVESTIGATOR)

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American University· Washington D.C., DCNova Southeastern University· Fort Lauderdale, FLBoston University· Boston, MA

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