Confirmation of Diet as a Treatment for Gulf War Illness

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-75
SponsorAmerican University

About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Dietary Intervention

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

American University

Lead sponsor

Boston University

Collaborator

Massachusetts General Hospital

Collaborator

Georgetown University

Collaborator

Nova Southeastern University

Collaborator