RecruitingPhase 3NCT05675878

Confirmation of Diet as a Treatment for Gulf War Illness


Sponsor

American University

Enrollment

160 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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)

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Interventions

BEHAVIORALDietary Intervention

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.


Locations(3)

American University

Washington D.C., District of Columbia, United States

Nova Southeastern University

Fort Lauderdale, Florida, United States

Boston University

Boston, Massachusetts, United States

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NCT05675878


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