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

Plain Language Summary

Simplified for easier understanding

This study tests whether a specific dietary intervention can reduce symptoms of Gulf War Illness (GWI) — a poorly understood chronic condition affecting many veterans of the 1990-1991 Gulf War. Researchers believe that dietary changes affecting brain chemistry may help reduce fatigue, pain, and cognitive symptoms. You may be eligible if... - You are a Gulf War veteran aged 50 to 75 - You meet both the CDC and Kansas definitions of Gulf War Illness - Your medications and supplements have been stable for at least 1 month - You are willing to maintain stable medications throughout the study You may NOT be eligible if... - You have had a substance use disorder in the past year - You are unwilling to stop using alcohol, tobacco, vaping, or marijuana - You are unwilling to change your diet as part of the study - You have a diagnosed seizure disorder or severe asthma requiring hospitalization - You currently take medications affecting glutamate or GABA brain signaling (unless you can safely wean off with your doctor) Talk to your doctor about whether your Gulf War Illness meets the required criteria, your current medications, and whether dietary changes are medically safe for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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