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Dietary Intervention for Gulf War Illness

This study is testing a special diet, called a Dietary Intervention, as a treatment for Gulf War Illness (GWI). This diet focuses on whole, nutrient-rich foods and avoids certain food additives that might affect the brain. The goal is to see if this diet can improve symptoms like pain, fatigue, and memory problems in a larger group of veterans with GWI, building on promising results from a smaller study. Researchers also want to understand how the diet might affect the nervous system and identify changes in the blood. You may be able to join if you are 50 to 75 years old, served in the 1990-1991 Persian Gulf War, and meet specific definitions for GWI. The study will measure how much your symptoms improve and your overall feeling of change after one month on the diet. The study status is currently unclear.

Study design
This is an interventional study planning to enroll 160 participants. Participants will be randomized into either the dietary intervention group or a wait-listed control group.
What's involved
Participants will have baseline measurements taken, follow their assigned group for one month, and then be reassessed.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at one month after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05675878

Confirmation of Diet as a Treatment for Gulf War Illness

UNKNOWN
PHASE3Ages 50–75InterventionalTreatment
American University
~160 participants
Updated 2024-07-09 on ClinicalTrials.gov
What's tested:Dietary Intervention

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total Symptom Score
Measured over 1-month
+1 more outcome measured

Conditions

Gulf War Syndrome
Gulf War Illness

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Gulf war syndrome

NCT05675878

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • American University

    Washington D.C., District of Columbiastudy coordinator listed

    Recruiting

  • Boston University

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Nova Southeastern University

    Fort Lauderdale, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kathleen F Holton, PhD, MPH · PRINCIPAL_INVESTIGATOR · American University

Who to contact

Houra Taheri, PhD
[email protected]
202- 885-3810
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Total Symptom Score1-month

    This measure computes the number of symptoms being experienced in this widespread chronic pain condition, and also computes a score based on severity of each symptom. The raw symptom score ranges from 0-32, and the symptom severity score ranges from 0-96, with higher scores indicative of worse outcomes.

  • Patient Global Impression of Change Scale (PGIC)1-month

    The PGIC is a self-report measure of the amount of change experienced from the treatment using a 7-point scale with the following options: very much worse, much worse, a little worse, no change, a little better, much better, very much better.