Clinical trial NCT05675878: Confirmation of Diet as a Treatment for Gulf War Illness
Official title: Confirmation of Diet as a Treatment for Gulf War Illness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gulf War Syndrome
Gulf War Illness
Keywords: Gulf War Illness
GWI
Gulf War Syndrome
Diet
Treatment
Lead sponsor: American University
Sponsor class: OTHER
Collaborators: name: Boston University
name: Massachusetts General Hospital
name: Georgetown University
name: Nova Southeastern University
First posted: 2023-01-09
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to either immediately start the intervention or to the wait-listed control group. The intervention group will be trained, and then will follow the diet for one month. The waitlisted controls will follow their normal diet for one month, and then will have the opportunity to be trained on the diet and follow the intervention for one month.
Primary purpose: TREATMENT

Brief 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.

Detailed description: The rationale for the proposed research comes from observations from a smaller study which demonstrated profound widespread symptom improvements in veterans with Gulf War Illness (GWI) after one month on the diet. Improvements were noted in every symptom domain and included significant reductions in overall symptom number (with an average of 9 symptoms going away), reduced pain, fatigue, depression, anxiety, and post-traumatic stress disorder (PTSD); and concurrent significant improvements in cognitive function and quality of life. Results also demonstrated that those who improved on the diet had a significant reduction in peripheral inflammation, as compared to those who did not improve on the diet. These benefits have been observed without any negative side effects and the majority of participants continued to follow the diet three months after study completion, suggesting continued improvement and good feasibility. The objectives of this study are: 1) to evaluate whether or not the substantial benefits observed in the recently completed clinical trial hold in a larger group of more diverse veterans with GWI, and 2) to identify blood and/or brain measures which predict improvement on the diet. By recruiting a large group of veterans which are representative of those with GWI, the findings of this research should be applicable to the larger GWI community. The impact of this research could be quite profound, with the diet being a no-risk, low-cost treatment option with no side effects, which allows each individual veteran to take back control of his/her health. There are no direct risks to following the diet since it is a healthy whole-food dietary approach which provides all necessary nutrients. The potential benefits of the diet include improvement in GWI symptoms; improvement in quality of life, potential for improvement in other health markers related to diet (such as obesity, diabetes, cardiovascular disease, high blood pressure) and the possibility of benefit to the larger community. If positive results are confirmed in the proposed study, then the next step would be to teach all Veterans Administration (VA) dietitians how to administer the low glutamate diet so that all veterans have access to it, which should be possible within 1-2 years of the completion of this study.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Total Symptom Score
timeFrame: 1-month
measure: Patient Global Impression of Change Scale (PGIC)
timeFrame: 1-month
Secondary outcomes:
measure: McGill Pain Questionnaire
timeFrame: 1-month
measure: Chalder Fatigue Score
timeFrame: 1-month
measure: Veterans RAND 36 Item Health Survey (VR-36)
timeFrame: 1-month
measure: Brief Irritability Questionnaire (BITe)
timeFrame: 1-month
measure: Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: 1-month
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: 1-month
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 1-month
measure: Cognitive Testing
timeFrame: 1-month
measure: Dolorimetry
timeFrame: 1-month
measure: Biophotonic scanner
timeFrame: 1-month
Other outcomes:
Locations:
city: Washington
country: United States
facility: American University
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University
state: Florida
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: American University
name: Kathleen F Holton, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: