Confirmation of Diet as a Treatment for Gulf War Illness

NCT ID: NCT05675878

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-12-30

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.

Conditions

Gulf War Syndrome; Gulf War Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dietary Intervention Group

Subjects will undergo a 2-hour in-depth training via Zoom on how to follow the diet and will receive a binder with helpful information. They will be give the weekend to prepare and then will start the diet the following Monday, and will continue following it for 4 weeks before being reassessed in the lab.

Group Type: EXPERIMENTAL

Dietary Intervention

Intervention Type: BEHAVIORAL

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.

Waitlisted Control Group

The waitlisted control group will follow their usual diet for one month and then will be reassessed (as a comparator group) before being trained on the dietary intervention which they will then follow for the next month.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dietary 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: collaborator

Nova Southeastern University

OTHER

Sponsor Role: collaborator

American University

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Holton

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen F Holton, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

American University

Locations

American University

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

Site Status: RECRUITING

Nova Southeastern University

Fort Lauderdale, Florida, United States

Site Status: RECRUITING

Boston University

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Houra Taheri, PhD

Role: CONTACT

htaheri@american.edu

202- 885-3810

Kathleen F Holton, PhD, MPH

Role: CONTACT

holton@american.edu

202-885-3797

Facility Contacts

Houra Taheri, PhD

Role: primary

htaheri@american.edu

Oleksandra Shchebet

Role: primary

oshchebe@nova.edu

954-262-2896

Dylan Keating

Role: primary

dmk13@bu.edu

617-358-2230

Camryn Isemann

Role: backup

camryns@bu.edu

617-358-1717

Other Identifiers

CDMRP-GW210080

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023-46

Identifier Type: -

Identifier Source: org_study_id