Confirmation of Diet as a Treatment for Gulf War Illness

NCT05675878 | Recruiting Phase 3

• 2 other identifiers: 2023-46CDMRP-GW210080
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

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.

Conditions

Gulf War Syndrome; Gulf War Illness

Keywords

Gulf War Illness; GWI; Gulf War Syndrome; Diet; Treatment

Outcome Measures

Primary Outcomes (2)

• Total Symptom Score

  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.

  1-month

• Patient Global Impression of Change Scale (PGIC)

  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.

  1-month

Secondary Outcomes (10)

• McGill Pain Questionnaire

  1-month

• Chalder Fatigue Score

  1-month

• Veterans RAND 36 Item Health Survey (VR-36)

  1-month

• Brief Irritability Questionnaire (BITe)

  1-month

• Center for Epidemiological Studies Depression Scale (CES-D)

  1-month

Study Arms (2)

Dietary Intervention Group

EXPERIMENTAL

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.

Behavioral: Dietary Intervention

Waitlisted Control Group

NO INTERVENTION

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.

Interventions

Dietary Intervention 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.

Dietary Intervention Group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• American University: lead
• Boston University: collaborator
• Massachusetts General Hospital: collaborator
• Georgetown University: collaborator
• Nova Southeastern University: collaborator

Study Sites (3)

American University

Washington D.C., District of Columbia, 20016, United States

RECRUITING

Nova Southeastern University

Fort Lauderdale, Florida, 33314, United States

RECRUITING

Boston University

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Persian Gulf Syndrome

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Kathleen F Holton, PhD, MPH

  American University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Houra Taheri, PhD

CONTACT

202- 885-3810; htaheri@american.edu

Kathleen F Holton, PhD, MPH

CONTACT

202-885-3797; holton@american.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 9, 2023
• Study Start: March 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 30, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

US (3)