Recruiting
Phase 3

Diet

Sponsor:

American University

Code:

NCT05675878

Conditions

Gulf War Syndrome

Gulf War Illness

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Dietary Intervention

Study Details

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

Study ID

NCT05675878

Start date

Mar 1, 2023

Status verified date

Jul, 2024

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Aug 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

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.

Primary outcome measure

  • Total Symptom Score [ Time Frame: 1-month ]
  • Patient Global Impression of Change Scale (PGIC) [ Time Frame: 1-month ]

Central Contacts and Locations

Central contacts

Houra Taheri, PhD

202- 885-3810htaheri@american.edu

Kathleen F Holton, PhD, MPH

202-885-3797holton@american.edu

Locations

American University

Recruiting

Washington, District of Columbia, United States, 20016

Contacts

Houra Taheri, PhD

htaheri@american.edu

Principal Investigator:

Kathleen F Holton, PhD, MPH

Nova Southeastern University

Recruiting

Fort Lauderdale, Florida, United States, 33314

Contacts

Oleksandra Shchebet

954-262-2896oshchebe@nova.edu

Principal Investigator:

Amanpreet Cheema, PhD

Boston University

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Dylan Keating

617-358-2230dmk13@bu.edu

Camryn Isemann

617-358-1717camryns@bu.edu

Principal Investigator:

Kimberly Sullivan, PhD

More Information

Sponsor

American University

Last update posted

Jul 9, 2024

Last verified

Jul, 2024

Keywords

  • Gulf War Illness
  • GWI
  • Gulf War Syndrome
  • Diet
  • Treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by American University on 2024-07-09.