Actively Recruiting
Confirmation of Diet as a Treatment for Gulf War Illness in Veterans
Led by American University · Updated on 2024-07-09
160
Participants Needed
3
Research Sites
17 weeks
Total Duration
On this page
Sponsors
A
American University
Lead Sponsor
B
Boston University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a dietary approach to treat Gulf War Illness (GWI) in veterans who served in the 1990-1991 Persian Gulf War. This trial aims to confirm earlier findings from a smaller study that showed significant improvements in symptoms such as pain, fatigue, depression, anxiety, PTSD, cognitive function, and quality of life after one month on a special diet. The study also seeks to understand how changes in the nervous system might explain these improvements and to identify blood markers that change with the diet. Participants will be randomly assigned to either the dietary intervention group or a waitlisted control group. Those in the intervention group will receive two hours of online training on following a whole-food, nutrient-dense diet designed to reduce exposure to food additives affecting the nervous system and improve nutrient intake. They will start the diet after a preparation weekend and follow it for four weeks before reassessment. The control group will continue their usual diet for one month, be reassessed, then receive the same training and follow the diet for the next month. During the study, participants will have baseline and one-month follow-up assessments including symptom scoring, cognitive tests, pain and fatigue measures, mental health questionnaires, and specialized scans. Researchers will monitor adherence, collect data on symptom changes, and evaluate quality of life. The study lasts about two months for each participant, including both diet and control periods, aiming to provide evidence for a safe, low-cost treatment option with no side effects for veterans with GWI.
CONDITIONS
Brief Title
Confirmation of Diet as a Treatment for Gulf War Illness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females of all races and ethnicities aged 50 to 75 years
- Served in the 1990-1991 Persian Gulf War
- Meet both CDC and Kansas definitions of Gulf War Illness
- Stable medication regimen for at least 1 month and willing to keep medications and supplements stable throughout study participation
You will not qualify if you...
- Recent substance use disorder within the past year
- Unwilling to stop using alcohol, tobacco (including vaping), or marijuana or unwilling to change diet
- Diagnosed seizure disorder or severe asthma requiring past hospitalization
- Currently taking medications affecting glutamatergic or GABAergic neurotransmission without ability to wean off before participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive a 2-hour in-depth training on how to follow a whole food, nutrient-dense diet designed to reduce exposure to specific food additives and optimize micronutrient intake. After preparation, participants follow the diet for 4 weeks before reassessment.
1 baseline training visit via Zoom and 1 follow-up visit in the lab after 4 weeks
Duration - 4 weeks
Participants in the waitlisted control group continue their usual diet for 1 month before reassessment and subsequent training on the dietary intervention.
1 follow-up visit after 1 month
Duration - 4 weeks
After the control period, waitlisted participants receive training on the diet and follow it for 4 weeks before reassessment.
1 training visit via Zoom and 1 follow-up visit after 4 weeks
Trial Site Locations
Total: 3 locations
1
American University
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
2
Nova Southeastern University
Fort Lauderdale, Florida, United States, 33314
Actively Recruiting
3
Boston University
Boston, Massachusetts, United States, 02118
Actively Recruiting
Research Team
H
Houra Taheri, PhD
K
Kathleen F Holton, PhD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here