NCT05675878 · American University
Confirmation of Diet as a Treatment for Gulf War Illness
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
Total Symptom Score
Time frame: 1-month
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.
Patient Global Impression of Change Scale (PGIC)
Time frame: 1-month
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Washington D.C., District of Columbia
- Fort Lauderdale, Florida
- Boston, Massachusetts
Collaborators
Boston University, Massachusetts General Hospital, Georgetown University, Nova Southeastern University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2024 · Source of record for eligibility and locations