Confirmation of Diet as a Treatment for Gulf War Illness
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-75
SponsorAmerican University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Dietary Intervention
BehavioralThis 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Dietary Intervention GroupExperimental treatment 1 intervention
Group B: Waitlisted Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
1-month2
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.
Time frame
1-monthSecondary outcomes
1
McGill Pain Questionnaire
This pain measure inquires about types of pain sensation ranked on a scale of 0 to 3, with a total score from 0-45. Higher scores indicate worse pain.
Time frame
1-month2
Chalder Fatigue Score
The Chalder Fatigue Scale measures the extent and severity of fatigue. It is a scale with answers to each question based on both bimodal and likert scores, resulting in a total score of 0-11 and 0-33, with higher scores indicating more fatigue.
Time frame
1-month3
Veterans RAND 36 Item Health Survey (VR-36)
This is a 36-item survey used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations. The items on the questionnaire correspond to eight principal health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health. This results in physical and mental health component quality of life scores, each scored from 0-100, with higher scores indicating a better quality of life.
Time frame
1-month4
Brief Irritability Questionnaire (BITe)
This short questionnaire assesses anger and irritability with 5 questions ranked on a 6-point scale. Higher scores indicate more irritability.
Time frame
1-monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
American University
Lead sponsor
Boston University
Collaborator
Massachusetts General Hospital
Collaborator
Georgetown University
Collaborator
Nova Southeastern University
Collaborator
Source ClinicalTrials.gov