Gulf War SyndromeNCT05736146
Validating Gulf War Illness Blood Biomarkers
An observational study of Gulf War Syndrome and Gulf War Illness, run by Roskamp Institute Inc. at 3 sites in United States.
Trial summary
The investigators goals are to identify blood lipids/metabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI. To determine the effect of dietary, medical and biological factors that influence lipid and metabolites in blood from GW veterans. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gulf War Syndrome, Gulf War Illness
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jun 2022to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Veterans who served in the Gulf War during 1990 to 1991.
Who may be able to join
- Age 35 years or older.
- For GWI cases, served in the 1990-1991 Gulf War as active duty, national guard, or reserves and meet criteria for the CDC Chronic Multisymptom Illness (CMI) GWI definition or Kansas GWI definition.
- For controls, must be a veteran in the same age range as those veterans with GWI as defined above.
- Ability to understand written and spoken English or availability of a legal representative who can understand written or spoken English. Participants and caregiver/informants must be able to read, write and speak the language in which psychometric tests are provided with visual and auditory acuity (corrected) sufficient to allow for accurate testing.
Who cannot join
- Diagnosed or being treated by a physician for any of the following (Steele et al, 2000) and deemed clinically significant per the discretion of the PI:
- Cancer (except for non-melanoma skin cancers)
- Chronic infectious disease
- Problems resulting from postwar injuries.
- Liver disease
- Lupus
Show all 12Show fewer
- Multiple sclerosis
- Stroke
- Serious psychiatric condition (those associated with psychosis and/or for which the respondent had been hospitalized since 1991).
- Dementia or any type of Parkinson's disease (PD).
- Hospitalized in the last 5 years for alcohol or drug dependence, depression, or post-traumatic stress disorder (PTSD).
- Female subject is either pregnant or nursing.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Boston University
Boston, Massachusetts, 02118
Leah Orlinsky, 617-358-2214, bbrain@bu.edu
Kim Sullivan, Ph.D
- Recruiting
Palto Alto Veterans Institute for Research
Palo Alto, California, 94304
Raj Brar, 650-374-9073, RBrar@pavir.org
Maheen Adamson, Ph.D
- Recruiting
The Roskamp Institute
Sarasota, Florida, 34232
Dakota M Helgager, B.S., 941-256-8019 ext. 3008, dhelgager@roskampclinic.org
Laila Abdullah, Ph.D
About this study
Official title: Validating Blood Biomarkers of Brain Immune and Metabolic Dysfunction in Gulf War Illness
The investigators goals are to identify blood lipids/metabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI. To determine the effect of dietary, medical and biological factors that influence lipid and metabolites in blood from GW veterans. To identify blood lipid/metabolite profiles that correlate with bioenergetics deficits and glial activation in the brains of GWI. To validate blood biomarker signatures of GWI using APOE genotyping and blood lipids/metabolites that correlate with the CNS dysfunction in GWI.
Read the detailed description
Nearly 30 years later, veterans with Gulf War Illness (GWI) continue to suffer from this persistent and debilitating illness, which remains difficult to diagnose due to the heterogeneity of clinical presentation and the complexity of biological responses to hazardous chemicals to which GW veterans were exposed during the 1990-1991 Gulf War (GW). Brain imaging studies of veterans with GWI and pre-clinical animal studies of rodents with GWI show that impaired bioenergetics and inflammation can be attributed to the atrophy of the axonal white matter tracts that link the cortical gray matter regions, and the alterations of lipid/metabolite levels. The investigators recent work shows that disturbed lipid profiles in the brain and blood after GW pesticide exposure in rodents accompany neurobehavioral and bioenergetics deficits and inflammation. The mechanisms of neurotoxicity after pesticide exposure include increases in the inactivation of lipid metabolizing enzymes. This may consequently result in accumulation of lipids in the body compartments that limit their availability for use as energy substrates, contributing to bioenergetic impairments and inflammation. These metabolic changes have also been linked to individuals who possess the apolipoprotein E (APOE) ε4 allele, a risk factor of aging related cognitive decline and neurodegenerative conditions, such as Alzheimer's disease (AD). Several studies have shown a correlation between lipid transport deficits and presence of the ε4 allele. The identification of specific lipids/metabolites and the APOE ε4 allele as important biomarkers of GWI would serve to objectively assess the brain pathology of GWI and identify subgroups of GWI based on symptom patterns and GW exposures.
- Conditions
- Gulf War Syndrome, Gulf War Illness
- Keywords
- Gulf War, APOE
- Medical subject headings
- Persian Gulf Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case: GWI | This group includes participants who served in the Gulf War during 1990 -1991 and have Gulf War Illness based on either the Kansas or CDC symptom criteria. | |
| Control | This group includes participants who served in the Gulf War during 1990 -1991 and have no symptoms of Gulf War Illness based on both the Kansas and CDC symptom criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate Blood Biomarkers
To validate blood biomarker signatures of GWI using APOE genotyping and blood lipids/metabolites that correlate with the CNS dysfunction in GWI.
Measured: 2022-2024
Identify Blood/Lipid Profiles
To identify blood lipid/metabolite profiles that correlate with bioenergetics deficits and glial activation in the brains of GWI.
Measured: 2022-2024
Effect of Dietary, Medical and Biological Factors
To determine the effect of dietary, medical and biological factors that influence lipid and metabolites in blood from GW veterans.
Measured: 2022-2024
Metabolites Correlating with Cognitive Decline
To identify blood lipids/metabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI.
Measured: 2022-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start30 Jun 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roskamp Institute Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, Palo Alto Veterans Institute for Research, United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Laila Abdullah, Ph.D., Principal investigator, The Roskamp InstituteMichael Hoffmann, MD, Principal investigator, The Roskamp InstituteKim Sullivan, Ph.D, Principal investigator, Boston UniversityMaheen Adamson, Ph.D., Principal investigator, Palo Alto Veterans Institute of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736146
- Sponsor's protocol ID
- RI-GWI-003
- Status last verified
- Nov 2024
- First submitted
- 9 Feb 2023
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating Blood Biomarkers of Brain Immune and Metabolic Dysfunction in Gulf War Illness
- ClinicalTrials.gov ID
- NCT05736146
- Acronym / sponsor ID
- RI-GWI-003
- Conditions
- Gulf War Syndrome, Gulf War Illness
- Keywords
- Gulf War, APOE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Roskamp Institute Inc.University, hospital or other
- Collaborators
- Boston University, Palo Alto Veterans Institute for Research, United States Department of Defense
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators goals are to identify blood lipids/metabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI. To determine the effect of dietary, medical and biological factors that influence lipid and metabolites in blood from GW veterans. To identify blood lipid/metabolite profiles that correlate with bioenergetics deficits and glial activation in the brains of GWI. To validate blood biomarker signatures of GWI using APOE genotyping and blood lipids/metabolites that correlate with the CNS dysfunction in GWI.
Detailed description
Nearly 30 years later, veterans with Gulf War Illness (GWI) continue to suffer from this persistent and debilitating illness, which remains difficult to diagnose due to the heterogeneity of clinical presentation and the complexity of biological responses to hazardous chemicals to which GW veterans were exposed during the 1990-1991 Gulf War (GW). Brain imaging studies of veterans with GWI and pre-clinical animal studies of rodents with GWI show that impaired bioenergetics and inflammation can be attributed to the atrophy of the axonal white matter tracts that link the cortical gray matter regions, and the alterations of lipid/metabolite levels. The investigators recent work shows that disturbed lipid profiles in the brain and blood after GW pesticide exposure in rodents accompany neurobehavioral and bioenergetics deficits and inflammation. The mechanisms of neurotoxicity after pesticide exposure include increases in the inactivation of lipid metabolizing enzymes. This may consequently result in accumulation of lipids in the body compartments that limit their availability for use as energy substrates, contributing to bioenergetic impairments and inflammation. These metabolic changes have also been linked to individuals who possess the apolipoprotein E (APOE) ε4 allele, a risk factor of aging related cognitive decline and neurodegenerative conditions, such as Alzheimer's disease (AD). Several studies have shown a correlation between lipid transport deficits and presence of the ε4 allele. The identification of specific lipids/metabolites and the APOE ε4 allele as important biomarkers of GWI would serve to objectively assess the brain pathology of GWI and identify subgroups of GWI based on symptom patterns and GW exposures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case: GWI | – | –This group includes participants who served in the Gulf War during 1990 -1991 and have Gulf War Illness based on either the Kansas or CDC symptom criteria. |
| Control | – | –This group includes participants who served in the Gulf War during 1990 -1991 and have no symptoms of Gulf War Illness based on both the Kansas and CDC symptom criteria. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans who served in the Gulf War during 1990 to 1991.
Key inclusion criteria (4 listed)
- Age 35 years or older.
- For GWI cases, served in the 1990-1991 Gulf War as active duty, national guard, or reserves and meet criteria for the CDC Chronic Multisymptom Illness (CMI) GWI definition or Kansas GWI definition.
- For controls, must be a veteran in the same age range as those veterans with GWI as defined above.
- Ability to understand written and spoken English or availability of a legal representative who can understand written or spoken English. Participants and caregiver/informants must be able to read, write and speak the language in which psychometric tests are provided with visual and auditory acuity (corrected) sufficient to allow for accurate testing.
Key exclusion criteria (12 listed)
- Diagnosed or being treated by a physician for any of the following (Steele et al, 2000) and deemed clinically significant per the discretion of the PI:
- Hospitalized in the last 5 years for alcohol or drug dependence, depression, or post-traumatic stress disorder (PTSD).
- Female subject is either pregnant or nursing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validate Blood Biomarkers
Time frame: 2022-2024
To validate blood biomarker signatures of GWI using APOE genotyping and blood lipids/metabolites that correlate with the CNS dysfunction in GWI.
Identify Blood/Lipid Profiles
Time frame: 2022-2024
To identify blood lipid/metabolite profiles that correlate with bioenergetics deficits and glial activation in the brains of GWI.
Effect of Dietary, Medical and Biological Factors
Time frame: 2022-2024
To determine the effect of dietary, medical and biological factors that influence lipid and metabolites in blood from GW veterans.
Metabolites Correlating with Cognitive Decline
Time frame: 2022-2024
To identify blood lipids/metabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- The Roskamp Institute Home PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Gulf War Syndrome
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Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laila Abdullah, Ph.D. principal investigator
The Roskamp Institute
Michael Hoffmann, MD principal investigator
The Roskamp Institute
Kim Sullivan, Ph.D principal investigator
Boston University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gulf War Syndrome and Gulf War Illness, run by Roskamp Institute Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dakota Helgager, B.S ((941) - 256 - 8019 ext. 3008, dhelgager@roskampclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate Blood Biomarkers (time frame: 2022-2024). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.