Validating Gulf War Illness Blood Biomarkers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35+
SponsorRoskamp Institute Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Cancer (except for non-melanoma skin cancers)
Chronic infectious disease
Problems resulting from postwar injuries.
Liver disease
Trial population
Veterans who served in the Gulf War during 1990 to 1991.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Case: GWI
Group B: Control
Trial outcomes
Primary outcomes
1
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.
Time frame
2022-20242
Identify Blood/Lipid Profiles
To identify blood lipid/metabolite profiles that correlate with bioenergetics deficits and glial activation in the brains of GWI.
Time frame
2022-20243
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.
Time frame
2022-20244
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.
Time frame
2022-2024Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Roskamp Institute Inc.
Lead sponsor
Boston University
Collaborator
Palo Alto Veterans Institute for Research
Collaborator
United States Department of Defense
Collaborator
Source ClinicalTrials.gov