Actively Recruiting

Age: 35Years +
All Genders
Healthy Volunteers
ID05736146

Validating Blood Biomarkers of Brain Immune and Metabolic Dysfunction in Gulf War Illness

Led by Roskamp Institute Inc. · Updated on 2025-07-24

100

Participants Needed

3

Research Sites

12 weeks

Total Duration

On this page

Sponsors

R

Roskamp Institute Inc.

Lead Sponsor

B

Boston University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating blood lipids and metabolites linked to cognitive decline in veterans with Gulf War Illness (GWI), focusing on those who carry the APOE ε4 allele. This observational study aims to understand how dietary, medical, and biological factors affect these blood markers and how they relate to brain bioenergetics deficits and glial activation seen in GWI. The goal is to validate blood biomarker signatures that correlate with central nervous system dysfunction in GWI, improving objective assessment of this complex condition. Participants include Gulf War veterans from 1990-1991, divided into groups based on whether they have GWI symptoms according to Kansas or CDC criteria or do not have GWI symptoms. The study does not involve treatment but collects blood samples and data to analyze lipid and metabolite profiles. Researchers assess how these profiles relate to brain imaging findings and genetic factors like the APOE ε4 allele. During the study, participants undergo evaluations including cognitive and symptom assessments, blood draws for lipid and metabolite analysis, and possibly brain imaging to measure bioenergetics and inflammation. The primary outcomes focus on validating blood biomarkers, identifying lipid profiles, and understanding the influence of various factors on these markers related to cognitive decline. The study began in 2022 and will continue through 2026, with careful monitoring of participants' health and symptoms throughout.

CONDITIONS

Brief Title

Validating Gulf War Illness Blood Biomarkers

Who Can Participate

Age: 35Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 35 years or older
  • For GWI cases, served in the 1990-1991 Gulf War as active duty, national guard, or reserves
  • Meet criteria for CDC Chronic Multisymptom Illness (CMI) or Kansas GWI definition
  • For controls, veteran in the same age range as GWI participants
  • Ability to understand written and spoken English or have a legal representative who can
  • Participants and caregivers must be able to read, write, and speak the language of psychometric tests
  • Visual and auditory ability (corrected) sufficient for accurate testing
Not Eligible

You will not qualify if you...

  • Diagnosed or treated for cancer (except non-melanoma skin cancer), chronic infectious disease, liver disease, lupus, multiple sclerosis, stroke, dementia, Parkinson's disease, or serious psychiatric conditions
  • Problems resulting from postwar injuries
  • Hospitalized in the last 5 years for alcohol or drug dependence, depression, or PTSD
  • Female participants who are pregnant or nursing

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 2022 to 2024

Participants undergo assessments to identify blood biomarkers and lipid profiles related to Gulf War Illness and cognitive decline.

Long-term Monitoring

Duration - 2022 to 2024

Participants are observed over time to evaluate the effects of dietary, medical, and biological factors on Gulf War Illness and related biomarkers.

Trial Site Locations

Total: 3 locations

1

Palto Alto Veterans Institute for Research

Palo Alto, California, United States, 94304

Actively Recruiting

2

The Roskamp Institute

Sarasota, Florida, United States, 34232

Actively Recruiting

3

Boston University

Boston, Massachusetts, United States, 02118

Actively Recruiting

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Research Team

D

Dakota Helgager, B.S

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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