Recruiting

Observational Study

Sponsor:

Roskamp Institute Inc.

Code:

NCT05736146

Conditions

Gulf War Syndrome

Gulf War Illness

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Accepted

Study Details

Brief 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. 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.

Conditions

Gulf War Syndrome

Gulf War Illness

Study ID

NCT05736146

Start date

Jun 30, 2022

Status verified date

Nov, 2024

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age 35 years or older.
2. 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.
3. For controls, must be a veteran in the same age range as those veterans with GWI as defined above.
4. 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.

Exclusion Criteria:

1. 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:

1. Cancer (except for non-melanoma skin cancers)
2. Chronic infectious disease
3. Problems resulting from postwar injuries.
4. Liver disease
5. Lupus
6. Multiple sclerosis
7. Stroke
8. Serious psychiatric condition (those associated with psychosis and/or for which the respondent had been hospitalized since 1991).
9. Dementia or any type of Parkinson's disease (PD).
2. Hospitalized in the last 5 years for alcohol or drug dependence, depression, or post-traumatic stress disorder (PTSD).
3. Female subject is either pregnant or nursing.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Validate Blood Biomarkers [ Time Frame: 2022-2024 ]
  • Identify Blood/Lipid Profiles [ Time Frame: 2022-2024 ]
  • Effect of Dietary, Medical and Biological Factors [ Time Frame: 2022-2024 ]
  • Metabolites Correlating with Cognitive Decline [ Time Frame: 2022-2024 ]

Central Contacts and Locations

Central contacts

Locations

Palto Alto Veterans Institute for Research

Recruiting

Palo Alto, California, United States, 94304

Contacts

The Roskamp Institute

Recruiting

Sarasota, Florida, United States, 34232

Contacts

Principal Investigator:

Laila Abdullah, Ph.D

Boston University

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

More Information

Sponsor

Roskamp Institute Inc.

Last update posted

Jul 24, 2025

Last verified

Nov, 2024

Keywords

  • Gulf War
  • APOE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roskamp Institute Inc. on 2025-07-24.