Gulf War Illness Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Clinical Trial of Oleoylethanolamide (OEA) for Targeting Lipid Metabolism in Gulf War Illness
Verified date | April 2024 |
Source | Roskamp Institute Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a single site, randomized, double-blind, placebo-controlled study with an open label extension to evaluate the effects of Oleoylethanolamine (OEA) on blood lipid and immune biomarkers in participants with Gulf War Illness (GWI).
Status | Active, not recruiting |
Enrollment | 52 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 70 Years |
Eligibility | Inclusion Criteria: - Both genders, all ethnic groups, and ages up to 70. - Subject willing and able to give informed consent. - Medically stable as per the investigator's discretion. - Negative urine pregnancy test for females of childbearing potential. A woman is considered of childbearing potential unless she is surgically sterile (hysterectomy or tubal ligation) or is postmenopausal (no menstrual cycle for 2 years or more). - Must be willing to use adequate birth control during the study and for 30 days after the last dose. Females agreeing to take an acceptable form of birth control per investigator discretion (where relevant). Females must prevent pregnancy or otherwise be unable to conceive. - Veterans deployed to the Gulf War between August 1990 and August 1991. - Veteran meets criteria for the CDC Chronic Multisymptom Illness (CMI) GWI definition or Kansas GWI definition. - Weight of 50.0kg - 200.0kg (110lbs - 440lbs). Exclusion Criteria: - Diagnosed by a physician with medical or psychiatric conditions that would account for their symptoms or interfere with their ability to report their symptoms. - Female subject is either pregnant or nursing. - Have contraindications, allergy, or sensitivity to OEA, olive oil, or excipients (microcrystalline cellulose, silicon dioxide, magnesium stearate, macrogol polyvinyl alcohol copolymer, talc, titanium dioxide, glycerol monocaprylocaprate and polyvinyl alcohol). - Any significant medical condition that could interfere with study conduct, as per investigator discretion. These may include but are not limited to the following: untreated chronic hypertension (defined as systolic > 180 mmHg; diastolic >110 mmHg), myocardial infarction within 6 months of screening, renal failure, hepatic failure, and/or receiving chemotherapy. - Clinically significant lab values for clinical laboratory assessments. - Poor venous access. - Current use of any OEA supplement products within 30 days of screening. - Participation in another clinical trial involving dietary or pharmaceutical intervention within 90 days of screening. |
Country | Name | City | State |
---|---|---|---|
United States | The Roskamp Institute | Sarasota | Florida |
Lead Sponsor | Collaborator |
---|---|
Roskamp Institute Inc. | United States Department of Defense |
United States,
Abdullah L, Crynen G, Reed J, Bishop A, Phillips J, Ferguson S, Mouzon B, Mullan M, Mathura V, Mullan M, Ait-Ghezala G, Crawford F. Proteomic CNS profile of delayed cognitive impairment in mice exposed to Gulf War agents. Neuromolecular Med. 2011 Dec;13(4):275-88. doi: 10.1007/s12017-011-8160-z. Epub 2011 Oct 11. — View Citation
Abdullah L, Evans JE, Bishop A, Reed JM, Crynen G, Phillips J, Pelot R, Mullan MA, Ferro A, Mullan CM, Mullan MJ, Ait-Ghezala G, Crawford FC. Lipidomic profiling of phosphocholine-containing brain lipids in mice with sensorimotor deficits and anxiety-like features after exposure to Gulf War agents. Neuromolecular Med. 2012 Dec;14(4):349-61. doi: 10.1007/s12017-012-8192-z. Epub 2012 Jul 14. — View Citation
Abdullah L, Evans JE, Joshi U, Crynen G, Reed J, Mouzon B, Baumann S, Montague H, Zakirova Z, Emmerich T, Bachmeier C, Klimas N, Sullivan K, Mullan M, Ait-Ghezala G, Crawford F. Translational potential of long-term decreases in mitochondrial lipids in a mouse model of Gulf War Illness. Toxicology. 2016 Nov 30;372:22-33. doi: 10.1016/j.tox.2016.10.012. Epub 2016 Oct 29. — View Citation
Abdullah L, Evans JE, Montague H, Reed JM, Moser A, Crynen G, Gonzalez A, Zakirova Z, Ross I, Mullan C, Mullan M, Ait-Ghezala G, Crawford F. Chronic elevation of phosphocholine containing lipids in mice exposed to Gulf War agents pyridostigmine bromide and permethrin. Neurotoxicol Teratol. 2013 Nov-Dec;40:74-84. doi: 10.1016/j.ntt.2013.10.002. Epub 2013 Oct 17. — View Citation
Emmerich T, Zakirova Z, Klimas N, Sullivan K, Shetty AK, Evans JE, Ait-Ghezala G, Laco GS, Hattiangady B, Shetty GA, Mullan M, Crynen G, Abdullah L, Crawford F. Phospholipid profiling of plasma from GW veterans and rodent models to identify potential biomarkers of Gulf War Illness. PLoS One. 2017 Apr 28;12(4):e0176634. doi: 10.1371/journal.pone.0176634. eCollection 2017. — View Citation
Joshi U, Evans JE, Joseph R, Emmerich T, Saltiel N, Lungmus C, Oberlin S, Langlois H, Ojo J, Mouzon B, Paris D, Mullan M, Jin C, Klimas N, Sullivan K, Crawford F, Abdullah L. Oleoylethanolamide treatment reduces neurobehavioral deficits and brain pathology in a mouse model of Gulf War Illness. Sci Rep. 2018 Aug 27;8(1):12921. doi: 10.1038/s41598-018-31242-7. Erratum In: Sci Rep. 2019 Jul 24;9(1):11011. — View Citation
White RF, Steele L, O'Callaghan JP, Sullivan K, Binns JH, Golomb BA, Bloom FE, Bunker JA, Crawford F, Graves JC, Hardie A, Klimas N, Knox M, Meggs WJ, Melling J, Philbert MA, Grashow R. Recent research on Gulf War illness and other health problems in veterans of the 1991 Gulf War: Effects of toxicant exposures during deployment. Cortex. 2016 Jan;74:449-75. doi: 10.1016/j.cortex.2015.08.022. Epub 2015 Sep 25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in lipid biomarker profiles | The primary objective of the study is to assess the change in lipid levels in the blood between the two treatment arms over the 10-week placebo-controlled phase. | 10 weeks | |
Primary | Changes in immune biomarker profiles | The primary objective of the study is to assess the change in cytokine levels in the blood between the two treatment arms over the 10-week placebo-controlled phase. | 10 weeks | |
Secondary | Changes in fatigue | The study will use the Multidimensional Fatigue Inventory (MFI-20) to assess fatigue. | 10 weeks | |
Secondary | Changes in mood | The study will use the Profile of Mood States (POMS) to assess mood. | 10 weeks | |
Secondary | Changes in pain | The study will use the McGill Pain Questionnaire (SF-MPQ) to assess pain. | 10 weeks | |
Secondary | Changes in cognition (neurocognitive) | The study will use the CNS Vital Signs computerized neurocognitive assessment software to assess memory. The computerized test uses individual tests to comprise a neurocognitive index score that can be used to evaluate neurocognitive status. | 10 weeks | |
Secondary | Changes in cognition (neuropsychological) | The study will use the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) cognitive test to assess memory. The test incorporates immediate memory, visuospatial/constructional, language, attention, and delayed memory components to determine a total scaled score for neuropsychological status. This total score ranges from 200 to 800, with higher scores increasing the associated percentile. | 10 weeks | |
Secondary | Changes in quality of life | The study will use the Quality of Life Scale (SF36). | 10 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04254627 -
TNF and Glucocorticoid Antagonist for GWI Associated Multi-symptom Disease Homeostasis Reset
|
Phase 1 | |
Terminated |
NCT02011542 -
Probiotic (VSL #3) for Gulf War Illness
|
Phase 2/Phase 3 | |
Recruiting |
NCT03078530 -
Probiotic (Visbiome) for Gulf War Illness
|
Phase 2/Phase 3 | |
Recruiting |
NCT04058275 -
"Immunomodulation in GWI (Phlebotomy)"
|
||
Recruiting |
NCT04255498 -
Understanding GWI: Integrative Modeling
|
Phase 1 | |
Completed |
NCT02782780 -
Cognitive Behavioral Therapy for Insomnia for Gulf War Illness
|
N/A | |
Recruiting |
NCT02983734 -
D-cycloserine: A Novel Treatment for Gulf War Illness (GWDCS)
|
Phase 2 | |
Recruiting |
NCT05972291 -
Mechanisms of Gulf War Illness
|
N/A | |
Recruiting |
NCT04046536 -
rTMS in Alleviating Pain and Co-Morbid Symptoms in Gulf War Veterans Illness (GWVI)
|
N/A | |
Recruiting |
NCT04182659 -
Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms
|
N/A | |
Recruiting |
NCT05377242 -
Curcumin, Resveratrol, and Stinging Nettle as Treatments for GWI
|
N/A | |
Recruiting |
NCT05675878 -
Confirmation of Diet as a Treatment for Gulf War Illness
|
Phase 3 | |
Recruiting |
NCT05736146 -
Validating Gulf War Illness Blood Biomarkers
|
||
Not yet recruiting |
NCT05820893 -
Resistant Potato Starch to Alleviate GWI
|
Phase 2 | |
Terminated |
NCT01846182 -
Research Examining Gulf War Illness in Our Nations Service Members
|
Phase 2 | |
Completed |
NCT02378025 -
Treating Chronic Pain in Gulf War Illness
|
N/A | |
Completed |
NCT02865460 -
Coenzyme Q10 Phase III Trial in Gulf War Illness
|
Phase 3 | |
Completed |
NCT02909686 -
Effects of Botanical Microglia Modulators in Gulf War Illness
|
N/A | |
Completed |
NCT01291758 -
Exercise in Gulf War Illness (GWI)
|
||
Completed |
NCT01011348 -
Q10 for Gulf War Veterans
|
N/A |