OEA for Gulf War Syndrome

Overseen By Dakota Helgager

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Roskamp Institute Inc.

Must not be taking: OEA supplements

Disqualifiers: Pregnancy, Nursing, Hypertension, Renal failure, others

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Oleoylethanolamide (OEA) to determine its effects on blood lipids and immune markers in individuals with Gulf War Illness (GWI). Participants will take either the OEA supplement or a placebo for 10 weeks. The study aims to determine if OEA can improve symptoms related to GWI. Veterans who served in the Gulf War between August 1990 and August 1991 and meet specific illness criteria may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new insights and treatments for GWI.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot use any OEA supplements within 30 days of screening.

Is there any evidence suggesting that Oleoylethanolamide (OEA) is likely to be safe for humans?

Research has shown that oleoylethanolamide (OEA) might help treat Gulf War Illness. Scientists are investigating how OEA affects brain function and symptoms of this illness. However, limited safety information from human studies specifically addresses using OEA for Gulf War Illness.

OEA is a molecule naturally found in the body that helps control appetite and fat usage. Because it occurs naturally, it might be well-tolerated. The study phase labeled "Not Applicable" usually indicates early testing, where researchers closely monitor safety. While this doesn't guarantee complete safety, it ensures careful observation for any side effects.

For those considering joining a trial, it's important to know that OEA's safety is still under study. Researchers will closely monitor participants to quickly address any side effects. Always consult a healthcare provider to make an informed decision about joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Gulf War Syndrome focus on managing symptoms like pain and fatigue with medications such as antidepressants, pain relievers, and sleep aids. However, Oleoylethanolamide (OEA) is unique because it targets the body's endocannabinoid system, potentially addressing the root causes of symptoms rather than just alleviating them. OEA is a naturally occurring lipid that may help regulate appetite, inflammation, and pain. Researchers are excited about OEA because it could offer a more holistic approach to treatment, possibly leading to improved quality of life for those affected by Gulf War Syndrome.

What evidence suggests that Oleoylethanolamide (OEA) might be an effective treatment for Gulf War Illness?

Research has shown that Oleoylethanolamide (OEA), which participants in this trial may receive, might be a promising treatment for Gulf War Illness (GWI). In studies with mice affected by GWI, OEA improved thinking skills and reduced symptoms like tiredness and lack of self-control. OEA also lowered brain inflammation by reducing the size of certain brain cells that swell during inflammation. Additionally, OEA has been linked to the growth of new brain cells. These findings suggest that OEA might help with both brain and fatigue problems seen in Gulf War Illness. ^{1 2 3 6 7}

Who Is on the Research Team?

Laila Abdullah, PhD

Principal Investigator

The Roskamp Institute

Michael Hoffmann, MD

Principal Investigator

The Roskamp Institute

Are You a Good Fit for This Trial?

This trial is for Gulf War veterans deployed between August 1990 and August 1991, up to age 70, who meet the CDC or Kansas definitions of GWI. Participants must be medically stable, not pregnant or nursing, willing to use birth control, and have no significant medical conditions that could affect the study.

Inclusion Criteria

Veterans deployed to the Gulf War between August 1990 and August 1991.

Both genders, all ethnic groups, and ages up to 70.

Subject willing and able to give informed consent.

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.

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.

Female subject is either pregnant or nursing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Oleoylethanolamide (OEA) or placebo for 10 weeks to assess changes in lipid and immune biomarker profiles

10 weeks

Regular visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may opt into continuation of treatment with OEA long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Oleoylethanolamide (OEA)
• Placebo

Trial Overview The study tests Oleoylethanolamide (OEA) against a placebo in a double-blind setup where neither participants nor researchers know who's getting what. It aims to see how OEA affects blood lipid and immune markers in those with Gulf War Illness.

How Is the Trial Designed?

Group I: Study Supplement: OEA Active Control 1 Intervention

26 subjects will take the supplement (oleoylethanolamide) during the first phase of the study. 200mg will be taken twice a day for the 10-week period in phase one.

Group II: Control Placebo Group 1 Intervention

26 subjects will take the placebo during the first phase of the study (10 weeks).

Who Is Running the Clinical Trial?

Roskamp Institute Inc.

Lead Sponsor

Trials

8

Recruited

930+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. nature.com nature.com/articles/s41598-018-31242-7

Oleoylethanolamide treatment reduces neurobehavioral ... In GWI mice, treatment with OEA corresponded with cognitive benefits and reduced fatigue and disinhibition-like behavior in GWI mice.

2. trial.medpath.com trial.medpath.com/clinical-trial/04ed37e7a8eef304/randomized-double-blind-placebo-controlled-trial-oleoylethanolamide-gulf-war-illness

OEA for Targeting Lipid Metabolism in GWI | MedPath The study is a single site, randomized, double-blind, placebo-controlled study with an open label extension to evaluate the effects of Oleoylethanolamine ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8011829/

Gulf War Illness: Mechanisms Underlying Brain Dysfunction ... The beneficial effects include reductions in hypertrophied astrocytes and activated microglia, enhanced NSC proliferation, and higher neurogenesis. Also, MSL ...

4. va.gov va.gov/RAC-GWVI/meetings/jun2019/Block_JUNE_2019_508compl.pdf

Gulf War Research Update Develop effective treatments for ill Gulf War Veterans. • Identify biomarkers and improve diagnosis for conditions affecting. Gulf War veterans.

5. withpower.com withpower.com/trial/phase-gulf-war-illness-5-2021-59b8e

OEA for Gulf War Syndrome · Info for Participants The study is a single site, randomized, double-blind, placebo-controlled study with an open label extension to evaluate the effects of Oleoylethanolamine ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6798371/

Progression of intervention-focused research for Gulf War illness The cluster of chronic symptoms, now referred to as Gulf War Illness (GWI), has been studied by many researchers over the past two decades.

7. cdmrp.health.mil cdmrp.health.mil/gwirp/pdfs/GWIRP_Landscape_2020.pdf

GWIRP Landscape studies targeting peroxisomal lipid metabolism with oleoylethanolamide (OEA) ... perpetuation of complex chronic illness: Gulf War illness and chronic fatigue ...