52 Participants Needed

OEA for Gulf War Syndrome

GB
DH
Overseen ByDakota Helgager
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Roskamp Institute Inc.

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

LA

Laila Abdullah, PhD

Principal Investigator

The Roskamp Institute

MH

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.
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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.
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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?
2Treatment groups
Active Control
Placebo Group
Group I: Study Supplement: OEAActive Control1 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: ControlPlacebo Group1 Intervention
26 subjects will take the placebo during the first phase of the study (10 weeks).

Find a Clinic Near You

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+
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