OEA for Targeting Lipid Metabolism in GWI

Completed · Not applicable · Has a placebo group

Conditions studied: Gulf War Illness

In brief

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).

Key facts

Study ID

NCT05252949

Run by

Roskamp Institute Inc.

People needed

52

Starts

2021-06-10

Expected to finish

2025-01-30

Last updated by the study team

2025-08-08

Who can join

Age: any, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• The Roskamp Institute — Sarasota, Florida, United States

Full record on ClinicalTrials.gov

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