NCT05252949

OEA for Targeting Lipid Metabolism in GWI

A Randomized, Double-blind, Placebo-controlled Clinical Trial of Oleoylethanolamide (OEA) for Targeting Lipid Metabolism in Gulf War Illness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Roskamp Institute Inc. · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

The 1991 Gulf War (GW) was fought by a coalition of 30 countries that included 700,000 U.S. troops. Although the war itself lasted two months, adverse health consequences from this conflict are still experienced by GW veterans. Soon after their return, many soldiers started reporting multiple, seemingly unrelated symptoms, such as memory impairment, fatigue, gastrointestinal problems, and widespread pain. This illness is termed Gulf War Illness (GWI) and affects about 32% of GW veterans. Several animal studies suggest that GWI presentation involves disturbed immune responses in the brain that correspond with altered lipid metabolism. Many of these lipid alterations are detected in blood of veterans with GWI and point to an abnormal function of peroxisomes and mitochondria which regulate lipids that are required for cellular signaling and for maintaining normal physiology. The investigators' preclinical studies using a GWI mouse model showed that targeting peroxisomal lipid metabolism with oleoylethanolamide (OEA) reduced corrected immune function and normalized brain and blood lipid profiles in GWI mice. Therefore, the objective of this pilot clinical research study is to determine if OEA supplementation in veterans with GWI maintains healthy blood lipid and immune profiles.

Conditions

• Gulf War Illness

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oleoylethanolamide (OEA)	Oleoylethanolamide (OEA) is a naturally occurring ethanolamide that acts as a peroxisome proliferator-activated receptor alpha (PPAR-α) agonist, thereby modulating lipid profiles.
DIETARY_SUPPLEMENT	Placebo	Visually matching placebo capsules will contain the same inactive ingredients present in the manufactured OEA capsules, with the exception of any OEA compound.

Timeline

• Start date: 2021-06-10
• Primary completion: 2024-09-30
• Completion: 2025-01-30
• First posted: 2022-02-23
• Last updated: 2025-08-08

Locations

1 site across 1 country: United States