OEA for Targeting Lipid Metabolism in GWI

Roskamp Institute Inc.

Status

Completed

Conditions

Gulf War Illness

Treatments

Dietary Supplement: Oleoylethanolamide (OEA)

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT05252949

RI-OEA-001

Details and patient eligibility

About

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).

Full 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.

Enrollment

52 patients

Sex

All

Ages

Under 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

52 participants in 2 patient groups, including a placebo group

Study Supplement: OEA

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Oleoylethanolamide (OEA)

Control

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo