Status:
COMPLETED
OEA for Targeting Lipid Metabolism in GWI
Lead Sponsor:
Roskamp Institute Inc.
Collaborating Sponsors:
United States Department of Defense
Conditions:
Gulf War Illness
Eligibility:
All Genders
Up to 70 years
Phase:
NA
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05252949
Start Date
June 10 2021
End Date
January 30 2025
Last Update
August 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Roskamp Institute
Sarasota, Florida, United States, 34243