OEA for Targeting Lipid Metabolism in GWI

NCT05252949 | Completed

• 1 other identifier: RI-OEA-001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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 participants with Gulf War Illness (GWI).

Conditions

Gulf War Illness

Outcome Measures

Primary Outcomes (2)

• Changes in lipid biomarker profiles

  The primary objective of the study is to assess the change in lipid levels in the blood between the two treatment arms over the 10-week placebo-controlled phase.

  10 weeks

• Changes in immune biomarker profiles

  The primary objective of the study is to assess the change in cytokine levels in the blood between the two treatment arms over the 10-week placebo-controlled phase.

  10 weeks

Secondary Outcomes (6)

• Changes in fatigue

  10 weeks

• Changes in mood

  10 weeks

• Changes in pain

  10 weeks

• Changes in cognition (neurocognitive)

  10 weeks

• Changes in cognition (neuropsychological)

  10 weeks

Study Arms (2)

Study Supplement: OEA

ACTIVE COMPARATOR

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.

Dietary Supplement: Oleoylethanolamide (OEA)

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Oleoylethanolamide (OEA) DIETARY_SUPPLEMENT

Oleoylethanolamide (OEA) is a naturally occurring ethanolamide that acts as a peroxisome proliferator-activated receptor alpha (PPAR-α) agonist, thereby modulating lipid profiles.

Study Supplement: OEA

Placebo DIETARY_SUPPLEMENT

Visually matching placebo capsules will contain the same inactive ingredients present in the manufactured OEA capsules, with the exception of any OEA compound.

Control

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Roskamp Institute Inc.: lead
• United States Department of Defense: collaborator

Study Sites (1)

The Roskamp Institute

Sarasota, Florida, 34243, United States

Location

Related Publications (8)

• White RF, Steele L, O'Callaghan JP, Sullivan K, Binns JH, Golomb BA, Bloom FE, Bunker JA, Crawford F, Graves JC, Hardie A, Klimas N, Knox M, Meggs WJ, Melling J, Philbert MA, Grashow R. Recent research on Gulf War illness and other health problems in veterans of the 1991 Gulf War: Effects of toxicant exposures during deployment. Cortex. 2016 Jan;74:449-75. doi: 10.1016/j.cortex.2015.08.022. Epub 2015 Sep 25.

  PMID: 26493934 BACKGROUND

• Abdullah L, Crynen G, Reed J, Bishop A, Phillips J, Ferguson S, Mouzon B, Mullan M, Mathura V, Mullan M, Ait-Ghezala G, Crawford F. Proteomic CNS profile of delayed cognitive impairment in mice exposed to Gulf War agents. Neuromolecular Med. 2011 Dec;13(4):275-88. doi: 10.1007/s12017-011-8160-z. Epub 2011 Oct 11.

  PMID: 21986894 BACKGROUND

• Abdullah L, Evans JE, Bishop A, Reed JM, Crynen G, Phillips J, Pelot R, Mullan MA, Ferro A, Mullan CM, Mullan MJ, Ait-Ghezala G, Crawford FC. Lipidomic profiling of phosphocholine-containing brain lipids in mice with sensorimotor deficits and anxiety-like features after exposure to Gulf War agents. Neuromolecular Med. 2012 Dec;14(4):349-61. doi: 10.1007/s12017-012-8192-z. Epub 2012 Jul 14.

  PMID: 22798222 BACKGROUND

• Abdullah L, Evans JE, Montague H, Reed JM, Moser A, Crynen G, Gonzalez A, Zakirova Z, Ross I, Mullan C, Mullan M, Ait-Ghezala G, Crawford F. Chronic elevation of phosphocholine containing lipids in mice exposed to Gulf War agents pyridostigmine bromide and permethrin. Neurotoxicol Teratol. 2013 Nov-Dec;40:74-84. doi: 10.1016/j.ntt.2013.10.002. Epub 2013 Oct 17.

  PMID: 24140745 BACKGROUND

• Abdullah L, Evans JE, Joshi U, Crynen G, Reed J, Mouzon B, Baumann S, Montague H, Zakirova Z, Emmerich T, Bachmeier C, Klimas N, Sullivan K, Mullan M, Ait-Ghezala G, Crawford F. Translational potential of long-term decreases in mitochondrial lipids in a mouse model of Gulf War Illness. Toxicology. 2016 Nov 30;372:22-33. doi: 10.1016/j.tox.2016.10.012. Epub 2016 Oct 29.

  PMID: 27931520 BACKGROUND

• Joshi U, Evans JE, Joseph R, Emmerich T, Saltiel N, Lungmus C, Oberlin S, Langlois H, Ojo J, Mouzon B, Paris D, Mullan M, Jin C, Klimas N, Sullivan K, Crawford F, Abdullah L. Oleoylethanolamide treatment reduces neurobehavioral deficits and brain pathology in a mouse model of Gulf War Illness. Sci Rep. 2018 Aug 27;8(1):12921. doi: 10.1038/s41598-018-31242-7.

  PMID: 30150699 BACKGROUND

• Emmerich T, Zakirova Z, Klimas N, Sullivan K, Shetty AK, Evans JE, Ait-Ghezala G, Laco GS, Hattiangady B, Shetty GA, Mullan M, Crynen G, Abdullah L, Crawford F. Phospholipid profiling of plasma from GW veterans and rodent models to identify potential biomarkers of Gulf War Illness. PLoS One. 2017 Apr 28;12(4):e0176634. doi: 10.1371/journal.pone.0176634. eCollection 2017.

  PMID: 28453542 BACKGROUND

• Abdullah L, Keegan AP, Hoffmann M, Baraniuk J, Mack W, Sullivan K, Luis C, Rindfleisch C, Huguenard CJC, Cseresznye A, Aldrich GJ, Evans JE, Paris D, Helgager D, Crawford F, Mullan M. Oleoylethanolamide supplementation improves mood and reduces fatigue in veterans with GWI in a 15-week randomized, double-blind, placebo-controlled exploratory clinical trial. Sci Rep. 2026 Jan 9. doi: 10.1038/s41598-026-35168-3. Online ahead of print.

  PMID: 41513981 DERIVED

MeSH Terms

Interventions

oleoylethanolamide

Study Officials

• Laila Abdullah, PhD

  The Roskamp Institute

  PRINCIPAL INVESTIGATOR

• Michael Hoffmann, MD

  The Roskamp Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will administer either OEA or placebo to the study participants over a blinded period of 10 weeks, followed by an open label phase with all participants receiving OEA for 5 weeks.

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 23, 2022
• Study Start: June 10, 2021
• Primary Completion: September 30, 2024
• Study Completion: January 30, 2025
• Last Updated: August 8, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)