Gulf War IllnessNCT05252949
OEA for Targeting Lipid Metabolism in GWI
A study testing Oleoylethanolamide (OEA) in people with Gulf War Illness, run by Roskamp Institute Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gulf War Illness
- What is being tested?
- Oleoylethanolamide (OEA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2021to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial of Oleoylethanolamide (OEA) for Targeting Lipid Metabolism in Gulf War Illness
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).
Read the 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
- Being tested
- Oleoylethanolamide (OEA), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDietary supplement
Visually matching placebo capsules will contain the same inactive ingredients present in the manufactured OEA capsules, with the exception of any OEA compound.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Oleoylethanolamide (OEA) |
| Control | Placebo comparator | 26 subjects will take the placebo during the first phase of the study (10 weeks). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 weeks
Secondary outcomes (6)
Changes in fatigue
The study will use the Multidimensional Fatigue Inventory (MFI-20) to assess fatigue.
Measured: 10 weeks
Changes in mood
The study will use the Profile of Mood States (POMS) to assess mood.
Measured: 10 weeks
Changes in pain
The study will use the McGill Pain Questionnaire (SF-MPQ) to assess pain.
Measured: 10 weeks
Changes in cognition (neurocognitive)
The study will use the CNS Vital Signs computerized neurocognitive assessment software to assess memory. The computerized test uses individual tests to comprise a neurocognitive index score that can be used to evaluate neurocognitive status.
Measured: 10 weeks
Changes in cognition (neuropsychological)
The study will use the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) cognitive test to assess memory. The test incorporates immediate memory, visuospatial/constructional, language, attention, and delayed memory components to determine a total scaled score for neuropsychological status. This total score ranges from 200 to 800, with higher scores increasing the associated percentile.
Measured: 10 weeks
Changes in quality of life
The study will use the Quality of Life Scale (SF36).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start10 Jun 2021
- Primary completion30 Sep 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roskamp Institute Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Laila Abdullah, PhD, Principal investigator, The Roskamp InstituteMichael Hoffmann, MD, Principal investigator, The Roskamp Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252949
- Sponsor's protocol ID
- RI-OEA-001
- Status last verified
- Apr 2024
- First submitted
- 25 Jan 2022
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26493934Abdullah 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.
PubMed 21986894Abdullah 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.
PubMed 22798222Abdullah 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.
PubMed 24140745Abdullah 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.
PubMed 27931520Joshi 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.
PubMed 30150699Emmerich 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.
PubMed 28453542Abdullah 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;16(1):4933. doi: 10.1038/s41598-026-35168-3.
PubMed 41513981
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Clinical Trial of Oleoylethanolamide (OEA) for Targeting Lipid Metabolism in Gulf War Illness
- ClinicalTrials.gov ID
- NCT05252949
- Acronym / sponsor ID
- RI-OEA-001
- Conditions
- Gulf War Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Roskamp Institute Inc.University, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Supplement: OEA | Active comparator | Dietary Supplement: Oleoylethanolamide (OEA)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. |
| Control | Placebo comparator | Dietary Supplement: Placebo26 subjects will take the placebo during the first phase of the study (10 weeks). |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Study Supplement: OEA |
| PlaceboVisually matching placebo capsules will contain the same inactive ingredients present in the manufactured OEA capsules, with the exception of any OEA compound. | Dietary supplement | Control |
Primary outcome
Changes in lipid biomarker profiles
Time frame: 10 weeks
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.
Changes in immune biomarker profiles
Time frame: 10 weeks
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.
6 secondary outcomes
Changes in fatigue
Time frame: 10 weeks
Changes in mood
Time frame: 10 weeks
Changes in pain
Time frame: 10 weeks
Changes in cognition (neurocognitive)
Time frame: 10 weeks
Changes in cognition (neuropsychological)
Time frame: 10 weeks
Changes in quality of life
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Background: PubMed 26493934White 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.
- Background: PubMed 21986894Abdullah 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.
- Background: PubMed 22798222Abdullah 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.
- Background: PubMed 24140745Abdullah 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.
- Background: PubMed 27931520Abdullah 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.
- Background: PubMed 30150699Joshi 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.
- Background: PubMed 28453542Emmerich 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.
- Derived from this study: PubMed 41513981Abdullah 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;16(1):4933. doi: 10.1038/s41598-026-35168-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laila Abdullah, PhD principal investigator
The Roskamp Institute
Michael Hoffmann, MD principal investigator
The Roskamp Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oleoylethanolamide (OEA) in people with Gulf War Illness, run by Roskamp Institute Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in lipid biomarker profiles (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05252949, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.