Healthy Volunteers - Male and FemalePhase 4NCT06840080
OEA and LipiSperse Metabolic Study
A Phase 4 study testing 125mg OEA with LipiSperse and 250mg OEA with LipiSperse in people with Healthy Volunteers - Male and Female and Pharmacokinetic Study in Healthy Volunteers, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial summary
A placebo controlled, single blind, cross-over study evaluating the short-term effect of oleoylethanolamide (OEA) with LipiSperse supplementation on metabolic pathways in healthy participants. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers - Male and Female, Pharmacokinetic Study in Healthy Volunteers
- What is being tested?
- 125mg OEA with LipiSperse and 250mg OEA with LipiSperse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Mar 2025to 4 Jun 2025
- Phase
- Phase 4
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 30 years and older
- Generally healthy
- BMI 25.0-34.9 kg/m2
- Able to provide informed consent
- Agree to not participate in another clinical trial while enrolled in this trial
- Agree not to change current diet and/or exercise frequency or intensity during entire study period
- Females using a prescribed form of birth control (e.g. oral contraceptive)
- Participant's ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points
Who cannot join
- Have a serious illness e.g. neurological disorders such as MS, kidney disease, liver disease or heart conditions
- History of any glucose or insulin regulation problem, including diabetes.
- Have an unstable illness e.g. thyroid gland dysfunction, uncontrolled mood disorders (e.g., depression, anxiety, bipolar).
- Diagnosed with any known metabolic or endocrine dysfunctions e.g., diabetes, NAFLD, hyperinsulinemia, hypoglycaemia.
- Use of any medication or supplements that may affect any metabolic pathway associated with satiety (e.g., GLP-1, GIP, glucagon), glucose or insulin.
- Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
Show all 14Show fewer
- Significant change in diet in the past 1-month (e.g., removal of a food group or calorie restriction)
- Active smokers, nicotine use or drug (prescription or illegal substances) abuse
- Chronic past and/or current alcohol use (>21 alcoholic drinks week)
- Pregnant or lactating women
- Allergic to any of the ingredients in active or placebo formula
- Participants who are or who have participated in any other clinical trial during the past 1 month (excludes RDC clinical trials which are to be assessed on a case-by-case basis).
- Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- Regular use within the past 4 weeks of supplements containing OEA and/or LipiSperse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Effect of Oleoylethanolamide (OEA) and LipiSperse Supplementation on Metabolic Pathways in Otherwise Healthy Participants - a Single Blind, Cross-over Study
A placebo controlled, single blind, cross-over study evaluating the short-term effect of oleoylethanolamide (OEA) with LipiSperse supplementation on metabolic pathways in healthy participants.
Read the detailed description
This study aims to compare the metabolic effects of two different doses of OEA with LipiSperse to a placebo in healthy participants over an 8-hour period. There are three trial arms in this study. Each participant will complete all 3 arms of the study, for a 3-way cross-over.
- Being tested
- Placebo, 125mg OEA with LipiSperse, 250mg OEA with LipiSperse
- Keywords
- Healthy volunteer, OEA, oleoylethanolamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Single dose of 2 capsules. Capsules contain the same excipients as the active arms, except for the OEA with LipiSperse in capsules that appear identical to the OEA with LipiSperse capsules
125mg OEA with LipiSperseDietary supplement
Also called 125mg oleoylethanolamide
Single dose of 2 capsules. 1 capsule contains 125mg of OEA and 13.9mg of LipiSperse, the other capsule is a placebo.
250mg OEA with LipiSperseDietary supplement
Also called 250mg oleoylethanolamide
Single dose of 2 capsules. Each capsule contains 125mg of OEA and 13.9mg of LipiSperse.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Single dose of 2 capsules will be administered that appear identical to active arms. Receives: Other: Placebo |
| 125mg OEA with LipiSperse | Experimental | Single dose of 2 capsules will be administered. 1 capsule will contain 125mg OEA and 13.9mg of LipiSperse and 1 capsule will be a placebo. Receives: Dietary Supplement: 125mg OEA with LipiSperse |
| 250mg OEA with LipiSperse | Experimental | Single dose of 2 capsules will be administered. Each capsule will contain 125mg OEA and 13.9mg of LipiSperse. Receives: Dietary Supplement: 250mg OEA with LipiSperse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum/plasma GLP-1 AUC
Change from baseline to the end of the study period in serum/plasma GLP-1 AUC for each arm of treatment.
Measured: Baseline and 8 hours
Secondary outcomes (42)
Changes in serum/plasma GIP AUC
Change from baseline to the end of the study period in serum/plasma GIP AUC for each of the 3 arms.
Measured: Baseline and 8 hours
Changes in serum/plasma DPP-4 AUC
Change from baseline to the end of the study period in serum/plasma DPP-4 AUC for each of the 3 arms.
Measured: Baseline and 8 hours
Changes in serum/plasma glucagon AUC
Change from baseline to the end of the study period in serum/plasma glucagon AUC for each of the 3 arms.
Measured: Baseline and 8 hours
Changes in serum/plasma glucose AUC
Change from baseline to the end of the study period in serum/plasma glucose AUC for each of the 3 arms.
Measured: Baseline and 8 hours
Changes in serum/plasma insulin AUC
Change from baseline to the end of the study period in serum/plasma insulin AUC for each of the 3 arms.
Measured: Baseline and 8 hours
Tmax of GLP-1
Tmax of GLP-1 for each of the 3 arms.
Measured: Baseline to 8 hours
Tmax of GIP
Tmax of GIP for each of the 3 arms.
Measured: Baseline to 8 hours
Tmax of DPP-4
Tmax of DPP-4 for each of the 3 arms.
Measured: Baseline to 8 hours
Tmax of glucagon
Tmax of glucagon for each of the 3 arms.
Measured: Baseline to 8 hours
Tmax of glucose
Tmax of glucose for each of the 3 arms.
Measured: Baseline to 8 hours
Tmax of insulin
Tmax of insulin for each of the 3 arms.
Measured: Baseline to 8 hours
Cmax of GLP-1
Cmax of GLP-1 for each of the 3 arms.
Measured: Baseline to 8 hours
Cmax of GIP
Cmax of GIP for each of the 3 arms.
Measured: Baseline to 8 hours
Cmax of DPP-4
Cmax of DPP-4 for each of the 3 arms.
Measured: Baseline to 8 hours
Cmax of glucagon
Cmax of glucagon for each of the 3 arms.
Measured: Baseline to 8 hours
Cmax of glucose
Cmax of glucose for each of the 3 arms.
Measured: Baseline to 8 hours
Cmax of insulin
Cmax of insulin for each of the 3 arms.
Measured: Baseline to 8 hours
Individual absorption data for each subject
Individual change data obtained for serum/plasma GLP-1, GIP, DPP-4, glucagon, glucose and insulin from each participant for each of the 3 study arms will be individually compared for change. Individual results will then be combined for whole group comparison/analysis.
Measured: Baseline to 8 hours
Tolerability including GIT tolerance
Tolerability including Gastrointestinal (GIT) tolerance. A GIT tolerance questionnaire will be administered prior to lunch. Will be reviewed for each of the 3 arms
Measured: Baseline to 8 hours
Safety via AE monitoring
Safety via AE monitoring for each of the 3 arms
Measured: Baseline to 8hours post dose
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GLP-1)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in GLP-1 over 8-hours
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GIP)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in GIP over 8-hours
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in DPP-4)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in DPP-4 over 8-hours
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucagon)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in glucagon over 8-hours
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucose)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in glucose over 8-hours
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in insulin)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for total AUC change in insulin over 8-hours
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GLP-1)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of GLP-1 over 8-hours
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GIP)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of GIP over 8-hours
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of DPP-4)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of DPP-4 over 8-hours
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucagon)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of glucagon over 8-hours
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucose)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of glucose over 8-hours
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of insulin)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Tmax of insulin over 8-hours
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GLP-1)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of GLP-1 over 8-hours.
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GIP)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for GIP over 8-hours.
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of DPP-4)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of DPP-4 over 8-hours.
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucagon)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of glucagon over 8-hours.
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucose)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of glucose over 8-hours.
Measured: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of insulin)
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of insulin over 8-hours.
Measured: Baseline to 8 hours
VAS for appetite
A visual analogue scale (VAS) for appetite will be administered 3.5 - 4 hours after dosing, and will be assessed for each of the 3 arms.
Measured: Baseline to 4 hours
Food consumption during the time in clinic (Lunch)
Participants will be supplied with a standardised lunch meal of known nutritional value (i.e., calories, carbohydrate, fat and protein content). Each participants food will be provided to them via a standardised container (i.e., the same dimension with foods segregated). Prior to and upon completion of the meal, all meal containers will be photographed. The photos will be used to assess the percentage of food that was consumed at each of the 3 visits.
Measured: Baseline to 8 hours.
Food consumption during the time in clinic (Breakfast)
Participants will be supplied with a standardised breakfast meal of known nutritional value (i.e., calories, carbohydrate, fat and protein content). Each participants food will be provided to them via a standardised container (i.e., the same dimension with foods segregated). Prior to and upon completion of the meal, all meal containers will be photographed. The photos will be used to assess the percentage of food that was consumed at each of the 3 visits.
Measured: Baseline to 8 hours.
Food consumption during the time in clinic (snacks)
Any snacks consumed during the day (baseline to 8-hours) at each visit will be recorded. The number of snacks consumed during each visit will be assessed as a numerical number (i.e., number of biscuits or pieces of fruit). The difference in snacks consumed at each visit will then be analysed for any differences
Measured: Baseline to 8 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start4 Mar 2025
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteers - Male and FemaleStudies 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gencor Pacific Limited, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Ramasamy Venkatesh, Study director, Gencor Pacific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840080
- Sponsor's protocol ID
- GLP1PK
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Briskey D, Pellow J, Viswanath P, Rao A. Acute TRPTI (oleoylethanolamide) supplementation enhances incretin hormone responses: a fixed-sequence crossover study. Front Endocrinol (Lausanne). 2026 Jul 15;17:1879799. doi: 10.3389/fendo.2026.1879799. eCollection 2026.
PubMed 42528740
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effect of Oleoylethanolamide (OEA) and LipiSperse Supplementation on Metabolic Pathways in Otherwise Healthy Participants - a Single Blind, Cross-over Study
- ClinicalTrials.gov ID
- NCT06840080
- Acronym / sponsor ID
- GLP1PK
- Keywords
- Healthy volunteer, OEA, oleoylethanolamide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Gencor Pacific Limited, Hong Kong
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 21 Feb 2025 (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.
A placebo controlled, single blind, cross-over study evaluating the short-term effect of oleoylethanolamide (OEA) with LipiSperse supplementation on metabolic pathways in healthy participants.
Detailed description
This study aims to compare the metabolic effects of two different doses of OEA with LipiSperse to a placebo in healthy participants over an 8-hour period. There are three trial arms in this study. Each participant will complete all 3 arms of the study, for a 3-way cross-over.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboSingle dose of 2 capsules will be administered that appear identical to active arms. |
| 125mg OEA with LipiSperse | Experimental | Dietary Supplement: 125mg OEA with LipiSperseSingle dose of 2 capsules will be administered. 1 capsule will contain 125mg OEA and 13.9mg of LipiSperse and 1 capsule will be a placebo. |
| 250mg OEA with LipiSperse | Experimental | Dietary Supplement: 250mg OEA with LipiSperseSingle dose of 2 capsules will be administered. Each capsule will contain 125mg OEA and 13.9mg of LipiSperse. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 30 years and older
- Generally healthy
- BMI 25.0-34.9 kg/m2
- Able to provide informed consent
- Agree to not participate in another clinical trial while enrolled in this trial
Key exclusion criteria (14 listed)
- Have a serious illness e.g. neurological disorders such as MS, kidney disease, liver disease or heart conditions
- History of any glucose or insulin regulation problem, including diabetes.
- Have an unstable illness e.g. thyroid gland dysfunction, uncontrolled mood disorders (e.g., depression, anxiety, bipolar).
- Diagnosed with any known metabolic or endocrine dysfunctions e.g., diabetes, NAFLD, hyperinsulinemia, hypoglycaemia.
- Use of any medication or supplements that may affect any metabolic pathway associated with satiety (e.g., GLP-1, GIP, glucagon), glucose or insulin.
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 |
|---|---|---|
| PlaceboSingle dose of 2 capsules. Capsules contain the same excipients as the active arms, except for the OEA with LipiSperse in capsules that appear identical to the OEA with LipiSperse capsules | Other | Placebo |
| 125mg OEA with LipiSperseAlso: 125mg oleoylethanolamideSingle dose of 2 capsules. 1 capsule contains 125mg of OEA and 13.9mg of LipiSperse, the other capsule is a placebo. | Dietary supplement | 125mg OEA with LipiSperse |
| 250mg OEA with LipiSperseAlso: 250mg oleoylethanolamideSingle dose of 2 capsules. Each capsule contains 125mg of OEA and 13.9mg of LipiSperse. | Dietary supplement | 250mg OEA with LipiSperse |
Primary outcome
Changes in serum/plasma GLP-1 AUC
Time frame: Baseline and 8 hours
Change from baseline to the end of the study period in serum/plasma GLP-1 AUC for each arm of treatment.
42 secondary outcomes
Changes in serum/plasma GIP AUC
Time frame: Baseline and 8 hours
Changes in serum/plasma DPP-4 AUC
Time frame: Baseline and 8 hours
Changes in serum/plasma glucagon AUC
Time frame: Baseline and 8 hours
Changes in serum/plasma glucose AUC
Time frame: Baseline and 8 hours
Changes in serum/plasma insulin AUC
Time frame: Baseline and 8 hours
Tmax of GLP-1
Time frame: Baseline to 8 hours
Tmax of GIP
Time frame: Baseline to 8 hours
Tmax of DPP-4
Time frame: Baseline to 8 hours
Tmax of glucagon
Time frame: Baseline to 8 hours
Tmax of glucose
Time frame: Baseline to 8 hours
Tmax of insulin
Time frame: Baseline to 8 hours
Cmax of GLP-1
Time frame: Baseline to 8 hours
Cmax of GIP
Time frame: Baseline to 8 hours
Cmax of DPP-4
Time frame: Baseline to 8 hours
Cmax of glucagon
Time frame: Baseline to 8 hours
Cmax of glucose
Time frame: Baseline to 8 hours
Cmax of insulin
Time frame: Baseline to 8 hours
Individual absorption data for each subject
Time frame: Baseline to 8 hours
Tolerability including GIT tolerance
Time frame: Baseline to 8 hours
Safety via AE monitoring
Time frame: Baseline to 8hours post dose
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GLP-1)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GIP)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in DPP-4)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucagon)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucose)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in insulin)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GLP-1)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GIP)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of DPP-4)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucagon)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucose)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of insulin)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GLP-1)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GIP)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of DPP-4)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucagon)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucose)
Time frame: Baseline to 8 hours
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of insulin)
Time frame: Baseline to 8 hours
VAS for appetite
Time frame: Baseline to 4 hours
Food consumption during the time in clinic (Lunch)
Time frame: Baseline to 8 hours.
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 18 Nov 2025.
- Derived from this study: PubMed 42528740Briskey D, Pellow J, Viswanath P, Rao A. Acute TRPTI (oleoylethanolamide) supplementation enhances incretin hormone responses: a fixed-sequence crossover study. Front Endocrinol (Lausanne). 2026 Jul 15;17:1879799. doi: 10.3389/fendo.2026.1879799. eCollection 2026.
- 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.
Ramasamy Venkatesh study director
Gencor Pacific
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 125mg OEA with LipiSperse and 250mg OEA with LipiSperse in people with Healthy Volunteers - Male and Female and Pharmacokinetic Study in Healthy Volunteers, run by RDC Clinical Pty Ltd at 1 site in Australia.
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 14 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 18 Nov 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 Australia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 serum/plasma GLP-1 AUC (time frame: Baseline and 8 hours). 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 NCT06840080, which also lists 1 linked publication.
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 18 Nov 2025.