OEA and LipiSperse Metabolic Study

November 16, 2025 updated by: RDC Clinical Pty Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4006
        • RDC Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Single dose of 2 capsules will be administered that appear identical to active arms.
Other: Placebo
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
Experimental: 125mg OEA with LipiSperse
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.
Dietary supplement: 125mg OEA with LipiSperse
Single dose of 2 capsules. 1 capsule contains 125mg of OEA and 13.9mg of LipiSperse, the other capsule is a placebo.
Other Names:
  • 125mg oleoylethanolamide
Experimental: 250mg OEA with LipiSperse
Single dose of 2 capsules will be administered. Each capsule will contain 125mg OEA and 13.9mg of LipiSperse.
Dietary supplement: 250mg OEA with LipiSperse
Single dose of 2 capsules. Each capsule contains 125mg of OEA and 13.9mg of LipiSperse.
Other Names:
  • 250mg oleoylethanolamide

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 8 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in serum/plasma GIP AUC
Time Frame: Baseline and 8 hours
Change from baseline to the end of the study period in serum/plasma GIP AUC for each of the 3 arms.
Baseline and 8 hours
Changes in serum/plasma DPP-4 AUC
Time Frame: Baseline and 8 hours
Change from baseline to the end of the study period in serum/plasma DPP-4 AUC for each of the 3 arms.
Baseline and 8 hours
Changes in serum/plasma glucagon AUC
Time Frame: Baseline and 8 hours
Change from baseline to the end of the study period in serum/plasma glucagon AUC for each of the 3 arms.
Baseline and 8 hours
Changes in serum/plasma glucose AUC
Time Frame: Baseline and 8 hours
Change from baseline to the end of the study period in serum/plasma glucose AUC for each of the 3 arms.
Baseline and 8 hours
Changes in serum/plasma insulin AUC
Time Frame: Baseline and 8 hours
Change from baseline to the end of the study period in serum/plasma insulin AUC for each of the 3 arms.
Baseline and 8 hours
Tmax of GLP-1
Time Frame: Baseline to 8 hours
Tmax of GLP-1 for each of the 3 arms.
Baseline to 8 hours
Tmax of GIP
Time Frame: Baseline to 8 hours
Tmax of GIP for each of the 3 arms.
Baseline to 8 hours
Tmax of DPP-4
Time Frame: Baseline to 8 hours
Tmax of DPP-4 for each of the 3 arms.
Baseline to 8 hours
Tmax of glucagon
Time Frame: Baseline to 8 hours
Tmax of glucagon for each of the 3 arms.
Baseline to 8 hours
Tmax of glucose
Time Frame: Baseline to 8 hours
Tmax of glucose for each of the 3 arms.
Baseline to 8 hours
Tmax of insulin
Time Frame: Baseline to 8 hours
Tmax of insulin for each of the 3 arms.
Baseline to 8 hours
Cmax of GLP-1
Time Frame: Baseline to 8 hours
Cmax of GLP-1 for each of the 3 arms.
Baseline to 8 hours
Cmax of GIP
Time Frame: Baseline to 8 hours
Cmax of GIP for each of the 3 arms.
Baseline to 8 hours
Cmax of DPP-4
Time Frame: Baseline to 8 hours
Cmax of DPP-4 for each of the 3 arms.
Baseline to 8 hours
Cmax of glucagon
Time Frame: Baseline to 8 hours
Cmax of glucagon for each of the 3 arms.
Baseline to 8 hours
Cmax of glucose
Time Frame: Baseline to 8 hours
Cmax of glucose for each of the 3 arms.
Baseline to 8 hours
Cmax of insulin
Time Frame: Baseline to 8 hours
Cmax of insulin for each of the 3 arms.
Baseline to 8 hours
Individual absorption data for each subject
Time Frame: Baseline to 8 hours
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.
Baseline to 8 hours
Tolerability including GIT tolerance
Time Frame: Baseline to 8 hours
Tolerability including Gastrointestinal (GIT) tolerance. A GIT tolerance questionnaire will be administered prior to lunch. Will be reviewed for each of the 3 arms
Baseline to 8 hours
Safety via AE monitoring
Time Frame: Baseline to 8hours post dose
Safety via AE monitoring for each of the 3 arms
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 for total AUC change in GLP-1 over 8-hours
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 for total AUC change in GIP over 8-hours
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 for total AUC change in DPP-4 over 8-hours
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 for total AUC change in glucagon over 8-hours
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 for total AUC change in glucose over 8-hours
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 for total AUC change in insulin over 8-hours
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 for Tmax of GLP-1 over 8-hours
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 for Tmax of GIP over 8-hours
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 for Tmax of DPP-4 over 8-hours
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 for Tmax of glucagon over 8-hours
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 for Tmax of glucose over 8-hours
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 for Tmax of insulin over 8-hours
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 for Cmax of GLP-1 over 8-hours.
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 for GIP over 8-hours.
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 for Cmax of DPP-4 over 8-hours.
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 for Cmax of glucagon over 8-hours.
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 for Cmax of glucose over 8-hours.
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
Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used for Cmax of insulin over 8-hours.
Baseline to 8 hours
VAS for appetite
Time Frame: Baseline to 4 hours
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.
Baseline to 4 hours
Food consumption during the time in clinic (Lunch)
Time Frame: Baseline to 8 hours.
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.
Baseline to 8 hours.
Food consumption during the time in clinic (Breakfast)
Time Frame: Baseline to 8 hours.
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.
Baseline to 8 hours.
Food consumption during the time in clinic (snacks)
Time Frame: Baseline to 8 hours.
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
Baseline to 8 hours.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
E/LFT for triglycerides, cholesterol and safety markers
Time Frame: Baseline and 8 hours
Electrolyte/Liver Function Test (E/LFT) for triglycerides, cholesterol and safety markers for each arm. Samples will be analysed for a range of safety biomarkers within the E/LFT including Sodium, Potassium, Chloride, Bicarbonate, Calcium.
Baseline and 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RDC Clinical Pty Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gencor Pacific Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ramasamy Venkatesh, Gencor Pacific

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GLP1PK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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