OEA and LipiSperse Metabolic Study

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: Completed
• Conditions: Healthy Volunteers - Male and Female; Pharmacokinetic Study in Healthy Volunteers
• Intervention / Treatment: Other: Placebo; Dietary supplement: 125mg OEA with LipiSperse; Dietary supplement: 250mg OEA with LipiSperse

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: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline and 8 hours
Tmax of GLP-1	Tmax of GLP-1 for each of the 3 arms.	Baseline to 8 hours
Tmax of GIP	Tmax of GIP for each of the 3 arms.	Baseline to 8 hours
Tmax of DPP-4	Tmax of DPP-4 for each of the 3 arms.	Baseline to 8 hours
Tmax of glucagon	Tmax of glucagon for each of the 3 arms.	Baseline to 8 hours
Tmax of glucose	Tmax of glucose for each of the 3 arms.	Baseline to 8 hours
Tmax of insulin	Tmax of insulin for each of the 3 arms.	Baseline to 8 hours
Cmax of GLP-1	Cmax of GLP-1 for each of the 3 arms.	Baseline to 8 hours
Cmax of GIP	Cmax of GIP for each of the 3 arms.	Baseline to 8 hours
Cmax of DPP-4	Cmax of DPP-4 for each of the 3 arms.	Baseline to 8 hours
Cmax of glucagon	Cmax of glucagon for each of the 3 arms.	Baseline to 8 hours
Cmax of glucose	Cmax of glucose for each of the 3 arms.	Baseline to 8 hours
Cmax of insulin	Cmax of insulin for each of the 3 arms.	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.	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	Baseline to 8 hours
Safety via AE monitoring	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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	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)	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)	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)	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

Outcome Measure	Measure Description	Time Frame
E/LFT for triglycerides, cholesterol and safety markers	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

• Sponsor: RDC Clinical Pty Ltd
• Collaborators: Gencor Pacific Limited
• Investigators: Study Director: Ramasamy Venkatesh, Gencor Pacific

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Actual): June 4, 2025
• Study Completion (Actual): June 4, 2025

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Healthy volunteer; OEA; oleoylethanolamide
• Additional Relevant MeSH Terms: oleoyl ethanolamine; oleoylethanolamide
• Other Study ID 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