OEA and LipiSperse Metabolic Study

NCT ID: NCT06840080

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-04
• Study Completion Date: 2025-06-04

Brief 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.

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.

Conditions

Healthy Volunteers - Male and Female; Pharmacokinetic Study in Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Placebo

Single dose of 2 capsules will be administered that appear identical to active arms.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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 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.

Group Type: EXPERIMENTAL

125mg OEA with LipiSperse

Intervention Type: DIETARY_SUPPLEMENT

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 LipiSperse

Single dose of 2 capsules will be administered. Each capsule will contain 125mg OEA and 13.9mg of LipiSperse.

Group Type: EXPERIMENTAL

250mg OEA with LipiSperse

Intervention Type: DIETARY_SUPPLEMENT

Single dose of 2 capsules. Each capsule contains 125mg of OEA and 13.9mg of LipiSperse.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: DIETARY_SUPPLEMENT

250mg OEA with LipiSperse

Single dose of 2 capsules. Each capsule contains 125mg of OEA and 13.9mg of LipiSperse.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

125mg oleoylethanolamide; 250mg oleoylethanolamide

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gencor Pacific Limited

UNKNOWN

Sponsor Role: collaborator

RDC Clinical Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramasamy Venkatesh

Role: STUDY_DIRECTOR

Gencor Pacific

Locations

RDC Clinical

Brisbane, Queensland, Australia

Countries

Australia

Other Identifiers

GLP1PK

Identifier Type: -

Identifier Source: org_study_id