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

NCT06840080•RDC Clinical Pty Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+4 more criteria

Locations (1)

RDC Clinical

Brisbane, Queensland, Australia

Key Dates

Start Date

March 4, 2025

Primary Completion Date

June 4, 2025

Completion Date

June 4, 2025

Last Updated

November 18, 2025

Enrollment

ACTUAL participants

Conditions

Healthy Volunteers - Male and FemalePharmacokinetic Study in Healthy Volunteers

Interventions

Placebo

OTHER

125mg OEA with LipiSperse

DIETARY_SUPPLEMENT

250mg OEA with LipiSperse

DIETARY_SUPPLEMENT