OEA and LipiSperse Metabolic Study

Last updated: April 1, 2025
Sponsor: RDC Clinical Pty Ltd
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

125mg OEA with LipiSperse

250mg OEA with LipiSperse

Placebo

Clinical Study ID

NCT06840080
GLP1PK
  • Ages > 30
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 duringentire 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 studyincluding attendance at all scheduled blood collection time points

Exclusion

Exclusion Criteria:

  • Have a serious illness e.g. neurological disorders such as MS, kidney disease, liverdisease 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 pathwayassociated with satiety (e.g., GLP-1, GIP, glucagon), glucose or insulin.

  • Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapytreatment for malignancy within the previous 2 years

  • Significant change in diet in the past 1-month (e.g., removal of a food group orcalorie 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 thepast 1 month (excludes RDC clinical trials which are to be assessed on acase-by-case basis).

  • Any condition which in the opinion of the investigator makes the participantunsuitable for inclusion

  • Regular use within the past 4 weeks of supplements containing OEA and/or LipiSperse

Study Design

Total Participants: 40
Treatment Group(s): 3
Primary Treatment: 125mg OEA with LipiSperse
Phase: 4
Study Start date:
March 04, 2025
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • RDC Clinical

    Brisbane, Queensland 4006
    Australia

    Active - Recruiting

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