OEA and LipiSperse Metabolic Study

NCT06840080 | Completed Phase 4

• 1 other identifier: GLP1PK
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Healthy volunteer; OEA; oleoylethanolamide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (42)

• Changes in serum/plasma GIP AUC

  Baseline and 8 hours

• Changes in serum/plasma DPP-4 AUC

  Baseline and 8 hours

• Changes in serum/plasma glucagon AUC

  Baseline and 8 hours

• Changes in serum/plasma glucose AUC

  Baseline and 8 hours

• Changes in serum/plasma insulin AUC

  Baseline and 8 hours

Other Outcomes (1)

• E/LFT for triglycerides, cholesterol and safety markers

  Baseline and 8 hours

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

125mg OEA with LipiSperse

EXPERIMENTAL

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

250mg OEA with LipiSperse

EXPERIMENTAL

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

Interventions

Placebo 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

Placebo

125mg OEA with LipiSperse DIETARY_SUPPLEMENT

Single dose of 2 capsules. 1 capsule contains 125mg of OEA and 13.9mg of LipiSperse, the other capsule is a placebo.

Also known as: 125mg oleoylethanolamide

125mg OEA with LipiSperse

250mg OEA with LipiSperse DIETARY_SUPPLEMENT

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

Also known as: 250mg oleoylethanolamide

250mg OEA with LipiSperse

Eligibility Criteria

• Age: 30 Years+
• Gender Eligibility Details: Males and Females who are cisgender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead
• Gencor Pacific Limited: collaborator

Study Sites (1)

RDC Clinical

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Interventions

oleoyl ethanolamine; oleoylethanolamide

Study Officials

• Ramasamy Venkatesh

  Gencor Pacific

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 21, 2025
• Study Start: March 4, 2025
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)