OEA and LipiSperse Metabolic Study

RDC Clinical Pty Ltd40 enrolled

Overview

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.

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

Allocation

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Healthy Volunteers - Male and Female Pharmacokinetic Study in Healthy Volunteers

Interventions

PlaceboOTHER

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 LipiSperseDIETARY_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 LipiSperseDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

RDC Clinical

Brisbane, Queensland, Australia

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 8 hours

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and 8 hours

Tmax of GLP-1

Tmax of GLP-1 for each of the 3 arms.