Clinical trial NCT06840080: OEA and LipiSperse Metabolic Study
Official title: Short-term Effect of Oleoylethanolamide (OEA) and LipiSperse Supplementation on Metabolic Pathways in Otherwise Healthy Participants - a Single Blind, Cross-over Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Healthy Volunteers - Male and Female
Pharmacokinetic Study in Healthy Volunteers
Keywords: Healthy volunteer
OEA
oleoylethanolamide
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Gencor Pacific Limited
First posted: 2025-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Changes in serum/plasma GLP-1 AUC
timeFrame: Baseline and 8 hours
Secondary outcomes:
measure: Changes in serum/plasma GIP AUC
timeFrame: Baseline and 8 hours
measure: Changes in serum/plasma DPP-4 AUC
timeFrame: Baseline and 8 hours
measure: Changes in serum/plasma glucagon AUC
timeFrame: Baseline and 8 hours
measure: Changes in serum/plasma glucose AUC
timeFrame: Baseline and 8 hours
measure: Changes in serum/plasma insulin AUC
timeFrame: Baseline and 8 hours
measure: Tmax of GLP-1
timeFrame: Baseline to 8 hours
measure: Tmax of GIP
timeFrame: Baseline to 8 hours
measure: Tmax of DPP-4
timeFrame: Baseline to 8 hours
measure: Tmax of glucagon
timeFrame: Baseline to 8 hours
measure: Tmax of glucose
timeFrame: Baseline to 8 hours
measure: Tmax of insulin
timeFrame: Baseline to 8 hours
measure: Cmax of GLP-1
timeFrame: Baseline to 8 hours
measure: Cmax of GIP
timeFrame: Baseline to 8 hours
measure: Cmax of DPP-4
timeFrame: Baseline to 8 hours
measure: Cmax of glucagon
timeFrame: Baseline to 8 hours
measure: Cmax of glucose
timeFrame: Baseline to 8 hours
measure: Cmax of insulin
timeFrame: Baseline to 8 hours
measure: Individual absorption data for each subject
timeFrame: Baseline to 8 hours
measure: Tolerability including GIT tolerance
timeFrame: Baseline to 8 hours
measure: Safety via AE monitoring
timeFrame: Baseline to 8hours post dose
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GLP-1)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in GIP)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in DPP-4)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucagon)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in glucose)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (AUC change in insulin)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GLP-1)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of GIP)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of DPP-4)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucagon)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of glucose)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (Tmax of insulin)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GLP-1)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of GIP)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of DPP-4)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucagon)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of glucose)
timeFrame: Baseline to 8 hours
measure: Non-inferiority/equivalence comparison of the two different OEA and LipiSperse doses used (CMax of insulin)
timeFrame: Baseline to 8 hours
measure: VAS for appetite
timeFrame: Baseline to 4 hours
measure: Food consumption during the time in clinic (Lunch)
timeFrame: Baseline to 8 hours.
measure: Food consumption during the time in clinic (Breakfast)
timeFrame: Baseline to 8 hours.
measure: Food consumption during the time in clinic (snacks)
timeFrame: Baseline to 8 hours.
Other outcomes:
measure: E/LFT for triglycerides, cholesterol and safety markers
timeFrame: Baseline and 8 hours
Locations:
city: Brisbane
country: Australia
facility: RDC Clinical
state: Queensland
Study officials:
affiliation: Gencor Pacific
name: Ramasamy Venkatesh
role: STUDY_DIRECTOR
References: