Evaluating the effects of oleoylethanolamide on metabolism in healthy adults
Short-term Effect of Oleoylethanolamide (OEA) and LipiSperse Supplementation on Metabolic Pathways in Otherwise Healthy Participants - a Single Blind, Cross-over Study
This study is testing if a supplement called oleoylethanolamide can improve metabolism in healthy adults aged 30 and older when taken with another product called LipiSperse.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | RDC Clinical Pty Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Brisbane, Queensland) |
| Trial ID | NCT06840080 on ClinicalTrials.gov |
What this trial studies
This interventional study investigates the metabolic effects of oleoylethanolamide (OEA) combined with LipiSperse in healthy volunteers. Participants aged 30 and older will undergo a placebo-controlled, single-blind, cross-over design, where they will receive different doses of OEA alongside LipiSperse over an 8-hour period. Each participant will complete all three arms of the study, allowing for direct comparison of the metabolic responses to the treatments. The study aims to provide insights into how OEA supplementation may influence metabolic pathways.
Who should consider this trial
Good fit: Ideal candidates are generally healthy adults aged 30 years and older with a BMI between 25.0 and 34.9 kg/m2.
Not a fit: Patients with serious illnesses, metabolic disorders, or unstable health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of metabolic regulation and potentially lead to new dietary supplements for weight management.
How similar studies have performed: While there is limited data on the specific combination of OEA and LipiSperse, similar metabolic studies have shown promising results with OEA supplementation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brisbane, Queensland
- RDC Clinical — Brisbane, Queensland, Australia (Recruiting)
Study contacts
- Study coordinator: David Briskey
- Email: david@rdcglobal.com.au
- Phone: 0061(0)421 784 077
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.