Long-term safety of PEA supplementation in healthy adults
A Randomised, Double-blind Placebo-controlled Study in Healthy Adults to Assess Long Term Population Exposure to Palmitoylethanolamide (Levagen™) to Assess Clinical Safety.
This study is testing if taking Palmitoylethanolamide (PEA) for a year is safe for healthy adults aged 18 and older.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RDC Clinical Pty Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Brisbane, Queensland) |
| Trial ID | NCT06717867 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the long-term safety of Palmitoylethanolamide (PEA) supplementation in healthy adults aged 18 and older. Participants will be randomly assigned to receive either PEA or a placebo for a duration of 12 months, with assessments conducted to monitor serious and non-serious adverse events, vital signs, and biochemical parameters. The study employs a randomized, double-blind, placebo-controlled design to ensure unbiased results. Participants will undergo a screening process to determine eligibility based on specific inclusion and exclusion criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 years and older with a BMI between 18.5 and 35.0 kg/m2.
Not a fit: Patients with serious illnesses, current malignancies, or those on anticoagulation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety profile of PEA supplementation for healthy individuals.
How similar studies have performed: While this study focuses on the long-term safety of PEA, similar studies on other supplements have shown promising results, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (18 years and older) * Generally healthy * Able to provide informed consent * BMI 18.5 - 35.0 kg/m2 * Agree to not participate in another clinical trial during enrolment period Exclusion Criteria: * Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years * Serious illness e.g., mood disorders (such as depression or bipolar disorder), anxiety, neurological disorders (such as MS), kidney disease, liver disease or heart conditions * Unstable illness (e.g., diabetes and thyroid gland dysfunction) * History of renal function impairment * Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy \[(excluding low dose aspirin (under 300 mg/day)\] * Regular consumption (\>4 times a week) of PEA over the past 2 weeks * Substance Abuse (illicit and/or prescription) Drug (prescription or illegal substances) abuse * Chronic past (within 12-months) and/or current alcohol use (\>14 alcoholic drinks week) * Pregnant or lactating women * Allergic, sensitive, or intolerant to any of the ingredients in active or placebo formula * Has a clinically significant abnormal finding on the medical assessment, medical history, or clinical laboratory results at screening. * Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month. * Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.
Where this trial is running
Brisbane, Queensland
- RDC Clinical — Brisbane, Queensland, Australia (Recruiting)
Study contacts
- Study coordinator: RV Venkatesh
- Email: venkat@gencorpacific.com
- Phone: (852) 2987 6894
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.