NCT06717867

Long-Term PEA Safety Study

A Randomised, Double-blind Placebo-controlled Study in Healthy Adults to Assess Long Term Population Exposure to Palmitoylethanolamide (Levagen™) to Assess Clinical Safety.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: RDC Clinical Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn about the long term safety of PEA supplementation in healthy adults. This clinical trial will be in both males and females who are 18 years or older and are healthy volunteers. The main aim of the study is to assess the safety of long-term use of PEA by assessing the difference between the two groups for serious adverse events, non-serious adverse events, vital signs and biochemistry following 12 months of PEA supplementation. Participants will: * Have their suitability for the study checked against the full inclusion/exclusion criteria during the screening process. * Eligible participants will then complete a baseline visit where assessments will be performed and the participant will be randomly assigned to receive the study product or a placebo. Participants will then consume their assigned study product every day for 12 months. Participants will not know what product they have been assigned during the study. * Following the baseline visit, there will be 4 visits over 12 months. On months where participants do not have a visit there will be a check in phone call. * During visits there will be safety assessments performed, blood sampling and questionnaires. The trial will include two participation modes: 1. In-clinic participation (Brisbane): Participants will attend all visits in-person at the RDC Clinical facility. 2. Remote participation for participants outside of Brisbane: A subgroup of up to 120 participants will participate remotely with virtual visits and at-home assessments. Participants will attend their local pathology centre for blood sampling.

Detailed description

This is an interventional, phase II, randomised, double-blind, placebo-controlled, parallel dose safety study in healthy adults to assess long term population exposure to Palmitoylethanolamide (Levagen™).

Conditions

• Healthy
• Safety

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Palmitoylethanolamide (PEA)	Levagen™ capsule containing 300mg Palmitoylethanolamide (PEA). 600mg PEA per day.
OTHER	Placebo	Placebo capsules contain 300 mg microcrystalline cellulose (MCC), 600mg per day.

Timeline

• Start date: 2025-01-22
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-12-05
• Last updated: 2025-12-18

Locations

1 site across 1 country: Australia