Actively Recruiting

Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
NCT06717867

Long-Term PEA Safety Study

Led by RDC Clinical Pty Ltd · Updated on 2025-12-18

200

Participants Needed

1

Research Sites

122 weeks

Total Duration

On this page

Sponsors

R

RDC Clinical Pty Ltd

Lead Sponsor

G

Gencor Pacific Limited, Hong Kong

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Long-Term PEA Safety Study

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years and older
  • Generally healthy
  • Able to give informed consent
  • Body mass index (BMI) between 18.5 and 35.0 kg/m2
  • Agree not to join another clinical trial during this study period
Not Eligible

You will not qualify if you...

  • Current cancer (except Basal Cell Carcinoma) or cancer treatment in the past 2 years
  • Serious illnesses including mood disorders, anxiety, neurological disorders, kidney, liver, or heart conditions
  • Unstable illness such as uncontrolled diabetes or thyroid problems
  • History of kidney function problems
  • Taking blood thinning medications excluding low dose aspirin (under 300 mg/day)
  • Regular use of PEA more than 4 times per week in the past 2 weeks
  • Substance abuse including prescription or illegal drugs
  • Alcohol use exceeding 14 drinks per week in the past year
  • Pregnant or breastfeeding women
  • Allergy or intolerance to ingredients in the study capsules
  • Significant abnormal medical or lab findings at screening
  • Participation in another clinical trial within the last month
  • Any condition that investigator believes makes participation unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

RDC Clinical

Brisbane, Queensland, Australia, 4006

Actively Recruiting

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Research Team

R

RV Venkatesh

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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