We are doing this research to assess the safety of palmitoylethanolamide (PEA) when used over a 12-month period.

PEA is currently approved by the TGA for use for up to 21-days as, to date, the safety of long-term use (longer than 21-days) has not yet been examined in a clinical trial setting. It is hypothesised that there will be no difference between groups for serious adverse events, non-serious adverse events, vital signs, and biochemistry following 12 months of PEA supplementation.

Your involvement in this study will be required for approximately 13 months, 12 of which you will be required to take the Study Product daily.

To make the timings of study requirements as convenient as possible for you, we are recruiting on a rolling basis which means that your individual start date is flexible.

You will be required to attend our RDC Clinic in Brisbane for a screening appointment, and then once enrolled there is an additional 5 clinic visits during the study. Our RDC Clinic is open Monday to Saturday from 6.30am, and we offer free undercover parking.

Please see below for further information. You can find the registration of interest form at the bottom of this page.

Palmitoylethanolamide (PEA) is a Therapeutics Goods Administration (TGA) approved ingredient for use in listed medicines and is available for commercial purchase in Australia. TGA approval as an ingredient means the substance (PEA) has been independently assessed to be safe for human consumption. In the body, PEA is synthesized from palmitic acid (C16:0), the most common fatty acid in animals. PEA has previously been studied for its pain-relieving and anti-inflammatory effects.

After screening and enrolment, eligible participants will be asked to take 2 capsules daily for 12 months.

As this study is placebo-controlled, you will be randomly allocated to either the PEA group, or the placebo group on a chance basis. This means you will have a 50% chance of being allocated a study product containing PEA. During the study period, neither you nor the study investigators will know the product you have been allocated. However, if it is necessary for your health, we can find out which product you have been allocated.

Placebos are designed to look like the real product being studied except they do not contain the active ingredient. Using a placebo helps us to be confident that any effects we measure in the active group really are due to the active ingredient and not due to the body’s own reaction to a perceived treatment.

Please note: This page is a summary of the study outline and participant requirements. A full Participant Information Sheet with more detailed information will be provided to you before you are asked to give your consent to participate.

During the screening period, you will be required to attend a pathology collection clinic local to you (such as Sullivan Nicolaides Pathology) to provide a blood sample. Your blood will be checked to ensure that a range of markers are within a healthy range.

Once you are deemed eligible to continue with the final part of the screening, you will be asked to attend the RDC Clinic screening visit for a medical consultation. This screening visit will take approximately 30-60 minutes in total.

Eligible participants will be required to attend the RDC Clinic 5 times during the study. Please find a summary of the requirements below…

RDC Clinic (Fortitude Valley, Brisbane)

You will be required to attend our clinic 5 times once enrolled in the study. Each appointment will take approximately 30 minutes and involve a blood sample collection, vital signs and questionnaires.

• Baseline
• Month 3
• Month 6
• Month 9
• Month 12

You will be eligible for payment/reimbursement of up to $500 for your time and out of pocket expenses (such as travel). The reimbursement will be made via direct deposit to your nominated bank account or by gift voucher (your choice) after study requirements have been met per below.

Screening appointment $50
Week 0 (Baseline) clinic appointment $80
Month 3 clinic appointment $80
Month 6 clinic appointment $80
Month 9 clinic appointment $80
Month 12 (final) clinic appointment $130

If you would like to participate, we’d love to hear from you. Please register your interest by answering the questionnaire and completing the form on this page…we’ll then get in touch to screen you for eligibility.

Our clinic is located on Level 3, 252 St Pauls Terrace, Fortitude Valley.

We have free undercover parking for participants directly next door under the Kennigo Hotel, 22 Kennigo Street, Fortitude Valley.

Getting to Us

• Private Transport: limited paid street parking is available in the nearby streets
• Train: Fortitude Valley Train Station (350m away)
• Bus: multiple bus stops within close proximity

• Adults over 18 years old
• BMI between 18.5-35 kg/m2 (Please use the BMI calculator on this page)
• Healthy with no uncontrolled serious illnesses
• Able to provide informed consent
• Able to commit to completing the study requirements over a 12 month period

Please register your interest by answering the questionnaire and completing the form on this page… we’ll then get in touch to screen you for suitability.

Please note: This page is a summary of the study outline and participant requirements. A full Participant Information Sheet with more detailed information will be provided to you before you are asked to give your consent to participate.

BMI Calculator

This RDC Clinical study has been approved by the Bellberry Human Research Ethics Committee under Approval Number: 2024-05-688. The study is also registered on the clinicaltrials.gov under Registration Number: {insert number}.

Trained Trial Co-ordinators will supervise your progress throughout the study. Your results will be made available to you at the conclusion of the study. Any of your personal information collected during the study will be kept in the strictest confidence.