We are doing this research to assess the safety and also the effectiveness in improving sleep, stress and joint health 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, and there will be a positive difference in the active group on sleep, stress and joint health.

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 have a telephone or video call for a screening appointment, and then once enrolled there is an additional 5 telehealth calls during the study. In addition to the calls, you will be required to attend an approved pathology collection centre (listed below) once at screening, and a further 4 times during the study.

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 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 local approved Pathology collection centre (see list below) 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 virtual 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 virtual appointment 5 times during the study. Please find a summary of the requirements below…

Virtual appointment via telephone or video call

You will be required to attend virtual visit 5 times once enrolled in the study. Each appointment will take approximately 15-30 minutes and include questionnaires relating to your sleep, stress, general health and joint health. In addition at each timepoint (besides Baseline) you will be required to attend a local pathology collection centre to provide a small blood sample.

• 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 call and blood sample $50
• Week 0 (Baseline) telehealth call $80
• Month 3 telehealth call and blood sample $80
• Month 6 telehealth call and blood sample $80
• Month 9 telehealth call and blood sample $80
• Month 12 (final) telehealth call and blood sample $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.

To make participation in this study possible in multiple locations around Australia, participants can attend any of the following collection centres. It is important that you do not attend any other type of collection centre.  Before registering your interest, please check that you have an approved collection centre near you.

NSW and ACT:

Douglass Hanly Moir Pathology (DHM): https://www.dhm.com.au/locations/

Southern.IML Pathology: https://www.southernpath.com.au

Capital Pathology: https://www.capitalpath.com.au/our-locations/

VIC:

Melbourne Pathology: https://www.mps.com.au/locations/

QLD:

Sullivan Nicholaides Pathology (SNP): https://www.snp.com.au/our-locations/

WA:

Clinipath Pathlogy: https://www.clinipathpathology.com.au/our-locations/

SA:

Clinpath Pathology: https://www.clinpath.com.au/locations/

NT:

Sullivan Nicholaides Pathology (SNP): https://www.snp.com.au/our-locations/

TAS:

Hobart Pathology: https://www.hobartpath.com.au/our-locations/

Launceston Pathology: https://www.launcestonpath.com.au/our-locations/

North West Pathology: https://www.northwestpath.com.au/our-locations/

• 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
• Able to attend an approved pathology collection centre (from the list above)

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.

BMI CALCULATOR

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.

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: NCT06717867.

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.