This is a 12 month study looking to assess the long term safety of Palmitoylethanolamide (PEA).
PEA is currently approved by the therapeutic goods administration (TGA) for use for up to 21-days. This is because to date, specific safety studies on the long-term use (longer than 21-days) of PEA have not been conducted. Therefore, the aim of the current study is to assess the safety of long-term (12 months) use of PEA.
PEA has previously been studied for its pain-relieving and anti-inflammatory effects. It has been shown to help modulate the inflammatory response and reduce pain. PEA is found in various foods, including egg yolk, peanuts, and soybeans. It can also be synthesized and is available as a dietary supplement.

We are looking to enrol 200 generally healthy adults willing to consume 2 capsules of study product daily for 12-months.

As this is a placebo controlled study, you will have a 50% chance of being allocated to the PEA group, and a 50% chance to being allocated to the placebo group. 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.

To determine your suitability for this study, we will start by asking you some questions over the phone today. As part of the screening process, you will need to attend an SNP pathology centre for a blood test. Once we have checked your results against our eligibility criteria, we'll then schedule a time for you to attend will a physical health assessment with our trial doctor at the RDC clinic in fortitude valley.

If you are found to be suitable for the study after all the screening measures have been completed, you will attend a baseline appointment where you will complete some questionnaires, basic measures and be allocated your study product.
It may be possible to complete your baseline appointment immediately after your health assessment with the trial doctor.

Once you have started the study product, you will need to return to the RDC clinic every 3 months for a follow up appointment and blood test.
We will also be in regular contact with you throughout the study with monthly check in calls.

You will be eligible for a payment/reimbursement of up to $500 for your time and travel expenses .
Do you have any questions about the study?

Thank you for your time on the phone. We will now email out a consent form for you to read through and sign. Please get that back to us as soon as possible so we can send out your referral form for SNP.
Once you have been for your blood test, please let us know so we can keep an eye out for your results and schedule in your screening and baseline clinic appointments.

Do you have any questions?