STUDY ANNOUNCEMENT
ARA Omega-6 Study
Seeking adults (from in or around Brisbane) aged 18 years or older who are interested in assisting in researching Omega-6 in the form of Arachidonic Acid (ARA).
Thank you for your interest
Thank you for your interest in our Omega-6 study. We are looking for healthy adults (aged 18 years or older) who are interested in helping with medical research over approximately 4 weeks.
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.
Why is this study being conducted?
This research is being conducted to assess the safety and tolerability of Omega-6 as a food additive containing Arachidonic Acid (ARA) over 28 days.
It is hypothesised that all dosages of ARA supplementation in this study will result in a low number of side effects and with no changes to safety pathology markers. It is also hypothesised that as the consumption quantity of ARA is increased, the amount of ARA seen in the blood will also increase.
How long is the study, and when does it start?
Your involvement in this study will be required for approximately 4 weeks. Within the study period you will be required to take the Study Product containing ARA daily for 21 days.
To make the timings of study requirements as convenient as possible for you, we are recruiting on a rolling basis in small groups of 6 people, which means that there will a selection of starting dates available.
During the screening process you will be required to attend our RDC Clinic (Fortitude Valley, Brisbane) for a screening appointment and also attend a local SNP pathology clinic to provide a blood and urine sample. Once you are enrolled there is an additional 13 clinic visits during the study comprising 1 full day (9 hours) and 12 short follow up visits (approximately 30 minutes – 1 hour).
Please see below for the study dates and further information. You can find the registration of interest form on this page.
Group 1
Tuesday April 15th – Visit 1 – Medical Screening with ECG – 1 hr appointment
Tuesday April 22nd – Visit 2 – Buccal Sample Collection – 45 min appointment
Tuesday April 29th – Visit 3 – 9 hr PK full day in the RDC clinic
Wednesday April 30th to May 5th – Visits 4-9 – 30-40 minute daily morning check-ins
Thursday May 8th – Visit 10 – 30 minute daily morning check-in
Monday May 12th – Visit 11 – 40 minute daily morning check-in
Thursday May 15th – Visit 12 – 30 minute daily morning check-in
Tuesday May 20th – Visit 13 – 1 hr daily morning check-in with final buccal sample
Tuesday May 27th – Visit 14 – Day 29 Final Medical and check-in – 1 hr appointment
Group 2
Tuesday April 22nd – Visit 1 – Medical Screening with ECG – 1 hr appointment
Tuesday April 29th – Visit 2 – Buccal Sample Collection – 45 min appointment
Tuesday May 6th – Visit 3 – 9 hr PK full day in the RDC clinic
Wednesday May 7th – May 12th – Visits 4-9 – 30-40 minute daily morning check-ins
Thursday May 15th – Visit 10 – 30 minute daily morning check-in
Monday May 19th – Visit 11 – 40 minute daily morning check-in
Thursday May 22nd – Visit 12 – 30 minute daily morning check-in
Tuesday May 27th – Visit 13 – 1 hr daily morning check-in with final buccal sample
Tuesday June 3rd – Visit 14 – Day 29 Final Medical and check-in – 1 hr appointment
Group 3
Tuesday April 29th – Visit 1 – Medical Screening with ECG – 1 hr appointment
Tuesday May 6th – Visit 2 – Buccal Sample Collection – 45 min appointment
Tuesday May 13th – Visit 3 – 9 hr PK full day in the RDC clinic
Wednesday May 14th – May 19th – Visits 4-9 – 30-40 minute daily morning check-ins
Thursday May 22nd – Visit 10 – 30 minute daily morning check-in
Monday May 26th – Visit 11 – 40 minute daily morning check-in
Thursday May 29th – Visit 12 – 30 minute daily morning check-in
Tuesday June 3rd – Visit 13 – 1 hr daily morning check-in with final buccal sample
Tuesday June 10th – Visit 14 – Day 29 Final Medical and check-in – 1 hr appointment
Group 4
Tuesday May 6th – Visit 1 – Medical Screening with ECG – 1 hr appointment
Tuesday May 13th – Visit 2 – Buccal Sample Collection – 45 min appointment
Tuesday May 20th – Visit 3 – 9 hr PK full day in the RDC clinic
Wednesday May 21st – May 26th – Visits 4-9 – 30-40 minute daily morning check-ins
Thursday May 29th – Visit 10 – 30 minute daily morning check-in
Monday June 2nd – Visit 11 – 40 minute daily morning check-in
Thursday June 5th – Visit 12 – 30 minute daily morning check-in
Tuesday June 10th – Visit 13 – 1 hr daily morning check-in with final buccal sample
Tuesday June 17th – Visit 14 – Day 29 Final Medical and check-in – 1 hr
Group 5 – TBC
Group 6 – TBC
About the product you'll help investigate...
Arachidonic acid (ARA) is a polyunsaturated omega-6 fatty acid found in the phospholipids of cell membranes, especially in the brain and muscles. It plays a crucial role in cellular signalling and is a precursor for the biosynthesis of prostaglandins, thromboxanes, and leukotrienes, which are involved in inflammation and immunity. The supplementation of ARA has been studied in various contexts, including athletic performance, inflammation, and mental health.
It is hoped that further research on ARA in the future will show that it can reduce cell damage from irradiation and chemotherapy in patients receiving cancer treatment.
For this study, the supplement containing ARA will be supplied in a powder, and will be consumed by being mixed into a drink or soft food each morning for 21 days (in the morning).
There are 6 study groups, and each will be allocated a different quantity of supplement containing ARA to consume. As this is an open-label study, both you and the investigators will know which group you have been allocated to.
What is required by participants?
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 the RDC Clinic for a medical consultation, and you will be provided with a referral form for a pathology collection clinic local to you (Sullivan Nicolaides Pathology) to provide a blood and urine sample. Your blood will be checked to ensure that a range of markers are within a healthy range (and females are not pregnant). Your urine will be tested to ensure that you don’t have any illicit drugs in your system.
RDC Clinic (Fortitude Valley, Brisbane)
Eligible participants will be required to attend the RDC Clinic 13 times during the study. Please find a summary of the requirements below…
Visit Schedule
- Visit 2: approx. 45 minutes
- Day 1 (visit 3): approximately 9 hours*
- Days 2 – 7 (visits 4 – 9): approx 30 minutes each
- Day 10 (visit 10): approx 30 minutes
- Day 14 (visit 11): approx 30 minutes
- Day 17 (visit 12): approx 30 minutes
- Day 21 (visit 13): approx 45 minutes
- Day 28 (visit 14): approx 30 minutes
*The Day 1 visit is an absorption study designed to assess how quickly and how much of the study product is absorbed in the blood. As such, on this day, participants will be required to remain in the RDC Clinic for approximately 9 hours where a blood sample will be collected every 2 hours (5 samples in total). On this day, rather than multiple needle pricks, a cannula will be inserted into the arm (at the inner elbow).
Subsequent visits will all be conducted in the morning between approx. 6am and 10am.
SNP (you may attend any Sullivan Nicolaides Pathology convenient to you)
- Once during the screening process to provide a blood and urine sample
Compensation
Compensation
You will be eligible for payment of up to $2,790 as reimbursement 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. Pro rata payments are available and full details are provided in the Participant Information and Consent Form.
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.
Check if you can register to take part…
- Adults 18 years or older
- BMI between 18.0-32 kg/m2 (Please use the BMI calculator on this page)
- Healthy with no uncontrolled or serious illnesses
- Able to provide informed consent
- Able to have multiple blood draws during the study period
- Able to attend the RDC Clinic for the specified visits
BMI Calculator
Ethics approval & privacy
This RDC Clinical study has been approved by the Bellberry Human Research Ethics Committee under Approval Number: 2024-09-1161.
Trained Investigators and Trial Coordinators will supervise your progress throughout the study. Personal information collected during the study will be kept in the strictest confidence. Results are analysed in a de-identified manner.