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 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, during this visit you will have a medical assessment and provide a blood and urine sample. Once you are enrolled there is an additional 12-13 clinic visits during the study (approximately 30 minutes – 1 hour).
Please see below for further information. You can find the registration of interest form at the bottom of this page.
Group 7
Visit 1 : Screening appointments (90 mins) available on Tuesdays and Wednesdays from September 8th
Visit 2 : Buccal Cell appointments (30 mins) available on Tuesdays and Wednesdays from September 8th
Visit 3 : (Day 1 of dosing) (45 mins) Tuesday September 29th
Visits 4 to 9 : (Days 2 to 7 of dosing) (20 to 30 mins each) Wednesday September 30th to Monday October 5th
Visit 10 : (Dosing day 10) (20 mins) Thursday October 8th
Visit 11 : (Dosing day 14) (30 mins) Monday October 12th
Visit 12 : (Dosing day 17) (30 mins) Thursday October 15th
Visit 13 : (Post-dosing day 22) (40 mins) Tuesday October 20th
Visit 14 : (Post-dosing day 29) (30 mins) Tuesday October 27th
Group 8
Visit 1 : Screening appointments (90 mins) available on Tuesdays and Wednesdays from September 8th
Visit 2 : Buccal Cell appointments (30 mins) available on Tuesdays and Wednesdays from September 8th
Visit 3 : (Day 1 of dosing) (45 mins) Wednesday September 30th
Visits 4 to 9 : (Days 2 to 7 of dosing) (20 to 30 mins each) Thursday October 1st to Tuesday October 6th
Visit 10 : (Dosing day 10) (20 mins) Friday October 9th
Visit 11 : (Dosing day 14) (30 mins) Tuesday October 13th
Visit 12 : (Dosing day 17) (30 mins) Friday October 16th
Visit 13 : (Post-dosing day 22) (40 mins) Wednesday October 21st
Visit 14 : (Post-dosing day 28) (30 mins) Tuesday October 27th
Group 9
Visit 1 : Screening appointments (90 mins) available on Tuesdays and Wednesdays from September 8th
Visit 2 : Buccal Cell appointments (30 mins) available on Tuesdays and Wednesdays from September 8th
Visit 3 : (Day 1 of dosing) (45 mins) Thursday October 1st
Visits 4 to 9 : (Days 2 to 7 of dosing) (20 to 30 mins each) Friday October 2nd to Wednesday October 7th
Visit 10 : (Dosing day 10) (20 mins) Saturday October 10th
Visit 11 : (Dosing day 14) (30 mins) Wednesday October 14th
Visit 12 : (Dosing day 17) (30 mins) Saturday October 17th
Visit 13 : (Post-dosing day 22) (40 mins) Thursday October 22nd
Visit 14 : (Post-dosing day 28) (30 mins) Wednesday October 28th
Group 10
Visit 1 : Screening appointments (90 mins) available on Tuesdays and Wednesdays from September 9th
Visit 2 : N/A
Visit 3 : (Day 1 of dosing) (45 mins) Tuesday October 6th
Visits 4 to 9 : Days 2 to 7 of dosing) (20 to 30 mins each) Wednesday October 7th to Monday October 12th
Visit 10 : (Dosing day 10) (20 mins) Thursday October 15th
Visit 11 : (Dosing day 14) (30 mins) Monday October 19th
Visit 12 : (Dosing day 17) (30 mins) Thursday October 22nd
Visit 13 : (Post-dosing day 22) (40 mins) Tuesday October 27th
Visit 14 : (Post-dosing day 29) (30 mins) Tuesday November 3rd
Group 11
Visit 1 : Screening appointments (90 mins) available on Tuesdays and Wednesdays from September 15th
Visit 2 : N/A
Visit 3 : (Day 1 of dosing) (45 mins) Wednesday October 7th
Visits 4 to 9 : Days 2 to 7 of dosing) (20 to 30 mins each) Thursday October 8th to Tuesday October 13th
Visit 10 : (Dosing day 10) (20 mins) Friday October 16th
Visit 11 : (Dosing day 14) (30 mins) Tuesday October 20th
Visit 12 : (Dosing day 17) (30 mins) Friday October 23rd
Visit 13 : (Post-dosing day 22) (40 mins) Wednesday October 28th
Visit 14 : (Post-dosing day 28) (30 mins) Tuesday November 3rd
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.
There are 11 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 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 12-13 times during the study. Please find a summary of the requirements below…
Visit Schedule
- Visit 2: approx. 45 minutes (only applicable for 3 arms, this visit can be combined with Day 1)
- Day 1 (visit 3): approximately 1 hour
- 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 or 22 (visit 13): approx 45 minutes
- Day 28 (visit 14): approx 30 minutes
Compensation
Compensation
You will be eligible for payment of up to either $1,940 or $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.
Study location...
Our clinic is located on Level 3, 252 St Pauls Terrace, Fortitude Valley.
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.
