ATLAS Study

The ATLAS study is a 12-week research study testing a new treatment for knee osteoarthritis. The new treatment is a combination of supplements containing Boswellia serrata extract, pine bark extract, methylsulfonylmethane, piperine and curcumin.

The aim is to find out if this combination can help relieve knee pain and if it is safe and easy to tolerate for people with knee osteoarthritis.

The supplement is in a capsule and will be taken orally. Our research team has already tested this dose in healthy volunteers and people with hand osteoarthritis.

In the ATLAS study, we're using a randomised placebo-controlled approach. This means we're comparing how well the supplement works against a placebo (a dummy pill with no active ingredients). Participants are randomly assigned to either take the supplement capsule or the placebo capsule. This helps to see if the supplement really works.

Watch the video below to learn more:

Study aims

Aim 1

To assess how effective a supplement combination is in reducing knee pain in people with symptomatic knee osteoarthritis compared to a placebo over 12 weeks.

Aim 2

To determine the safety of the supplement combination compared to placebo over 12 weeks.

Who can take part?

The study is suitable for people who:

• Are aged 40 years or older

• Have knee pain for more than half of the days in the past month

• Are willing to maintain a routine (i.e., consistent dosage and frequency) of any other over-the-counter and prescription therapies while on the study

• Are willing to abstain from any supplements targeting osteoarthritis for the duration of the study

  • • Diagnosis of knee osteoarthritis as defined by the Clinical and Radiographic American College of Rheumatology (ACR) criteria

    • Pain in at least one knee for at least half of the days in the previous month

    • Moderate average knee pain intensity during activities of daily living

    • Radiographic tibiofemoral (TF) and/or patellofemoral (PF) osteoarthritis Kellgren-Lawrence Grade (KLG) 2 or more of the knee

What is involved for participants?

• The study will go for 12 weeks and will be conducted as an online trial using online surveys. We will mail the study treatments to you free of charge.

• If you are interested in participating in this trial, you will be asked to fill out an online screening survey to see if the study is suitable for you.

• If you meet the survey eligibility criteria, you will need to have an X-ray taken of both knees using a referral that the study team will send to you.

• If you are taking pain medication or supplements, we will ask you to discontinue them for the week leading up to your first round of pain assessment surveys.

• During the study you will be required to complete weekly surveys for 12 weeks to record your pain intensity, treatment compliance, any adverse events and the consumption of pain medication.

• You will need to refrain from taking study-prohibited medications for the 12-week study period. A list of all prohibited medications will be provided to you.

• If you choose to donate your blood samples you’ll be asked to visit Royal North Shore Hospital and 10ml of blood will be collected at your baseline visit (before taking the products), at week 2 and at week 12. This is optional.

• During the study, you will need to take the study treatment as 2 capsules in the morning and 2 in the evening every day for the 12 weeks.

ATLAS Study FAQs

  • If you are interested in joining the study, first you will need to complete the online screening survey. The online screening survey will assess if the study might be suitable for you.

    After you submit the online screening survey and you are potentially eligible, a member of the study team will be in contact with you to explain the next steps of the screening process.

  • An online, double-blind, randomised, placebo-controlled sTudy to assess the efficacy and safety of an oraL supplement combinAtion in people with Symptomatic knee osteoarthritis.

  • You will remain in the study for 12-weeks from the first day that you take your first capsules.

  • No. This is a randomised trial meaning that participants will be randomly assigned to either the supplement group or the placebo group.

    There is a 50/50 chance of being allocated to either group.

  • The placebo capsule contains microcrystalline cellulose and sunflower seed oil.

  • Participants will receive a $50 gift voucher at the end of the 12 weeks.

    Participants who choose to participate in the sub-study will receive an additional $20 gift voucher after each blood collection visit.

  • Participants will need to have an X-ray taken. You may choose to participate in the sub-study which will require three additional study visits for blood collection at baseline (before taking the products, week-2 and week 12.

    All other components of the study will be conducted over the internet, which means it is an online trial.

    Online research means that you will not need to attend face-to-face during the study. All the procedures, including the screening, enrolment and follow-up assessments, will be conducted remotely using online surveys.

    We will provide the study products to you via courier free of charge.

  • If living in Sydney, participants are encouraged to have their initial X-ray taken at Castlereagh Imaging in St. Leonards. If this is not possible, participants will be able to generate a X-ray referral online and take this X-ray referral to any imaging centre.

  • If you have had an X-ray on your study knee in the last 12 months then we can use that X-ray scan in our assessment. If your X-ray was more than 12 months ago, you will need to have a new scan done using a X-ray referral we will send to you via email.

  • Blood samples are collected at your first visit (baseline), week 2 and week 12. Blood samples will be stored in a biobank and used for future studies or clinical trials investigating osteoarthritis.

  • We will provide the study products to you via courier free of charge.

  • You will need to take 2 capsules in the morning and 2 capsules in the evening every day for 12 weeks.

  • For your safety, we will prohibit the use of some drugs during the study. This is to avoid a mix-up of effects between your medication and the intervention being tested. A full list of prohibited medications will be provided to you once you join the study, however, include:

    • Corticosteroids (oral, intra-articular or intramuscular)

    • Muscle relaxants: amphetamines, barbiturates, benzodiazepines

    • Supplements containing any of the ingredients in the study treatment

  • All surveys except for the baseline survey take approximately 10-15 minutes to complete. The baseline survey will take approximately 1 hour to complete. . A total of three and a half hours or so will be required during this study.

  • If you are interested in joining the study, please complete the online pre-screening survey here. If you meet the eligibility criteria, the study team will be in contact via email or phone.

  • Yes. At the end of your time in the study, you will be notified via email whether you were allocated to the supplement group or the placebo group.

Have a question?

Please send an email to atlas.study@sydney.edu.au

Join the ATLAS study

Have you stopped doing your favourite activities due to knee pain? We may be able to help. Check your eligibility today by clicking the button below: