FAQs

What is the probiotic food supplement we are testing?

The probiotic supplement being used in the study is provided by Pendulum®. Pendulum® is a commercial biotechnology company involved in improving health through products targeting the human microbiome (gut bacteria).

Regarding the OsteoPreP study, Pendulum® provides capsules (active and placebo) and is funding the endpoints regarding blood glucose regulation. The capsules contain five unique strains of bacteria that help digest dietary fiber and produce butyrate, a key molecule in bone health. They also contain inulin, a prebiotic complex carbohydrate that will be fermented by the bacterial strains upon absorption. For more information about the supplements, please click here.

Can anyone participate in the study?

Unfortunately, only certain women can be considered. We are looking for 160 Caucasian women who are 40-65 years old, at least one year since last menses, and are living in Victoria, Australia.

Our main exclusion criteria include:

• Osteoporosis
• Diabetes
• Rheumatoid arthritis
• Inflammatory bowel disease
• Hormone replacement therapy
• Taking/taken osteoporosis medication

If you are interested in finding out if you are eligible to participate, please complete the OsteoPreP screening survey. Prior to being eligible for participation, a phone call and online screening survey must be completed.

What do we ask of our participants?

Commitment - 12 month long participation

Seven appointments over a 12 month period; 2 are online and the rest face to face. Duration of visits depends on what visit it is, but none are more than three hours long. Initial, six and twelve month visits include an interview, cognitive tasks, blood and stool sample collection, questionnaires, and measurements of attributes such as blood pressure and weight. Participants will be required to wear an activity monitor and a continuous glucose monitor for ten days at these timepoints. We also conduct bone density scans at initial and 12 month visits, and online surveys at three and six months. So yes, it is a big commitment, but the study visits are well spread over the year and there is some flexibility with completion of each study timepoint. And you do get something in return. Please see the OsteoPreP study schedule of visits for more information.

The study will look at how these measure might be affected by consuming a probiotic food supplement compared to a placebo. You will be asked to take one capsule of study supplement (provided by Pendulum®) twice a day (one capsule with breakfast and one with dinner) for one year.

What is in it for you?

Potential benefit(s) of participating in the study are:

• Free health check-ups over a twelve month period, including comprehensive bone health and body composition scans as well as blood and physical function tests.
• We cannot guarantee that you will receive any health benefits from participating in this study, however, a possible benefit may be improved bone health.
• We hope that in the future, the information gathered from this study will be used to inform new therapeutics that improve bone health and aid in the prevention of osteoporosis.
• You will be reimbursed $200 at the completion of all study visits to cover your expenses and transport related to the study.
• And finally, you will have the satisfaction of knowing you have made a vital contribution to a major research study on an especially important and current topic that affects postmenopausal women.

Where is the study conducted?

Participants will be asked to attend the ACU Melbourne Campus at the commencement of the study and again at six and twelve months.

Here is a map of our location.

Will I get the results for the study assessments / tests?

Results will be released to you and your doctor only if they come back abnormal.

Does the OsteoPreP study have ethics approval?

Yes. The study was granted research ethics approval by the ACU Human Research Ethics Committee (HREC 2021-122HC).

What is the ACU link?

The Australian Catholic University is an increasingly prominent Australian university with campuses in Victoria, New South Vales, Queensland, and Australian Capital Territory. It includes the Mary MacKillop Institute for Health Research (MMIHR), based in Melbourne. The MMIHR is an international leader in health research and is home to the OsteoPreP study. There is no catholic or religious "angle" to MMIHR or the OsteoPreP study.

Where can I get more information?

Please contact the OsteoPreP research team.

Contact number: 0484 190 073

Email: OsteoPreP@acu.edu.au

For the study participant information sheet please click here.

If you are interested in finding out if you are eligible to participate, please complete the OsteoPreP screening survey.