As part of the screening process for the study, you will have a DEXA scan to check your current bone density. This scan is provided as part of the study and is at no cost to you. If you are within the normal range, you will be eligible to join the study. If your scan detects abnormally low bone density, you will be referred to our study doctor for a consultation (at no cost to you).
Once we have confirmed that you have normal bone density, you will be allocated to one of the treatment groups.
The study is a randomized clinical study with two treatment groups. Each group will involve approximately 150 participants (300 in total).
- 150 participants will receive prebiotic/probiotic capsules + Vitamin D
- 150 participants will receive control (placebo) capsules + Vitamin D
As well as taking the study product, you will be asked to attend interviews, either at the clinic or via telephone consultation, and complete several assessments over the 12 months of the study.
The assessments for this study are as follows:
In your home
- Online Gastrointestinal Questionnaire (Weekly at weeks 1, 2, 3 and 4)
- Fecal Sample – via in home kit (Baseline, 6 months and 12 months)
At RDC Clinic Newstead (free parking available at the door)
- Blood Sample (Baseline, 6 months and 12 months)
- Online Questionnaires (Baseline, 3, 6, 9 and 12 months)
Exact Radiology Newstead (free parking available at the door)
- DEXA Scan (Baseline, 6 months and 12 months)
- CT Scan (Baseline and 12 months)
You will be provided with your bone density results within 2 weeks of each assessment. At the conclusion of your participation in the study, you will also be provided with a summary of your menopause symptom questionnaire results.
Blood and fecal samples will be analysed after all participants of the trial have completed. In a large, long term study such as this one, this may be up to 2 years after you have completed your individual participation in the study. Therefore, your individual blood and fecal sample results will not be available to you.
Being part of the study, all health assessments are free and paid for by the study funds. You will also be renumerated ($600 in total) for your time and travel to participate in the study with payments for completed timepoints as follows:
- 3 months: $100
- 6 months: $150
- 9 months: $100
- 12 months: $250
If you would like to help research bone density after menopause, 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.