Frequently Asked Questions

MENOCOG is a university-led clinical feasibility trial investigating the feasibility, acceptability, and safety of creatine monohydrate supplementation in postmenopausal females with dementia risk. The full approved title of the study is:

"Feasibility, acceptability, and safety of creatine monohydrate supplementation for cognitive function and mood in postmenopausal females with dementia risk: a randomised, double-blind, placebo-controlled, feasibility trial."

It is conducted by NICM Health Research Institute at Western Sydney University and has received ethics approval from Western Sydney University Ethics Committee (Ethics Approval Reference: H16573).

No. This is an important distinction. MENOCOG is a feasibility trial. Its purpose is to determine whether a larger, full-scale clinical trial could be conducted — not to test whether creatine monohydrate prevents or treats dementia.

Primary outcomes are related to feasibility (e.g., can we recruit and retain participants?), acceptability (e.g., is the protocol manageable for participants?), and safety (e.g., are there any adverse effects?). Cognitive and mood measures are included as secondary and exploratory outcomes only, to inform the design of potential future research. No efficacy claims are made or implied by this study.

Creatine monohydrate is a naturally occurring compound found in small quantities in some foods (particularly meat and fish) and produced by the body. It is widely used as a nutritional supplement and has a well-established safety profile in healthy adult populations over many years of research.

It is important to note that creatine monohydrate is not approved as a treatment or preventive agent for any medical condition. Its use in this study is investigational. The study is exploring whether supplementation in this specific population is feasible and safe, not whether it is effective as a medical treatment.

Randomised means that participants are assigned to a group (creatine monohydrate or placebo) by chance — similar to a coin toss. Neither you nor the research team chooses which group you are in.

Double-blind means that during the trial, neither participants nor the research team members who interact with them know which group each participant has been allocated to. This reduces bias.

Placebo-controlled means that one group receives the active supplement (creatine monohydrate) and the other receives an identical-looking and -tasting placebo (inactive supplement). This allows for a controlled comparison.

Participants will be informed of their group allocation at the conclusion of the study, or earlier if required for safety.

No — not during the study. As described above, the study is double-blind. You will not be told whether you are receiving creatine monohydrate or a placebo until the study has concluded. This is necessary to maintain the scientific integrity of the study and reduce the risk of bias.

Unblinding may occur if required for your safety. At the conclusion of the study, all participants will be informed of their allocation.

Yes, participation is entirely voluntary. Registering interest, completing the screening process, and commencing the study are all voluntary. You are under no obligation to participate at any stage, and you may choose not to continue at any point for any reason.

Deciding not to participate will not affect your relationship with the research team, Western Sydney University, or any other services.

Yes. You may withdraw from the study at any time, without providing a reason, and without any consequence to your relationship with the research team and Western Sydney University.

If you withdraw, data collected up to the point of withdrawal may still be used in research analyses unless you specifically request that it be removed. The research team will discuss your preferences with you at the time of withdrawal.

As with any supplement, there is a possibility of side effects. Creatine monohydrate has a well-established safety record in healthy adult populations; however, all potential risks are not yet fully characterised in postmenopausal females, which is one reason this feasibility and safety study is being conducted.

Commonly reported and generally mild effects associated with creatine supplementation in other populations may include temporary gastrointestinal discomfort (e.g., bloating, nausea) and water retention. These are not universal and vary between individuals.

Any risks specific to this population and study protocol will be described fully in the Participant Information Sheet, which you will receive before deciding whether to consent to the study. You are encouraged to discuss any health concerns with your GP or the research team before enrolling.

Safety monitoring occurs throughout the study. You are asked to report any unexpected symptoms to the research team promptly.

No. There is no cost to participants. The study supplement (creatine monohydrate or placebo) is provided free of charge for the duration of the study. Any assessments conducted as part of the study are also provided at no cost. If you decide to participate in the trial, you will be offered reimbursement for your time.

Reimbursement provisions will be outlined in the Participant Information Sheet.

Yes. All personal and health information collected during this study will be treated as confidential. Data will be stored securely in accordance with the Privacy Act 1988 (Cth) and Western Sydney University's data security policies.

Your name and contact details will not appear in any published research. Study results may be reported in aggregate (de-identified) form in academic publications and research reports. The research team may access your identified data for the purposes of conducting and managing the study.

Full details of data collection, storage, access, and retention are provided in the Participant Information Sheet.

You can register your interest by completing the online expression of interest form via the Register Interest page. This form is hosted on REDCap, a secure research data collection platform used by universities and research institutions worldwide.

Completing the expression of interest form is not enrolment and does not commit you to participating. The research team will review your responses and contact you about the next steps if appropriate.

You may also contact the research team directly via email or telephone — details are available on the Contact page.

For questions about the study, please contact the research team:

📧 [INSERT STUDY EMAIL]
📞 [INSERT STUDY PHONE]

If you have concerns about the conduct of this study that you do not wish to raise with the research team, you may contact the Human Research Ethics Committee at Western Sydney University:

Tel +61 2 4736 0229 or email humanethics@westernsydney.edu.au.

You also have the right to contact the NSW Health Care Complaints Commission (or equivalent body) if you have broader concerns about research conduct.