About MENOCOG
Understanding what this study is, what it is investigating, and the outcomes being assessed.
Approved study title
"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."
What is the study about?
Menopause is a natural biological transition that typically occurs in midlife. For some women, this life stage may coincide with changes in cognitive function — such as memory, concentration, and processing speed — as well as changes in mood. Research in this area is still developing, and the relationship between menopause, hormonal changes, and brain health is the subject of ongoing scientific investigation.
Creatine monohydrate is a well-studied nutritional supplement with an established safety profile in healthy adults. Some preliminary research has explored its potential effects on brain health and cognition. Whilst current studies show promise, more research is needed to understand the effects of creatine on cognition, mood and emotional regulation.
Before a full-scale efficacy trial could be designed and conducted, it is essential to first determine whether such a trial is feasible, acceptable to participants, and safe. This is the purpose of the MENOCOG trial.
The findings of MENOCOG will be used to inform the design of future research, not to establish whether creatine monohydrate is effective.
Primary focus
Feasibility, Acceptability & Safety
The primary outcomes of MENOCOG are measures of study feasibility — including recruitment rates, protocol adherence, and participant retention — and a safety assessment of creatine monohydrate supplementation in postmenopausal females with dementia risk.
Secondary & exploratory
Cognitive & Mood Measures
Cognitive function and mood assessments are included as secondary and exploratory outcomes. These data are collected to help design future research, not to test efficacy.
What this study is not claiming
It is important that potential participants understand the scope and limitations of this research before registering interest.
Not a dementia prevention trial
MENOCOG is not investigating whether creatine monohydrate prevents dementia. This study does not claim, suggest, or imply any protective effect against dementia or cognitive decline.
Not a cognitive enhancement trial
This study is not testing whether creatine monohydrate improves cognitive function. While cognitive improvements may occur, cognitive assessments are exploratory and secondary only, to inform future study design.
Not a menopause treatment
This study does not investigate or claim any effect on menopausal symptoms, hormonal changes, or menopause-related health outcomes.
Not a mood disorder treatment
Mood assessments are included as exploratory measures. This study does not investigate or claim any therapeutic effect on depression, anxiety, or other mood-related conditions.
What MENOCOG is investigating:
✓ Is a 12-week creatine monohydrate supplementation protocol feasible in this population?
✓ Is the study protocol acceptable to participants (e.g., burden, compliance, decentralised design)?
✓ What is the safety profile of this supplementation in postmenopausal females with dementia risk factors?
✓ Are the selected cognitive and mood outcome measures appropriate for use in a future full trial?
How the study is structured
Randomised
Allocation by chance
Participants are assigned by chance to receive either creatine monohydrate or a placebo. Randomisation helps to minimise bias and ensure that the groups are comparable.
Double-blind
Neither party knows allocation
During the trial, neither participants nor the research team know which group each participant has been allocated to. This is unblinded only if required for safety reasons.
Placebo-controlled
Comparison group
One group receives creatine monohydrate supplementation; the other receives an identical-looking and -tasting placebo. This design allows for controlled comparison.
Ethics & oversight
This study has been approved by Western Sydney University Ethics Committee (Ethics Approval Reference: H16573) and is conducted in accordance with the National Statement on Ethical Conduct in Human Research (2025) and the Declaration of Helsinki.
The study is overseen by Western Sydney University and the NICM Health Research Institute. A Data Safety Monitoring Committee provides independent safety oversight.
Would you like to register interest?
Registering interest is not a commitment to participate. The research team will review your enquiry and be in touch about eligibility.