What Participation Involves
A step-by-step overview of the study timeline, what is expected of participants, and what support the research team provides throughout.
At a glance
Understanding randomisation and blinding
What does randomised mean?
Randomisation means that participants are assigned by chance to one of two groups: the creatine monohydrate group, or the placebo group. This process is similar to a coin toss and is conducted by an independent system. Neither you nor the research team choose which group you are assigned to. Randomisation helps to ensure that the two groups are as comparable as possible, reducing the likelihood of bias in results.
What does double-blind mean?
Double-blind means that during the trial, neither you as the participant nor the members of the research team who interact with you know which group you have been allocated to. The supplement provided (creatine monohydrate or placebo) is identical in appearance and taste. Blinding is maintained for the safety and scientific integrity of the study. Unblinding may occur if required for safety reasons, and you will be informed of your allocation at the conclusion of the study.
Placebo group
Participants in the placebo group will receive a supplement that is identical in appearance and taste to creatine monohydrate but contains no active ingredient. Being in the placebo group is an equally important contribution to the research. At the conclusion of the study, all participants will be informed of their allocation.
Study timeline
The following is a general overview of the study process. Specific procedures will be described in the Participant Information Sheet.
Expression of interest & pre-screening
Complete the online expression of interest form (via REDCap). This collects basic eligibility information. The research team will review your responses and contact you. This is not enrolment.
Online · ~5–10 minutesEligibility screening
If initial criteria are met, the research team will conduct a more detailed eligibility assessment. This may include a health questionnaire, a brief cognitive screen, and a review of your medical history. The research team will discuss any questions you have. You are under no obligation to proceed.
Phone / online · ~20 minutes]Informed consent
If you are eligible and wish to proceed, you will receive the Participant Information Sheet and Consent Form (PISCF). You are encouraged to read this carefully, discuss participation with family or your doctor if you wish, and ask the research team any questions. When you are ready, informed consent is provided in writing (including electronic consent via REDCap). You may withdraw consent at any time.
Your decision — take your timeBaseline assessment
Before commencing the intervention, you will complete a baseline assessment. This includes cognitive assessments, mood questionnaires, health measures, and other study-specific measures as described in the PISCF. Most components are completed online; however your blood sample requires an in person visit to your local pathology centre.
Online · ~60-90 minutesRandomisation
Following baseline assessment, you will be randomly assigned to receive either creatine monohydrate or a placebo supplement for 12 weeks. This assignment is made by an independent, automated system. You will not be told which group you are in until the study concludes, unless unblinding is required for safety.
By chance — independent system12-week intervention
Over the 12 weeks, you will take the assigned supplement daily as directed by the research team. The specific dose and frequency will be described in the PISCF. You will be asked to complete regular check-ins (e.g., brief online questionnaires or phone calls) to monitor adherence and wellbeing. Safety monitoring occurs throughout.
12 weeks · daily supplement · regular check-insMonthly Check-ins
There will be monthly online assessments and a brief check-in call from the research team, however they will be available to support at any time throughout the trial. Safety data will be reviewed throughout the intervention period.
Week 0, Week 4, Week 8, Week 12End-of-study assessment
At the end of the 12-week period, you will complete a final assessment. This mirrors the baseline and includes cognitive assessments, mood questionnaires, and health measures. Any remaining supplement will be returned or disposed of as directed.
Online · ~60-90 minutesUnblinding & follow-up
Following the completion of assessments and data review, participants will be informed of their group allocation. There may be a follow-up contact at Week 16 (four weeks after the trial finishes) to assess your wellbeing. Results from the study will be communicated to participants in a summary report.
Study complete — allocation revealedKey aspects of participation
Time commitment
We estimate participation will require approximately 10 hours in total across the study, including assessments, supplement intake, and regular check-ins. We are committed to minimising burden on participants and have designed the study with your time in mind.
Remote & online components
Most components of the study are designed to be completed remotely, including the expression of interest, informed consent, cognitive assessments, and mood questionnaires. In-person requirements, if any, will be clearly described in the Participant Information Sheet.
Assessments
Assessments include standardised cognitive tests, validated mood questionnaires, and health-related measures as specified in the protocol. The research team will guide you through each assessment. Some assessments may be administered by telephone or videoconference.
Safety monitoring
Your safety is the priority throughout this study. Regular safety monitoring is conducted by the research team. Participants are asked to report any unexpected symptoms or health events to the research team promptly. An independent Data Safety Monitoring Committee provides oversight. Unblinding may occur at any time if required for your safety.
Your rights as a participant
Participation is entirely voluntary. You may withdraw from the study at any time, without providing a reason, and without any consequence to your healthcare, your relationship with the research team, or any other service. Your withdrawal will not affect data already collected unless you specifically request its removal. You may ask questions at any point during the study.
Confidentiality & data
All personal and health information collected during this study will be treated as confidential. Data will be stored securely and handled in accordance with the Privacy Act 1988 (Cth) and the Western Sydney University Privacy Policy. De-identified data may be used in academic publications. The Participant Information Sheet provides full details on data handling.
Have questions about participation?
Read the FAQs or contact the research team directly. We are happy to discuss what participation involves before you decide.