Not Yet RecruitingPhase 1ACTRN12625001344482

The MENOCOG Trial: Feasibility, acceptability, and safety of creatine monohydrate supplementation for cognitive function and mood in postmenopausal females with subjective cognitive decline: a randomised, double-blind, placebo-controlled, parallel-group trial

Sponsor

Western Sydney University

Enrollment

86 participants

Start Date

Feb 2, 2026

Study Type

Interventional

Conditions

Postmenopause Subjective Cognitive Decline

Summary

In Australia, dementia is the leading cause of death in females over 65 years of age. The menopause transition is an important physiological event unique to women that can increase susceptibility to cognitive decline and risk of dementia. During menopause, the ability for the brain to produce cellular energy to support healthy function is reduced. Emerging evidence suggests creatine monohydrate can support brain energy production and improve cognitive function and mood. The current study will evaluate the feasibility, acceptability, and safety of oral creatine monohydrate for cognitive function and mood in postmenopausal females with SCD using a 12-week randomised, double-blind, placebo-controlled, parallel group trial.

Eligibility

Sex: FemalesMin Age: 45 YearssMax Age: 65 Yearss

Inclusion Criteria9

Female sex.
Postmenopausal: Stage 1+ A according to Stages of Reproductive Ageing Workshop + 10 (STRAW+ 10, defined as > 12 months since last menstrual cycle).
– 65 years of age.
Present with subjective cognitive decline according to SCD-1 criteria (self-experienced decline in cognitive capacity in comparison with previously normal status persisting at least 6 months, that is not related to an acute event, and normal performance on standardised cognitive tests used to classify mild cognitive impairment (score < 35 with M@T tool).
Increased risk of dementia based on the CogDRisk assessment tool (score > 12).
Family history of dementia (1st degree relative).
Ability to read, write, and communicate proficiently in English.
Must have internet access, computer and/or tablet and/or smart phone at home, and mobile phone access (for SMS and calls).
Willing to complete all study-related activities for the complete trial including pathology tests, assessments and follow-ups.

Exclusion Criteria14

Current or historical use of creatine monohydrate supplementation within the past 5 weeks (a period considered sufficient for brain creatine levels to return to baseline).
A diagnosis of MCI or dementia or scoring < 35 on M@T.
Participants considered to be at low risk of developing dementia (score < 12 on CogDrisk).
Diagnosed psychiatric affective and non-affective disorders including dissociative disorder, obsessive-compulsive disorder, personality disorders, schizophrenia, bipolar disorder.
Participants with suspected severe mental health complaints defined by scoring > 30 in the K-10.
Heavy alcohol consumption defined as > 2 standard drinks per day.
Current smokers.
Current or historical use (within the past 3 months) of menopausal hormone therapies.
Presence of abnormal liver or kidney function as determined by the study physician.
Presence of any major haematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal (particularly hepatic), renal or neurological disease (as determined by the study physician).
High dependence on medical care (including medications, particularly drugs with a narrow therapeutic index) due to past or current medical conditions (e.g., cancer) as deemed by the study physician.
Individuals who are not willing to commit to taking the medication as directed, complete all the required assessments, agree to having blood samples drawn and/or do not agree to maintain their current lifestyle and refrain from introducing any new exercise regimes, dietary pattern, supplements or lifestyle modifications for the duration of the trial.
Individuals who are actively participating in another clinical trial(s).
Individuals with premature ovarian failure or onset of menopause earlier than 40 years of age.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

The MENOCOG trial will investigate the feasibility, acceptability and safety of creatine monohydrate supplementation versus placebo for cognitive function and mood in postmenopausal women with subjective cognitive decline. Participants will take a powdered sachet containing 5g of creatine monohydrate powder or placebo, two times daily orally mixed in 250mL of water with food. Total daily dose is 10g. The intervention duration is 12 weeks in length, with a follow up at 16 weeks to assess residual treatment effects. Following randomisation, participants will be allocated to one of the two trial arms (active or placebo treatment). Both the active and placebo treatment arms will take a total of 10g of creatine monohydrate or placebo daily, split into two 5g doses, taken AM and PM with food. Outcome measures will be assessed at Week 0, 4, 8, 12 and 16 (follow up). These will be conducted remotely, online. The research team will contact the participant at these monthly intervals to connect with the participant, check for any adverse events and provide any necessary support needed. The intervention will be delivered remotely, care of Western Sydney University's Westmead Campus. Participants will be mailed an onboarding kit containing the intervention, along with a tape measure to record their anthropometric measurements and a welcome card with a QR code that will direct them to a resource library with videos and instructions to support their participation. All outcome measures will be assessed online via secure research platform REDCap. The PhD candidate delivering the intervention is a qualified naturopath and nutritionist with over 7 years of experience. Participants will return all remaining medication at the end of the intervention and adherence will be measured by counting all remaining doses (sachets) to check compliance with trial protocol.