None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 80 peri- or early post-menopausal women aged 40 to 65 years who believe that their cognitive function has worsened since the transition into menopause will be randomly assigned to receive either a curcumin extract (Curcugen) or a matching placebo for 12 weeks. Changes in cognitive performance, self-reported menopausal symptoms, brain fog, and general wellbeing will be assessed over time. Moreover, to examine potential mechanisms of action, changes in blood markers associated with inflammation, glucose regulation, and appetite markers will be evaluated.
Interventions
Curcumin extract (Curcugen) (1 capsule taken orally, twice daily, in the morning and evening, with food, delivering 800 mg a day for 12 weeks). Adherence to capsule intake will be measured by a count of capsules returned at week 12.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 40 to 65 years. 2. Have an intact uterus and ovaries. 3. Are peri-menopausal or early postmenopausal, defined as either: no menses in the previous 12 months; or for at least 3 months, have experienced changes in the menstrual cycle, such as changes in bleeding days, heaviness of bleeding, or days between menses. 4. Last menstrual period occurred within the previous 6 years. 5. Self-reported worsening in cognitive abilities since the menopausal transition. 6. Subjective difficulties with memory and concentration, defined as a score of 6 or lower on a 0–10 self-rated memory, attention, focus and thinking scale over the previous 3 months. 7. Non-smoker. 8. BMI between 18 and 35 kg/m². 9. No plan to commence new treatments during the study period. 10. Willing and able to comply with all study procedures. 11. Willing to provide signed informed consent.
Exclusion criteria
1. Menstrual changes are considered to be exclusively due to a medical condition and/or pharmaceutical medication use, such as the contraceptive pill or hormonal intrauterine device. 2. Recently diagnosed or unmanaged medical condition, including but not limited to diabetes, hypertension, cardiovascular disease, gastrointestinal disease, biliary disease, autoimmune disease, endocrine disease, or a chronic/acute pain condition. 3. Diagnosis of a neurological or psychiatric condition, including but not limited to Parkinson’s disease, Alzheimer’s disease, intracranial haemorrhage, head injury, or psychiatric disorder other than mild-to-moderate depression or anxiety. 4. Use of supplements containing curcumin or turmeric in the previous 8 weeks. 5. Regular use, defined as more than 3 times per week, of medications likely to affect study outcomes, including but not limited to analgesics, anti-inflammatory drugs, benzodiazepines, anticholinergics, or antipsychotics. 6. Commencement of, or change in, pharmaceutical medication likely to affect cognitive function, menopausal symptoms, mood, or sleep in the previous 8 weeks, or expected change during the study period. 7. Intake, commencement, or change in nutritional or herbal supplements likely to affect cognitive function, menopausal symptoms, mood, or sleep in the previous 4 weeks, or expected change during the study period. 8. Planned major lifestyle or dietary change during the study period. 9. Alcohol intake greater than 14 standard drinks per week. 10. Current or 12-month history of regular illicit drug use. 11. Pregnant, breastfeeding, or intending to become pregnant during the study period. 12. Significant surgery in the previous 6 months that affects general health or daily function, or planned surgery during the study period. 13. Participation in another clinical trial in the previous month.
Outcome results
None listed