None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 100 adults aged 40 to 70 years with self-reported memory complaints will be randomly assigned to receive capsules containing either a Bacopa Monnieri extract (Bacumen) (150mg twice daily) or a placebo for 12 weeks. We will assess changes in cognitive performance, mood, and fatigue using self-report questionnaires. Changes in blood markers associated with neuronal activity (brain-derived neurotrophic factor and acetylcholinesterase) and free radical damage (Malondialdehyde will be assessed over time.
Interventions
Bacopa monnieri extract (Bacumen) (1 capsule taken orally, twice daily with food, delivering 300 mg a day for 12 weeks). Adherence to capsule intake will be measured by capsule return at week 12.
At baseline and week 12, before any cognitive testing, participants will complete a computerised stress-induction task known as the Multi-tasking Framework (MTF). The MTF is a computer-based, cognitively demanding task where individuals are required to attend and respond to 4 different tasks simultaneo
Bacopa monnieri extract (Bacumen) (1 capsule taken orally, twice daily with food, delivering 300 mg a day for 12 weeks). Adherence to capsule intake will be measured by capsule return at week 12. At baseline and week 12, before any cognitive testing, participants will complete a computerised stress-induction task known as the Multi-tasking Framework (MTF). The MTF is a computer-based, cognitively demanding task where individuals are required to attend and respond to 4 different tasks simultaneously (mental arithmetic, Stroop, visual warning, and number tap)
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 70 Years
Healthy volunteers
No
Inclusion criteria
1. Healthy individuals (male and female) aged between 40 to 70 years 2. Residing in independent living accommodation 3. Subjective report of memory or attention problems by answering ‘yes’ to the following question: Do you have problems with your memory, attention, or concentration? 4. Non-smoker 5. BMI between 18 and 35 kg/m2 6. No plan to commence new treatments over the study period 7. Understand, willing and able to comply with all study procedures 8. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Exclusion criteria
1. Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer’s Association (NIA/AA) criteria 2. A score below the 5th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M) 3. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, or cancer/ malignancy 4. Diagnosis of a psychiatric disease (other than mild-to-moderate depression or anxiety) and/or neurological condition/ disease (e.g., Parkinson’s, Alzheimer’s disease) 5. History of paralysis, stroke or seizures or head injury (with loss of consciousness). 6. Regular medication intake including but not limited to anticholinergics, acetylcholinesterase inhibitors, or steroid medications. 7. Change in medication in the last 3 months or an expectation to change during the study duration 8. Taking vitamins or herbal supplements that are reasonably expected to influence study measures. 9. In the last 6 months, commenced or changed the dose of nutritional and/or herbal supplements that may impact on treatment outcome 10. Alcohol intake greater than 14 standard drinks per week 11. Current or 12-month history of illicit drug abuse 12. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant. 13. Any significant surgeries over the last year 14. Planned major lifestyle change in the next 3 months
Outcome results
None listed